Roche stops shipping Sarepta gene therapy in some countries outside US

The Swiss company, which markets Elevidys abroad, said it believes the benefit-risk balance to treatment remains positive in Duchenne patients who can still walk, however.

By Ned Pagliarulo • July 23, 2025

Replimune drug rejected by FDA; Omega raises $647M biotech fund

Analysts questioned whether the complete response letter Replimune received was evidence of changing approval standards at the FDA.

By BioPharma Dive staff • July 22, 2025

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

AstraZeneca grows US presence with $50B in spending plans

The $50 billion target, which AstraZeneca plans to meet by 2030, includes new manufacturing projects in Virginia and elsewhere, as well as R&D investment.

By Ned Pagliarulo • July 21, 2025

Apples to apples: Stelara biosimilars and the fight for market share

How will payers determine which Stelara biosimilar to add to their formularies?

By Samantha Ngan, Associate Manager, Market Research, MMIT and Andrew Rouff, Senior Consultant, Advisory Services, MMIT • July 21, 2025

Bristol Myers’ Reblozyl falls short in Phase 3; Blenrep voted down by FDA panel

The anemia treatment missed its main goal in a myelofibrosis study. Meanwhile, Blenrep's return to the U.S. market may have become more difficult after the negative advisory committee vote.

By BioPharma Dive staff • July 18, 2025

Bristol Myers, Pfizer to offer Eliquis at a discount for some patients

The program is the latest example of pharmaceutical companies bypassing traditional drug distribution channels for people who aren’t insured or are willing to pay cash for their medications. 

By Ben Fidler • July 17, 2025

J&J absorbs Stelara, tariff hits to deliver beat-and-raise quarter

Quarterly pharmaceutical sales surpassed $15 billion for the first time as strong performance from J&J's cancer medicines offset slumping Stelara sales.

By Ned Pagliarulo • July 16, 2025

Vertex secures Alyftrek coverage in England; Merck starts Phase 3 trials of HIV drug

NHS England agreed to reimburse Vertex's newest cystic fibrosis medicine. Meanwhile, Merck advanced a once-monthly PrEP pill into late-stage trials.

By BioPharma Dive staff • July 15, 2025

Takeda to seek approval of new kind of narcolepsy drug after study data

Positive late-stage study results position the company to file for clearance of what could be the first narcolepsy drug that targets orexin proteins. 

By Ben Fidler • July 14, 2025

From data to decisions: How pharma can move faster without sacrificing trust

Pharma's speed advantage depends on trust. Is your data foundation strong enough?

By Pankit Bhalodia, Partner at West Monroe Life Sciences • July 14, 2025

Jazz names new CEO; Ultragenyx, Mereo shares slide on trial update

Current operations chief Renee Gala will succeed Bruce Cozadd at Jazz. Meanwhile, Nuclidium raised about $99 million to develop radiopharmaceuticals that involve copper isotopes.

By BioPharma Dive staff • July 11, 2025

AbbVie to pay $700M for trispecific drug from Ichnos Glenmark

The deal hands AbbVie a drug that’s shown early promise in multiple myeloma and may be useful treating other cancers and autoimmune conditions, too. 

By Kristin Jensen • July 10, 2025

Gilead signs lenacapavir access deal; Arvinas CEO to step down

The drugmaker will provide, at no profit, doses to treat up to 2 million people in resource-limited countries. Meanwhile, Arvinas' John Houston is retiring from his role leading the biotech.

By BioPharma Dive staff • July 9, 2025

Trump says pharmaceutical, copper tariffs coming ‘very soon’

While Trump indicated drug levies would be set at a “very high” rate, he added that pharma firms would first be given time to bring manufacturing to the U.S.

By Philip Neuffer • July 8, 2025

Novartis gets approval of first malaria medicine for newborns

Coartem Baby, which was cleared by health authorities in Switzerland, will fill an important gap in treatment. Novartis plans to sell it “largely” on a not-for-profit basis.

By Delilah Alvarado • July 8, 2025

[Podcast] Trial Trailblazers: Behind clinical breakthroughs

Explore how innovative clinical trials are transforming treatments for children with rare diseases in this compelling podcast.

By BioPharma Dive's studioID • July 7, 2025

Regeneron bispecific approved for myeloma; Concentra to buy IGM

Lynozyfic is one of two bispecific antibodies Regeneron hopes will lift its oncology business. Meanwhile, IGM is the latest struggling biotech to agree to a buyout deal from Concentra.

By BioPharma Dive staff • July 2, 2025

Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

Biocryst is offloading part of its business for $250 million. Meanwhile, the former FDA leader took issue with a new policy for COVID-19 shots.

By BioPharma Dive staff • June 27, 2025

RFK Jr.-appointed panel recommends flu shots be free of contested preservative

Thimerosal, targeted by activists who claim it’s linked to autism, shouldn't be used in vaccines given in the U.S. this coming flu season, the CDC panel said.

By Jonathan Gardner • Updated June 27, 2025

Incyte replaces CEO Hoppenot with dealmaker Meury

Bill Meury, who shepherded Karuna and Anthos to multibillion-dollar buyouts, will take over Incyte, a successful drug developer now at a crossroads.

By Ned Pagliarulo • June 26, 2025

CDC panel, newly remade by RFK Jr., questions vaccine evidence

New members of the ACIP panel raised questions about the evidence supporting COVID vaccines, and signaled plans to look at other established shots, like those for measles and hepatitis B.

By Delilah Alvarado • June 25, 2025

FDA investigating Elevidys safety; Nektar shares spike on eczema data

The agency said it will evaluate whether regulatory action is needed after investigating the deaths of two patients treated with Sarepta's therapy.

By BioPharma Dive staff • June 24, 2025

Cassidy challenges RFK Jr. with call for delay to CDC vaccine meeting

The GOP senator objected to Secretary Kennedy's recasting of the influential advisory panel, which has sparked criticism from medical groups and Democratic lawmakers.

By Delilah Alvarado • Updated June 24, 2025

New Amgen obesity drug data disappoint Wall Street

Full Phase 2 study results showed side effects that led people to stop treatment with MariTide, as well as weight loss effects that weren’t as strong as previously reported.

By Jonathan Gardner • June 24, 2025

Novo abruptly ends obesity drug deal with Hims

The Wegovy maker says the telehealth company didn't stop selling compounded versions of the blockbuster drug after Novo resolved its shortage.

By Jonathan Gardner • Updated June 23, 2025