Regeneron defeats Amgen in PCSK9 case; 2 cell therapy biotechs cut staff

A federal jury found Amgen liable for violating antitrust and tort laws. Elsewhere, Allogene and Kyverna trimmed staff and the FDA scheduled an advisory meeting.

By Ben Fidler • May 16, 2025

Novo CEO to depart as obesity drugmaker’s challenges rise

Lars Fruergaard Jørgensen will step down after eight years helming the Danish drugmaker, shares of which have shed half their value in the past 12 months.

By Ned Pagliarulo • Updated May 16, 2025

Explore the Trendline➔

The expanding world of RNA therapies

Medicines from Alnylam, Ionis, Moderna and others have proven the power of RNA in medicine. A growing field of startups is advancing alongside them.

By BioPharma Dive staff

Sanofi to pour more than $20B into US drug research and manufacturing

The French drugmaker joined several peers in promising new investments in U.S. drug production, but cautioned plans could change amid shifting Trump administration policies.

By Kristin Jensen • May 15, 2025

Stopping a ‘moral obscenity’: Senate Judiciary Committee expresses support for PBM reform

Sen. Chuck Grassley, R-Iowa, suggested Congress could once again move to overhaul PBMs’ controversial business practices after legislators pass President Donald Trump’s conservative megabill this summer.

By Rebecca Pifer • May 15, 2025

Trump revives ‘most favored nation’ plan in effort to cut US drug prices

The proposal would see the HHS set price targets other countries pay for certain medicines, kicking off a round of discussions with substantial ramifications for drugmakers. It’s likely to be challenged in court, however.

By Jonathan Gardner , Ned Pagliarulo • Updated May 12, 2025

Eli Lilly extends Purdue alliance; EMA investigates Valneva shot

The big pharma will spend up to $250 million over the next eight years of the collaboration. Elsewhere, CRISPR Therapeutics unveiled new data and Vivo Capital raised funds.

By BioPharma Dive staff • May 9, 2025

Gilead, bracing for tariffs, joins peers in US drug production push

The company added to a recent flurry of pledges by pharmaceutical companies, promising $11 billion in new capital and operational investments in U.S. drug manufacturing.

By Kristin Jensen • May 8, 2025

Novo cuts forecasts as compounded GLP-1s weigh on sales

The maker of Ozempic and Wegovy expects lower sales and profit growth this year despite recent victories against compounders.

By Ned Pagliarulo • May 7, 2025

Trump orders FDA to help speed building of new drug factories

Yet regulatory relief for U.S. expansion could be accompanied by new tariffs and drug pricing rules.

By Jonathan Gardner • May 6, 2025

Bluebird pleads for deal support; Unity, Mersana lay off staff

Bluebird urged shareholders to back a take-private deal that could close imminently. Elsewhere, Unity Biotechnology began a strategic review and Mersana announced plans to cut more than half its workforce.

By BioPharma Dive staff • May 6, 2025

Amgen’s Stelara biosimilar gets off to fast start

Sales of the company’s copycat to J&J’s blockbuster reached $150 million in the first quarter, adding to a surge in revenue for Amgen's biosimilar business.

By Jonathan Gardner • May 2, 2025

Pharma downplays tariff threat, even as risks remain unclear

Drugmaker executives have projected confidence they can mitigate the impact of any levies Trump imposes on the industry. Yet they're adjusting inventory and production nonetheless.

By Ned Pagliarulo , Jonathan Gardner • May 1, 2025

CVS strikes Wegovy deal with Novo Nordisk

The deal could expand access to its in-demand obesity drug at the expense of Eli Lilly, whose shares fell by double digits on Thursday.

By Rebecca Pifer • May 1, 2025

AstraZeneca quietly exits neuroscience

The company removed experimental drugs for Alzheimer’s, migraine and pain from its pipeline to focus more resources on “core therapeutic areas” and “high value” programs.

By Jacob Bell • May 1, 2025

J&J secures FDA OK for immune drug touted as future blockbuster

The company has predicted that Imaavy — now approved for myasthenia gravis — could eventually earn more than $5 billion in annual sales at its peak.

By Ned Pagliarulo • April 30, 2025

Pfizer’s Bourla ‘cautiously optimistic’ on looming US pharma tariffs

The company’s CEO said he’s had “productive discussions” with Trump administration officials on a recently launched trade probe.

By Ned Pagliarulo • Updated April 30, 2025

Novavax says vaccine application still ‘approvable,’ despite FDA delay

Comments over the weekend by FDA chief Martin Makary suggest the agency views Novavax’s updated COVID shot as a “new product” requiring additional clinical study.

By Delilah Alvarado • April 28, 2025

Merck KGaA to buy biotech SpringWorks for $3.9B

The deal, which has been in the works for months, hands the German pharmaceutical company two approved drugs for rare tumors.

By Ned Pagliarulo • April 28, 2025

Top Republican calls for 340B reform in long-awaited investigation

Sen. Bill Cassidy’s report calls on Congress to improve the transparency of the drug discount program in a move praised by pharmaceutical companies and criticized by hospitals.

By Emily Olsen • April 28, 2025

How integrated real-world data helps identify and improve outcomes for rare disease patients

Pharmaceutical companies are turning to integrated RWD approaches to overcome challenges in rare disease research.

By Ilan Behm • April 28, 2025

Halozyme sues Merck; FDA blames cuts for Vanda delay

Halozyme claims Merck infringed on patents in developing a subcutaneous form of Keytruda. Elsewhere, Vanda’s challenge to an FDA rejection dragged on, while Sanofi revealed an immune drug setback. 

By BioPharma Dive staff • April 25, 2025

Bristol Myers says schizophrenia drug launch ‘off to a solid start’

Net sales of Cobenfy, whose success is imperative for Bristol Myers, totaled $27 million in the first quarter, handily beating Wall Street expectations.

By Jacob Bell • April 24, 2025

Merck takes $200M tariff hit, trimming its gross profits

The drugmaker absorbed additional tariff-related costs in the first quarter, but has taken steps to lower the financial impact it’ll have for the rest of the year and beyond. 

By Jonathan Gardner • April 24, 2025

Sanofi stays on course amid tariff turmoil

The company reiterated its financial outlook for the year but is struggling to predict the likely impact of pharmaceutical tariffs given their “speculative” nature, its CFO told analysts. 

By Kristin Jensen • April 24, 2025

Bristol Myers’ prized schizophrenia drug stumbles in testing

A late-stage study found Cobenfy wasn’t better than a placebo as an add-on to atypical antipsychotics. Some analysts view the failure as a “significant hit” to the drug’s commercial outlook.

By Jacob Bell • April 23, 2025