Med-Chemist

Tea Plants' Secret Weapon Against Disease: The Power of Sakuranetin

2026-11-05T09:32:01.147+05:30

Tea plants use sakuranetin as a natural antifungal shield against anthracnose, offering hope for greener farming Tea, one of the world's most cherished beverages, may have a powerful natural defense system hidden within its leaves

Scientists from the Zhejiang Academy of Agricultural Sciences have uncovered a molecular mechanism that enables certain tea plants to resist anthracnose—a destructive fungal disease that causes significant losses in tea plantations worldwide.

Their research reveals that a naturally occurring compound called sakuranetin (SAK) acts as a potent antifungal shield, helping resistant tea varieties stop infections before they spread.

The findings, published in Horticulture Research, provide fresh insights into how tea plants defend themselves and could open new avenues for sustainable tea cultivation.

Understanding Tea Plant Resistance

Anthracnose, caused by the fungus Colletotrichum camelliae, is among the most damaging diseases affecting tea crops. The pathogen spreads through wind and rain, infecting leaves and reducing both yield and quality.

Current control methods rely heavily on synthetic fungicides, raising concerns about environmental impact and chemical residues in a beverage consumed globally as a direct infusion.

Although tea plants naturally produce defensive compounds such as catechins and caffeine, researchers wanted to understand how the plant activates additional defenses after a fungal attack.

To investigate, the team compared two tea cultivars with contrasting disease responses: 'Zijuan', which is naturally resistant to anthracnose, and 'Longjing43', a widely cultivated but more susceptible variety.

The Science Behind Sakuranetin

The researchers discovered that when C. camelliae attacks, the resistant cultivar 'Zijuan' rapidly produces high levels of sakuranetin, a plant defense molecule known as a phytoalexin. This compound creates a hostile environment for the fungus, significantly restricting its growth.

Laboratory tests revealed that sakuranetin displayed stronger antifungal activity against C. camelliae than epigallocatechin gallate (EGCG), one of tea's most abundant and well-known catechins.

The key to this defense lies in an enzyme called naringenin 7-O-methyltransferase (NOMT), produced by the CsNOMT gene. The enzyme converts a flavonoid precursor, naringenin, into sakuranetin, effectively equipping the plant with a powerful chemical weapon.

Researchers observed that infected 'Zijuan' leaves accumulated substantial amounts of sakuranetin, whereas the susceptible cultivar 'Longjing43' produced very little.

A Molecular Relay Activates the Defense

The study uncovered an intricate defense pathway controlled by the plant hormone jasmonic acid (JA), a key regulator of immune responses in plants.

When the fungus invades, JA signaling becomes activated. This, in turn, stimulates a transcription factor called CsMYC2.1, which binds directly to the promoter region of the CsNOMT gene and switches it on.

Once activated, CsNOMT boosts sakuranetin production, creating a rapid chemical barrier against fungal invasion.

Researchers describe this process as a molecular relay:

Pathogen attack → JA signaling → CsMYC2.1 activation → CsNOMT expression → Sakuranetin production → Antifungal defense

This cascade was considerably stronger in 'Zijuan' than in 'Longjing43', explaining why the resistant cultivar is better protected from anthracnose.

Experiments Confirm the Protective Role

To confirm the importance of this pathway, scientists altered the expression of the CsNOMT gene.

When CsNOMT was silenced, sakuranetin levels dropped and plants became more vulnerable to anthracnose infection. Conversely, increasing CsNOMT expression elevated sakuranetin production and significantly reduced disease symptoms.

These experiments demonstrated that disease resistance is not determined by the presence of a single gene alone, but by how efficiently the plant activates its entire defense network when challenged by a pathogen.

Implications for Sustainable Tea Farming

The discovery has important implications for the future of tea cultivation.

The genes CsNOMT and CsMYC2.1 could serve as molecular markers, allowing breeders to identify and develop anthracnose-resistant tea varieties more quickly through marker-assisted breeding.

In addition, sakuranetin itself may provide a blueprint for developing natural biopesticides or plant defense stimulants that reduce reliance on synthetic fungicides.

Such approaches could help tea growers improve crop resilience while addressing growing concerns over environmental sustainability and chemical residues.

Beyond Tea: A Broader View of Plant Immunity

The findings also broaden scientists' understanding of plant immunity. While phytoalexin-based defenses have been extensively studied in crops such as rice and model plants, this research demonstrates that woody perennial crops like tea also rely on inducible chemical defenses to combat disease.

By linking hormone signaling, gene regulation, metabolite production, and disease resistance into a single framework, the study offers one of the clearest pictures yet of how tea plants mount a sophisticated defense against fungal attack.

For tea lovers around the world, this hidden molecular shield may one day help ensure healthier crops, more sustainable farming practices, and a more resilient future for one of the world's most beloved beverages.

Ref : JA–CsMYC2.1–CsNOMT–sakuranetin module contributes to differential anthracnose resistance in Camellia sinensis - (https://academic.oup.com/hr/article/13/5/uhag022/8444634?login=false)

https://en.wikipedia.org/wiki/Sakuranetin

Tea Plants' Secret Weapon Against Disease: The Power of Sakuranetin

FDA Approves Baxfendy (baxdrostat) as the First Aldosterone Synthase Inhibitor Treatment for Adults with Hypertension

2026-11-04T09:30:23.293+05:30

AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

Approval based on BaxHTN Phase III results showing statistically significant and clinically meaningful reduction in systolic blood pressure in patients with uncontrolled or resistant hypertension
Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo- adjusted) from baseline in BaxHTN trial

There are 1.4 billion people worldwide living with hypertension.¹ In the US, approximately 50% of patients living with hypertension who are already taking multiple antihypertensive medications still struggle with persistently elevated blood pressure,² which is a leading risk factor for cardiovascular disease and premature death.^3,4 Hypertension is the most prevalent and significant modifiable cardiovascular risk factor worldwide, accounting for more deaths and disability than any other modifiable risk.^5-7

Baxfendy is a first-in-class, highly selective and potent ASI designed to lower blood pressure in a new way by specifically inhibiting the production of aldosterone,⁸ a hormone that raises blood pressure to unhealthy levels and increases the risk of heart and kidney problems.^9-11

The approval by the US Food and Drug Administration (FDA) was based on positive results from the BaxHTN Phase III trial,¹² with Baxfendy demonstrating statistically significant and clinically meaningful seated systolic blood pressure reduction at both 2mg and 1mg doses in patients with uncontrolled and resistant hypertension on two or more medications. Baxfendy was generally well-tolerated with no unanticipated safety findings.

Dr. Bryan Williams, Chair of Medicine at University College London, and BaxHTN primary investigator, said: “We have been waiting for an innovative medication like Baxfendy for hypertension for many years. Its novel way of lowering blood pressure has the potential to transform clinical practice by targeting a root cause of persistently uncontrolled hypertension. In addition, the nearly double-digit placebo-adjusted systolic blood pressure reduction achieved with Baxfendy is exciting and clinically meaningful for clinicians and patients. Epidemiological data indicate that a 10 mmHg decrease in systolic blood pressure is associated with a roughly 20% lower risk of serious cardiovascular events.”

John M. Clymer, Executive Director, National Forum for Heart Disease & Stroke Prevention, said: “Hypertension remains a staggeringly widespread silent killer and a leading risk factor for stroke, heart attack, kidney damage and dementia. Tens of millions of people struggle to control their blood pressure despite lifestyle changes and currently available treatments. Innovative, new treatments could help millions protect their heart, kidney and brain health.”

Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca, said: “The approval of Baxfendy offers a much‑needed, first-in-class innovation for people living with persistently uncontrolled hypertension who have not responded to or tolerated existing medicines. In the US, about 23 million patients are uncontrolled despite being on two or more medicines for hypertension, which is a disease that has seen little therapeutic progress for the past two decades.”

In the BaxHTN Phase III trial,¹³ published in the New England Journal of Medicine,¹² Baxfendy (baxdrostat) demonstrated statistically significant and clinically meaningful efficacy for the treatment of patients with hypertension on top of standard of care. At week 12, the absolute reduction from baseline in mean seated SBP was 15.7 mmHg (95% confidence interval [CI], -17.6 to -13.7) and placebo-adjusted reduction was 9.8 mmHg (95% CI, -12.6 to -7.0; p<0.001) for the 2mg dose. For the 1mg dose, the absolute reduction from baseline was 14.5 mmHg (95% CI, -16.5 to -12.5) and placebo-adjusted reduction was 8.7 mmHg (95% CI, -11.5 to -5.8; p<0.001). The reduction in mean seated SBP with placebo was 5.8 mmHg (95% CI, -7.9 to -3.8). Results were consistent across both uncontrolled and treatment-resistant subgroups.

https://en.wikipedia.org/wiki/Baxdrostat

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

2026-11-03T11:32:42.815+05:30

In continuation of my update on Adapalene

Galderma (SIX: GALD), the pure-play dermatology category leader, announced the United States (U.S.) Food and Drug Administration (FDA) approval of Differin EpiduoAcne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care.

Adapalene

unique Prescription-to-OTC switch in acne care, this approval expands access to a dermatologist-trusted, prescription-strength treatment for millions of acne sufferers ages 12 years and older
Backed by more than 15 years of real-world dermatologist use and a robust clinical research program, this milestone demonstrates the depth of science behind the Differin and Epiduo heritage
Adapalene plus benzoyl peroxide (0.1/2.5%) was the first FDA-approved, stable, fixed- dose prescription acne treatment to combine of benzoyl peroxide with a retinoid, and is now available over-the-counter
The formulation is engineered to target multiple causes of acne more effectively than either of its individual active ingredients alone

This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care.

With the approval of Differin Epiduo OTC, Galderma is bringing its proven acne science to a broader population of acne sufferers through wider access to a dermatologist-recommended, prescription-strength treatment, while further strengthening its global leadership in acne care.

Delivering continued innovation in acne prevention and care

Differin Epiduo is a topical acne treatment that combines adapalene, a third-generation retinoid originally discovered and developed by Galderma to address the stability and tolerability challenges of earlier retinoids, with benzoyl peroxide (0.1/2.5%). This adapalene molecule reflects Galderma’s long-standing leadership in retinoid science, delivering an innovation-led approach that goes beyond traditional OTC acne actives. Together, these two dermatologist-trusted ingredients address key biological drivers of acne – clearing clogged pores, killing acne-causing bacteria, and reducing acne inflammation – to help clear acne, prevent future breakouts and improve skin tone, texture, and overall appearance.^1,2

The formulation is further powered by its Simulgel™ Gel Base, which stabilizes and evenly distributes both active ingredients while maintaining benzoyl peroxide’s efficacy and improving overall tolerability. This enables a simple, one-pump, once-daily regimen – a level of ease that is critical to building consistent routines and achieving clearer skin over time.

