Company has priced its Factor Xa anticoagulant at $15 per capsule, on par with competitors, and is gearing up for a launch, but it first must resolve manufacturing issues with FDA as it scales up to commercial capacity.
Portola Pharmaceuticals Inc. faces a potential setback and further delay for the launch of the Factor Xa anticoagulant Bevyxxa as it works with the US FDA to resolve manufacturing issues related to scaling up commercially.
FDA approved Bevyxxa (betrixiban) on June 23 for prophylaxis (35 to 42 days) of venous thromboembolism in patients hospitalized for an acute medical illness and at risk for thromboembolic complications
InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.
The Japanese drug maker is on track for three pivotal Phase III readouts and two regulatory submissions in 2025.
Neurocrine, Madrigal and Vanda updated investors on new drug launches, while Cytokinetics talked to investors about an FDA extension for aficamten.
