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Amid an unprecedented turnover in leadership at the FDA and mass layoffs of staff, communication has crumbled and uncertainty runs rampant, leaving small and medium biopharma companies without a clear path forward for their therapies.
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Vaccine skepticism is at an all-time high in the U.S., and HHS Secretary Robert F. Kennedy Jr. is making some drastic moves in the name of reversing that trend. But misinformation and inconsistencies within the country’s healthcare agencies highlight problems with his approach.
Analysts reacted positively to the news that uniQure is in alignment with the FDA on an accelerated approval pathway and on target for a Q1 2026 submission for its one-time gene therapy for Huntington’s disease—but patients have been here before.
J&J has a multi-year head start, but Gilead believes it can win market share by delivering a drug with better safety and at least as good efficacy.
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Recently, GenScript Biotech Corporation, a world leader in technologies and services for life science R&D and manufacture, released its 2023 Environmental, Social, and Governance report.
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Following restricted vaccine approvals and changes to CDC immunization schedules, Merck, Pfizer, GSK and Sanofi are all suffering revenue hits to their vaccine programs.
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Sarepta did not hold an investor call for its second-quarter earnings report or provide an updated full-year revenue outlook.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses the emerging geopolitical battle for AI supremacy and global AI governance with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
The small molecule drug, acquired by Jazz Pharmaceuticals in its $935 million Chimerix pick-up this spring, is intended for relapsed adult and pediatric patients with H3 K27M mutations.
The German giant has already trimmed more than 10,000 employees since initiating a massive restructuring initiative in July 2023. Bayer said even more cuts are coming as it weathers up-and-down sales across its portfolio.
Terns, once a rising star in obesity and the MASH space, will refocus on cancer and partner out a handful of obesity assets.
Maziar Mike Doustdar, who was named as Novo Nordisk’s new CEO last week, spoke on a second quarter earnings call of reallocating resources to the company’s “main core” of metabolic disease.
President Donald Trump plans to start with a “small tariff” on pharmaceutical imports before ramping duties up to 250% within a year and a half.
BioNTech also laid off 63 employees in June in conjunction with the discontinuation of its cell therapy manufacturing operations in Gaithersburg, Maryland.
The Department of Health and Human Services is terminating around $500 million in BARDA contracts associated with mRNA vaccine development, a move that will affect several pharma companies, including Moderna, Pfizer, Sanofi and AstraZeneca.
From tariffs to drug pricing to the FDA, biopharma CEOs find themselves pulled into policy discussions on this year’s second quarter earnings calls.