Boehringer, LEO ink deal for IL-36 drug; Bayer’s Kerendia gets another...
Plus, news about Illimis Therapeutics and Azurity: Boehringer Ingelheim, LEO Pharma sign €90M upfront pact: The deal focuses on Spevigo, an IL-36 drug approved to treat generalized pustular psoriasis....
View ArticleAnne Wojcicki's nonprofit completes acquisition of 23andMe assets
At long last, Anne Wojcicki has officially bought 23andMe. The co-founder and former CEO's nonprofit, TTAM Research Institute, on Monday said it had completed the acquisition of 23andMe's consumer...
View ArticleMakary pushes for lower user fees as agency kicks off PDUFA negotiations
FDA Commissioner Marty Makary said that PDUFA, the every-five-years law that governs agency-industry interactions, has largely been working as intended, though he would like to lower user fees. Known...
View ArticleJudge rejects AbbVie’s fight against Missouri 340B contract pharmacy law
AbbVie failed to convince a judge to strike down a Missouri law regulating 340B discounts, marking the second setback in two weeks in the drugmaker’s fight against alleged abuses in the federal...
View ArticleFDA employees let go in April receive final termination notices
As many as 3,500 FDA employees received an email Monday evening informing them that they have been officially fired, an HHS spokesperson confirmed to Endpoints News. The layoffs, first announced on...
View ArticleUpdated: Hengrui plans China filing for obesity shot following pivotal success
Jiangsu Hengrui Pharmaceuticals’ injected GLP-1/GIP agonist helped obese patients in a China-based trial lose around 18% of their weight after around 11 months’ treatment, Hengrui and its US partner...
View ArticleThe Trump administration disbanded a federal newborn screening panel....
Patient groups face a harder and unpredictable path going state-by-state to boost screening for rare but treatable conditions after the Trump administration disbanded a federal advisory committee on...
View ArticleOtsuka buys immunology drugs; JCR, Acumen team up on Alzheimer’s program
Plus, news about UTEC, Sellas and Oncomatryx Biopharma: Otsuka acquires immunology drugs from Cantargia: The agreement will send early-stage CAN10 and preclinical 3G5 to Otsuka for $33 million upfront....
View ArticleLabcorp drums up competition for health testing startups
Health testing startups like Function Health and Superpower are about to face more competition — and it’s the very type of business they depend on that’s drumming it up. A few weeks ago, Labcorp...
View ArticleMerck's partner LaNova Medicines is acquired for $951M by Sino Biopharmaceutical
One of Merck’s most prominent partners just got acquired. LaNova Medicines is being bought out by Hong Kong-based Sino Biopharmaceutical for $950.9 million, Sino announced Tuesday morning. Sino took a...
View ArticleFDA questions the return of GSK's Blenrep in multiple myeloma ahead of adcomm
The FDA is questioning whether GSK has done enough to show that Blenrep should return to the market as a second-line multiple myeloma treatment ahead of a Thursday advisory committee meeting. Agency...
View ArticlePrasad overrode FDA vaccine reviewers on Moderna's Covid shot for young kids
The FDA's vaccines and biologics chief Vinay Prasad overrode the agency's vaccine reviewers for a third time in recent weeks, when he narrowed the approval of Moderna’s Covid-19 shot to a smaller...
View ArticleGenBioPro loses bid to overturn West Virginia anti-abortion law
West Virginia’s near-total abortion ban doesn’t conflict with the FDA’s authority to regulate mifepristone, a federal appeals court ruled Tuesday in a case against the generic abortion pill maker. The
View ArticleAbout 2.5% of all drug patents cite government funding, new study finds
Of the nearly 10,000 patents protecting small molecule drugs and listed in the FDA's Orange Book, 2.5% cite government funding, according to a new study published in Nature Biotechnology on Tuesday ...
View ArticleBMS warns against ‘indiscriminate use’ of renegotiations as CMS plans next...
Bristol Myers Squibb is calling for transparency in drug price talks if the government selects products for renegotiation under the Inflation Reduction Act, cautioning against “indiscriminate use” of...
View Article#IAS25: As PEPFAR funding gets congressional support, HIV leaders warn of...
KIGALI, RWANDA — The opening night message was clear. “UNAIDS warns that if urgent steps are not taken, we may find ourselves back in the dismal era of 2000. We must all agree here today ...
View ArticleDebiopharm licenses Repare’s first-in-class cancer drug for $10M upfront
Debiopharm is spending $10 million in cash on a cancer drug developed by its partner Repare Therapeutics. Debiopharm will get global rights to lunresertib, a first-in-class PKMYT1 inhibitor. Repare...
View ArticleAstraZeneca says amyloidosis drug anselamimab failed in Phase 3 trials
Last year, AstraZeneca predicted that its drug for the rare disease light chain amyloidosis could have peak revenue of up to $3 billion. But after Wednesday, that forecast will surely be revised...
View ArticleJ&J's Stelara faces continued biosimilar competition, with Q2 revenue falling...
Johnson & Johnson said revenue for its megablockbuster Stelara continued to decline in the face of emerging biosimilar competition. The company said Tuesday that global sales of Stelara were down...
View Article#IAS25: Jeanne Marrazzo, NIAID director placed on leave, on 'biggest threats'...
KIGALI, RWANDA — A federal health official put on leave by the Trump administration is calling for sustained investment in HIV research. The remarks are some of the first that Jeanne Marrazzo has...
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