Gilead pulls Trodelvy's accelerated label in bladder cancer after drug failed...
Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after it failed to improve survival odds for patients in a Phase 3 study earlier...
View ArticleLaNova’s VEGF bispecific enters human trial in China, with plans for a US...
LaNova Medicines has advanced its PD-1xVEGF bispecific antibody to a first in-human trial in China after securing $42 million in a Series C1. The Shanghai-based biotech said Friday that it kicked off a...
View ArticleAura’s bladder cancer data; Poseida discloses $15M milestone from Roche
Plus, news about Verastem Oncology, Bright Minds Biosciences and Telix Pharmaceuticals: Aura Biosciences unveils early bladder cancer data: The Boston biotech shared that its light-activated drug led...
View ArticleFDA partially holds BioNTech's Phase 3 anti-CTLA-4, company pauses enrollment
The FDA put a partial clinical hold on a Phase 3 trial of an anti-CTLA-4 antibody from OncoC4 and its partner BioNTech, the German biotech disclosed in a Friday SEC filing. BioNTech paid $200 million...
View ArticleNobel winner David Baker on AI in biology and protein design
David Baker has been pushing the limits of designing proteins for decades. The computational biologist started developing software, called Rosetta, to study and design proteins in the 1990s. He’s now...
View ArticleEuropean Commission to work more closely with European Medicines Agency
The European Commission said Friday that it has officially adopted a new regulation explaining how it will cooperate more closely with the European Medicines Agency on health technology assessments...
View ArticleEMA again recommends against Duchenne muscular dystrophy drug Translarna
The European Medicines Agency’s human medicines committee again decided not to recommend the renewal of the conditional marketing authorization for PTC Therapeutics’ Duchenne muscular dystrophy drug...
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Apertura and Atalanta reduce headcount en route toward the clinic
Two central nervous system disorder biotechs laid off employees recently. New York gene therapy startup Apertura and Boston RNAi biotech Atalanta Therapeutics have trimmed their workforces, the two...
View ArticleFDA approves Astellas' gastric cancer drug Vyloy ahead of schedule
The FDA on Friday approved Astellas’ treatment for a type of gastric cancer, marketed as Vyloy (zolbetuximab). The approval came three weeks ahead of its scheduled PDUFA date of Nov. 9. Vyloy targets a...
View ArticleGLP-1 drugs from compounders won't be targeted by FDA, for now
The FDA clarified Thursday that it won’t take action against GLP-1 compounders for certain violations while it reevaluates Eli Lilly’s weight loss and diabetes drug tirzepatide’s removal from its...
View ArticleLykos is optimistic about MDMA treatment after meeting with FDA
Lykos Therapeutics said it had a “productive” meeting with the FDA to discuss a path forward for its recently rejected PTSD treatment, in the first public statement from the company since a tumultuous...
View ArticleNJ judge tosses Novartis' IRA lawsuit in another win for government
Novartis has lost its legal challenge against the Inflation Reduction Act on Friday, making it the sixth drugmaker rejected in federal court. New Jersey Judge Zahid Quraishi on Friday granted a summary...
View ArticleA Q&A with a Nobel Prize winner; Pfizer meets with Starboard; J&J reports Q3...
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add...
View ArticleVertex shares full pivotal non-opioid pain data, showing better safety than...
Vertex detailed Phase 3 data for its non-opioid treatment that could mark a drastic shift in pain management. The company expanded on its interim readout on Sunday at the American Society of...
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Former Karuna crew quickly assembles $225M for next neuro bet at Seaport
The team at Seaport Therapeutics, a Boston neuropsychiatry biotech, is having a good fall season. Seaport said Monday it has pieced together $225 million from hefty crossover names and some of the...
View ArticleCatalent acts to reassure customers amid questions about antitrust
The contract manufacturer Catalent sent a letter to its customers Monday seeking to reassure them that little will change after the company’s deal with Novo Holdings, a transaction that will send...
View ArticleSepterna outlines $157M IPO after entering the clinic with GPCR pipeline
GPCR drug developer Septerna plans to raise about $157 million in net proceeds from its proposed initial public offering, according to a new securities filing Monday morning. The Nasdaq debut would...
View ArticleNovo says oral GLP-1 reduces heart events in Phase 3 diabetes trial
Novo Nordisk’s oral semaglutide lowered the risk of certain heart events in a late-phase study in people with type 2 diabetes and related metabolic conditions, sparking plans to file for a label...
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Q3 biotech roundup: The 2024 turnaround sputters into a critical Q4 finale
Some, though certainly not all, chief indicators of biotech business activity are pointed shakily north as we head into a critical Q4. But biotech shows signs of taking another step in the long, slow...
View ArticleGSK to put £50M into Cambridge University partnership; Angelini’s new deal
Plus, news about Takeda, Foresee Pharmaceuticals and Capricor Therapeutics: GSK, Cambridge University team up on immune diseases: The UK drugmaker is pouring £50 million ($65 million) into a five-year...
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