#ACR24: Bristol Myers takes on autoimmune diseases with cell therapy; New...
Bristol Myers Squibb recently presented data for the first time from its clinical trial of a cell therapy for autoimmune diseases, which has quickly become one of the most crowded fields in biopharma....
View ArticleJ&J, Protagonist reveal two Phase 3 wins for oral IL-23 drug that's expected...
Johnson & Johnson and Protagonist Therapeutics announced two Phase 3 successes for their oral IL-23 drug, showcasing the first results out of an expansive pivotal trial program in plaque psoriasis....
View ArticleLilly’s oral lipid drug passes mid-stage test
Eli Lilly reported positive data for its drug candidate for elevated lipids, marking a key milestone for a potential oral option in a space dominated by injectable candidates. Lilly’s muvalaplin met...
View ArticleBeiGene settles final suit over future Brukinsa generics
BeiGene has settled a lawsuit with generics manufacturer MSN Pharmaceuticals, resolving all cases associated with the entry of Brukinsa alternatives in the US. The pharma said Tuesday that MSN agreed...
View ArticleChinese drugmaker receives FDA warning letter after management hindered...
The FDA handed Chinese pharmaceutical company Tianjin Darentang Jingwanhong Pharmaceutical a warning letter after it removed information from translated manufacturing records and refused to let agency...
View ArticleFDA raises safety questions on AstraZeneca's bleeding reversal agent
The FDA on Thursday will convene an advisory committee to discuss the safety and efficacy of AstraZeneca’s Andexxa, which won accelerated approval in 2018 to reverse the anticoagulation effects of...
View ArticleFDA 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 ArticleSage reports Phase 2 failure in Huntington's disease, ends drug's development
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...
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