Merck & Co is acquiring Terns Pharmaceuticals for $6.7 billion, a move that’s set to help build out its haematology pipeline.

The deal includes Terns’ oral allosteric BCR::ABL1 tyrosine kinase inhibitor (TKI), a potential best-in-class candidate for chronic myeloid leukaemia (CML).

TERN-701 is currently being evaluated in the phase I/II CARDINAL trial for Philadelphia chromosome-positive (Ph+), chronic phase CML. The participants have had previous treatment with at least one prior TKI treatment failure, suboptimal response or treatment intolerance.

Dr Dean Li, President of Merck Research Laboratories, said: “The first approval of a BCR::ABL1 tyrosine kinase inhibitor 25 years ago transformed the prognosis for many patients with chronic myeloid leukaemia. Despite new therapeutic options, there is significant need for innovative, well-tolerated therapies with faster time to onset of molecular response leading to deeper responses and better disease control.

“Based on early clinical evidence, TERN-701, a novel allosteric BCR::ABL1 inhibitor, may have the potential to provide a meaningfully differentiated option for certain patients living with CML.”

Clinical data shows the oral TKI has provided promising major molecular response rates and deep molecular response observed by week 24. This includes responses in those with high disease burden who have received multiple lines of therapy.

Robert Davis, Chairman and Chief Executive Officer, Merck, said: “The acquisition of Terns builds on our growing presence in haematology with TERN-701, a potential best-in-class candidate for the treatment of certain patients with chronic myeloid leukaemia.

“This transaction further diversifies and strengthens our position in oncology as we continue to look for opportunities to broaden our portfolio into other therapeutic areas.”

The proposed transaction is subject to customary closing conditions and is expected to be finalised in Q2 of 2026.

This development arrives in final weeks before Kai Beckmann joins as Merck’s new CEO, where he will replace Belén Garijo at the end of next month.

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UCB is bolstering its US manufacturing capabilities with a new biologics manufacturing facility in Gwinnett County, Georgia.  

The investment forms part of its $5 billion US commitment announced last June and represents one of the largest in Georgia’s history, according to Georgia Governor Brian Kemp.

The new site will strengthen UCB’s global biologics manufacturing network and supply resilience globally, support growing demand across its portfolio and pipeline, and help meet the increasing need for treatments to address severe diseases, noted Jacques Marbehant, the firm’s Head of Transformational Programs & Infrastructure.

The facility’s digital-first approach, leveraging AI, robotics and automation, is expected to provide continuous production of complex biologics primarily for the US market, strengthening the efficiency and sustainability of UCB’s manufacturing operations.

Jean-Christophe Tellier, UCB CEO, said: “By investing in Gwinnett County and the Rowen Foundation in Georgia, where our US headquarters have been based for more than three decades, we are strengthening our biologics manufacturing capabilities, supporting our innovation pipeline and creating high-quality jobs in a state that offers outstanding talent, a strong manufacturing tradition and an ecosystem designed for sustainable, long-term success.”

The investment is expected to support around 330 new jobs.

Other pharmaceutical companies have made similar moves in recent months to onshore their US manufacturing operations. In February, Johnson & Johnson invested $1 billion in cell therapy, a slice of the $55 billion total being directed into its US strategy up to 2029. AbbVie directed $380 million to boost its API capabilities and Novartis laid out plans for its fifth radioligand therapy facility. The latter site will be the firm’s first manufacturing facility in Texas to produce cancer therapies. It is part of its planned $23 billion US investment over the next five years.

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Gilead Sciences is strengthening its inflammation portfolio with addition of a bispecific T cell engager for immune-mediated diseases, as part of its $2 billion acquisition of Ouro Medicines.

The US-based biotechnology company’s potential first-in-class BCMAxCD3-targeting candidate OM336 (gamgertamig) is the key asset in the deal. Gilead will pay $1.675 million upfront. Ouro is also eligible for up to $500 million in milestone payments.

Currently in phase I/II development, a single treatment cycle of OM336 has demonstrated “transformative efficacy and a differentiated safety profile” in severe antibody-mediated orphan disease, according to Gilead.

Dr Dietmar Berger, PhD, Chief Medical Officer of Gilead, said: “BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care.”

Gilead and Galapagos plan to collaborate on the acquired assets as part of Gilead’s acquisition of Ouro Medicines. Ongoing discussions include potential development of OM336.

