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FDA offers more clarity on safety testing for cell therapies
The FDA is providing sponsors of cell therapies with a new draft guidance document on the kinds of safety testing they should perform. The 14-page guidance, published late last month, provides sponsors...
View ArticleDestruction of documents, insufficient data lead FDA to reject hep B vaccine...
Dynavax’s hepatitis B vaccine was rejected for a label expansion in the US after patient data was destroyed by a third-party clinical trial site operator, the company announced Tuesday. The complete...
View ArticleAscendis’ hypoparathyroidism drug saddled with three-month delay at FDA
Ascendis Pharma will likely wait three more months to get an answer from the FDA on the review of its hypoparathyroidism drug. On Tuesday, Ascendis announced that US regulators had delayed their...
View ArticleEisai heads to FDA with subcutaneous version of Alzheimer’s treatment...
Eisai and Biogen said Tuesday that they started an application for an under-the-skin maintenance dosing version of their Alzheimer’s treatment Leqembi. The subcutaneous submission was expected earlier...
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BioMarin to lay off 170 staffers after pipeline reorg
Less than a month after revealing pipeline cuts amid disappointing gene therapy sales, BioMarin is now downsizing its team. The biotech said it will lay off about 170 workers worldwide after recent...
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Bolt Biotherapeutics revamps as it drops lead cancer asset, changes CEO and...
Bolt Biotherapeutics is reshuffling to cut costs and extend its cash runway to the second half of 2026. The California biotech said Tuesday afternoon that it is dropping its lead oncology asset, as...
View ArticleEisai projects near-term Leqembi sales 'considerably higher' than analyst...
Eisai is hoping to grow Leqembi sales 13-fold to around $360 million in fiscal year 2024, as it plans “aggressive investment” and looks to expand its Biogen-partnered Alzheimer’s drug’s market both in...
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Updated: Blackstone commits $300M to a former Merck antibody for asthma, COPD
Blackstone’s next major bet is on a former Merck monoclonal antibody for atopic dermatitis that a new biotech will test for asthma and COPD. The alternative asset manager’s life sciences division,...
View ArticleMerck KGaA stays positive on CDMO arm’s future despite first-quarter slump
Merck KGaA’s revenue from its CDMO arm dropped in the first quarter due to customer destocking, but it still expects business to pick up in the second half of the year due to the timing of customer...
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Researchers consider why Wegovy provides heart benefits beyond weight loss
The cardiovascular benefits of Novo Nordisk’s blockbuster weight loss drug Wegovy are not dependent on the amount of weight patients lost, according to a new analysis. The findings from the analysis of...
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GoodRx gets back in Kroger's good graces, will work directly with grocer
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) GoodRx said on Wednesday that it has won back its relationship with Kroger to offer prescription...
View ArticleAdaptimmune’s debt financing deal; Tenaya to cut workers
Plus, news about Brixton Biosciences, Merck KGaA, Medincell, CellProthera and GSK: Adaptimmune inks up to $125M debt financing: The biotech gets $25 million to start as it prepares for a commercial...
View ArticleICER raises questions over Lykos’ MDMA studies as adcomm looms
The Institute for Clinical and Economic Review said it cannot fairly judge Lykos Therapeutics’ MDMA-assisted therapy for post-traumatic stress disorder because of concerns about certain elements of its...
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LG spins off a new business that bets big on health software
(This story is from our new Health Tech newsletter. If you’d like to sign up, just click here.) Electronics giant LG on Monday launched a spinoff business in a bid to branch out and make money from...
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House committee advances bipartisan bill targeting Chinese biotech suppliers
A bill that would effectively force dozens of biopharma companies to cut ties with WuXi AppTec and four other Chinese biotech suppliers by 2032 advanced with bipartisan support in the House Oversight...
View ArticleWHO prequalifies Takeda's dengue vaccine Qdenga
The World Health Organization prequalified Takeda’s new dengue vaccine on Wednesday, a year after the company withdrew its FDA application for the candidate — though the company now says it will soon...
View ArticleEli Lilly settles with medical spa over its marketing of compounded tirzepatide
Eli Lilly reached a settlement with a South Carolina medical spa, marking a win in a broader legal campaign against how compounders have marketed versions of its diabetes and weight loss products....
View ArticleBeiGene looks at new partnerships, with a full cancer pipeline and growing...
Less than a year after the end of a PD-1 deal with Novartis, BeiGene is looking at new partnerships that could bring in new assets it could develop or commercialize, or out-license some of its...
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Aiming to decentralize CAR-T manufacturing, Galapagos partners with largest...
Galapagos is teaming up with the US’s largest blood supply group to try to establish a nationwide network of decentralized CAR-T manufacturing. The partnership with Blood Centers of America, or BCA,...
View ArticleRoche teases 'encouraging' Phase 1 data for weight loss drug from $2.7B...
Roche offered a glimpse at promising early efficacy data on Thursday morning from a GLP-1/GIP agonist it obtained as part of its $2.7 billion acquisition of Carmot Therapeutics. In a Phase 1 trial...
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