NL Times9d
Russian spies had access to EMA systems for four months in 2020 hack: report
Russian attackers were behind the hack of the European Medicines Agency EMA in 2020. They had “unauthorized access to ...
Reuters28d
EU medicines agency quits X, moves to Bluesky
AMSTERDAM, Jan 27 (Reuters) - The European Medicines Agency (EMA) said on Monday it would no longer post on X and would use rival Bluesky instead, becoming the latest organisation to quit a social ...
pharmaphorum3d
EMA’s strategy for speeding up drug approvals in the EU
The European Medicines Agency (EMA) has experienced a turbulent few years. Brexit left the agency reeling, as it was forced to move from its base in London and reduce its services whilst ...
pharmaphorum9d
Don't let Brexit disrupt European Medicines Agency, warn pharma leaders
Heads of R&D at all major pharma companies have come together to express their concerns about severe disruption to the European Medicines Agency (EMA) as it faces a Brexit-induced relocation.
Pharmabiz2d
Sobi & Apellis Pharma announces EMA validates indication extension application for Aspaveli for treatment of C3G and primary IC-MPGN
Stockholm, Sweden Saturday, February 22, 2025, 09:00 Hrs [IST] ...
centerforbiosimilars6d
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' ...
GEN4d
C3i Center Receives EMA Approval to Manufacture Cell Therapy Products for Europe
C3i obtained a Drug Establishment License (DEL) to produce cell therapies for patients across Canada commercially.
Managed Healthcare Executive3d
FDA, EMA See Differences in Cell and Gene Therapy Trial Data
Researchers have suggested that uniform evidence standards and reporting requirements could help speed patient access to cell ...
manilatimes3d
Apellis and Sobi Announce EMA Validation of Indication Extension Application for Aspaveli® (pegcetacoplan) for C3G and Primary IC-MPGN
Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialization rights for systemic pegcetacoplan, and Apellis has exclusive U.S.
C3i Center, a Canadian company, receives approval from the EMA to manufacture cell therapy products for the European market
C3i became the first contract development and manufacturing organization (CDMO) for cell and gene therapies in Canada to obtain a Drug Establishment License (DEL) to produce life-saving cell therapies ...