Cardiovascular disease
The Italian pharma will gain access to Gossamer Bio’s candidate seralutinib, which reached its primary endpoint in a Phase II pulmonary arterial hypertension trial in 2022 and started a Phase III study last year.
Sanofi is dropping its Sjögren’s syndrome candidate due to disappointing Phase II efficacy data, while AstraZeneca is stopping work on some early-stage assets amid a portfolio reprioritization.
A report from the Kaiser Family Foundation estimates that the FDA’s recent approval of Novo Nordisk’s Wegovy to reduce the risk of heart attack and stroke in people with cardiovascular disease will open Medicare coverage to one in four beneficiaries with obesity.
On the heels of a Phase IIb win, Arrowhead Pharmaceuticals’ plozasiran could fulfill a critical unmet need in dyslipidemia treatment bringing in $707 million in sales by 2032, according to data analytics firm GlobalData.
Novo Nordisk and Ionis Pharmaceuticals unveiled promising respective data at the American College of Cardiology’s Annual Scientific Session, while Boehringer Ingelheim and Eli Lilly’s Jardiance missed the endpoint in a myocardial infarction study.
Verve Therapeutics is pausing enrollment in the Phase Ib Heart-1 study for its gene editor VERVE-101 after a patient developed grade 3 laboratory abnormalities, the company announced Tuesday.
Merck’s Winrevair is the second PAH drug to get the FDA’s green light in the past week, following Johnson & Johnson’s Opsynvi, which won approval on Friday.
Esperion bagged broader-than-expected FDA labels for its cholesterol-busting drugs Friday, allowing the biotech to target seven times as many people in the U.S. compared to the old labels.
Just weeks after Wegovy won FDA approval for cardiovascular disease, Novo Nordisk has bought mid-stage biotech Cardior Pharmaceuticals and its miRNA-targeting candidate for heart failure.
Johnson & Johnson’s Opsynvi has been approved by the FDA for the treatment of pulmonary arterial hypertension, combining macitentan, which cuts the risk of clinical worsening and hospitalization, while tadalafil boosts patients’ exercise capacity.
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