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

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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

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

Sanofi licenses immune disease drugs from startup Earendil

The startup, affiliated with China-based antibody designer Helixon Therapeutics, is developing bispecific drugs aimed at multiple popular immune disease targets, such as TL1A and IL23. 

By Kristin Jensen • April 17, 2025

CDC panel backs broader use of RSV shots

The committee endorsed lowering the age at which some people can receive RSV vaccines, but stopped short of recommending booster shots.

By Delilah Alvarado • April 17, 2025

Leqembi finally secures EU clearance; Sandoz sues Amgen over Enbrel patents

After a lengthy regulatory back-and-forth, Eisai and Biogen's Alzheimer's drug is on the market in Europe. Elsewhere, Sarepta will start testing a new gene therapy for limb-girdle muscular dystrophy.

By BioPharma Dive staff • April 16, 2025

J&J keeps forecasts steady as pharma confronts tariff threat

While J&J expects tariffs will cost it $400 million this year, the company maintained its earnings estimate and upped its sales guidance for 2025.

By Ned Pagliarulo • April 15, 2025

Bristol Myers stumbles in bid to widen heart drug’s use

Camzyos’ failure in a form of hypertrophic cardiomyopathy dampened its commercial outlook and spurred debate as to whether other drugs like it would similarly struggle in testing.

By Ben Fidler • April 15, 2025

US launches probe that could set stage for pharma tariffs

The Commerce Department has begun a so-called Section 232 investigation into the national security effects of the U.S. importing pharmaceuticals and their starting materials.

By Ned Pagliarulo • Updated April 14, 2025

Safety worries spur Pfizer to drop another obesity pill

Signs of potential liver damage in a study participant led the company to abandon danuglipron, a drug it hoped would help it break into the highly lucrative market for obesity drugs.

By Jonathan Gardner • April 14, 2025

Pharma bosses face down investor angst on tariffs, HHS chaos

As first quarter earnings begin, executives are confronting market turmoil, regulatory instability and the threat of U.S. tariffs on their products.

By Ned Pagliarulo • April 14, 2025

Mining the hidden gems in unstructured EMR data

With AI, the rich details hidden in unstructured clinical data are now available for analysis.

By Ilan Behm, VP of Real-World Data Engagement, Norstella • April 14, 2025