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As Sangamo runs out of cash, Eli Lilly and Astellas have emerged as stalking horse bidders for key assets, including a Fabry gene therapy currently being submitted for potential FDA approval.
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Former FDA, CDC and NIH leaders convene at the BIO International Convention to discuss the dismantling of the Department of Health and Human Services under the Trump administration—and where we go from here.
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.
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.
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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?
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Roche and Nurix Therapeutics will advance their BTK degrader for chronic lymphocytic leukemia, as well as immunology and neurology indications.
While survodutide’s 16.6% overall weight loss was underwhelming, Boehringer Ingelheim and Zealand Pharma’s drug achieved “impressive” fat loss, according to BMO Capital Markets.
After a $625 million IPO, the biggest ever in biotech, obesity-focused Kailera Therapeutics is readying a commercial strategy that puts patients at the center.
Much work needs to be done for Pfizer to be able to catch up to the weight-loss frontrunners, according to Guggenheim Partners, but new data from Metsera’s lead asset could set the pharma apart from competitors with a monthly injection.
Over two years of treatment, Eli Lilly’s triple-G drug cut body weight by more than 30% in certain patients with obesity, cementing the pharma’s position as the frontrunner in the metabolic space.
The FDA has expanded the regulatory toolkit during President Donald Trump’s second term, adding new mechanisms for rare diseases while putting the Biden-era platform technology designation into action.
As the FDA tries to clarify its intent for former FDA Commissioner Marty Makary’s plausible mechanism framework for bespoke therapies, experts emphasize the importance of expanding its scope to encompass rare diseases that affect more than just one or a few individuals.
Eli Lilly sauntered into the American Diabetes Association meeting with a commanding lead in the metabolic space and put down more evidence for its pipeline, including new pill Foundayo and next-gen asset retatrutide, in new indications.
Analysts and investors were unimpressed by Phase 2 data posted in the spring showing that an amylin analog developed by Roche and partner Zealand Pharma elicited 9% weight loss, less than Eli Lilly’s rival candidate. Executives from both companies told BioSpace that premium weight loss is not the point of petrelintide.
The American Diabetes Association’s annual congress will feature a superstar lineup, including weight loss giants Eli Lilly and Novo Nordisk. But several scrappy biotechs will also present obesity candidates with the potential to match—if not outperform—their deep-pocketed competitors.