“This approval marks an important milestone in acne care and reflects Galderma’s longstanding leadership in acne and retinoid science. Differin Epiduo pairs two complementary, evidence‑based actives: adapalene, a highly stable and well‑tolerated retinoid developed by Galderma, and benzoyl peroxide, a proven antimicrobial agent. This retinoid-benzoyl peroxide combination aligns with dermatology guidelines, which strongly recommend using both together as a first‑line, multimodal approach to acne treatment. Bringing this scientifically grounded combination to the OTC setting allows us to extend that legacy to patients across the U.S. while preserving the clinical rigor that underpins its effectiveness.” BILL ANDRIOPOULOS, PH.D., HEAD OF GLOBAL MEDICAL AFFAIRS, GALDERMA

Clinical data supporting the approval demonstrated:

Proven efficacy across multiple randomized, controlled Phase 3 studies, with adapalene/benzoyl peroxide gel consistently outperforming adapalene alone, benzoyl peroxide alone, and vehicle gel across inflammatory, non-inflammatory, and total acne lesions, as well as Investigator Global Assessment (IGA) success rates (“clear” or “almost clear”).^3-5
Clinically meaningful improvement in lesion counts seen as early as Week 1, with antimicrobial activity beginning on Day 1 and up to 70.3% reduction in inflammatory acne lesions at Week 12.³
Sustained efficacy with long‑term use, maintaining ~65% total lesion reduction in a single arm study through 12 months, which supports once‑daily, ongoing acne control.⁶
Proven efficacy across diverse patient populations, with consistent results and favorable tolerability across skin tones.

“This milestone reflects a meaningful advancement for patients, as it expands access to a clinically proven, dual-active acne solution without the need for a prescription. In my practice, the combination of easy access and a simple, once-daily application can help patients use treatment more consistently in their treatment journey for the best possible outcomes.” HEATHER WOOLERY-LLOYD, MD, BOARD-CERTIFIED DERMATOLOGIST, UNITED STATES

First approved as a prescription treatment, Epiduo^® (Adapalene 0.1% and Benzoyl Peroxide 2.5%) Gel has been trusted by dermatologists for more than 15 years, with millions of prescriptions written worldwide. Its global clinical legacy includes more than ten Galderma studies involving over 3,200 patients, along with extensive third-party studies, across a wide range of ages, skin tones and acne severity. With this Prescription-to-OTC switch, Galderma continues to play a defining role in shaping modern acne care, leveraging its own proprietary science to advance dermatology, and expanding access to effective treatments.

Differin Epiduo will be available over-the-counter at most major retailers, including Walmart, Ulta, Target and Amazon, beginning in the summer of 2026. With a commitment to providing effective solutions across consumers’ acne journey, the Differin portfolio also includes cleansers, treatments, and moisturizers to support and provide wholistic solutions. For more information on Differin Epiduo and other Differin products, please visit www.differin.com and join the Differin community on Instagram, Facebook and YouTube to stay up to date on the latest innovations.

https://en.wikipedia.org/wiki/Adapalene

FDA Approves Differin Epiduo Acne Gel (adapalene/benzoyl peroxide) for Nonprescription Use in the Treatment of Acne

FDA Grants Accelerated Approval to Hepcludex for HDV

2026-11-02T10:53:07.996+05:30

Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) granting accelerated approval for Hepcludex (bulevirtide-gmod) 8.5 mg for the treatment of adults living with chronic hepatitis delta virus (HDV) infection, making it the first and only approved treatment for HDV in the United States.

Chronic HDV is considered the most severe form of viral hepatitis due to rapid disease progression towards liver failure and liver-related death
Approval introduces the first FDA-approved therapy for this disease with limited treatment options and high unmet need

The FDA granted accelerated approval to Hepcludex based on reductions in HDV RNA and normalization of alanine aminotransferase (ALT), supported primarily by data from the pivotal, controlled Phase 3 MYR301 study. At Week 48, the study demonstrated a statistically significant improvement versus the control (delayed treatment) group in a combined virologic and biochemical response. Improvement in disease-related clinical outcomes has not been established. Continued approval for the approved indication may be contingent on verification and description of clinical benefit in a confirmatory trial.

Chronic HDV is considered the most severe form of viral hepatitis and is associated with a markedly higher risk of rapid disease progression, liver failure, and mortality compared with HBV alone. In the United States, studies in general populations have estimated that HDV affects between 2% and 4% of individuals who have chronic hepatitis B virus (HBV), representing ~40,000-80,000 people.

“Hepatitis delta virus is associated with rapid progression of liver disease and a high risk of serious or even life-threatening liver-related complications,” said Dr. Ira Jacobson, MD, Department of Medicine at NYU Grossman School of Medicine. “For patients, an HDV diagnosis means managing two distinct viral liver diseases—hepatitis B and hepatitis D—each contributing to disease progression, monitoring demands, and treatment complexities. The approval of Hepcludex for chronic HDV represents a critical advancement, introducing a long-awaited option that begins to address a significant unmet medical need and has the potential to meaningfully alter the course of this devastating disease for people living with HDV in the United States.”

MYR301 (NCT03852719) evaluated the efficacy and safety of Hepcludex in adults with chronic HDV, with treatment administered for up to 144 weeks followed by 96 weeks of off-treatment follow-up. Hepcludex met its primary endpoint at Week 48, with continued treatment, demonstrated sustained efficacy and was generally well tolerated through up to 144 weeks of on-treatment exposure.

“The approval of Hepcludex represents a historic milestone for people living with HDV in the United States, marking the first FDA-approved treatment for HDV,” said Dietmar Berger, MD, PhD, Chief Medical Officer at Gilead Sciences. “This reflects years of close engagement with the FDA and the application of rigorous science to address a serious disease with long-standing unmet need. With Hepcludex, we now have the opportunity to deliver a meaningful clinical advancement that has the potential to change the trajectory of HDV for patients in the U.S.”

U.S. Access and Hepcludex Approval Across Markets

The Gilead Support Path^® Program offers information and resources to help patients diagnosed with chronic HBV, HDV and hepatitis C virus (HCV) and primary biliary cholangitis (PBC), as well as healthcare professionals, understand coverage and financial options for prescribed Gilead treatments.

Bulevirtide 2 mg is also approved for use in the European Economic Area (EEA) and other countries globally to treat people living with chronic HDV.

Please see below for U.S. Indication and Important Safety Information for Hepcludex.

U.S. Indication for Hepcludex

Hepcludex (bulevirtide-gmod) 8.5 mg for injection is indicated for the treatment of chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis.

This indication is approved under accelerated approval based on a decrease in HDV RNA and alanine aminotransferase (ALT) normalization. An improvement in disease-related clinical outcomes has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

https://en.wikipedia.org/wiki/Bulevirtide

FDA Grants Accelerated Approval to Hepcludex (bulevirtide-gmod) Treatment for Chronic Hepatitis Delta Virus (HDV)

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

2026-10-31T08:29:43.587+05:30

In continuation of my update on cefepime

cefepime

Zidebactam

FDA approved Zaynich (cefepime and zidebactam), a novel intravenous antibiotic for the treatment of adults with complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible Gram-negative pathogens. Zaynich previously received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA.

Zaynich is a multi- penicillin-binding protein targeting combination of the 4 th generation cephalosporin cefepime and zidebactam working synergistically against the most challenging multidrug-resistant Gram-negative bacteria
In the Phase 3 ENHANCE-1 clinical trial, Zaynich demonstrated higher combined clinical cure and microbiologic response (composite endpoint) at the test of cure (TOC) visit versus meropenem, 89.0% vs 68.4% respectively and was generally well tolerated
More than 2.8 million antimicrobial-resistant infections occur each year in the U.S., resulting in more than 35,000 deaths¹

“The threat of drug-resistant infections is an escalating crisis, leaving clinicians with fewer tools to treat patients facing these aggressive pathogens. The FDA approval of Zaynich is a monumental step forward in validating a new option for these underserved populations,” said Dennis Deruelle, MD, FHM, Chief Medical Officer at Wockhardt. “This milestone underscores our commitment to addressing critical unmet needs and offers a profound sense of hope to the families we are working to serve.”

“This approval is a significant realization of our mission to provide patients with novel antibiotics that help to address one of the most urgent global health threats—antimicrobial resistance,”² said Dr. Habil F. Khorakiwala, Founder and Chairman of Wockhardt Group. “Furthermore, Zaynich is the first New Chemical Entity fully developed and commercialized by an Indian pharmaceutical company to receive an FDA approval, representing a historic milestone not only for Wockhardt, but for the Indian pharmaceutical industry.”

Zaynich, unlike most other beta-lactam combinations, targets multiple penicillin binding proteins (PBP 1a/b, 2 and 3) simultaneously. This unique, multi-target synergy provides bactericidal activity against the most challenging drug-resistant Gram-negative bacteria for which there are currently very limited treatment options.

“Multidrug-resistant bacterial infections are a substantial burden for patients and the healthcare system, as patients with these infections typically require longer, more intensive care, and are at increased risk of lifethreatening complications,” explained Keith Kaye, MD, MPH, Professor of Medicine and Division Chief for Infectious Diseases at Rutgers Robert Wood Johnson Medical School. “There is an ongoing need for new antibiotics to combat these drug-resistant pathogens, and we are pleased that this approval means patients will soon have an exciting unique option that is urgently needed in the US and worldwide.”

cUTI is responsible for over 600,000 hospitalizations in the U.S. annually. A growing number of cUTIs are caused by antimicrobial resistant bacteria, including multidrug-resistant bacteria, a leading cause of bacteremia and associated with significant morbidity and mortality and a burden on the health care system.³

The FDA approval was based, in part, on the results from ENHANCE-1, a Phase 3, randomized, double-blind, multicenter study which evaluated the efficacy, safety and tolerability of Zaynich compared with meropenem in the treatment of hospitalized adults with cUTI or acute pyelonephritis (AP). Zaynich demonstrated efficacy at the primary endpoint, achieving a composite clinical cure and microbiological response rate of 89.0% versus 68.4% for meropenem Treatment difference 20.6% (95% CI; 12.3, 29.5). Zaynich was generally well tolerated in the phase 3 study. The study enrolled 530 patients from the U.S., Europe, LATAM, China and India, and spanned across 64 sites.