Closing of the deal is subject to customary conditions.

This week, Sanofi also announced it gained rights to a T cell engager for autoimmune diseases through a license agreement involving Kali Therapeutics’ tri-specific candidate. Sanofi has agreed to pay $1.05 billion in development and commercialisation milestone payments, if these are met.

On the collaboration agreement, Weihao Xu, CEO of Kali Therapeutics, said: “By depleting a broad range of B cell populations effectively while minimizing cytokine release, we believe KT501 can address significant unmet needs of autoimmune patients. We are confident that Sanofi’s extensive expertise will accelerate the development of this promising therapy.”

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Researchers in China have developed a nanoparticle-based process that could enhance the production of engineered exosomes as a novel class of cell therapy.

Dr Gang Ruan, the study’s lead, said: “We have seen successes with stem cells repairing damaged tissues and immune cells fighting cancer. An engineered exosome is like a supercharged version of a natural exosome.”

Conventional methods slow down as production scale increases and existing technologies improve only one or two of the four exosome production steps. Dr Xiaowei Wen, a co-first author of the study, noted that their novel manufacturing system “improves all four steps at once”.

The technique involved isolating exosomes using mobile internal magnetic separation (MIMS), a magnetic technique that enables rapid and efficient collection of exosomes even at large scales.

In their study, the team grew mesenchymal stem cells with these nanoparticles, which enabled the cells to release a higher quantity of exosomes than normal. Drugs and magnetic particles were automatically packed into the exosomes as they formed. This facilitated imaging and tracking in a biological environment. Additionally, the engineered exosomes were stable during storage, following rehydration after being freeze-dried.

Dr Wen added that the manufacturing process “works because we combined three new ideas: a new interaction between nanoparticles and cells, a new type of nanomaterial, and a new design for the manufacturing equipment. This is the first time the entire process has been integrated in this way”.

The technology has only reached pre-clinical testing, however Dr Ruan highlighted that the proposed process is “not only practical and scalable but also maintains consistent quality, which is essential for industrial use, and could help patients gain faster access to safer and more effective engineered exosome therapies”.

The paper was published in Advanced Science.

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Biologic Opdivo (nivolumab) is now authorised as a combination therapy for two new classical Hodgkin Lymphoma indications.

Firstly, the FDA has authorised the monoclonal antibody alongside doxorubicin, vinblastine and dacarbazine (AVD) in individuals 12 years old and over with previously untreated, Stage III or IV cHL. It represents the first immunotherapy combination approved for patients with this indication.

The US authorisation is based on the phase III SWOG 1826 (CA2098UT) study. Data shows the combination treatment enabled a 58 percent reduction in the risk of disease progression or death.

Dr Alex Herrera, Chief of Division of Lymphoma, City of Hope National Medical Center, US, said: “In the US, the nivolumab-based combination for patients with previously untreated Stage III or IV cHL demonstrated improved progression-free survival compared with standard of care, BV-AVD. The SWOG 1826 study provides data for frontline use of this immunotherapy-based regimen.”

Alongside this, in the EU, Opdivo is now approved in combination with brentuximab vedotin for individuals between five and 30 years old with relapsed or refractory cHL following one prior line of therapy.

Dr Monica Shaw, Senior Vice President of Oncology Commercialisation, noted that this authorisation in the EU represents “a milestone as the first immunotherapy combination for certain relapsed or refractory patients”.

The European Commission’s decision is based on the phase II CheckMate -744 (CA209744) study. The combination treatment provided high complete metabolic response rates in children, adolescents, and young adults. Additionally, durable responses were observed at follow-up. These findings were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

European Medicines Agency (EMA) is currently reviewing a regulatory submission based on SWOG 1826 trial.

Ono Pharmaceutical agreed that BMS could develop Opdivo globally following a collaboration agreement in 2011.

However, Bristol Myers Squibb is one of the companies expected to bear the brunt of the upcoming patent cliff as Opdivo, alongside its anticoagulant drug Eliquis (apixaban), are set to lose exclusivity in the US market over the next decade.

Sandoz recently agreed a new licensing deal with Samsung Bioepis to help it navigate this shift in the biosimilars market. It involves a candidate for the reference medicine Entyvio, used to treat Crohn’s disease.

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Novartis is acquiring Pikavation Therapeutics, a subsidiary of Synnovation Therapeutics, for up to $3 billion, gaining access to a portfolio of investigational PI3Kα inhibitors for HR+/HER2- breast cancer.

