Stoke CEO exits; Medicare drug price talks advance

Ed Kaye, Stoke’s longtime leader, will be replaced by former Vertex executive Ian Smith. Elsewhere, all 12 drugmakers targeted for second round of Medicare price talks agreed to participate.

By BioPharma Dive staff • March 18, 2025

AstraZeneca adds ‘in vivo’ cell therapy capabilities with EsoBiotech deal

The pharma is paying up to $1 billion to buy the Belgian startup, whose technology it sees as useful in treating cancer and autoimmune conditions.

By Ben Fidler • March 17, 2025

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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

Makary advances to full senate vote; Acelyrin, Pliant adopt ‘poison pills’

President Trump’s nominee to run the FDA secured the Senate HELP Committee’s backing. Elsewhere, Sutro cut jobs and a cell and gene therapy pilot appeared to survive.

By BioPharma Dive staff • March 14, 2025

Mallinckrodt, Endo to combine in $7B deal

The merger will give the combined entity the financial flexibility to pursue drug licensing deals and broaden its therapeutic focus, executives said on a conference call.

By Kristin Jensen • March 13, 2025

A new obesity biotech launches; Gilead plans to quickly advance once-yearly PrEP for HIV

Harbour BioMed created Élancé Therapeutics to develop bispecific antibody drugs for weight loss. Elsewhere, Geron’s CEO is departing after 14 years.

By BioPharma Dive staff • March 12, 2025

IRA reforms could be on the table. Will Trump and the GOP pursue them?

Industry insiders are pushing to fix the small molecule ‘penalty’ by setting their hopes on a Republican majority.

By Amy Baxter • March 12, 2025

Novo’s Wegovy successor disappoints in second large trial

A study in people with obesity and diabetes again found CagriSema helps people lose weight, but not by enough to clearly surpass Eli Lilly’s Zepbound.

By Jonathan Gardner • March 10, 2025

J&J scraps depression testing for potential blockbuster drug

Analysts say the decision is a “big blow” to a once-promising class of brain therapies that include’s J&J’s aticaprant and a drug from Neumora.

By Jacob Bell • March 7, 2025

Roche launches new Boston center; NIH centralizes peer review

The Swiss pharma will base cardiometabolic drug research at the new Allston site. Elsewhere, AskBio, Bayer’s gene therapy subsidiary, advanced an experimental treatment for limb-girdle muscular dystrophy. 

By BioPharma Dive staff • March 7, 2025

Amgen readies pivotal MariTide trials; Novo offers discounted Wegovy

Phase 3 studies for Amgen’s closely watched obesity drug were posted on a federal database. Elsewhere, the FDA cleared for testing a first-of-its-kind base editing therapy for Duchenne.

By BioPharma Dive staff • March 6, 2025

Bayer braces for ‘difficult’ year before turnaround pays dividends

CEO Bill Anderson warned investors that profits will decline in 2025 before the company’s ongoing shake-up leads to an “improved trajectory” next year. 

By Kristin Jensen • March 5, 2025

Trump administration policies could create headwinds across healthcare: Fitch

The administration’s initiatives could negatively impact the credit ratings of an array of companies, among them large drugmakers, Fitch said. 

By Susanna Vogel • March 4, 2025

Neumora bids farewell to R&D head; Biohaven’s ‘one step forward, one step back’ data

Robert Lenz is leaving the brain drug developer to “pursue other interests.” Elsewhere, Atara is cutting half of its staff after shelving two cell therapy programs.

By BioPharma Dive staff • March 4, 2025

Leqembi, after delay, gets back on track toward EU approval

European regulators “reaffirmed” a positive view of Eisai and Biogen’s Alzheimer’s drug after conducting a new safety review.

By Jonathan Gardner • Feb. 28, 2025

Praxis hits trial setback; Bristol Myers lays off staff in New Jersey

The brain drug developer is continuing a trial despite a recommendation it be stopped for futility. Elsewhere, Eli Lilly struck a molecular glue deal and Zevra sold a priority review voucher.

By BioPharma Dive staff • Feb. 28, 2025

Lilly CEO wields manufacturing plans to push pharma-friendly policies

While announcing billions of dollars in new U.S. investments, David Ricks called for an extension of 2017 tax cuts and changes to Medicare's drug negotiation program.

By Ned Pagliarulo • Feb. 26, 2025

AstraZeneca’s next breast cancer drug; Madrigal’s accelerating MASH launch

The British drugmaker claimed success in a first-line breast cancer study. Elsewhere, Rezdiffra sales continued to grow and a cancer biotech cut staff.

By BioPharma Dive staff • Feb. 26, 2025

Lilly expands US manufacturing build-out with $50B target

The company is doubling plans for capital spending on U.S. factories as President Donald Trump pressures the pharma industry to reshore drug production.

By Ned Pagliarulo • Feb. 26, 2025

Summit partners with Pfizer to study bispecific, ADC combinations

The partners will test Summit’s ivonescimab alongside Pfizer’s antibody-drug conjugates in hopes of finding “potentially landscape-changing combinations.”

By Jonathan Gardner • Feb. 24, 2025

Pfizer names Patrizia Cavazzoni, former top FDA official, as chief medical officer

Cavazzoni stepped down from her role as head of the FDA’s main drug review office in mid-January. She will succeed Aida Habtezion.

By Ned Pagliarulo • Feb. 24, 2025

Ozempic, Wegovy shortage resolved; Pfizer CEO is PhRMA’s new chair

The FDA determined that Novo Nordisk’s obesity and diabetes drugs are no longer in short supply. Elsewhere, Concentra made a competing bid for Acelyrin and Intra-Cellular sales rose.

By BioPharma Dive staff • Updated Feb. 24, 2025

Pfizer stops selling hemophilia gene therapy, citing weak demand

Pfizer’s decision to halt further marketing of Beqvez is further sign of the sparse patient interest in gene therapies for the bleeding condition.

By Ned Pagliarulo • Feb. 21, 2025

AstraZeneca deepens China presence with FibroGen deal

The $160 million acquisition of a FibroGen subsidiary expands AstraZeneca’s foothold in China while the company works through government investigations into its business practices there. 

By Kristin Jensen • Feb. 20, 2025

Sanofi reaches consumer health deal; Supernus antidepressant fails study

The pharma signed an agreement handing PE firm CD&R a 50% stake in its Capella unit. Elsewhere, Ultragenyx secured a PDUFA date for its Sanfilippo gene therapy.

By BioPharma Dive staff • Feb. 19, 2025

FTC retains stricter merger guidelines under Trump

Agency chair Andrew Ferguson sent a memo to staff on Tuesday clarifying that Biden-era guidelines will remain in place — for now.

By Rebecca Pifer Parduhn • Feb. 19, 2025