Zaynich® was approved by the Drugs Controller General of India (DCGI) on May 27, 2026. Wockhardt has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency.

FDA Approves Zaynich (cefepime and zidebactam) for the Treatment of Complicated Urinary Tract Infections

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

2026-10-30T10:23:56.769+05:30

In continuation of my update on ensitrelvir

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, PhD; hereinafter “Shionogi”) announced that the U.S. Food and Drug Administration (FDA) has approved Xocova (ensitrelvir), an oral antiviral, for post-exposure prophylaxis (PEP) of COVID‑19 in adults and adolescents 12 years of age and older following contact with an individual who has COVID-19.³ This approval introduces the first and only oral option to help prevent COVID-19 after exposure in the current therapeutic landscape, addressing a critical gap in prevention. Xocova is a five-day oral regimen with three tablets taken on day one and one tablet taken on days two through five.³The approval occurred ahead of the Prescription Drug User Fee Act (PDUFA) action date of June 16, 2026.

Approval is based on SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 following exposure to an infected individual*
Xocova offers a new approach to help prevent COVID-19 by blocking viral replication during the critical window between exposure and COVID-19 symptom onset^1,2

“The FDA approval of Xocova provides an important new approach to preventing COVID-19, which continues to impact lives. COVID-19 can become severe and even when mild or moderate, it can worsen or exacerbate chronic conditions or trigger new ones, including long COVID,” said Frederick Hayden, MD, Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine, University of Virginia School of Medicine. “Ensitrelvir inhibits viral replication, helping protect people who have been exposed to COVID-19 from developing illness. The PEP strategy has the potential to benefit anyone who does not want to get COVID-19. It could be useful not only in household settings but also in other exposure circumstances, such as outbreaks in nursing homes, chronic or acute care facilities and following travel-related exposures.”

The approval is based on positive results from SCORPIO-PEP, the only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing symptomatic COVID-19 following exposure to an infected individual.* Xocova significantly reduced the risk of symptomatic COVID-19 by 67% in uninfected individuals following exposure to an infected individual through Day 10 compared with placebo (ensitrelvir n=1,030; placebo n=1,011).^3,4 Overall, Xocova was generally well tolerated, with similar rates of adverse events across groups (15.1% in the Xocova group (n=1,190) and 15.5% in the placebo group (n=1,187)).⁴The most common adverse events (regardless of causality) occurring in greater than or equal to 1% of the Xocova group and at a greater frequency compared to placebo were headache, diarrhea, and cough.³ There were no reports of altered taste (dysgeusia) attributed to Xocova in the trial.^4,5 Results from the SCORPIO-PEP trial were published in the New England Journal of Medicine on May 14, 2026.

“The FDA approval of Xocova is an exciting new chapter in the Shionogi antiviral story, which includes innovative medicines that have changed the way we manage other viruses including HIV and influenza,” said Nathan McCutcheon, President and CEO, Shionogi Inc. “Xocova is the first and only oral option clinically proven to help prevent symptomatic COVID-19 after exposure among study participants regardless of vaccination status or baseline immunity from prior infection. With Xocova, people who are exposed to COVID-19 can act early to help protect themselves.”

The impact of this matter on the consolidated financial results for the fiscal year ending March 2027 has already been reflected in the earnings forecast announced on May 12, 2026.

The Ongoing Impact of COVID-19

COVID-19 remains highly transmissible, driven by Omicron and its subvariants, and up to 47% of people living with an infected individual may develop COVID-19.⁶ The U.S. Centers for Disease and Control estimates that between October 1, 2025 and May 23, 2026 there were 3.8-12.4 million new cases in the U.S., resulting in 800,000 – 2.3 million outpatient visits, 120,000 – 240,000 hospitalizations and 13,000 - 42,000 deaths.⁷

Beyond acute infection, COVID-19 can have lasting impacts. People diagnosed with COVID-19 had increased rates of both new and worsening neurologic, cardiovascular, respiratory, and renal conditions during the year following infection.^8-17COVID-19 also disproportionately affects older adults with greater risk for severe illness and death in close-community settings, such as long-term care facilities.¹⁸

About SCORPIO-PEP

The global, double-blind, randomized, placebo-controlled Phase 3 study, SCORPIO-PEP, assessed the safety and efficacy of Xocova as post-exposure prophylaxis for COVID-19. The study included 2,387 study participants aged 12 years and older with a negative local screening test for SARS-CoV-2 infection and no symptoms at the time of enrollment, who were exposed to a person living in their household with symptomatic COVID-19. The primary analysis included 2,041 household contact participants with a central laboratory-confirmed negative SARS-CoV-2 test at baseline.

The trial was conducted from June 2023–September 2024. More than 99% of household contacts tested positive for antibodies against SARS-CoV-2 N (nucleocapsid) or S (spike) proteins, indicating that nearly all had evidence of previous SARS-CoV-2 infection or vaccination, or both.

Study participants were randomly assigned at a 1:1 ratio to receive Xocova (375 mg on day 1 and 125 mg on days 2-5) or placebo, once daily, and began treatment within 72 hours of when the household member with COVID-19 began showing symptoms. Participants then continued Xocova (125 mg) or placebo for five days. SCORPIO-PEP is the first and only Phase 3 study of an oral antiviral to meet the primary endpoint of preventing COVID-19 following exposure to an infected individual.

https://en.wikipedia.org/wiki/Ensitrelvir

FDA Approves Xocova (ensitrelvir), the First and Only Oral Option to Help Prevent COVID-19 Following Exposure

Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

2026-10-29T11:20:57.863+05:30

In continuation of my update on psychedelic

Monash University researchers have launched Australia's first clinical trial to test whether the psychedelic drug psilocybin is an effective treatment for persistent post-concussion symptoms.

There are few effective therapies for the debilitating long-term effects of mild traumatic brain injury, more commonly known as concussion.

But researchers now think psilocybin, a psychedelic compound found in some mushrooms, could be the answer.

A recent preclinical study from Monash University indicates that a single macrodose can reduce the symptoms that often appear after brain injury. The research is published in the journal Cell Reports Medicine.

The project will leverage leading-edge capability and a track record in neuroimaging and biomarkers of psychedelics within the Monash Trauma Group, and clinical implementation and assessment within the Clinical Psychedelic Lab.

Why researchers are hopeful

Lead researcher on the trial, Professor Terence O'Brien, head of Monash University's School of Translational Medicine, program director Alfred Brain, and deputy director of research at Bayside Health Alfred, said the clinical trial is a huge step forward and will provide hope for many patients.

"Given the lack of effective treatment options for persistent and debilitating concussion symptoms, we are excited to be studying a promising new approach," O'Brien said.

"In addition to alleviating symptoms, research suggests it can also target the biological effects concussion has on the brain."

Up to 50% of people who sustain a concussion will experience persistent post-concussion symptoms.

These commonly include cognitive and emotional issues, plus other debilitating symptoms such as headache, dizziness, irritability and sleep disturbances.

How the trial will work

The Monash-led trial will take place in Melbourne over three years, beginning in 2026.

It is Australia's first randomized, double-blind, active placebo-controlled clinical trial investigating the efficacy of psilocybin-assisted therapy for persistent post-concussion symptoms in humans.

It will study the effect of the drug on people who have had persistent post-concussion symptoms for at least six months, regardless of the cause of the original concussion.

Professor Sandy Shultz, from the Monash Trauma Group in the School of Translational Medicine, said researchers expect psilocybin will reduce neuroinflammation and enhance the brain's ability to form new neural connections.

"We will also be looking at blood and neuroimaging biomarkers in the brain so we can understand exactly what the drug is doing in the body and how it is helping reduce symptoms," Shultz said.

"These benefits could last for at least six months post-treatment, which would be a game changer, and we will test this in the trial."

Support and broader collaboration

Dr. Josh Allen, a research fellow in the Clinical Psychedelic Lab at Monash's School of Clinical Sciences, said while many think this kind of trial isn't for them, it's worth reaching out if you suffer from persistent post-concussion symptoms.

"Participants are supported every step of the way," he said.

"This includes preparation sessions before, guided care during the psychedelic experience, and integration therapy afterward.

"Our approach will promote safety and maximize benefits for all trial participants."

Dr. Paul Liknaitzky, head of the Clinical Psychedelic Lab, said the research will address a major unmet need for people with persistent post-concussion symptoms.

"We're testing a combined treatment approach that targets both the neurological and psychological drivers of patients' symptoms and functionality," Liknaitzky said.

The project is a collaboration between the university's Department of Neuroscience and Department of Psychiatry. Also part of the research team are Dr. Georgia Symons, Dr. Jennifer Makovec Knight, Dr. Zhibin Chen and Dr. Andrew Gibbons, all from Monash University, as well as Professor Karen Caeyenberghs from Deakin University, Professor Joshua Byrnes from the University of Queensland, Professor Karen Barlow from the University of Queensland, and Naomi Fuller from Connectivity Traumatic Brain Injury Australia.

Ref: https://en.wikipedia.org/wiki/Psilocybin

Psilocybin to target persistent concussion symptoms in Australia's first clinical trial

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial

2026-10-28T09:27:12.546+05:30

In coninuation of my update on Baricitinib

Baricitinib had a significant glucocorticoid (GC)-sparing effect in people with newly diagnosed polymyalgia rheumatica (PMR), who participated in the phase 3 JAK-Spare trial, was according to results reported at the European Alliance of Associations for Rheumatology (EULAR) 2026 Annual Meeting.

GC-free remission at week 16 was achieved in nearly two thirds (65.2%) of the 23 people who had received the drug in the trial, as compared to 17.4% of the 23 people who had been treated with placebo (P < .01).

And when participants who had initially been treated with placebo crossed over to treatment with baricitinib, their GC-free remission rate at week 28 increased to 65.2%. The GC-free remission rate in the baricitinib arm also increased to 78.3%.

Study investigator Helga Lechner-Radner, MD, of the Medical University of Vienna in Vienna, Austria, reported the trial’s findings during the late-breaking abstract session. She told Medscape Medical News that the findings were “important because we do still have a lot of patients on steroids, because whenever we try to reduce or taper steroids, they relapse again.”

