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Top Biotech News (21 Nov 2024)

Healthcare Policies to Watch in the New Trump Administration

Summary: Investors and entrepreneurs will track decisions affecting drugs, medical devices and telehealth.

FDA endorses speedy approval path for Regenxbio Duchenne gene therapy

Summary: The agency’s openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

‘Find any advantage’: 3 biotech leaders on driving R&D success

Summary: Companies need to reach the clinic quickly to prove they have a drug that can stand apart from competitors, according to executives and investors who spoke on a BioPharma Dive panel.

CAR T for Lupus Takes Center Stage at ACR 2024

Summary: Investigational CAR T therapies stole the spotlight at the American College of Rheumatology Convergence as data presented by Bristol Myers Squibb, Kyverna Therapeutics and more highlighted their potential to effectively treat lupus.

ATTR-CM Approval for BridgeBio Could Trigger Tight Race with Pfizer

Summary: Experts view BridgeBio’s acoramidis—which has an FDA action date of Nov. 29—as either similar to or incrementally better than Pfizer’s already established tafamidis.

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