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

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Top 5 stories from BioPharma Dive

Looming patent expiries this decade and intensifying competition from China are forcing drugmakers to adapt, while new opportunities open up in oncology and in neuroscience.

By BioPharma Dive staff

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 Parduhn • 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

Roche, answering tariff threat, pledges $50B to US drug production

The big pharma joined several of its peers in committing to invest billions of dollars in new and expanded manufacturing facilities in the U.S., among them a gene therapy plant in Pennsylvania.

By Jonathan Gardner • April 22, 2025

RFK Jr. is remaking HHS. Track the changes here.

Following an executive order from President Trump, the FDA plans to “aggressively deploy its available enforcement tools” to police direct-to-consumer drug ads.

By BioPharma Dive staff • Updated Aug. 28, 2025

Arkansas passes law banning PBMs from owning pharmacies

The law in particular will affect CVS and UnitedHealth, both of which operate physical pharmacies in the state along with specialty and mail-order pharmacy businesses.

By Rebecca Pifer Parduhn • April 22, 2025

Enhertu combo tops standard drugs in first-line HER2 breast cancer

The data could help the Enhertu regimen overtake a drug combination that’s been used as the initial treatment for HER2-positive breast tumors for more than a decade.

By Ben Fidler • April 21, 2025

GSK prepares to relaunch Blenrep; Activists challenge another ‘zombie’ biotech

U.K. regulators cleared a multiple myeloma drug GSK withdrew from market three years ago. Elsewhere, RNA editing startup Airna tapped a former Sarepta executive to oversee its pipeline.

By BioPharma Dive staff • April 18, 2025

Lilly’s obesity pill scores in large diabetes trial

The drug, orforglipron, helped people with diabetes reduce their blood sugar levels while spurring significant weight loss, swelling Lilly's market value by more than $100 billion.

By Jonathan Gardner • Updated April 21, 2025