Baricitinib is a drug that is “efficacious and safe in many of our [rheumatic and musculoskeletal] diseases. We know the mechanism, we know the safety profile, and therefore, it also makes sense to also test this drug in this patient population,” Lechner-Radner added.

The JAK-Spare Study

The JAK-Spare study involved 46 people with recently diagnosed PMR who were recruited between July 2022 and May 2024 across five European centers. The mean age of the recruited participants was 65 years, just over half were men, and all were White.

Crucially, a very early diagnosis (within 3 weeks) was needed for inclusion so that participants had not been taking GCs for very long, Lechner-Radner said. The average disease duration before enrollment was just 16 days, and the average daily oral GC dose was 18 mg.

Participants were randomly allocated to receive baricitinib 4 mg/d or to a placebo. A rapid GC-tapering regimen was used in both arms, which aimed to reduce the dose of GCs to zero within 11 weeks rather than the usual 52 weeks. After the initial 16-week study period, patients in the placebo group crossed over to treatment with baricitinib, while those in the baricitinib arm continued treatment. Then at 28 weeks, participants in GC-free remission were randomly assigned again either to continue baricitinib 4 mg/d through week 44 or lower their dose of baricitinib to 2 mg/d, stopping it altogether from 36 to 44 weeks.

Lechner-Radner said in an interview that GCs were given from the outset in the trial in both treatment arms because the investigators felt that it would not have been ethical to give patients newly diagnosed with PMR no treatment at all.

This is in contrast to the BACHELOR trial in which baricitinib was compared against no treatment initially in the placebo arm, with intravenous (IV) and oral GCs used only as a rescue treatment from week 4 onward. However, IV GCs are not licensed for this purpose in Austria, she said, and “they have a high dropout rate because many of those patients needed to be rescued.”

Lechner-Radner also said that, as an oral tablet, baricitinib is “an easy medication [to take]” when compared to those that require injection.

Reductions in GC Use

Assessment at week 28 showed continued improvement in the baricitinib arm, with 78.3% of participants in GC-free remission, but 65.2% of those originally in the placebo group were also now in GC-free remission, up from 17.4% at 16 weeks.

The time to relapse was significantly longer with baricitinib than placebo (P = .008). Participants in the baricitinib arm also took a lower median cumulative GC dose than those in the placebo group, at 736 mg vs 1065 mg at 16 weeks (P = .015) and 736 mg vs 1086 mg at 28 weeks (P = .013).

After re-randomization of the 33 patients who were in GC-free remission at 28 weeks, GC-free remission continued out to 44 weeks in 93.3% of those still taking baricitinib 4 mg/d and in 72.2% of those who tapered to 2 mg/d and then 0 mg/d (P = .186). Flare-free survival was higher among people who continued to take baricitinib 4 mg/d but was not statistically significant from those who tapered and then stopped baricitinib.

In each phase of the study, the percentages of participants with at least one adverse event were similar between the groups, at 87% in both in the first phase, 60.9% with baricitinib 4 mg/d vs 43.5% in the placebo crossover in the second phase, and 80% with baricitinib 4 mg/d vs 66.7% in those who tapered baricitinib in the third phase.

New Steroid-Sparing Option in PMR?

“With PMR, one wants to get patients off steroids as quickly as possible. Steroid therapy is quite toxic, and this is minimized by short duration of use and at a low dose,” Jonathan Kay, MD, professor of medicine and population and quantitative health sciences and the Timothy S. and Elaine L. Peterson Chair in Rheumatology at the UMass Chan Medical School in Worcester, Massachusetts, told Medscape Medical News. He was not involved in the trial.

But “if you can get someone on a medication that has less likelihood of causing toxicity than the steroid, the better that is going to be for the patient,” he added.

While these were positive data for a JAK inhibitor, Kay wondered whether such a drug would be likely to gain approval for use in this indication from regulatory authorities.

“In the United States, JAK inhibitors are restricted to patients who failed TNF [tumor necrosis factor] inhibitors,” he explained. “So will the FDA allow the label change to allow JAK inhibitors to be used in PMR before TNF inhibition?”

Kay pointed out that the interleukin 6 inhibitor sarilumab, which is given by subcutaneous injection every 2 weeks, is already approved to treat PMR.

https://en.wikipedia.org/wiki/Baricitinib

Baricitinib Exhibits Steroid-Sparing Effect in PMR Trial

Psilocybin linked to reduction in depression

2026-10-27T11:04:12.860+05:30

In continuation of my update on Psilocybin

A study of 19 patients with treatment-resistant depression treated with psilocybin in Switzerland found psilocybin was associated with a significant reduction in depression symptoms. The study is published in The Lancet Regional Health—Europe.

Psilocybin—a naturally occurring psychedelic compound found in some species of mushrooms—has demonstrated promising antidepressant effects in depression and treatment-resistant depression in controlled clinical trials. However, its effectiveness and safety in real-world treatment settings remain largely unknown.

This study analyzed the medical records of 19 patients who received one to four clinical dosing sessions of psilocybin at the Psychiatric University Hospital Zurich as treatment for treatment-resistant mild to severe depression.

On average, the clinician-reported depression rating scores decreased from approximately 31/60 before psilocybin treatment to 20/60 within 42 days after the final dosing session. The patient-reported depression scores decreased from an average of 32/63 to 23/63. Side effects were reported in 30/40 psilocybin dosing sessions, with the most common being fatigue, headache, and tearfulness, but no serious or sustained side effects were documented.

The authors say their findings suggest that results from clinical trials may translate into routine clinical practice, although outcomes appear smaller in scale. They highlight that the small sample size of this study limits generalizability and, as there was no longer-term follow-up, it is not known if the improvements in depression symptoms were maintained. They call for larger real-world studies.

https://en.wikipedia.org/wiki/Psilocybin

Psilocybin linked to reduction in depression

Drug duo synergy may help cystic fibrosis patients clear lung mucus, animal tests suggest

2026-10-24T13:05:22.296+05:30

Two existing types of drugs synergize to improve the clearing of mucus from the lungs of animals with cystic fibrosis, a Stanford Medicine research team has found. The findings are published in the June 2026 issue of the Journal of Clinical Investigation. If replicated in humans, the discovery may provide a way to reduce chronic lung infections in people with cystic fibrosis.

Methacholine

Formoterol

"I really hope this discovery can help CF patients," said lead author Nam Soo Joo, Ph.D., a senior research scientist at Stanford Medicine. "If these drugs improve mucociliary clearance in people as much as they do in our animal models, we expect this to help remove pathogens from the lungs and reduce patients' airway infections."

The study's senior author is Carlos Milla, MD, a professor of pediatrics at Stanford Medicine and a pulmonologist who treats children with CF at Stanford Medicine Children's Health.

The research team showed that the drug combination—a beta adrenergic agonist, formoterol, and a low-dose cholinergic agonist, methacholine—was safe and well-tolerated in a small group of people, including individuals with CF and healthy volunteers. The drugs are already approved by the U.S. Food and Drug Administration for other uses, and the scientists are now planning a trial of the combination's effectiveness in CF patients.

The finding could be especially beneficial for the 10% to 20% of CF patients who do not respond to targeted medications for cystic fibrosis known as CFTR (cystic fibrosis transmembrane conductance regulator) modulators, Joo noted.

The synergistic medications may also help people with other respiratory conditions, such as chronic obstructive pulmonary disease or bronchiectasis, a chronic lung disease characterized by severe airway scarring, he added.

Cystic fibrosis is a relatively common genetic disease, affecting 1 in every 3,000 to 4,000 babies born in the United States. Patients have mutations in the cystic fibrosis transmembrane conductance regulator gene. In healthy people, the CFTR gene encodes protein channels that let chloride and bicarbonate ions cross cell membranes. But in CF patients, the channels malfunction, causing the lungs and digestive system to produce thick mucus. This sticky mucus harbors bacteria and makes CF patients vulnerable to chronic lung infections.

Drugs called CFTR modulators that restore the chloride channels' function have improved the lives of many CF patients by allowing their bodies to manufacture normal mucus. But up to 20% of patients' gene mutations are incompatible with CFTR modulator drugs, meaning the medications don't help.

That's why Joo's team was excited to find a different approach to the mucus problem.

A fortuitous finding

The researchers' discovery was an accident. They were studying whether various drugs could speed mucociliary clearance, in which the cilia, hairlike projections that line the passages into the lungs, beat in a coordinated way to move mucus and bits of foreign matter, such as bacteria or dust, out of the airways. The process keeps the lungs healthy.

During drug tests on tissue in a dish, the researchers used a combination of a beta adrenergic agonist and a cholinergic agonist to check that the tissues were viable. (Each of the two medication categories includes several drugs; at first, the researchers were not using drugs approved for use in people.) To the scientists' surprise, the drug combination—intended only as an experimental control—sped up mucociliary clearance.

Joo discussed this unexpected observation with study co-author Jeffrey Wine, Ph.D., an emeritus professor of psychology and of human biology.

"Jeff said, 'Do you think this may work in CF?'" Joo recalled. "I said, 'Well, probably not.'"

The combination seemed unpromising because people with CF are already known to have an abnormal response to beta adrenergic agonists. Meanwhile, cholinergic agonists administered alone cause people's airways to constrict in an asthma-like manner, which presents a safety concern.

A counterintuitive result

Even though they suspected the drug combination would fail, Joo's team tested it, first in airway tissue samples from a ferret model of CF, then in tissue and live animals including ferrets, rats, sheep, and pigs with pharmacologically induced or genetic CF.

In the new study, the researchers used formoterol and methacholine, which are a beta adrenergic agonist and a cholinergic agonist, respectively. The scientists chose these specific drugs because they are already approved by the FDA for use as inhaled medications.

Each drug caused a small increase in mucociliary clearance when given alone, but together their effects were far more pronounced. For instance, in rats with CF, the drug combination increased the animals' mucociliary clearance velocity to about 80% of that seen in healthy rats.

Follow-up experiments on tracheal tissue showed that the drugs given together increase fluid secretion, inhibit absorption of fluid, and raise the pH of the secreted fluid. These changes make the mucus less viscous and more mobile.

Furthermore, the researchers showed that when the drug combination was given to ferrets with CF that were also receiving a CFTR modulator drug, the animals could clear mucus more easily than when they received only the CFTR modulator, suggesting that the drug combination may benefit all CF patients.

In a small safety test in humans, as expected, methacholine caused airway constriction when given alone. But the two drugs in combination did not.

