Cardiovascular disease
Novo Nordisk on Monday reported the oral version of its drug semaglutide reduced the risk of major adverse cardiovascular events in adults with type 2 diabetes by 14% in a large Phase III trial.
The FDA’s reviewers pointed out that Stealth’s elamipretide missed its primary efficacy endpoints in the main study used to establish its effectiveness.
For an exclusive license to the preclinical Lp(a) disruptor, AstraZeneca is paying CSPC Pharmaceutical Group $100 million upfront and offering up to $1.92 billion in regulatory and commercial milestones.
Clinical trial results shared by Boehringer Ingelheim and Insilico Medicine showed improvement in idiopathic pulmonary fibrosis, an intractable lung disease for which current treatment options fail to stop progression, but the data were limited, leaving experts wanting.
With Thursday’s positive opinion from the Committee for Medicinal Products for Human Use, the matter now heads to the European Commission which will have the final say on whether Wegovy’s label will be updated.
As it nears a crucial FDA action date for its transthyretin amyloid cardiomyopathy candidate, BridgeBio focuses on its late-stage pipeline.
A recent study estimated that Wegovy’s label expansion beyond obesity could push Medicare spending to $145 billion annually, but analysts remain dubious of the estimate.
A broad indication for MariTide could help Amgen secure Medicare coverage for the treatment following FDA approval, CEO Robert Bradway said at Wednesday’s Morgan Stanley Global Healthcare Conference.
Bayer’s Kerendia, at the center of a $3 billion sales forecast, reduced the risk of cardiovascular death and heart failure in a Phase III trial.
Despite the added survival benefit for its drug, Alnylam still faces steep competition from Pfizer, whose ATTR-CM therapies have become established treatment options.
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