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

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

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 • 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

Amgen says Imdelltra extended survival; Parker Institute adds new leaders

The bispecific antibody helped people with small cell lung cancer live longer, Amgen said. Elsewhere, J&J shared new autoimmune drug data and Alzheon reported an Alzheimer’s drug failure.

By BioPharma Dive staff • April 11, 2025

Amid tariff turmoil, Novartis commits to spending $23B on US manufacturing

Novartis expects the new capacity will allow it to produce all of its key medicines “end to end” in the U.S., as the Trump administration buffets global trade with tariffs.

By Jonathan Gardner • April 10, 2025

Ferring gene therapy sales grow; ASH calls for restoration of cut CDC division

In its first full year on the U.S. market, bladder cancer treatment Adstiladrin earned about $77 million. Elsewhere, Lilly backed a cancer drug startup and Bristol Myers won a new Opdivo approval.

By BioPharma Dive staff • April 9, 2025

Trump says ‘major’ tariffs coming on pharmaceuticals

Shares in many large drugmakers initially fell Wednesday on the president's threat, only to rebound later when he announced a 90-day pause.

By Kristin Jensen • April 9, 2025

Trial monitors recommend Elevidys studies continue; Novartis kidney drug approved

Sarepta and Roche will share the monitors' findings with EMA to resolve a temporary hold. Elsewhere, Allakos agreed to a buyout and high-dose Ocrevus missed a study goal.

By BioPharma Dive staff • April 4, 2025

M&A recap: Big pharma starts the year mostly avoiding billion-dollar deals

Just two acquisitions in the first quarter, that of Intra-Cellular Therapies and IDRx, crossed the $1 billion mark, a notable decrease from the six seen during the same period last year.

By Jacob Bell • April 4, 2025

Roche halts testing of Sarepta Duchenne gene therapy in Europe

The Swiss drugmaker, which holds European rights to Elevidys, suspended three trials while researchers investigate the death of a young man who died following treatment.

By Kristin Jensen • April 3, 2025

Leqembi’s EU review drags on; Sanofi gets a new development head

The European Commission has referred Eisai and Biogen’s application to an appeals committee. Elsewhere, Opthea warned of insolvency and Novartis hired a new top lawyer.

By BioPharma Dive staff • April 2, 2025

FDA broadens use of Novartis’ radiopharma drug Pluvicto

Pluvicto can now be used before chemotherapy to treat a kind of metastatic prostate cancer, tripling the number of patients who are eligible for treatment.

By Ned Pagliarulo • March 28, 2025

FDA approves first-of-its-kind antibiotic from GSK

The drug is a needed new option for treating uncomplicated UTIs, a common infection that’s becoming harder to treat as rates of microbial resistance rise.

By Delilah Alvarado • March 26, 2025