FDA again raises doubts on Stealth's ultra-rare disease drug ahead of adcomm
Data submitted to the FDA by Stealth BioTherapeutics for its ultra-rare disease drug likely aren’t sufficient for an approval or even an accelerated approval, agency staff said in briefing documents...
View ArticlePfizer culls RSV treatment from ReViral acquisition
Pfizer has terminated development of its RSV treatment candidate sisunatovir, a viral inhibitor picked up in its up to $525 million acquisition of ReViral in 2022. The New York drug company — which is...
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GSK's RSV vaccine Arexvy shows long-term protection in Phase 3 trial
GSK said a dose of its RSV vaccine protected against illness over three years, according to new data presented at the CHEST 2024 Annual Meeting. In the Phase 3 trial, called AReSVi-006, a dose of...
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Purespring nabs $105M to take gene therapy into the clinic as IgAN field matures
Purespring Therapeutics has reeled in £80 million ($105 million) to test two gene therapies in humans. The Sofinnova Partners-led Series B, disclosed Wednesday morning, will carry the London startup...
View ArticleKevin Tang's Concentra swoops in on another struggling biotech, offering to...
Concentra Biosciences, a shell company from Tang Capital, wants to buy another biotech that has found itself in a bind. Kevin Tang’s shop told Kezar Life Sciences’ board on Tuesday that it is willing...
View ArticleBasecamp raises $60M to travel the globe and fill AI data gaps, signs deal...
London-based startup Basecamp Research has closed a $60 million Series B round that will help expand its genomic database and what it sees as gaps in biological information that will be needed to build...
View ArticleAI biotech insitro partners with Lilly on metabolic disease drugs
If all goes according to plan, insitro could finally start testing its first drug in clinical trials in 2026, eight years after Daphne Koller founded the AI-powered biotech. To get there, it’s teaming...
View ArticleDavid Baker, Demis Hassabis and John Jumper win chemistry Nobel for...
This year’s prestigious Nobel Prize in Chemistry has been awarded to David Baker, the director of the Institute for Protein Design at the University of Washington, and to Google DeepMind CEO Demis...
View ArticleClearside shares jump as reformulated TKI drug passes mid-stage test in wet AMD
Clearside Biomedical reported positive results from a Phase 2b trial of its tyrosine kinase inhibitor in patients with wet age-related macular degeneration, bolstering its prospects of bringing a...
View ArticleZealand Pharma hit with second CRL for glucagon receptor agonist
The FDA handed down a second complete response letter to Zealand Pharma for its glucagon receptor agonist in an ultra-rare genetic disease called congenital hyperinsulinism for pediatric patients....
View ArticleCrinetics’ $500M offering; Boehringer inks deal with macrocycles biotech
Plus, news about Inhibikase, Bio-Thera, Richter, InnoCare and Scholar Rock: Crinetics prices $500M offering: The San Diego biotech upsized the offering by $100 million from $400 million. The biotech...
View ArticleNobel Prize AI winners talk about how technology could reinvent drug R&D
Artificial intelligence has its Nobel Prize moment. On Tuesday, the Nobel Prize in Physics went to a pair of longtime AI pioneers in Geoffrey Hinton and John Hopfield. Then, on Wednesday, the committee...
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Illumina's pitch for new machines: You, too, can sequence DNA
Can Illumina win over labs that have never tried DNA sequencing? The company on Wednesday unveiled what it called its simplest machines yet for parsing molecular building blocks. The Miseq i100 and...
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Major PBMs call for removing three FTC commissioners from insulin lawsuit
The three major PBMs being sued by the FTC have filed motions to disqualify the Democratic commissioners who would rule on the case, accusing them of bias. Alvaro Bedoya In its motion, CVS alleged the...
View ArticleCovering obesity drugs could cost Medicare $35B by 2034, budget office estimates
While Medicare doesn’t currently cover anti-obesity drugs, a new report from the Congressional Budget Office estimates that coverage could cost Medicare $35 billion from 2026 to 2034. The office...
View ArticleGSK to pay up to $2.2B to settle almost all Zantac-related court cases
GSK said Wednesday that it is paying up to $2.2 billion to resolve 93% of its US state-based liability cases related to its heartburn medicine Zantac. The UK company also agreed to a separate agreement...
View ArticleExclusive Q&A: FDA's principal deputy commissioner on taking over for Califf,...
With a new presidential administration next year, FDA Principal Deputy Commissioner Namandjé Bumpus would be in line to lead the agency if current Commissioner Robert Califf steps down after the...
View ArticleCMS looks to $2 out-of-pocket cap for some commonly used generic drugs
The Centers for Medicare and Medicaid Services on Wednesday published a list of 101 commonly used generic medicines that would cost some Medicare patients no greater than $2 per month under a proposed...
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Spatial biology companies Vizgen and Ultivue merge amid ongoing lawsuits
Vizgen and Ultivue, two companies at the forefront of developing technologies that allow scientists to map the molecular makeup of cells in exquisite detail, are joining forces. The merger, announced...
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Former Pfizer CEO and CFO flip on activist and say they now support company
In a late-night reversal, Pfizer’s former CEO and CFO issued a statement saying they now support the company’s existing management over activist investor Starboard Value. Frank D’Amelio “We have...
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