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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...

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FDA 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

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Philadelphia 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 ...

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Eli 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...

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New 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...

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Eisai 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 ...

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Regeneron 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 ...

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Top 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...

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Kennedy adopts new chikungunya vaccine guidance, but other actions wait

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Novo 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...

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It'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...

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Novo 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 ...

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FDA 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...

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BioMarin 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...

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Mark 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...

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#ASGCT25: In three patients, Rocket’s second heart gene therapy shows promise

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#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...

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Amarin 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...

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FDA 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...

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Deputy 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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