If cleared, MAVIRET would become one of the few therapies in the European Union approved to treat both acute and chronic hepatitis C infections
The recommendation is powered by blockbuster results from the pivotal Phase III SERENA-6 trial
Transition to a fermentation-based globally integrated CDMO platform
Biologics manufacturing veteran brings over two decades of expertise in biosimilars, GMP operations, and large-scale biopharmaceutical manufacturing
Net profit stood at Rs. 921 crore for the quarter, while Europe revenues surged 30.2% YoY to Rs. 2,795 crore
Approved product is therapeutically equivalent to Synthroid of AbbVie and is indicated for the treatment of congenital or acquired hypothyroidism
SERB has a substantial European commercial presence and a successful track record in critical care and rare disease commercialization
The product has received tentative USFDA approval, Health Canada notice of compliance, and Indian regulatory approval
The drug is indicated for the maintenance treatment of patients with Chronic Obstructive Pulmonary Disease (COPD)
The development comes as stroke remains one of the world’s biggest health threats
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