The results are exciting both for their implications for cystic fibrosis and for patients with other lung conditions, Joo said.

"Patients with other respiratory disorders like chronic obstructive pulmonary disease or bronchiectasis also have mucociliary clearance impairment, but compared with CF, it's mild," he said. "If we use this drug in other airway diseases, it may improve those patients as well, but we still require large-scale clinical trials to know the optimal combination and concentrations of these drugs."

https://en.wikipedia.org/wiki/Methacholine

https://en.wikipedia.org/wiki/Formoterol

Drug duo synergy may help cystic fibrosis patients clear lung mucus, animal tests suggest

Acetaminophen reaffirmed as first-line medication for treating pain and fever during pregnancy

2026-10-22T09:31:48.873+05:30

In continuation of my update on acetaminophen

Acetaminophen remains the recommended first-line medication to treat pain and fever during pregnancy, according to an updated statement from the Society for Maternal-Fetal Medicine (SMFM). A comprehensive review of the available scientific evidence does not establish a causal relationship between acetaminophen taken during pregnancy and an increased risk of autism spectrum disorders and attention deficit and hyperactivity disorder (ADHD) in children, according to SMFM. The work is published in the journal Pregnancy.

SMFM's statement is based on a thorough review of recent studies and earlier research on acetaminophen during pregnancy. The newest studies vary in their findings on the potential association between prenatal acetaminophen exposure and risk of childhood neurobehavioral issues and have significant limitations in their study design.

"After another careful review of the existing research, we continue recommending acetaminophen as a safe treatment for our pregnant patients who need it for pain relief and to reduce fever," said Judette M. Louis, MD, MPH, chair of the SMFM Publications Committee.

Acetaminophen is a commonly used non-opioid analgesic during pregnancy. An estimated 65% of pregnant women use acetaminophen at some point during pregnancy, mostly to treat headache and fever. Acetaminophen is the active ingredient in many over-the-counter and prescription medications, including Tylenol.

"Both untreated fever and pain during pregnancy carry potential health risks, so you shouldn't just 'tough it out,'" said Louis. "Untreated fever, particularly in the first trimester, is known to be linked to birth defects and miscarriage. We also know that maternal fever during labor can be associated with poor neonatal outcomes."

Along with acetaminophen, SMFM recommends nonpharmacological interventions, including hydration and physical therapy, to help manage pain during pregnancy.

Nonsteroidal anti-inflammatory drugs (NSAIDs) and opioids are not recommended to treat fever and pain during pregnancy. NSAIDs increase the risk of fetal renal impairment, premature closure of the ductus arteriosus, oligohydramnios, and maternal bleeding. Opioid medications taken during pregnancy are associated with neonatal abstinence syndrome, addiction, and sedation, and are also not recommended as first-line treatments for pain during pregnancy.

https://en.wikipedia.org/wiki/Paracetamol

Acetaminophen reaffirmed as first-line medication for treating pain and fever during pregnancy

With trial success, Gilead paves way for broader use of Livdelzi

2026-10-19T09:47:00.465+05:30

A phase 3 study of Gilead’s Livdelzi has met its primary endpoint, showing the drug's ability to normalize a key marker of disease progression for those with the rare liver disorder primary biliary cholangitis (PBC).

In the IDEAL trial, which compared Livdelzi to placebo, Gilead’s pill allowed significantly more patients to gain control of their alkaline phosphatase (ALP) levels, which are a key signal of disease progression. The trial's primary endpoint hinged on the number of patients who achieved ALP levels in the normal range with at least a 15% decrease from baseline, the company said Tuesday.

The trial included 96 participants ages 18 to 75 who had inadequately controlled PBC. Patients in this group are associated with increased risk of progression to liver transplant or death compared with patients at normalized ALP levels, Gilead explained.

The patient pool in the trial included only those with an incomplete response or intolerance to ursodeoxycholic acid (UDCA), the standard first-line treatment for PBC. UDCA treatments replace bile acids, slowing disease progression and improving liver function.

“These results extend the evidence base for Livdelzi to a broader population of people living with PBC and support ALP normalization as an achievable therapeutic goal in patients with ALP between 1 to 1.67,” Cynthia Levy, M.D., of the University of Miami Miller School of Medicine, said in a release.

Gilead said it will provide full results from the trial at a future medical meeting and engage with global regulators on the data.

https://en.wikipedia.org/wiki/Seladelpar

With trial success, Gilead paves way for broader use of Livdelzi

Chia seeds show promise in supporting heart health, metabolic function

2026-10-15T10:27:44.406+05:30

Chia seeds: A superfood for cardiometabolic health

Chia seeds, long a dietary staple in Mesoamerican cultures dating back to the Aztecs and Mayans, have attracted modern scientific scrutiny for their unusually dense nutritional profile. A 28-gram (g) serving—approximately two tablespoons—contains 138 calories, 8.7 g of fat, 11.9 g of carbohydrates, 9.7 g of fiber and 4.7 g of complete protein, according to data from the U.S. Department of Agriculture. Chia seeds also provide significant amounts of calcium, magnesium, iron and potassium.

Heart benefits

The most compelling evidence for chia seeds' cardiovascular benefits comes from studies examining their effect on blood pressure. In a study published in the journal Plant Foods for Human Nutrition, participants who consumed 35 grams of chia flour daily for 12 weeks experienced reduced blood pressure, even among those already taking antihypertensive medication. Researchers noted this effect occurred alongside reductions in inflammatory markers, including C-reactive protein, and improvements in clotting protein profiles.

Additional research has focused on chia seeds' potential to improve cholesterol levels. A meta-analysis of 10 clinical trials reported that regular consumption of chia seeds can reduce total cholesterol, triglycerides and LDL cholesterol while increasing HDL, suggesting a positive effect on lipid profile.

The seeds' high omega-3 fatty acid content appears central to these effects. Chia seeds contain alpha-linolenic acid, a plant-based omega-3 that the human body cannot produce independently. This fatty acid supports heart health, brain function and systemic anti-inflammatory activity. Chia seeds also contain multiple antioxidant compounds, including chlorogenic acid, caffeic acid, myricetin, quercetin and kaempferol, which may protect against oxidative damage linked to heart disease, cancer and aging.

Blood sugar control

For those managing Type 2 diabetes, chia seeds may offer particular value. Studies suggest that daily consumption of chia seeds—either 7-24 g incorporated into white bread or 34 g of whole-grain chia—reduces post-meal blood sugar levels as well as blood pressure in healthy individuals and diabetics alike. As explained by BrightU.AI's Enoch engine, chia seeds help lower blood sugar because their soluble fiber slows the absorption of sugar into the bloodstream, which prevents sharp spikes in glucose levels. This stabilizing effect is especially beneficial for managing diabetes and maintaining steady energy.

Animal studies report similar effects on diabetic rat models fed with chia seeds, suggesting that the seeds not only help with blood sugar control but may also help reduce cardiovascular risk factors in people with Type 2 diabetes.

How to safely incorporate chia seeds into your diet

Despite these promising findings, medical professionals emphasize that chia seeds are not without potential risks. Chia seeds' high oxalate content may increase kidney stone risk in susceptible individuals. Additionally, because chia seeds can lower both blood pressure and blood sugar, they may interact additively with prescription medications for hypertension and diabetes, potentially causing excessive reductions.

Gastrointestinal side effects remain the most common complaint. Chia seeds' high fiber content—nearly 10 grams per serving—can cause bloating, cramping and gas when introduced too quickly to the diet. Experts recommend gradually increasing fiber intake to allow the digestive system to adjust, and always consuming chia seeds with adequate water to prevent bowel obstruction.

The growing body of evidence supporting chia seeds' health benefits coincides with increasing consumer interest in functional foods. Chia seeds can be incorporated into diets through multiple methods: sprinkled on yogurt, salads or cereal; blended into smoothies; used as a thickener for soups and sauces; or soaked in water to form a gel that can substitute for eggs in baking. Ground chia seeds can be added to pancake batter or mixed into hummus and other dips.

Chia seeds represent one of several plant-based foods being studied for their potential to support cardiovascular health through accessible, affordable dietary changes rather than pharmaceutical interventions alone. The seeds join other functional foods, such as oats, flaxseed and fatty fish, in a growing list of whole foods associated with reduced cardiovascular and metabolic risks.

https://en.wikipedia.org/wiki/Chia_seed

Chia seeds show promise in supporting heart health, metabolic function – NaturalNews.com

China approves fruquintinib combination for kidney cancer

2026-10-14T09:23:11.997+05:30

China’s National Medical Products Administration (NMPA) has approved a combination of ELUNATE (fruquintinib) and TYVYT (sintilimab) for patients with advanced renal cell carcinoma whose disease has progressed following prior VEGFR-tyrosine kinase inhibitor (VEGFR-TKI) therapy.

The approval applies to patients with locally advanced or metastatic disease who have not previously received programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor therapy in the first-line setting.

The decision was based on results from the phase 3 FRUSICA-2 study, which evaluated fruquintinib combined with sintilimab against axitinib or everolimus monotherapy in second-line treatment.

The study met its primary endpoint of progression-free survival (PFS), with patients receiving the combination therapy achieving median PFS of 22.2 months compared with 6.9 months in the comparator arm.

Objective response rates were also higher in the combination group, while the safety profile was reported to be consistent with the known effects of each treatment.

Professor Dingwei Ye of Fudan University Shanghai Cancer Center said advances in targeted therapies and immunotherapy combinations were continuing to reshape treatment approaches in advanced renal cell carcinoma.

“The rapid advancements in targeted therapies, immunotherapies and their combination regimens have led to a significant evolution in the treatment landscape for advanced renal cell carcinoma. Optimising the selection of treatment for individual patients is a key focus of clinical interest,” said the professor.

Kidney cancer remains a significant global health burden, with around 435,000 new diagnoses estimated worldwide in 2022. Approximately 90% of kidney tumours are renal cell carcinoma.

