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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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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.
Precision science is ruling the M&A scene as pharmas prepare for loss of exclusivity on key products, PwC says in a new report. Biotechs should be prepared with a dual-track process with the IPO window now open.
While biopharma’s overarching mission is to develop innovative medicines to improve patient outcomes, for these six people, the motivation came from much closer to home.
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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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The acquisition gives Johnson & Johnson access to Firefly Bio’s next-gen platform designed to create degrader antibody conjugates that can crack the tricky KRAS cancer target.
Incyte is acquiring Vega Therapeutics, a subsidiary of Star Therapeutics, for a bleeding disorder program that analysts say has “pipeline-in-a-product” potential.
After Revolution Medicine’s groundbreaking data drop in April, its Tango-partnered combination approach has demonstrated what analysts called “unprecedented” results for 12 patients with pancreatic cancer, teeing up a late-stage study.
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.