FDA again questions Lexicon diabetes drug ahead of adcomm
The FDA is raising repeat safety and efficacy questions ahead of an advisory committee meeting on Thursday for Lexicon Pharmaceuticals' SGLT2 inhibitor sotagliflozin, which the agency rejected in 2019...
View ArticleWhat would RFK Jr. do on healthcare? Trump ally's FDA plans raise alarm
Donald Trump's embrace of Robert F. Kennedy Jr. is forcing biotech and pharma leaders to grapple with having US life sciences policy influenced by a figure who has extensively criticized vaccines and...
View ArticleFollowing March inspection, Novo Nordisk's semaglutide manufacturing facility...
The FDA on Tuesday released an inspection report sent to Novo Nordisk earlier this year citing quality-related issues at a site in Kalundborg, Denmark, that manufactures its blockbuster semaglutide...
View ArticlePfizer shares new details on obesity pipeline, hints at ‘other opportunities’
As Pfizer talked up the strength of its pipeline Tuesday, it shared details for the first time about its plans in obesity and said it has a multi-pronged strategy to catch up to rivals in ...
View ArticleZurzuvae won't be developed for major depression, Sage says
It’s official: Sage and Biogen will not attempt to get their postpartum depression pill Zurzuvae approved in the broader population of people with major depressive disorder. Sage, which has recently...
View ArticleAxonis snags $115M to test oral drugs for epilepsy and neuropathic pain
Boston biotech Axonis Therapeutics has raised a $115 million Series A to test whether its oral drug AXN-027 can help patients with focal epilepsy and diabetic neuropathic pain. The financing, disclosed...
View ArticleGSK remains ‘very confident’ in RSV vaccine amid competition, sales slump
Competition is heating up in the RSV space, despite a lukewarm quarter for vaccine uptake. Pfizer beat GSK’s Arexvy for the first time in the third quarter, as Arexvy sales dipped 72% from the year ...
View ArticleNobel winner David Baker co-founds another startup, as Archon takes an AI...
The newest David Baker biotech startup launched Wednesday, as Archon Biosciences has raised a $20 million seed round to develop what it believes could be a new class of antibody-based drugs. The...
View ArticleUpdated: Lilly’s shares tank after trimming revenue guidance. It also cut...
Eli Lilly lowered the top end of its full-year revenue guidance by $600 million on Wednesday, as its third-quarter sales were about $800 million below Wall Street’s expectations. The pharma giant had...
View ArticleBiogen signs molecular glue deal, raises yearly projections
Is 2024 the year of molecular glues? Biogen on Tuesday became the latest company to partner on the increasingly popular subject, teaming up with private San Diego biotech Neomorph. Biogen will pay...
View ArticleBlue Earth Therapeutics snags $76M for both alpha and beta radiotherapies
The radiopharma field continues to buzz with private financings and more clinical-stage programs. The latest is Oxford, UK-based Blue Earth Therapeutics, which unveiled a $76.5 million Series A on...
View ArticleLundbeck doubled its offer for Longboard over six months, new filing shows
Danish pharma Lundbeck vastly increased its offer to buy Longboard Pharmaceuticals over six months as other parties came to the dealmaking table, a new SEC filing shows. Lundbeck initially proposed $29...
View ArticleLeal Therapeutics raises $45M; SynOx adds to Series B
Plus, news about Zai Lab, Spero Therapeutics and EyePoint Pharmaceuticals: Leal Therapeutics raises $45M: The biotech, which emerged from stealth earlier this year, said the financing was led ...
View ArticleGSK cuts 24-valent pneumococcal program for adults due to competition
GSK is setting aside a mid-stage 24-valent pneumococcal vaccine program for adults to instead focus on a preclinical option that covers 30-plus valents, the company announced Wednesday alongside its...
View ArticleAstraZeneca China exec probed by local authorities
AstraZeneca said Wednesday its China president Leon Wang is under investigation in the country, days after it was reported a BeiGene exec was under scrutiny for insurance fraud while she was ...
View ArticleFDA says all versions of Novo's GLP-1 weight loss drugs are now available
The FDA on Wednesday updated its drug shortage database to say that all dosages and versions of Novo Nordisk's Wegovy and Ozempic are now "available." A Novo spokesperson ...
View ArticleBiogen seeks growth from pipeline as investors show signs of impatience
Biogen's investors are growing restless. Wednesday's third-quarter earnings call checked most of the boxes for a successful report. The company raised its full-year guidance, and sales of its...
View ArticleAtlas of tumors reveals in 3D how cells change into cancer
The story of cancer has long started with a single mutated cell that divides and eventually grows into a tumor causing disease and death. But new research, part of a large-scale effort to map in ...
View ArticleAbbVie’s immunology blockbusters make up for Humira sales drop in Q3
AbbVie is lifting its profit outlook and full-year 2024 guidance as its immunology blockbusters Skyrizi and Rinvoq beat quarterly revenue estimates, according to the company’s third-quarter filing....
View ArticleRoche presents early-stage results for latest amyloid-based Alzheimer's attempt
Roche revealed early-stage data for a new Alzheimer’s program on Wednesday as it seeks to jump back into a field littered with failures. In a 60-patient trial testing four different doses of...
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