Merck claims study success with PCSK9 cholesterol pill

Enlicitide, which could be the first oral medication that blocks the protein PCSK9, helped cut cholesterol levels in a pair of closely watched trials.

By Ben Fidler • June 9, 2025

Otsuka tops Vera with kidney drug data; Regenxbio sinks on Duchenne update

Late-stage results Otsuka presented in IgA nephropathy triggered a sell-off in Vera shares. Elsewhere, investors scrutinized Regenxbio’s Duchenne data and a brain drug study failed.

By BioPharma Dive staff • June 6, 2025

Explore the Trendline➔

Alzheimer's disease

Many companies hope to follow in the footsteps of Biogen, Eisai and Eli Lilly by developing new therapies for the debilitating disease, which affects tens of millions of people and costs healthcare systems hundreds of billions of dollars each year.

By BioPharma Dive staff

Daiichi Sankyo struck gold with ‘ADC’ cancer drugs. Its new CEO has to figure out what’s next.

Enhertu, Datroway and other antibody-drug conjugates developed by Daiichi Sankyo have made the company a leader in a competitive field. Hiroyuki Okuzawa is working to keep it that way.

By Ned Pagliarulo • June 4, 2025

Lilly partners with Camurus in search of a long-lasting obesity drug

The deal, which could be worth up to $870 million overall, will give Lilly access to a delivery technology that may help extend the durability of up to four of its weight-loss medicines.

By Kristin Jensen • June 4, 2025

Regeneron makes obesity push; Atai, Alto ink brain drug deals

Regeneron licensed a weight loss drug and revealed study data for a pair of muscle-preserving medicines. Elsewhere, two neuroscience biotechs cut deals and Bluebird officially went private.

By BioPharma Dive staff • June 4, 2025

Merck, Daiichi pull approval application for ADC in lung cancer

A therapy at the center of their $22 billion alliance failed to extend survival in a type of lung tumor, leading the companies to abandon a U.S. submission.

By Ben Fidler • May 29, 2025

[Podcast] Behind the Breakthroughs: How Almac Powers Clinical Trial Success with Care

Agile biopharma firms are driving breakthroughs. Learn how they ensure clinical trial success in this podcast.

By BioPharma Dive's studioID • May 28, 2025

Biogen strikes RNAi deal with City; Aurion withdraws IPO

City will receive $46 million from Biogen under the alliance. Elsewhere, Angelini Pharma licensed a rare disease therapy and the FDA refused to review a Savara lung drug.

By BioPharma Dive staff • May 27, 2025

Zepzelca, Tecentriq combo extends survival in hard-to-treat lung cancer

Still, the therapies’ modest benefit as a maintenance therapy points to how better treatments are needed for small cell lung cancer, according to one physician.

By Jonathan Gardner • May 22, 2025

FDA advisers pan Pfizer’s PARP drug; Sarepta to resume Duchenne study

An eight-member panel voted unanimously against wider use of Pfizer’s Talzenna in advanced prostate cancer. Elsewhere, U.K. regulators cleared Sarepta to restart an Elevidys study and Altos Labs bought a startup.

By BioPharma Dive staff • May 22, 2025

FDA panel backs Darzalex for early stage multiple myeloma

Agency drug reviewers had questioned patient risk criteria and the efficacy endpoint used in a key trial supporting J&J's drug.

By Jonathan Gardner • May 21, 2025

Tourmaline shares fall on Phase 2 data; Schrödinger cuts staff

Tourmaline Bio disclosed results for a potential rival to a Novo Nordisk drug. Elsewhere, data emerged for a psychedelic and CRISPR Therapeutics expanded its toolkit.

By BioPharma Dive staff • May 20, 2025

Pfizer buys into PD-1/VEGF competition with 3SBio deal

Pfizer will pay China’s 3SBio $1.25 billion up front to access a cancer drug that could rival Akeso and Summit’s closely watched immunotherapy ivonescimab.

By Ben Fidler • May 20, 2025

Bridging the data gaps that impact retail and specialty-lite success

Learn how to leverage predictive analytics and measure top KPIs to maximize patient outcomes, provider engagement and brand performance on this webinar from PHIL and Syneos Health.

May 19, 2025

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

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