Synnovation’s lead asset SNV4818 is an oral PI3Kα inhibitor in Phase I/II development for breast cancer and other advanced solid tumours.

Dr Shreeram Aradhye, President of Development at Novartis, said: “While mutated PI3Kα is a well‑established driver in HR+/HER2‑ breast cancer, there remains a challenge in achieving effective pathway inhibition with a tolerable therapeutic profile.

“SNV4818 applies new mutant‑selective chemistry to more precisely target tumour biology while sparing normal cells. This approach has the potential to translate proven biology into improved tolerability and more durable benefit for patients through precision medicine.”

Under the agreement, the firm will pay the US biotech $2 billion upfront and up to $1 billion in milestone payments.

Novartis noted that Synnovation’s PI3Kα inhibitor programme has potential use in combination with CDK inhibitors and endocrine therapies.

Wenqing Yao, PhD, Chief Executive Officer of Synnovation, added: “We will continue advancing other promising programmes in our R&D pipeline, including our selective PARP1 inhibitor, SNV1521, as well as additional oncology and immunology projects.”

The transaction is expected to be finalised in the first half of 2026, subject to customary closing conditions.

Novartis has made multiple acquisition and collaboration deals over the past six months or so, bolstering its neuroscience, immunology and cardiovascular pipelines. Agreements include a $12 billion acquisition of Avidity Biosciences last October,  a $5.7 billion expanded collaboration with Monte Rosa Therapeutics and a $1.4 billion acquisition of Tourmaline Bio last September.

Alongside Novartis, Gilead and Johnson & Johnson have agreed deals to advance oral drugs for breast cancer and other solid tumours. Last year, Gilead invested $3 billion in Kymera Therapeutics, giving it access to a potential first-in-class prostate cancer therapy, while J&J gained rights to a suite of CDK2 molecular glue degraders through its $750 million licensing agreement with Halda Therapeutics.

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A new radiopharmaceuticals manufacturing facility is being built in the Bellwether District of Philadelphia, Pennsylvania, US, supporting supply and production of actinium-225 (ac-225) for cancer therapies.

TerraPower Isotopes (TPI)’ new current good manufacturing practice (cGMP) site will help address the increasing drug development need for this treatment worldwide.

TerraPower President and CEO Chris Levesque said: “This new facility will help us increase the global supply of actinium-225 and increase access for researchers and drug developers who are advancing new cancer treatments.”

Jaap Duiker, Managing Director of manufacturer Von Gahlen Nederland BVV, added: “TPI’s Actinium-225 is already enabling clinical programmes around the world as a key component of next-generation targeted alpha therapies.”

Scott Claunch, President of TerraPower Isotopes, said: “Our team is proud to be building a large-scale cGMP manufacturing facility in Philadelphia, which will play a pivotal role in expanding global access to this rare isotope.”

TPI also plans to boost production capacity at its existing Everett, Washington facility by 20-fold.  

Production of the cGMP actinium-225 facility is expected to commence at the start of 2029.

Last month, two big pharmaceutical companies announced plans to site their new manufacturing facilities in Pennsylvania. First, Eli Lilly shared that it’s establishing the last of four new US sites in the region, investing $3.5 billion for the production of injectable medicines.

Johnson & Johnson is also directing a large sum into its cell therapy manufacturing operations there. A total of $1 billion is set to expand the firm’s production capacity for its medicines for cancer, immune-mediated and neurological diseases.

On the broader radiopharmaceuticals front, last December UK biotech Bicycle Therapeutics signed a 15-year, sustainability-focused supply agreement for reprocessed uranium. In 2024, Novartis and Ratio Therapeutics partnered to advance a potential best-in-class next-gen radiotherapeutic.

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The European Commission has approved AstraZeneca’s Imfinzi (durvalumab) alongside chemotherapy as the first perioperative immunotherapy for early gastric and gastroesophageal cancers.

The regimen comprises the monoclonal antibody in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin and docetaxel) in adults with Stages II, III, IVA, gastric and gastroesophageal junction (GEJ) cancers. This involves two cycles prior to and post surgery, then Imfinzi monotherapy.

The approval is based on positive data from the Matterhorn Phase III trial, published in the NEJM. Its authorisation follows the CHMP’s decision on the regimen in February.

Findings from the interim analysis found that the regimen reduced the risk of disease progression, recurrence or death by 29 percent, versus chemotherapy only.

