Cupid achieves CE (EU IVDR) certification for pregnancy and syphilis test kits

Dr. Reddy's receives positive CHMP opinion from EMA for denosumab 'AVT03'

Prolia is a prescription medicine used to treat osteoporosis in women

Briefs: Emcure Pharmaceuticals and Gland Pharma

Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility

Biocon Biologics receives MHRA UK approval for Vevzuo and Evfraxy, Denosumab Biosimilars

Vevzuo is authorized for the prevention of skeletal related events in adults with advanced malignancies involving bone

European Commission fines Alchem for participating in API cartel

The companies admitted taking part in the cartel in exchange for reduced fines but Alchem did not settle

Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde

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

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway

Myovant Sciences and Accord Healthcare partner to commercialise Orgovyx in Europe

Myovant to receive an upfront payment of US $50 million, is eligible to receive commercial launch, sales-based and other milestones totaling up to US $90.5 million

VBI’s 3-antigen Hepatitis B vaccine gets CHMP nod

If approved, PreHevbri will be the only approved 3-antigen hepatitis B vaccine for adults in the E.U.