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After debuting on the public markets with $256.3 million and raking in an additional $472 million, Veradermics has emerged as one of biotech’s biggest post-IPO standouts. CEO Reid Waldman credits the weight loss craze for establishing consumer-driven channels.
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Last month, the FDA launched TrialBlazer, intended to streamline the IND path and bring early clinical trials and medical innovation home to the U.S. It’s a start, but new agency leadership must see it through.
Significant leadership instability at the FDA—compounded by continued workforce attrition—led to a slight slowdown in overall regulatory productivity in the first half of this year, but the agency has been catching up of late.
Congressional letters sent to the CEOs of Eli Lilly, Pfizer, Merck, BMS and AbbVie this week voicing concerns about the pharmas’ clinical trials in China highlight an ongoing discrepancy in how government and industry think about the rise of the Asian country’s biotech industry.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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The FDA’s Oncologic Drugs Advisory Committee voted 8-5 that two single-arm trials would be “sufficient to characterize the benefits and risks” of Jemperli in locally advanced rectal cancer.
Trade secrets litigations and disputes have been on the rise in recent years, and given the FTC’s recent proposal to ban all non-compete agreements nationwide, the trend is likely to continue.
Amid growing demands for generic versions of Vertex’s Trikafta, the company provided an update on the late-stage clinical development of its next-in-class triple combination for cystic fibrosis.
Though there is no sure-fire tell, there are a few signs to look out for that indicate leadership could be planning to cut staff. Here are the signs layoffs may be coming soon at your organization.
Bristol Myers Squibb has returned the rights for interleukin-12 immunotherapy program DF6002 back to its original owner, Dragonfly Therapeutics, the companies announced Monday.
Data from a Phase III study show Genentech’s crovalimab is non-inferior to AstraZeneca’s Soliris, the current standard of care in paroxysmal nocturnal hemoglobinuria (PNH).
Merck and Nectin Therapeutics announced a research collaboration agreement to study the safety and efficacy of Nectin’s investigational antibody in locally advanced and metastatic solid tumors.
Industry leaders say the second generation of interventions for nonalcoholic steatohepatitis is likely to succeed where first-generation approaches stumbled.
Janssen reported positive topline data from a Phase II proof of concept study assessing nipocalimab in severe hemolytic disease of the fetus and newborn.
Biogen and its partner, Sage Therapeutics, announced the FDA has accepted the New Drug Application for zuranolone and granted it priority review in two mental health indications.