Final overall survival analysis showed the regimen reduced the risk of death by 22 percent compared to chemotherapy alone. Additionally, an estimated 69 percent were alive at three years compared with 62 percent in the comparator arm.

Dr Josep Tabernero, the trial’s principal investigator, said: “Despite curative-intent surgery and chemotherapy, patients with resectable gastric and gastroesophageal cancers still face high recurrence rates and an urgent need for improved long-term survival.

“In Matterhorn, nearly 70 percent of patients were still alive three years after treatment with the durvalumab-based perioperative regimen. This EU approval brings patients the first immunotherapy regimen to extend survival in this early setting and is poised to become the new standard of care.”

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “This approval marks our third perioperative approval in Europe for an Imfinzi-based regimen, underscoring AstraZeneca’s commitment to transforming outcomes in early-stage disease, where cure is possible. For patients with early gastric and gastroesophageal cancers, this immunotherapy-based regimen delivers a durable survival benefit that increases over time.”

Overall survival results from Matterhorn were presented last year at the European Society for Medical Oncology (ESMO) Congress.

Imfinzi was first approved in May 2017. The biologic is authorised in combination with FLOT chemotherapy in the US and other countries based on the Matterhorn results.

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Sandoz and Samsung Bioepis are collaborating to broaden access to high-quality biosimilar medicines globally, in a new deal that could advance up to five biosimilars.

The licensing and development agreement has potential to expand Sandoz’s pipeline by up to 32 assets. The first biosimilar included in the deal is Samsung’s SB36, a vedolizumab biosimilar, currently in preclinical development. Its reference medicine is Entyvio, indicated for Crohn’s disease, ulcerative colitis or pouchitis.

Samsung Bioepis will develop the biosimilars and handle regulatory and manufacturing operations, while Sandoz will commercialise the medicines globally. This excludes China, Hong Kong, Taiwan, Macau and Republic of Korea. 

The news builds on Sandoz’s planned new global biosimilar development, manufacturing and supply unit, headed by Armin Metzger and starting 1 April.

The collaboration could help the firm capitalise on the biosimilar loss-of-exclusivity market, estimated at around $320 billion over the next ten years.

Richard Saynor, Chief Executive Officer, Sandoz, said: ”This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalising on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”

Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis, said: “The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines.”

Financial details of the transaction were undisclosed.

This month, the US Food and Drug Administration (FDA) made a key move to advance biosimilar regulation with the publication of new draft guidelines set to streamline unnecessary clinical pharmacokinetic (PK) testing.

Additionally, last October the FDA issued draft guidance proposing updated recommendations to reduce costs and timelines for biosimilar development.

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Polyethylene terephthalate (PET) plastic set for landfill could be transformed into L-DOPA, a key medicine for Parkinson’s disease, according to research from the University of Edinburgh.

The innovative study showed that once the plastic is broken down into terephthalic acid, engineered E. coli bacteria can convert the molecules into L-DOPA.

The new technique offers a sustainable approach that helps address the challenge of recycling fossil fuel-based PET, of which current processes are not fully efficient, the team noted.

Dr Liz Fletcher, Director of Impact and Deputy CEO at the Industrial Biotechnology Innovation Centre (IBioIC), said: “This project highlights the potential of biology to reshape the way we think about waste. Turning plastic bottles into a Parkinson’s drug isn’t just a creative recycling idea, it’s a way of redesigning processes that work with nature to deliver real-world benefits.

“By demonstrating that a harmful material can be converted into something that improves human health, the team is proving that sustainable, high-value applications of biology are both practical and effective.”

The team plan to further optimise the process and enhance scalability of the technology so it can be advanced towards industrial application.

The research was published in Nature Sustainability.

An earlier promising development in the neurological therapy landscape includes the MHRA last November giving the green light to Eisai and Biogen’s antibody drug Leqembi IV maintenance as an additional treatment option for Alzheimer’s.

More recently, researchers showed it is possible to utilise waste bread as a feedstock for E. coli to generate naturally-produced hydrogen gas. The findings suggest the technique could offer a sustainable alternative for pharmaceutical bioproduction.

Last year also saw an environmentally-friendly innovation that could change how key medicines are produced. In their study, researchers were able to convert agricultural waste, such as rice husks and corncobs, into the medical substances required to produce furosemide, a hypertension treatment.

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