EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

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

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

GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials

Pfizer and Cipla forge exclusive marketing and distribution pact for key brands in India

This marks the first partnership between Pfizer and Cipla in India

Alembic announces USFDA final approval for Travoprost Ophthalmic Solution USP, 0.004%

Travoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension

Zydus signs exclusive agreement with Myriad Genetics of US to launch cancer-risk assessment diagnostic tests in India

Lupin signs exclusive licensing pact with Neopharmed for Plasil in Philippines and Brazil

This agreement will enhance Lupin’s gastroenterology portfolio and expand its presence in emerging markets

Godavari Biorefineries launches US biotech arm to advance novel cancer therapies

The move strengthens GBL’s clinical-stage presence in the United States

Astellas & Pfizer report breakthrough Phase 3 results in muscle-invasive bladder cancer

The combination also outperformed chemotherapy on another important secondary endpoint