Lilly’s Omvoh approved by FDA for Crohn’s

The clearance broadens use of Omvoh, which is part of a slate of new medicines Lilly is counting on to build on its success in diabetes and obesity. 

By Kristin Jensen • Jan. 16, 2025

JPM25: The FDA’s future, AbbVie’s second thoughts and Lilly’s lesson

AbbVie's CEO hinted his company may be less willing to invest in psychiatry, while Lilly explained what it got wrong forecasting GLP-1 drug demand.

By Gwendolyn Wu , Jonathan Gardner , Ned Pagliarulo • Jan. 16, 2025

Explore the Trendline➔

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

J&J files a potential blockbuster; Lykos shakes up its board

The pharma began submitting its TAR-200 bladder cancer treatment to the FDA. Elsewhere, Sarepta and Madrigal reported strong revenue numbers, while Bausch + Lomb made an acquisition.

By BioPharma Dive team • Jan. 15, 2025

JPM25: Amgen’s defense, Merck’s patent ‘hill’ and Viking’s long-term planning

Executives at Amgen made the case for MariTide's differentiation, while Merck's CEO contended Keytruda's coming loss of exclusivity can be managed.

By Ben Fidler , Gwendolyn Wu , Jonathan Gardner • Jan. 14, 2025

Lilly blames slower-than-expected growth for 2024 sales miss

The company said it overestimated demand of its obesity and diabetes drugs in the fourth quarter, but projected a further ramp-up in sales this year.

By Jonathan Gardner • Jan. 14, 2025

JPM25: Deals, Summit’s bravado and gene therapy headwinds

Drug executives talked M&A and the incoming administration, but also weighed the outlook for cell and gene therapy developers after a difficult year. 

By Ben Fidler , Delilah Alvarado , Gwendolyn Wu • Updated Jan. 14, 2025

J&J to buy psychiatric drug developer Intra-Cellular for $14.6B

Intra-Cellular has had success selling Caplyta, a brain-rebalancing drug that's approved to treat schizophrenia and bipolar depression.

By Ned Pagliarulo , Jacob Bell • Updated Jan. 13, 2025

Lack of regulatory harmonization and other challenges facing clinical services organizations in the APAC market

How clinical services organizations are overcoming challenges in the APAC market.

Jan. 13, 2025

Pfizer’s PD-1 drug succeeds; AbbVie writes down $3.5B in Cerevel assets

Sasanlimab, a subcutaneous immunotherapy developed by Pfizer, could help treat bladder cancer. Elsewhere, Royalty Pharma moved to simplify its corporate structure and Biogen made another hire.

By BioPharma Dive staff • Jan. 10, 2025

5 questions facing pharma in 2025

Political and economic uncertainty hangs over the industry, while major bets on metabolic and immune disease drug research are set to play out.

By Ned Pagliarulo , Jonathan Gardner , Delilah Alvarado • Jan. 9, 2025

Bayer says menopause drug succeeds in breast cancer study

The results suggest Bayer’s elinzanetant may help a broader group of women with vasomotor symptoms, which are associated with menopause as well as a common breast cancer therapy.

By Delilah Alvarado • Jan. 9, 2025

FDA adds warning to RSV shots from GSK, Pfizer

The regulator is requiring labeling that warns of Guillan-Barré syndrome, although it said data don’t prove a causal link and affirmed the shots’ benefit outweighs their risks.

By Delilah Alvarado • Jan. 8, 2025

Tenvie raises $200M for brain drug R&D; Sana spikes on single patient’s results

The Arch-backed startup begins life with several assets acquired from Denali Therapeutics. Elsewhere, Jasper got a negative reaction to data for its hives drug and Stoke finalized Phase 3 trial plans.

By BioPharma Dive staff • Jan. 8, 2025

An evolution in leadership and vision for this pharma company

Esperion CEO Sheldon Koenig reflects on personal challenges and advancing innovative heart therapies.

Jan. 6, 2025

Pfizer exits Sangamo pact; Roche, Ideaya strike ADC deals

Sangamo shares fell on Pfizer’s decision to hand back rights to a hemophilia gene therapy. Elsewhere, Novartis got long-awaited data and BioNTech settled with the NIH.

By BioPharma Dive staff • Jan. 2, 2025

Ionis gets a milestone approval; Another top FDA official to step down

The clearance of Tryngolza gives Ionis its first wholly-owned, marketed medicine. Elsewhere, Robert Temple became the latest FDA leader to leave the agency, and two biotechs cut research deals.

By BioPharma Dive staff • Dec. 20, 2024

Novo’s next-gen obesity drug misses expectations in closely watched trial

Novo shares lost nearly a fifth of their value after an experimental combination treatment called cagrisema fell short of the bar set by executives.  

By Jonathan Gardner • Updated Dec. 20, 2024

Regeneron says study data support big bet on new blood thinners

The company is planning a “broad Phase 3 program” for two anticoagulants after they outperformed marketed medicines in a pair of mid-stage trials. 

By Jonathan Gardner • Dec. 19, 2024

Novartis shutters MorphoSys sites, lays off staff

While the pharma is still developing a MorphoSys drug acquired in its $2.9 billion deal for the biotech, it is closing down sites in the U.S. and Germany.

By Delilah Alvarado • Dec. 19, 2024

Merck moves into obesity with deal for Hansoh’s GLP-1 pill

News of Merck’s licensing of Hansoh’s preclinical medicine pressured shares in Viking and other obesity drug developers seen as likely buyout targets.

By Jonathan Gardner • Dec. 18, 2024

Tessera gets sickle cell funding; Corvus shares slide on eczema data

The Bill & Melinda Gates Foundation will invest up to $50 million in Tessera’s in vivo sickle cell therapy. Elsewhere, Cara agreed to a reverse merger and J&J had a drug application rejected.

By BioPharma Dive staff • Dec. 18, 2024

Pfizer predicts stability, to Wall Street’s relief

The company forecast revenue next year will grow slightly versus this year, when excluding certain factors. “The uncertainty caused by COVID [is] mostly resolved,” its CFO said.

By Ned Pagliarulo • Dec. 17, 2024

Sanofi, Teva say study results show gut disease drug could be ‘best in class’

Phase 2 results in inflammatory bowel disease hinted the therapy could be more potent than similar medicines from Merck and Roche, each of which were acquired in multibillion-dollar deals.

By Ben Fidler • Dec. 17, 2024

Novo builds up manufacturing; Pepgen Duchenne trial put on hold

Novo Nordisk is investing more than $1 billion in a new production facility in Denmark. Elsewhere, drugs from Neurocrine Biosciences, Checkpoint and Galderma won new FDA approvals.

By BioPharma Dive staff • Dec. 16, 2024

Merck calls quits on two immunotherapies for cancer

The company is scrapping two drugs aimed at targets called TIGIT and LAG-3, both of which were in the middle of Phase 3 testing.

By Jonathan Gardner • Dec. 16, 2024