The approval represents the latest indication for sintilimab in China and expands use of the combination regimen following earlier approval in advanced endometrial cancer.

https://en.wikipedia.org/wiki/Fruquintinib

China approves fruquintinib combination for kidney cancer -

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

2026-10-12T13:41:43.768+05:30

Chiesi USA, Inc. (key-A-zee), a global biopharmaceutical company, announced the U.S. Food and Drug Administration approval of Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G; 86 mcg/4.9 mcg/10.6 mcg and 172 mcg/4.9 mcg/10.6 mcg) for the maintenance treatment of asthma in adults. Trimbow delivers three active ingredients in a single device, referred to as a single inhaler triple therapy (SITT), presenting an option for adults whose asthma may require more than one inhaled medicine for daily maintenance treatment. Trimbow was the first treatment approved in the single inhaler triple therapy class outside of the U.S. and is commercialized in nearly 50 countries, including those within the European Union, the United Kingdom, and China.

Glycopyrrolate

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G) is the first U.S. FDA-approved product from Chiesi’s respiratory portfolio, bringing with it more than four decades of global expertise in respiratory leadership.

Formoterol

Beclometasone or beclomethasone

Approval was supported by Phase 3 TRIMARAN and TRIGGER studies, which included lung function as a co-primary endpoint in adults with asthma,1 building on its long-standing use as the first therapy in its class approved outside the U.S.

Approximately 27 million people in the U.S. live with asthma, which remains a significant burden to patients, caregivers, and society.2 Roughly 50% to 91% of people across all asthma disease severities show evidence of Small Airway Disease (SAD), which affects the tiny bronchioles deep within the airway tree.3,4

“The approval of Trimbow marks an important milestone as healthcare professionals continue to expand options for individualized care for the millions of people in the U.S. living with asthma, many of whom still struggle with symptoms,”2 said Nicola Hanania, MD, MS, Director, Airways Clinical Research Center, Professor of Medicine, Baylor College of Medicine and Chief, Section of Pulmonary, Critical Care and Sleep Medicine, Ben Taub Hospital, Houston, Texas. “This treatment has demonstrated improvement in lung function in Phase 3 clinical trials.”1

The FDA approval is supported by data from two Phase 3, double-blind, parallel-group, randomized, active-controlled clinical trials, TRIMARAN and TRIGGER, that evaluated the safety and efficacy of Trimbow in more than 2,200 adults with uncontrolled asthma.1 Across studies, Trimbow demonstrated improvements in lung function compared with BDP/FF, an inhaled corticosteroid (ICS) and long-acting beta-agonist (LABA) product. Trimbow demonstrated a safety profile comparable with BDP/FF, with common adverse events, occuring at an incident rate greater than or equal to 1%, including bronchitis, hypertension, back pain, blood pressure increase, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis.1

“This is an important development for the community at a time when access to treatment and the cost of care remain significant challenges for many individuals living with asthma,” said Lynda Mitchell, MA, CAE, CEO of the Allergy & Asthma Network. “There is no cure for asthma, and the condition presents a major burden to patients, caregivers, and society. Patients benefit when they have more options to treat their asthma – we are eager to see continued progress in innovation to address ongoing unmet needs in asthma care.”

https://en.wikipedia.org/wiki/Formoterol

https://en.wikipedia.org/wiki/Beclometasone

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List.

2026-10-09T11:30:59.150+05:30

The U.S. Food and Drug Administration announced the proposal to exclude semaglutide, tirzepatide, and liraglutide on the 503B bulks list, finding no clinical need for outsourcing facilities to compound these drugs from bulk substances.

The 503B bulks list identifies bulk drug substances that outsourcing facilities may use in compounding under the conditions of section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). In most cases, outsourcing facilities cannot compound drugs using bulk drug substances unless the substance appears on the 503B bulks list, or the compounded drug is on the FDA’s drug shortage list at the time of compounding, distribution, and dispensing.

After evaluating the nominations for these three substances, the FDA did not identify a clinical need for outsourcing facilities to compound semaglutide, tirzepatide, and liraglutide from bulk drug substances.

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, M.D., M.P.H. “This action reflects our responsibility to protect patients and preserve the integrity of the drug approval process while continuing to provide a transparent, science-based pathway for public input.”

The FDA carefully reviewed the nominations it received and did not identify sufficient evidence to include semaglutide, tirzepatide and liraglutide on the 503B bulks list. A determination of clinical need is based on patient safety and medical necessity under the law.

The FDA is now inviting interested parties to submit comments electronically through the docket by June 29, 2026. The agency will consider submitted comments before making a final determination.

https://en.wikipedia.org/wiki/Liraglutide

https://en.wikipedia.org/wiki/Tirzepatide

https://en.wikipedia.org/wiki/Semaglutide

FDA Proposes to Exclude Semaglutide, Tirzepatide, and Liraglutide on 503B Bulks List | FDA

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia

2026-10-07T09:52:33.396+05:30

The U.S. Food and Drug Administration has approved an expanded use for Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride) extended-release tablets to treat agitation associated with dementia due to Alzheimer’s disease in adults. The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults.

Bupropion

Dextromethorphan

"This approval represents a significant advancement in our ability to help patients and families dealing with one of the most challenging aspects of Alzheimer's disease," said FDA Commissioner Marty Makary, M.D., M.P.H. "With today’s action, patients and their families have access to an additional important treatment for complications of this devastating disease."

Agitation is a common and distressing symptom in patients with Alzheimer's disease dementia, characterized by excessive motor activity, or verbal or physical aggression. It can significantly impact quality of life for patients and caregivers.

"Auvelity was found to be efficacious for treating agitation in Alzheimer’s disease in two randomized trials and now represents an additional option to address one of the most difficult sequelae of the disease, especially as it progresses,” said Tracy Beth Hoeg, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research. "We hope this approval will provide meaningful benefit to patients, their families, and caregivers."

The first randomized study (NCT 03226522) was a five-week trial in which participants received either Auvelity or a placebo. The primary endpoint was the change from baseline to week five in the total score of the Cohen-Mansfield Agitation Inventory (CMAI), a survey that assesses the frequency of manifestations of agitated behaviors in elderly patients, based on caregiver reports. Auvelity was significantly superior to placebo in The Cohen-Mansfield Agitation Inventory score improvements.

The second randomized study (NCT 04947553) was a withdrawal study in participants who responded to Auvelity. Upon reaching a sustained clinical response to Auvelity, patients were randomly assigned to continue treatment with Auvelity or switch to placebo. The primary endpoint was time to relapse. Participants who continued Auvelity treatment had a significantly longer time to relapse of agitation symptoms compared to patients receiving the placebo.

The most common side effects include dizziness, upset stomach, headache, diarrhea, drowsiness, dry mouth, sexual dysfunction, and uncontrolled sweating. Auvelity has a Boxed Warning about increased risk of suicidal thoughts and behaviors in adolescents and young adults taking antidepressants. Health care providers should monitor patients for clinical worsening and emergence of suicidal thoughts and behaviors, especially during initial treatment. The medicine can cause seizures, with risk increasing with dose. It can also cause elevated blood pressure and hypertension, and may activate mania or hypomania (irritable mood) in susceptible patients.

Before starting Auvelity, health care providers should assess blood pressure, screen for personal or family history of bipolar disorder, and determine if patients are taking other medications containing bupropion or dextromethorphan.

The FDA granted breakthrough therapy designation and priority review designation for this action. The approval of Auvelity for agitation associated with dementia due to Alzheimer's disease was granted to Axsome Therapeutics.

https://en.wikipedia.org/wiki/Bupropion

https://en.wikipedia.org/wiki/Dextromethorphan

FDA Approves First Non-Antipsychotic Drug to Treat Agitation Associated with Dementia |

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug | FDA

2026-10-06T09:43:38.000+05:30

Today, the U.S. Food and Drug Administration is announcing that it issued a “safe to proceed” letter to Revolution Medicines, allowing the sponsor to initiate an expanded access treatment protocol (EAP) for its experimental pancreatic cancer drug, daraxonrasib.

The expanded access treatment protocol is for patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). The FDA received the expanded access request from Revolution Medicines on April 28 and signed it on April 30.

FDA regulations allow expanded access to investigational drugs for treatment purposes for larger populations under a treatment protocol or treatment investigational new drug application. Per EAP guidelines, requests for expanded access must be submitted to the sponsor by physicians licensed in the U.S. on behalf of eligible patients.

“Granting the request two days after receiving the expanded access application reflects the FDA’s strong commitment to facilitate early access to therapies for serious and life-threatening conditions, including pancreatic cancer,” said FDA Commissioner Marty Makary, M.D., M.P.H. “Having taken care of many patients with metastatic cancer, I am hopeful that today’s action will improve the lives of patients suffering from this disease.”

Daraxonrasib is a RAS inhibitor designed to inhibit a protein (RAS) that is mutated in most pancreatic cancer tumors.

The company said on April 13 that it intends to submit a new drug application for daraxonrasib under the Commissioner’s National Priority Voucher (CNPV) pilot program. The FDA granted a national priority voucher to daraxonrasib, also called RMC-6236, in October 2025.

https://en.wikipedia.org/wiki/Daraxonrasib

FDA Permits Expanded Access for Investigational Pancreatic Cancer Drug | FDA

Can supplements containing NMN, NAD+ and resveratrol really slow aging? Here's what the evidence says

2026-10-05T11:37:23.419+05:30

As more people look for ways to stay younger for longer, the supplement industry has moved beyond creams and cosmetic fixes to something more ambitious: products that claim to slow aging by acting on cellular processes.

Nicotinamide mononucleotide ("NMN" and "β-NMN"

Among the most heavily marketed compounds are NAD+, NMN and resveratrol, often described as supporting cellular repair, energy production and healthy aging. But what do they actually do, where are they being used, and how strong is the evidence?

To make sense of the claims, it helps to separate three things: the molecule NAD+, the compounds sold to raise it, and the products, such as supplements, creams and serums, that contain them.

Nicotinamide adenine dinucleotide, or NAD+, is a coenzyme found in all living cells. A coenzyme is a helper molecule that allows enzymes to carry out chemical reactions in the body. NAD+ plays an essential role in energy metabolism, DNA repair, inflammation and the activity of a family of proteins involved in cellular stress responses.

NAD+ levels tend to decline with age, although this decline is complex and may vary between tissues. Lower NAD+ availability has been linked to reduced mitochondrial function, meaning reduced activity in the cell structures that help produce energy. This is one of the biological changes associated with aging.

NAD+ in creams and serums

NAD+ has begun appearing in skincare creams and serums, but the evidence is even less developed here than it is for supplements.

While NAD+ is important for skin-cell energy and repair, it remains unclear whether topical NAD+ in ordinary creams can penetrate the skin in sufficient amounts to produce meaningful anti-aging effects.

