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A few short days after announcing an FDA pivot on a separate asset, REGENXBIO is planning to test the agency’s apparent newfound rare disease outlook on another late-stage gene therapy.
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Speaking to media on Tuesday, BIO CEO John Crowley complimented China’s rise as a biotech powerhouse but said U.S. policy needs to protect and maintain America’s lead.
While merger and acquisition activity has been robust of late, frequent changes in guidance and leadership at the regulator add risk to any transaction.
With drug pricing now embedded in U.S. policy, business development teams in biotech and pharma are changing the way they strike deals, including acknowledging policy uncertainties with renegotiation clauses.
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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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Members of the American Biotech Innovation Alliance (ABIA) want to build a national biotech strategy—just like China did years ago.
The money will enable the addition of aseptic filling and oral solid dose capabilities to support Hikma’s products and contract manufacturing clients.
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.
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.
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.
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.