Fierce Pharma

Gastroenterologists flag clinical remission and its durability as unmet needs in IBD care: survey

Jul 24, 2026 8:58am

A survey of 36 U.S. gastroenterologists found that significant treatment gaps remain in the growing IBD drug market despite an expanding range of therapies.

Peptide adcomm Day 2: Emideltide voted down in panel's 1st pushback

Jul 24, 2026 12:13pm

As outside experts gathered for a second day to discuss adding certain popular-yet-unapproved peptides to the U.S.’ bulk compounding list, the first to go up against a vote did not fare as well as those assessed Thursday.

The Oral GLP-1 Tracker: Obesity prescriptions jump for both Novo and Lilly

Apr 21, 2026 10:06am

Fierce Pharma is launching the weekly Oral GLP-1 Tracker, leveraging analysts’ notes and IQVIA data to monitor prescription trends and shifting market shares as Novo Nordisk's Wegovy pill and Eli Lilly's Foundayo vie to become the go-to oral weight-loss solution for millions.

Another setback for Ipsen's Albireo portfolio as Bylvay flunks phase 3 trial

Jul 24, 2026 10:16am

Three years after gaining three liver disease assets in its $952 million buyout of Albireo, Ipsen is struggling to develop the trio. The company has reported the failure of liver disease drug Bylvay in a phase 3 study in biliary atresia.

Amgen hands in data package in hopes of FDA hearing for Tavneos defense

Jul 24, 2026 10:22am

With all eyes on Tavneos’ seemingly precarious approval status in the U.S., Amgen is advancing plans to defend the ANCA-associated vasculitis (AAV) drug it inherited in its $3.7 billion buyout of ChemoCentryx.

Novo escalates Lilly false advertising suit with planned bid to halt comparative ads

Jul 24, 2026 10:48am

The company is targeting Lilly ad campaigns that cite what Novo calls “outdated” clinical trials comparing Lilly’s drugs with Ozempic and Wegovy.

Merck stages expanded access to monthly HIV PrEP pill ahead of approval

Jul 24, 2026 9:35am

Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.

GSK’s first lung cancer approval, a new IPO path and more

Jul 24, 2026 9:49am

This week on “The Top Line”: GSK’s lung cancer approval, an unusual IPO strategy and a push to update animal testing rules.

Fierce Pharma Asia—Trump’s generic drug tariffs; Samsung Bio’s $1.8B acquisition; An unusual IPO

Jul 23, 2026 4:54pm

Generic drugmakers will face import tariffs in the U.S., President Donald Trump announced this week. Samsung Biologics is pursuing the biggest M&A deal ever for a Korean biopharma company. In an unconventional move, a U.S. biotech is gunning for an IPO in Hong Kong first. And more.

UPDATE: Peptides favored on 1st day of closely watched FDA compounding adcomm

Jul 23, 2026 2:21pm

An FDA advisory committee has recommended that four peptide drugs that were previously restricted because of potential safety concerns be restored to the 503A Bulk Drug Substances list, which would remove the limits on how they are produced by compounders. It marks the first four of seven peptide drugs the FDA's Pharmacy Compounding Advisory Committee is addressing on Thursday and Friday.

Roche defends 6B franc Vabysmo peak sales target despite another quarterly miss

Jul 23, 2026 11:05am

On an investor call Thursday, Roche Pharmaceuticals CEO Teresa Graham assured analysts that the U.S. branded market has stabilized after a period of contraction, though the explosive growth that Vabysmo enjoyed early in its launch is likely behind it.

BeOne jumps aboard onshoring train with $300M to add small molecule production in US

Jul 23, 2026 10:54am

As the recent reshoring zeal rolls on in the United States, BeOne Medicines is beefing up its flagship manufacturing and R&D campus in New Jersey to the tune of $300 million.

Regulatory tracker: AZ gains EU nod for camizestrant; China 1st to endorse Takeda's narcolepsy drug

Jul 1, 2026 1:33pm

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

FDA rebukes 2 Indian API plants over data controls, sanitation issues

Jul 23, 2026 7:57am

The FDA slammed a pair of India-based API manufacturers in separate warning letters outlining poor record-keeping, problems maintaining sanitation and licensing issues, among other observations.

J&J’s bispecific combo slashes myeloma progression risk by 89% in phase 3 trial

Jul 22, 2026 11:22pm

Johnson & Johnson has unveiled remarkable phase 3 survival data for its dual bispecific combination in earlier-line multiple myeloma, potentially adding a new twist in the commercial trajectories of off-the-shelf T-cell engagers versus personalized CAR-T therapies.

Australian biopharma Clinuvel to shed up to 20% of workforce in move to US

Jul 23, 2026 5:49am

Australian biopharma Clinuvel Pharmaceuticals is moving its headquarters to the U.S.— but up to a fifth of the company’s workforce won’t be staying for the trans-Pacific pivot.

‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins

Jul 16, 2026 4:14pm

A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.

ARS Pharma drafts NFL legend Drew Brees in allergy awareness push

Jul 22, 2026 6:18pm

The former quarterback spoke with Fierce Pharma Marketing on teaming up with ARS, his journey with food allergies and why needle-free epinephrine Neffy is an "incredible option."

GSK secures first lung cancer approval as FDA clears Jideytro in quick payoff from Nuvalent deal

Jul 22, 2026 2:54pm

In a landmark moment for its oncology ambitions, GSK has secured FDA approval for Jideytro as the first commercial lung cancer drug in the company’s history. The milestone was made possible by GSK’s recent acquisition of Nuvalent for $10.6 billion.

FDA calls out Sanofi emails for giving 'misleading impression' of Beyfortus use in RSV

Jul 22, 2026 11:45am

The FDA's Office of Prescription Drug Promotion took issue with Sanofi's characterization of antibody Beyfortus as an RSV preventative, as the med is specifically indicated for RSV lower respiratory tract disease.

What to Expect at PODD 2026

Jul 22, 2026 2:11pm

Directors Andrew Goldstein and Valerie Bowling discuss what to expect at the 2026 PODD: Partnership Opportunities in Drug Delivery conference.

Trump floats countdown to 200% tariffs on generic drugs imported to US

Jul 22, 2026 10:35am

While the White House focused its initial Section 232 pharmaceutical tariffs on branded drugs, generics makers—who supply the vast majority of U.S. prescriptions—won’t stay in the clear for long.

Summit Therapeutics updates ivonescimab survival data ahead of FDA decision date

Jul 22, 2026 10:20am

Aiming to bolster ivonescimab’s case ahead of a key FDA decision, Summit Therapeutics has provided updated overall survival data from the phase 3 HARMONi trial for its PD-1xVEGF bispecific antibody.

Look out Ionis, here comes Arrowhead with promising hypertriglyceridemia data

Jul 22, 2026 10:53am

Less than a month after Ionis scored an FDA expansion for Tryngolza to become the first drug to specifically treat severe hypertriglyceridemia, Arrowhead has countered with head-turning data from two phase 3 trials that could set the company up for a matching nod.

Biotech industry leaders file brief backing FDA against ‘malicious’ mifepristone challenge

Jul 21, 2026 5:12pm

A group of 61 biopharma companies, executives and investors has filed an amicus brief in support of the FDA in an ongoing case brought by Louisiana meant to remove access to the abortion pill mifepristone.