Better-established ingredients, such as sunscreen, retinoids and niacinamide, currently have much stronger evidence for improving visible signs of skin aging.

NAD+ precursors as supplements

Nicotinamide adenine dinucleotide (NAD)

Because NAD+ itself is not thought to be absorbed efficiently when swallowed, much research has focused on NAD+ precursors. Precursors are compounds the body can convert into another substance. In this case, they are compounds the body can convert into NAD+. Two of the best known are nicotinamide mononucleotide (NMN) and nicotinamide riboside (NR).

In animal studies, NAD+ precursors have produced promising results. Older mice given these compounds have shown improvements in energy metabolism, insulin sensitivity and aspects of physical function. Some studies have also reported improvements in healthspan and lifespan-related measures in animal models, although these findings vary by model and do not translate neatly into humans. These results have helped drive enormous commercial interest, but turning promising mouse studies into meaningful benefits for people has proved far harder.

Human clinical trials suggest that NMN and NR can raise NAD+ levels, or related markers of NAD+ activity, in blood and tissues. However, the strongest evidence is for changes in blood, while evidence for meaningful effects in specific tissues is still limited.

Some small studies have reported possible benefits for metabolic health, including insulin sensitivity in specific groups. Others have explored potential effects on muscle mass, but recent reviews have not found convincing evidence that NMN or NR preserve muscle mass or function in older adults.

When researchers look at outcomes that matter more directly to everyday aging, such as strength, cognition, frailty or biological age, the picture is much less clear. Biological age is a contested estimate of how old the body appears at a cellular or molecular level. One major problem is that aging unfolds over a long period, while most supplement trials last only weeks or months.

Resveratrol

Resveratrol is another compound often promoted for anti-aging, but it is different from NMN and NR. It is not an NAD+ precursor. It belongs to a group of natural plant chemicals called polyphenols and is found in red grapes, berries and peanuts.

In laboratory and animal studies, resveratrol has been associated with lower levels of inflammation and improved mitochondrial function, meaning better activity in the parts of cells that help produce energy.

The difficulty is that resveratrol has poor oral bioavailability. This means much of what is swallowed is broken down or modified before it can reach tissues in the form and concentration used in laboratory experiments. This creates a large gap between what resveratrol can do in cells in a dish and what a supplement is likely to do in the human body. So far, human trials have not shown convincing evidence that resveratrol slows aging, and findings on cardiovascular and anti-inflammatory benefits remain mixed.

Resveratrol may interact with some medications, especially anticoagulant and antiplatelet drugs, often described as blood-thinning medicines. High doses can also cause side effects such as gastrointestinal symptoms. Anyone taking regular medication, managing a chronic condition, pregnant or breastfeeding should seek medical advice before taking high-dose supplements.

So, are NAD+, NMN and resveratrol the elixir of youth? No. The key distinction is between biological plausibility and proven benefit. These compounds are not biologically implausible: they act on real pathways involved in energy production, stress responses and cellular maintenance. But affecting a pathway is not the same as slowing aging in a person.

In humans, the evidence so far suggests possible benefits in limited contexts, but major questions remain about long-term safety, optimum doses and who is most likely to benefit. The science is plausible, but the marketing often turns "this affects a process associated with aging" into "this supplement will keep you young."

For now, the best-supported ways to support healthy aging remain far less glamorous: regular exercise, good sleep, a balanced diet, avoiding smoking, limiting alcohol and managing long-term health conditions. Supplements may eventually prove useful, but at present, the evidence for staying younger for longer is much stronger for everyday habits than for anti-aging products.

https://en.wikipedia.org/wiki/Nicotinamide_adenine_dinucleotide

https://en.wikipedia.org/wiki/Resveratrol

https://en.wikipedia.org/wiki/Nicotinamide_mononucleotide

Can supplements containing NMN, NAD+ and resveratrol really slow aging? Here's what the evidence says

Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy) | American Journal of Respiratory and Critical Care Medicine | Oxford Academic

2026-10-02T14:17:25.901+05:30

At a Glance Commentary.

Atomoxetine

Aroxybutynin

Scientific Knowledge on the Subject: AD109 (aroxybutynin 2.5 mg/atomoxetine 75 mg), an investigational, first-in-class, once-daily oral tablet, is designed to target the neuromuscular dysfunction underlying obstructive sleep apnea (OSA) by increasing upper airway muscle tone during sleep. In the phase 2b MARIPOSA trial, AD109 demonstrated significant improvement in the apnea–hypopnea index (AHI) in adults with mild-to-severe OSA over 4 weeks. An earlier phase 2 study suggested that AD109 may reduce AHI from the first dose. AD109 efficacy/safety beyond 4 weeks remain unknown.

What This Study Adds to the Field: SynAIRgy, a part of one of the largest clinical development efforts conducted for an OSA pharmacotherapy, is one of 2 phase 3 registrational trials evaluating the efficacy/safety of AD109. SynAIRgy is a randomized, double-blind, placebo-controlled, parallel-arm trial conducted in 646 participants with mild-to-severe OSA who were intolerant to or refused positive airway pressure therapy. SynAIRgy demonstrated significant improvements in airway obstruction and oxygenation across mild-to-severe OSA participants, supporting the potential for AD109 to be a new oral treatment option for patients with mild-to-severe OSA. Given existing OSA therapy limitations, AD109 may fill a large unmet medical need in providing patients with a pharmacologic therapy targeting the neuromuscular dysfunction underlying OSA pathogenesis.

https://academic.oup.com/ajrccm/advance-article/doi/10.1093/ajrccm/aamag215/8680221?login=false

https://en.wikipedia.org/wiki/Atomoxetine

https://drugs.ncats.io/substance/5BRQ29UUB7

Aroxybutynin and atomoxetine (AD109) for obstructive sleep apnea: a randomized phase 3 trial (SynAIRgy) | American Journal of Respiratory and Critical Care Medicine | Oxford Academic

Teriparatide + Zoledronic Acid Does Not Reduce Fracture Risk in Osteogenesis Imperfecta

2026-10-01T09:58:13.917+05:30

In continuation of my update on Teriparatide and Zoledronic Acid

Zoledronic Acid

Teriparatide

Among adults with osteogenesis imperfecta, teriparatide plus zoledronic acid does not reduce fracture risk compared with standard care, according to a study published online May 14 in the Journal of the American Medical Association.

Jannie Dahl Hald, Ph.D., from Aarhus University Hospital in Denmark, and colleagues examined whether the parathyroid hormone analogue teriparatide followed by zoledronic acid reduces the risk for fractures in adults with osteogenesis imperfecta in a multicenter randomized clinical trial. Participants were randomly assigned to receive 20 μg of teriparatide daily by subcutaneous injection for two years, followed by 5 mg zoledronic acid infusion (176 participants), or to standard care, in which bisphosphonates and other bone-targeted medicines could be used (174 participants).

Most of the participants had type I osteogenesis imperfecta caused by pathogenic variants in the type 1 collagen genes. The researchers found that 36.9 and 36.4 percent of patients in the teriparatide plus zoledronic acid group and the standard care group, respectively, had incident fractures. There was significantly more of an increase in lumbar spine and total hip bone mineral density with teriparatide plus zoledronic acid than standard care. Teriparatide plus zoledronic acid was favored in several quality-of-life measures. The groups reported similar adverse events.

"We have been using drugs to increase bone density for decades in the hope that they might prevent fractures but the TOPaZ trial clearly shows that these medicines simply do not work," lead author Stuart Ralston, M.D., from the University of Edinburgh Institute of Genetics and Cancer in the United Kingdom, said in a statement.

Ref : https://jamanetwork.com/journals/jama/fullarticle/2849063

https://en.wikipedia.org/wiki/Zoledronic_acid

https://en.wikipedia.org/wiki/Teriparatide

Teriparatide + Zoledronic Acid Does Not Reduce Fracture Risk in Osteogenesis Imperfecta - Drugs.com MedNews

Ensitrelvir cuts household COVID-19 risk when given after exposure

2026-09-30T09:46:59.082+05:30

Ensitrelvir COVID-19 Prevention Background

The coronavirus disease 2019 (COVID-19) pandemic caused millions of deaths worldwide. Although its acute phase has waned, it continues to cause illness and death, especially in high-risk groups. This is partly due to its high mutation rate, waning immunity, and high household transmission rates of 32%-48%.

Since the use of masks and social distancing measures is not enough to completely prevent transmission, there is a need for effective preventive drugs, at least for those at increased risk. Earlier trials of nirmatrelvir-ritonavir and molnupiravir did not show significant protection against COVID-19 in exposed household contacts.

Ensitrelvir showed potent in vitro activity against multiple SARS-CoV-2 variants, including omicron. It is approved in Japan for the treatment of mild-to-moderate COVID-19 in patients aged 12 years or older. Currently, it has been approved in Japan for post-exposure prophylaxis in contacts aged 12 years or older, based on the findings of this study.

In the phase 3 SCORPIO-SR trial, it reduced COVID-19 symptoms when initiated within 72 hours of symptom onset. The phase 3 SCORPIO-HR trial demonstrated the drug's antiviral efficacy but failed to show a significant difference in time to symptom resolution.

This motivated the current phase 3 SCORPIO-PEP trial. It was conducted as a double-blind randomized controlled trial involving 2387 randomized household contacts, of whom 2041 were included in the modified intention-to-treat population. The mean age of the population was 42.4 years.

SCORPIO-PEP Trial Study Design

At baseline, all participants had a history of contact with someone with COVID-19, the index patient. All had nasopharyngeal swabs submitted on days 1, 3, 6, 10, 15, 21, and 28 for reverse transcriptase-polymerase chain reaction (RT-PCR) detection of SARS-CoV-2.

Those who were test-negative and asymptomatic at baseline were randomly assigned to receive either ensitrelvir (1,030 participants) or placebo (1,011 participants) for 5 days beginning within 72 hours after symptom onset in the index patient. The primary endpoint was symptomatic RT-PCR-confirmed COVID-19 by day 10.

This required symptomatic RT-PCR positivity within ten days of trial-drug or placebo administration. This included the appearance of one or more symptoms from a panel of 14, lasting at least 48 hours, or worsening in the case of preexisting symptoms.

Approximately 71% of participants were randomized within 48 hours of the index patient's onset of symptoms. About 37% had one or more risk factors for severe COVID-19, including obesity, smoking, and age above 65 years. Nearly 19% of index patients received antiviral therapy, mostly with ensitrelvir. Approximately 85% or more of those in each group completed the regimen.

