Akums bags key EU GMP certifications for 2 Haridwar plants

Plant 1 continues to serve as a core manufacturing hub for oral solid dosage forms

Dr. Reddy’s launches first generic equivalent of extra-strength Pataday in US

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% is an antihistamine eye drop, indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander

FDA nod to first-ever treatment for fatal pediatric Menkes disease

Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

UK’s healthcare regulator warns against dangerous online weight-loss drugs

Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients

Edwards Lifesciences’ SAPIEN M3 becomes first FDA-approved transseptal mitral valve replacement

The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is designed for patients with symptomatic moderate-to-severe or severe MR

Cosette Pharmaceuticals launches first generic CIPRO HC with 180 Days market exclusivity

The approval comes with 180 days of Competitive Generic Therapy (CGT) exclusivity,

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time

Denali clinches $275 million royalty deal to power potential breakthrough Hunter Syndrome therapy