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As uniQure prepares its closely watched Huntington’s disease gene therapy for FDA review, the biotech is also making waves in chronic epilepsy with another gene therapy that Stifel says is off to a “promising start.”
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While drugmakers and other stakeholders want to see faster approvals, experts say the FDA’s Commissioner’s National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency’s senior leaders topping the list.
UniQure’s planned third-quarter submission for its Huntington’s disease gene therapy may be a harbinger of a more flexible FDA under acting commissioner Kyle Diamantas—but how long will it last? And how can companies be sure these positive decisions won’t just be reversed?
While agents like AbbVie’s Humira have transformed the treatment landscape, not all patients benefit equally from the drug. Better biomarker analysis and more investment in mechanistic trials can inform the development of more effective therapies with broader clinical value.
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FDA veteran Peter Marks will now shape the future of Eli Lilly’s vaccines work after the buys of Curevo, LimmaTech Biologics and Vaccine Company for up to $3.8 billion total.
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“King Keytruda’s reign continues,” analysts at BMO Capital Markets declared after Chinese data for Summit Therapeutics’ ivonescimab were revealed at the American Society for Clinical Oncology in Chicago.
Riding a newfound surge of interest on infectious disease concerns, Moderna is linking up with a global vaccine foundation in hopes of developing a vaccine to slow the new surge in Ebola underway in the Congo and Uganda.
Expanding in the metabolic space, Eli Lilly has struck a back-loaded licensing deal with South Korea’s Hanmi Pharm for a mid-stage GLP-2 agonist being trialed for short bowel syndrome.
In addition to eliciting 17.3 months median overall survival vs. 8.5 months for patients given standard of care treatment in a prior study, Immuneering’s atebimetinib demonstrated a robust tolerability profile—something CEO Ben Zeskind said equates highly with survival.
Interim overall survival data on a TROP2 ADC from Merck and Chinese partner Kelun-Biotech provide support for the pharma’s big bet on its potential to help navigate Keytruda’s impending loss of exclusivity.
Revolution Medicines and its RAS inhibitor daraxonrasib stole the show at the American Society of Clinical Oncology’s annual meeting this weekend, as Truist Securities predicts a possible third quarter launch for the pancreatic cancer drug.
After trial flops in spinal muscular atrophy, depression and bipolar disorder—and a costly rare disease drug rejection—Biohaven is undergoing a reset, recasting its former SMA candidate for obesity.
Analysts, investors and partner Summit Therapeutics had all been keenly awaiting the overall survival update, after previous data from Akeso’s HARMONi-6 trial left them wanting.
FDA inspectors found Alchymars failed to adequately maintain equipment used to make active pharmaceutical ingredients for the U.S. market. Over-the-counter drugmakers GC America and Sato Pharmaceutical also received warning letters.
As Summit Therapeutics’ Chinese partner prepares to reveal data for a key trial at ASCO, analysts consider the impact on rivals Merck, Bristol Myers Squibb and BioNTech.