BridgeBio Pharma’s approval of Beyonttra comes three months after the drug landed FDA approval for cardiomyopathy caused by transthyretin amyloidosis. Our recap of recent regulatory news also spans approvals in cancer, immunology, vaccines, and more.
BridgeBio Pharma claims its drug, Attruby, has an edge over a Pfizer drug as a treatment for cardiomyopathy caused by transthyretin-mediated amyloidosis. But new competition to both products could come soon from Alnylam Pharmaceuticals, now set to receive an FDA decision in this indication by late March.
Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all.
BridgeBio will receive $500 million in exchange for royalties from sales of acoramidis, a drug currently under FDA review for treating heart complications caused by the rare disease transthyretin amyloidosis. The deal also refinances lending agreements, providing BridgeBio with access to additional capital.
Bristol Myer Squibb is getting rights to BBP-398, a contender in the chase for drugs that address difficult-to-target KRAS mutations. Meanwhile, BridgeBio Pharma receives some needed cash as it restructures in the wake of the Phase 3 failure of its lead program late last year.
BridgeBio reported its drug acoramidis missed the main goal of a pivotal study in patients with transthyretin amyloidosis affecting the heart—the same type of patients helped by a currently approved blockbuster Pfizer drug. BridgeBio attributed the trial failure to a surprisingly strong placebo response, and it will continue the study, hoping for better outcomes on additional goals.
The FDA decision makes Nulibry the first drug approved to treat MoCD type A, a rare metabolic disease. It's also the first FDA-approved product for rare disease drug developer BridgeBio Pharma.
When it comes to managing inbound phone calls, underperformance has devastating cost implications.
The company sources product candidates from academic and commercial research and then launches subsidiary companies to develop them.