Dr. Reddy's receives positive CHMP opinion from EMA for its proposed Rituximab biosimilar

Dr. Reddy's had previously received the EU GMP certificate for its Rituximab drug substance

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024

USFDA completes inspection at Biocon Biologics’ facilities in Bengaluru

The inspection scope included 6 separate Biologics manufacturing units comprising 4 Drug Substance and 2 Drug Product manufacturing plants

India reiterates commitment to adolescents on launch of ‘Economic Case for Investment in the Well-being of Adolescents in India’ report

Report highlights significant improvements in adolescent well-being in India

Merck Life Science inks MoU with ICAR-CIFT, Kochi for research in fishing process

Emcure Pharmaceuticals signs PPA with Sunsure Energy for solar power

The partnership will significantly advance their sustainability initiatives by meeting around 67% of their power requirements for these plants

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis

USFDA inspects Gland Pharma’s Dundigal facility

The inspection was concluded with two 483 observations

European Commission approves Pfizer’s Durveqtix gene therapy for adults with hemophilia B

A one-time dose of DURVEQTIX has reduced bleeds post-treatment compared to standard of care with a median annualized bleed rate (ABR) of zero bleeds (range 0 to 9.9)

Sun Pharmaceutical receives USFDA approval for oral JAK inhibitor ‘Leqselvi’

Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials