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The FDA rejected bitopertin in February amid reports of skepticism from former CBER director Vinay Prasad, who has since departed the agency.
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The public biotech universe has shrunk by more than 20% since 2021, yet financial stress remains entrenched across the sector, according to a report from EY Tuesday.
Novo Nordisk and Eli Lilly presented data extolling the benefits of their relative weight loss therapies in obesity-linked indications, while analysts at BMO Capital Markets were “encouraged” by the strategy communicated by Novo management.
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.
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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 money will enable the addition of aseptic filling and oral solid dose capabilities to support Hikma’s products and contract manufacturing clients.
While Merck and Gilead Sciences reported back-to-back late-stage victories for their weekly HIV pill, the partners also discontinued a Phase 3 program for their cancer combo after disappointing lung cancer survival data.
AstraZeneca is pushing its small molecule GLP-1 drug to Phase 3 development for weight control, diabetes and other cardiometabolic conditions despite the asset failing to best one from Structure Therapeutics.
Nuvalent Bio is GSK’s third big-ticket purchase this year, after the pharma dropped $2.2 billion in January for RAPT Therapeutics and $950 million in February for 35Pharma.
Newly approved weight loss pill Foundayo reduced blood sugar more than Novo Nordisk’s semaglutide and other comparators in multiple Phase 3 type 2 diabetes trials. Eli Lilly will seek approval in this indication.
City Therapeutics, one of BioSpace’s NextGen companies for 2026, was started by RNA royalty John Maraganore, former CEO of Alnylam.
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.