Intercept's liver disease drug faces full approval delay following negative...
Following a nearly unanimous adcomm against Alfasigma and Intercept Pharmaceuticals’ rare liver disease drug Ocaliva, the FDA has delayed its decision on whether to convert the drug from an accelerated...
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Amicus stock jumps after resolution of Galafold patent litigation against Teva
Amicus Therapeutics resolved a patent dispute with Teva on Thursday, allowing Teva to launch a generic version of its Fabry disease treatment Galafold in 2037. Leerink Partners analysts called it a...
View ArticlePfizer’s RSV vaccine has 90% efficacy against severe respiratory disease
Pfizer’s RSV vaccine was 90% effective at preventing the most severe outcomes in the first-ever vaccination season, the company said, underscoring its potential benefits as another respiratory virus...
View ArticleRSV antibody data from Merck cut risk of illness in infants
Merck’s experimental antibody for RSV reduced infants’ risk of certain lower respiratory infections by 60.4% compared to placebo, meeting the trial’s primary endpoint. The Phase 2b/3 data, presented at...
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Exclusive: Ex-Affimed CEO heads to UK nanomedicine biotech; Jami Rubin leaves...
Adi Hoess Adi Hoess describes himself as someone who “likes to build” companies focused on “challenging technologies.” It’s fitting, then, that after spending more than a decade as CEO of German...
View ArticleSupernus’ depression drug shows ‘rapid’ onset in mid-stage test
Supernus Pharmaceuticals’ mTORC1 activator has cleared a small trial in patients with major depressive disorder, potentially bringing the biotech one step closer to offering a treatment that could be...
View ArticleCVS replaces CEO Karen Lynch with PBM exec David Joyner
CVS Health is parting ways with CEO Karen Lynch as the pharmacy giant continues to struggle with problems in its insurance business. The company said Friday that it named David Joyner, the president of...
View ArticleUpdated: Pfizer ends trial of SHP2 inhibitor after similar cuts by peers
Pfizer has ended its trial of an SHP2 inhibitor that was being developed in cancer, the latest blow to the target after several other drugmakers have suffered setbacks. The New York drugmaker ended the...
View ArticleConsumer and union groups call on FTC to ‘challenge’ Novo-Catalent deal
The temperature is heating up around Novo Holdings’ acquisition of contract manufacturer Catalent, as consumer and union groups write to the Federal Trade Commission to “challenge” the deal, with a...
View ArticleGilead 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...
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