Tag: EU
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 (VEGF-A)
Biocon Biologics secures market entry date for Denosumab biosimilars in...
The agreement allows the company to commercialize both its Denosumab biosimilars (Vevzuo® and Evfraxy®) in Europe starting December 2, 2025
Godavari Biorefineries’ anti-cancer patent secures key European validations
Anti-cancer patent now validated in Spain, the UK, and as a unitary patent covering multiple EU member states
Loopworm secures prestigious EU TRACES certification for silkworm pupae-derived products, opens...
This milestone positions Loopworm, which operates a GMP+, ISO 22000, and HACCP-certified facility with a 6,000 metric tonnes per annum capacity, as a key player in the EU market for sustainable protein sources
Auxein strengthens its leadership in global orthopaedic solutions with EU-MDR certification
Asia’s first orthopaedic implant manufacturing organization to reach this milestone for its Trauma Orthopaedic Solutions for Trauma Plating, Screws, and Nailing Systems
Exclude medical devices from the list of India-EU Free Trade Agreement...
India already dependent on imports of medical devices to the tune of 70% presently
OPPI welcomes Indian govt’s move to waive off local clinical trials...
This will be applicable to a few select drugs already approved in well-regulated markets like the USA, UK, Japan, Australia, Canada, and the EU
Lupin completes Phase 3 trials for Lucentis Biosimilar
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Biopharma industry’s response to EU reform proposals varies: GlobalData
Survey reveals mixed sentiments among industry leaders regarding impending EU regulatory changes
Qure.ai adds new FDA breakthrough device status to growing list of...
4 FDA clearances & 61 EU MDR CE tags achieved for AI in 18 months