Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention

Wockhardt submits NDA to USFDA for Zidebactam-Cefepime injection

The NDA submission follows the successful completion of a pivotal Phase III global clinical trial

Lupin launches Liraglutide injection in US

Liraglutide Injection, 18 mg/3 mL (6 mg/mL) Single-Patient-Use Prefilled Pen is bioequivalent to Victoza Injection, 18 mg/3 mL (6 mg/mL) of Novo Nordisk

Briefs: Panacea Biotec, Lotus Eye Hospital and Uflex

Panacea Biotec receives Rs. 315 crore LoA from UNICEF

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Supriya Lifescience’s Ambernath facility receives WHO GMP certification

With global certification in place, the Ambernath site expands Supriya’s footprint beyond APIs into high-margin formulations

IPA welcomes Dr. Sharvil Patel as President and Glenn Saldanha as Vice President

Genmab to acquire Merus for $8 billion

Proposed acquisition adds petosemtamab, a late-stage asset with two Breakthrough Therapy Designations, to Genmab’s portfolio

Novartis to launch DTP platform for Cosentyx in US

Through the new DTP platform, Novartis will make Cosentyx available to patients at a price that reflects the average savings typically retained by insurers and pharmacy benefit managers

Lupin receives FDA approval Rivaroxaban for oral suspension

The product will be manufactured at Lupin’s Chhatrapati Sambhajinagar facility in India