FDA rejects Astellas' effort to support longer use of Izervay
The FDA has denied Astellas’ attempt to bolster the label for its vision loss treatment Izervay with additional two-year data. Izervay, the centerpiece of Astellas’ $5.9 billion acquisition of Iveric...
View ArticleNICE has 'done all we can' to negotiate for Enhertu coverage
The UK's drug pricing body has affirmed its earlier decision not to recommend coverage of AstraZeneca and Daiichi Sankyo’s breast cancer treatment Enhertu. “As we’ve always made clear, the fastest and...
View ArticleGSK plots regulatory filings for PBC itch after positive Phase 3 readout
GSK’s linerixibat helped reduce itch in patients with a rare bile duct disease, meeting its primary endpoint in a late-stage trial. If approved, linerixibat would be the first drug on the US market to...
View ArticlePfizer partners with two more Flagship biotechs on obesity, cancer
Pfizer is enlisting another Flagship startup to help it create new obesity medicines. After June's ProFound Therapeutics tie-up, Pfizer will work with the incubator's Ampersand Biomedicines in the hunt...
View ArticleExclusive: Former Pfizer commercial chief Angela Hwang to join Flagship
Former Pfizer exec Angela Hwang is joining Flagship Pioneering as a CEO-partner and chief executive of its startup Metaphore Biotechnologies on Jan. 1, the incubator exclusively told Endpoints News....
View ArticleCarolyn Bertozzi’s new biotech debuts with $30M for immunotherapy work
Valora Therapeutics has $30 million to jump-start research on immunotherapies based on sugars — the kind that dots cell surfaces and helps devastating cancers evade immune system attacks. The San Diego...
View ArticlePfizer taps oncology head Boshoff as Dolsten's chief scientific officer...
Chris Boshoff, the head of Pfizer's cancer R&D unit, will become the pharma giant's new chief scientific officer and president of R&D on Jan. 1, the drugmaker said Wednesday morning. ...
View ArticleUpdated: Sage reports Phase 2 failure in Huntington's disease, ends drug's...
Sage’s final hope to turn its business around has failed, leaving the future of the once high-flying company and its postpartum depression drug uncertain. The company announced Wednesday morning that a...
View Article23andMe inks new research partnership as it winds down internal drug...
23andMe has notched a research partnership with Mirador Therapeutics to provide the biotech company with access to its trove of genetic data. Mirador, which launched with more than $400 million in...
View ArticleNovo and Viking present new MASH data, but analysts remain confident in...
Novo Nordisk and Viking Therapeutics took to the annual Liver Meeting to make the case for their experimental MASH drugs as they chase Madrigal Pharmaceuticals' first-ever approved treatment for the...
View ArticleWhen generative AI meets the FDA: First digital health adcomm kicks off...
How to regulate generative AI was the central topic of the inaugural two-day meeting of the FDA’s new digital health advisory committee that began on Wednesday. FDA Commissioner Rob Califf opened the...
View ArticleFDA updates label of 33-year-old cancer drug with new dose and warning
The FDA on Wednesday updated the label for Sandoz's decades-old leukemia drug fludarabine phosphate, as part of a wider initiative to revamp the labels for cancer drugs approved long ago. Fludarabine...
View ArticleVenrock adds $500M to healthcare investing strategy after outlining 10th fund...
Venrock has added half a billion dollars to its healthcare investing strategy, the firm confirmed to Endpoints News on Wednesday. It comes on top of its $650 million 10th fund — which goes toward
View ArticleNewAmsterdam aces Phase 3 trial, but investors are skeptical
NewAmsterdam Pharma’s lead cardio program obicetrapib passed another Phase 3 trial, demonstrating its ability to lower “bad cholesterol” in combination with a drug called ezetimibe. The TANDEM study...
View ArticleKyowa Kirin buys into Kura leukemia treatment rights for $330M+
Japanese drugmaker Kyowa Kirin is acquiring most of the commercial rights for Kura Oncology’s targeted leukemia treatment, paying $330 million upfront and almost $1.2 billion in possible milestones....
View ArticleAmgen names geneticist and biotech founder to CSO post
Amgen is joining the chorus of large pharmas naming new science leaders. The company said Wednesday that Stanford physician-scientist Howard Chang will be its new chief scientific officer and senior...
View ArticleNovartis buys Kate Therapeutics in $1.1B deal, eyes more bolt-on M&A
Novartis is buying gene therapy and neuroscience biotech Kate Therapeutics in a deal worth $1.1 billion in upfront and milestone payments, the Swiss pharma confirmed to Endpoints News on Thursday. And...
View ArticleAizen debuts with AI-driven 'mirror peptide' platform
Aizen Therapeutics has left stealth with $13 million in seed funding and a mission to advance “mirror peptide” drug candidates, with an initial focus on solid tumors and neuroscience. The San...
View ArticleFDA vaccine chief Peter Marks pledges to stay as long as he's welcome
LONDON — The FDA's top leader of vaccines and biologics said Thursday he is not planning to leave his role in light of the incoming Trump administration and the potential for Robert F. Kennedy Jr ...
View ArticleCidara's $100M PIPE; Pyxis Oncology's stock falls on Phase 1 data
Plus, news about argenx, Forte Biosciences, Verrica, Pep2Tango Therapeutics, Eli Lilly, Laekna, Lineage Cell Therapeutics and OneCell Diagnostics: Cidara Therapeutics nabs $105M: The immunotherapy...
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