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FDA pledges to take next steps on advisory committee changes
As the potential end of Robert Califf’s time as FDA commissioner nears, he and a key deputy are continuing to push forward with changes to the advisory committee process. In a Nature commentary...
View ArticleAppeals court rules in favor of FDA regulating certain stem cell clinics more...
A court ruling Friday will open the door to the FDA more tightly regulating stem cell clinics and a commonly-used stem cell mixture known as stromal vascular fraction (SVF) treatments. The ruling, made...
View ArticleFederal judge dismisses longstanding suit over Bristol Myers' $74B Celgene...
A New York federal judge dismissed allegations on Monday that Bristol Myers Squibb purposely delayed Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights. Judge Jesse Furman...
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IGM scraps oncology work to focus on autoimmune, loses three executives
IGM Biosciences will stop working in cancer and shrink its T cell engager pipeline to focus on autoimmune diseases, the California biotech said late Monday. Fred Schwarzer The company’s CEO, Fred...
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Metsera partners with Amneal to manufacture obesity drugs, and Clive Meanwell...
Obesity startup Metsera is getting a new manufacturing partner and a new CEO. On Tuesday, the well-funded startup announced that it would bring on specialty pharmaceutical and generics manufacturer...
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Ron Renaud's new obesity biotech, Kailera, has $400M to go straight to Phase 3
There’s major money behind efforts to speed the next significant obesity company to the market. First, it was Metsera, which launched in April with $290 million and a busy pipeline. Now it’s Kailera...
View ArticleShattuck Labs cuts CD47 program and 40% of workforce as it focuses on IBD drug
Shattuck Labs is laying off 40% of its workforce and discontinuing its CD47 program in acute myeloid leukemia and higher-risk myelodysplastic syndromes following disappointing early-stage data. The...
View Article23andMe CEO says she is no longer open to outside takeover offers
23andMe CEO Anne Wojcicki has said she is no longer open to considering other buyers for the company in a securities filing Monday, the latest in her monthslong attempt to take the turbulent genetics...
View ArticleCVS considers breaking up the company as investors urge turnaround — reports
Struggling healthcare giant CVS Health is considering breaking up the company, including separating its pharmacy and insurance businesses, as part of a strategic review, Reuters first reported late...
View ArticleCAMP4, preparing for IPO, announces partnership with BioMarin
Regulatory RNA startup CAMP4 Therapeutics has inked another collaboration deal as it prepares for an initial public offering. The Cambridge, MA-based startup has lined up a pact with BioMarin to create...
View ArticleGritstone bio’s stock dips after it shares more data from failed Phase 2...
Months after announcing the failure of a mid-stage trial for its personalized neoantigen vaccine in cancer, Gritstone bio reported more data that it plans to take to regulators. In the Phase 2 trial,...
View ArticleTargeting Novartis' Scemblix, Enliven lays out case for leukemia drug in...
Enliven Therapeutics released new Phase 1 data for its chronic myeloid leukemia program (CML) it hopes can eventually compete with Novartis’ Scemblix. The experimental therapy, called ELVN-001, was...
View ArticleBiohaven aims to raise $250M; Activist investor's stake in Galapagos exceeds 10%
Plus, news about IN8bio, Sanofi, Vicore Pharma, Cartherics, Zephyrm Bioscience, Tharimmune and Intract Pharma: Biohaven’s $250M offering: The move comes after Biohaven announced Monday that it started...
View ArticleJ&J and Bayer to lay off almost 300 staffers in New Jersey
Two pharma giants are cutting staff in New Jersey, with Johnson & Johnson and Bayer making new layoffs between now and the end of December. Johnson and Johnson plans to cut 231 employees, according...
View ArticleJudge keeps Amgen's $10.7B tax liability suit alive
A New York federal judge has denied Amgen’s motion to dismiss a class action lawsuit alleging the company misled investors about a potential $10.7 billion tax liability. Plaintiffs, led by a Detroit...
View ArticleSenators question FDA and FTC over patent and PBM reforms
Senators may be back in their districts gearing up for next month’s elections, but that isn’t stopping them from questioning both the FDA and Federal Trade Commission on matters related to patent and...
View ArticleGSK’s ViiV stops development of Phase 2 HIV antiviral
GSK’s ViiV Healthcare has suspended development of a Phase 2-stage HIV antiviral named VH3739937, a GSK spokesperson confirmed to Endpoints News on Tuesday. The halt was prompted by “preliminary...
View ArticleLoQus23 bags $43M in Series A to move Huntington's drug into first human study
LoQus23 Therapeutics has secured £35 million ($43 million) in a Series A fundraise led by Forbion and backed by the venture arm of Novartis to help advance its lead Huntington’s disease program into...
View ArticleTriveni to take experimental eczema drug to the clinic, backed by new $115M...
On Wednesday, Triveni Bio became the latest immunology and inflammation startup this year to announce a $100 million-plus financing round. Money has come thick and fast to I&I companies this year,...
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Exclusive: After discovering antibiotics with AI, a 31-year-old first-time...
Jim Collins, the famed MIT professor and a godfather of the synthetic biology field, describes Felix Wong as one of the most talented researchers to come out of his lab in recent years. Wong, 31, is...
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