Over 98% had antibodies to the SARS-CoV-2 nucleocapsid or spike antigens.

COVID-19 Prevention Efficacy Findings

Compared with the ensitrelvir group, the placebo group had a significantly higher rate of new COVID-19 cases (9% vs. 2.9%). The risk ratio in favor of the ensitrelvir group was 0.33, indicating a 67% reduction in relative risk in ensitrelvir recipients post-exposure, compared to placebo.

The observed reduction appears larger than reported in previous household contact PEP studies. However, comparisons of efficacy across trials should be interpreted cautiously in light of differences between trials, definitions of illness, and shorter time limits for delineating primary infection rates. Notably, these differences persisted even when adjusting for differences in the definition of COVID-19.

By day 2, the placebo group showed a rapid rise in symptomatic infections, which was both smaller and spread out over 12 days in the ensitrelvir group. The benefit appeared to be generally consistent across participants with and without risk factors, although subgroup analyses were not adjusted for multiplicity. Across the participating countries, COVID-19 incidence among household contacts was lower in the US than in Japan.

In this study, the drug maintained plasma concentrations above the estimated target concentration, compared to estimates derived from nonclinical studies. This might indicate the persistence of effective prophylaxis beyond the five-day regimen.

Viral Load and Safety Findings

RT-PCR-confirmed SARS-CoV-2 infection rates were also lower with ensitrelvir than with placebo. Among participants with baseline-positive RT-PCR, viral loads were lower, as were those among those who developed infection or symptomatic COVID-19 while on ensitrelvir.

Adverse events were similar in both groups, and neither group reported hospitalizations or deaths from COVID-19. Ensitrelvir was associated with reversible reductions in HDL cholesterol, and its use requires attention to potential drug-drug interactions because it is a moderately strong CYP3A inhibitor.

The researchers did not have data on other measures used to limit household transmission or on the difference in outcomes due to antiviral administration, which is common in Japan and was offered to 38% of patients versus 6% in the US. The risk of selecting for viral mutations associated with resistance following ensitrelvir administration could not be completely excluded due to missing viral sample data from index patients treated with ensitrelvir. Participants using contraindicated medications were also excluded, which may limit real-world generalizability in patients at risk of CYP3A-mediated drug interactions.

Ensitrelvir Post-Exposure Prophylaxis Implications

The findings suggest that when administered within 72 hours of symptom onset in a COVID-19 index patient, ensitrelvir effectively prevented symptomatic illness in household contacts and reduced the relative risk of the illness up to day 10 by 67% among participants who received at least one dose of the drug. Among high-risk participants, about 2.4% of those who received ensitrelvir developed COVID-19, compared with 10% in the placebo group.

https://en.wikipedia.org/wiki/Ensitrelvir

Ensitrelvir cuts household COVID-19 risk when given after exposure

US FDA & Japan’s MHLW accept Bayer’s FXIa inhibitor, asundexian for prevention of ischemic stroke

2026-09-29T09:34:11.161+05:30

Bayer announced that the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW) have accepted the company’s New Drug Applications (NDA) for its investigational Factor XIa (FXIa) inhibitor, asundexian, for the prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). In addition, the US FDA granted asundexian Priority Review designation.

Approximately 12 million people experience a stroke every year. Of those who survive a stroke, approximately 1 in 10 will have another stroke within 1 year, even with available secondary stroke prevention strategies.

“The acceptances of submissions in key markets represent another milestone in the development of asundexian and in our commitment to secondary stroke care. More than 90 million people worldwide are living with the consequences of a stroke, highlighting its significant impact on public health,” said Christian Rommel, Ph.D., head of research and development at Bayer`s Pharmaceuticals Division. “We are collaborating with health authorities to advance the approval process.”

Bayer is continuing to submit applications for marketing authorization for asundexian to other health authorities globally. China’s Center of Drug Evaluation has also recently accepted Bayer’s marketing authorization application for asundexian and granted it Priority Review designation.

The phase III OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary efficacy endpoint was time to ischemic stroke; the primary safety endpoint was ISTH major bleeding. The full results from OCEANIC-STROKE have recently been published in The New England Journal of Medicine.

The applications to the US FDA and to Japan’s Ministry of Health, Labour and Welfare are based on positive data from the phase III OCEANIC-STROKE study. The study found that asundexian 50 mg, significantly reduced ischemic stroke by 26 per cent in patients after a non-cardioembolic ischemic stroke or high-risk TIA compared to placebo, both in combination with antiplatelet therapy, with no increase in ISTH (International Society on Thrombosis and Hemostasis) major bleeding.

Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. However, FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury.

Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication.

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) and cerebrovascular diseases of high unmet medical need. The company has set a clear focus on developing therapies to treat such diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is our ambition to take a leading role in the care of patients with these diseases. Bayer is actively shaping the future of cardiology and neurology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. Bayer’s portfolio already includes several innovative products and compounds in various stages of preclinical and clinical development.

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses.

https://en.wikipedia.org/wiki/Asundexian

US FDA & Japan’s MHLW accept Bayer’s FXIa inhibitor, asundexian for prevention of ischemic stroke

Breakthrough drug reverses aging in skin and dramatically speeds healing

2026-09-28T12:11:23.939+05:30

A drug designed to eliminate worn out, aging cells may help older skin recover from injury much faster, according to research published in Aging (Aging-US). The work, titled "Topical ABT-263 treatment reduces aged skin senescence and improves subsequent wound healing," suggests that targeting "zombie cells" in the skin could one day improve healing after surgery, injury, or chronic wounds in older adults.

The research team included Maria Shvedova, Rex Jeya Rajkumar Samdavid Thanapaul, Joy Ha, Jannat Dhillon, Grace H. Shin, Jack Crouch, Adam C. Gower, Sami Gritli, and Daniel S. Roh from Boston University Aram V. Chobanian and Edward Avedisian School of Medicine.

Clearing Out Aging Cells

As skin gets older, damaged cells can accumulate instead of dying off. These cells, known as senescent cells, no longer work normally, but they remain active enough to interfere with nearby tissue. Over time, they can release inflammatory signals and other molecules that weaken the skin's ability to repair itself.

The researchers tested whether ABT-263, a senolytic drug, could reduce this burden when applied directly to aged skin. Senolytic drugs are designed to selectively remove senescent cells, which have been linked to aging, inflammation, and slower tissue repair.

In the study, aged mice received ABT-263 on their skin for five days. After treatment, the skin showed fewer signs of cellular aging. When the researchers then created small wounds, the treated mice healed more quickly than untreated mice.

By day 24, 80% of the mice treated with ABT-263 had fully healed wounds, compared with 56% of untreated mice.

A Surprising Healing Boost

One of the more unexpected findings was that ABT-263 briefly increased inflammation in the skin. In many cases, inflammation is seen as harmful, especially when it becomes chronic. But in this case, the short burst appeared to help prepare the skin for repair.

The treatment seemed to wake up healing pathways that are normally sluggish in older tissue. Gene activity increased in areas tied to wound repair, including collagen production, blood vessel growth, tissue remodeling, and other processes needed to close and strengthen damaged skin.

This matters because aging skin does not just wrinkle or thin. It also becomes less responsive after injury. That slower response can increase the risk of prolonged recovery after surgery, delayed closure of wounds, and complications in people with chronic skin injuries.

Why Topical Treatment Matters

ABT-263 has drawn interest because it can target senescent cells, but oral senolytic drugs may cause side effects because they circulate through the body. Applying the drug directly to the skin could offer a more focused approach.

In this study, topical ABT-263 reduced signs of senescence in aged mice, but it did not appear to have the same effect in young mice. That suggests the treatment may be most active in older tissue, where senescent cells have built up.

The researchers believe this targeted approach could be especially useful before surgery or in people at risk for poor wound healing. Instead of waiting for a wound to struggle, a treatment might one day help prepare older skin in advance.

"Our study underscores the potential of topical senolytic treatments to enhance wound healing in aging skin, presenting a potentially promising strategy for preoperative care."

Newer Research Points in the Same Direction

Since this 2024 work, the broader field has continued moving toward localized senolytic strategies for skin repair. A 2025 review in Ageing Research Reviews described cellular senescence as a key contributor to skin aging and skin disease, while noting that senolytics and related therapies could become useful tools for targeting harmful senescent cells in the skin.

A 2026 study took the idea further in diabetic wound healing, a major medical challenge often marked by chronic inflammation, poor blood vessel growth, and cellular senescence. Researchers developed a localized wound dressing carrying ABT-263 and reported that it reduced senescent cell burden, improved healing in diabetic mice, and showed no detectable systemic toxicity in that model.

At the same time, scientists are careful not to portray senescent cells as purely bad. A 2024 Frontiers in Immunology review emphasized that senescence can play a helpful role during normal wound repair, but persistent senescent cells may contribute to chronic wounds, fibrosis, and abnormal healing. The challenge is timing and precision: removing the harmful lingering cells without disrupting the useful early repair signals.

Promise With Important Caution

The findings are exciting, but they are still early. The ABT-263 skin study was done in mice, and more work is needed before scientists know whether the treatment is safe or effective in people.

Researchers will also need to answer key questions about dosing, timing, long term safety, and whether the benefits apply to human skin, surgical recovery, diabetic wounds, or other slow healing conditions.

Still, the idea is powerful. By clearing away cells that hold aging skin back, topical senolytic treatments could someday help the body repair itself more quickly and more effectively. For older adults facing surgery or chronic wounds, that could make healing less difficult, less risky, and far faster.

https://en.wikipedia.org/wiki/Navitoclax

https://www.aging-us.com/article/206165/text

Breakthrough drug reverses aging in skin and dramatically speeds healing |

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma

2026-09-26T09:20:19.302+05:30

In continuation of my update on beclomethasone, Formoterol & Glycopyrrolate

Formoterol

beclomethasone,

Glycopyrrolate

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate; or BDP/FF/G) is the first U.S. FDA-approved product from Chiesi’s respiratory portfolio, bringing with it more than four decades of global expertise in respiratory leadership.
Approval was supported by Phase 3 TRIMARAN and TRIGGER studies, which included lung function as a co-primary endpoint in adults with asthma,1 building on its long-standing use as the first therapy in its class approved outside the U.S.

FDA Approves Trimbow (beclomethasone/formoterol/glycopyrrolate) Inhaler for the Maintenance Treatment of Asthma