Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia

NATCO Pharma receives 7 observations from USFDA for API unit at Manali

Moderna bags $1.5 billion 5-Yr loan to boost financial flexibility

The non-dilutive financing includes three tranches

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris

Mankind Pharma inks licencing pact with Actimed to bring cachexia treatments to South Asia

The licence covers Actimed’s existing patents, its proprietary know-how and any future related patents, giving Mankind full control to advance the products under its own brands

Innovent Biologics’ experimental weight-loss drug achieves breakthrough in Phase 3 trial

Innovent plans to soon submit a new drug application (NDA) to China’s National Medical Products Administration

Piramal Pharma Solutions’ UK facility bags updated MHRA GMP certification

Grangemouth serves as PPS’s dedicated antibody-drug conjugate development and manufacturing hub

Siolta Therapeutics’ novel microbiome therapy shows promise in preventing allergic diseases in infants