Bristol Myers CEO says America’s biopharma pole position is not guaranteed
NEW YORK — Bristol Myers Squibb CEO Chris Boerner said America’s role as the global biopharma leader is at a “pivot point” as the Trump administration aims to remake the country’s institutions and...
View ArticleFDA warns Mayne Pharma over 'misleading' birth control pill claims
The FDA’s drug promotion office is calling out Australia's Mayne Pharma for making “false or misleading claims” about the benefits and risks of its birth control pill Nextstellis. The agency's
View ArticlePhiladelphia doctors treat infant with first custom CRISPR therapy that fixes...
PHILADELPHIA — Soon after Kyle Patrick Muldoon, Jr. was born in August 2024, his doctors knew something was wrong. KJ, as his parents call him, was too tired to feed, his ...
View ArticleEli Lilly teams up with RNA editing biotech for hearing loss
Eli Lilly is building out its gene therapy pipeline for hearing loss through a new deal with RNA-focused startup Rznomics. The Indianapolis drug giant and Seongnam-based biotech will work together on...
View ArticleNew CBER chief is readying 'massive framework' for vaccines, Makary says
Vinay Prasad may have just started as the new director of the FDA's biologics center, but he's "planning to unleash a massive framework" on vaccines in the "coming days," FDA Commissioner Marty Makary...
View ArticleEisai says Leqembi sales are expanding steadily in US
Eisai executives said on Thursday that Leqembi sales and shipments in the US are showing “steady growth and expansion,” just a couple months after the company slashed its 2027 sales expectations for ...
View ArticleRegeneron gets $400M+ jury win in Amgen cholesterol drug case
A Delaware jury on Thursday said Regeneron should get more than $400 million in damages in its long-running antitrust case against Amgen. Regeneron brought the case almost three years ago alleging ...
View ArticleTop RFK Jr. advisor dares drugmakers over threats to drop manufacturing promises
NEW YORK — Calley Means, a special White House employee and top advisor to HHS Secretary Robert F. Kennedy Jr., effectively dared Roche to pull its US investment after the company said it would...
View ArticleNovo Nordisk’s global obesity leader is moving on; Flagship biotech gets CEO...
→ Leo Pharma is doing an extensive revamp of its leadership team as it splits product strategy and international operations into two separate divisions. Frederik Kier, the head of the global obesity...
View ArticleIt's been three months without a biotech IPO
The last time a biotech went public on a US stock exchange, people were buying flowers for Valentine's Day. Those petals withered long ago. It's been 13 weeks since Aardvark Therapeutics' $94 million...
View ArticleNovo Nordisk CEO to step down, timeline for successor unknown
In a startling decision, Novo Nordisk CEO Lars Fruergaard Jørgensen will step down as the company deals with pressures on its stock price and GLP-1 business. Novo said Friday it started a search for J ...
View ArticleFDA lifts hold on Scynexis trial; Incyte’s Zynyz notches another FDA approval
Plus, news about vTv Therapeutics, Dynavax, Aura Biosciences and ArkBio: FDA lifts hold on Scynexis’ Phase 3 fungal infection trial: The agency concluded last month that the MARIO trial of...
View ArticleBioMarin makes Phase 3 buy, paying $270M for rare disease outfit Inozyme
BioMarin, multiple quarters into its portfolio refinement, is inking a small acquisition for a rare disease therapy about two years before a potential regulatory approval. The California drugmaker...
View ArticleMark Cuban compounder joins Trump's new manufacturing initiative
The Trump administration is partnering with Mark Cuban’s compounding business and four other entities to improve the manufacturing of eight generic drugs, in the White House's latest move to boost US...
View Article#ASGCT25: Lower conference attendance mirrors challenged cell and gene field
NEW ORLEANS — The annual American Society of Gene & Cell Therapy meeting felt quieter this year, amid federal funding cuts and a tough time for the sector as a whole. While conference organizers...
View ArticleAmarin urges Supreme Court to decline Hikma's drug label spat
The US Supreme Court should decline to review a generic drug labeling fight between Amarin and Hikma Pharmaceuticals because the case is “intensely fact-bound” and Hikma’s arguments are...
View ArticleFDA raises issues with four cancer drugs ahead of adcomm
The FDA on Friday raised efficacy, safety and trial design issues surrounding three new cancer drug indications and one new cancer drug ahead of a two-day meeting of its Oncologic Drugs Advisory...
View ArticleDeputy FDA chief mulls shaking up PDUFA reauthorization structure
The FDA is prepping to renegotiate its multibillion-dollar, quinquennial user fee agreements with the drug industry later this summer, and a new deputy commissioner on Friday suggested the structure of...
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