Takeda’s first-in-class narcolepsy drug succeeds in two registrational studies
Takeda’s oral orexin agonist has cleared a pair of Phase 3 trials in a sleep disorder, marking the first late-stage win for a drug class that Wall Street analysts say has multi-billion dollar...
View ArticleFDA rejects Ultragenyx's Sanfilippo gene therapy over manufacturing issues
The FDA hit Ultragenyx with a complete response letter for its AAV gene therapy, called UX111, over manufacturing issues. However, the company believes those issues can be solved and that the therapy...
View Article#IAS25: GSK's ViiV expands licensing pact to include long-acting HIV treatment
KIGALI, RWANDA — ViiV Healthcare, the HIV-focused biotech that's majority-owned by GSK, said it's expanding its voluntary licensing agreement with the Medicines Patent Pool and three generic...
View Article#IAS25: Merck sends new monthly oral PrEP to Phase 3 after earlier islatravir...
KIGALI, RWANDA — Three years after a safety disappointment halted earlier plans for a once-monthly HIV PrEP candidate, Merck is back in the late stages of development with a next-generation effort. The...
View Article#IAS25: WHO adds Gilead's twice-yearly injection to global PrEP guidelines
KIGALI, RWANDA — Weeks after the FDA's watershed approval of Gilead's twice-yearly HIV prevention injection, the World Health Organization recommended the product to further stop the spread of HIV. The...
View ArticleBoehringer, 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...
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