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Amgen files KRAS inhibitor sotorasib with EMA pharmatimes
December 24, 2020
Amgen has submitted a marketing authorisation application the European Medicines Agency (EMA) for its investigational KRAS inhibitor sotorasib for previously-treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).
European Commission to purchase additional 80 mn doses of Moderna’s COVID-19 vaccine expresspharma
December 21, 2020
Moderna announced that the European Commission has exercised its option to purchase an additional 80 million doses of mRNA-1273, Moderna’s COVID-19 vaccine candidate, bringing its confirmed order commitment to 160 million doses.
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application worldpharmanews
December 17, 2020
EMA's human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2 ...
Pfizer’s COVID-19 vaccine data accessed in EMA cyber-attack europeanpharmaceuticalreview
December 15, 2020
Pfizer and BioNTech told that documents relating to their COVID-19 vaccine approval were accessed during a cyber-attack on the European Medicines Agency (EMA).
Bumper December meeting sees CHMP recommend 15 new medicines pharmatimes
December 15, 2020
The European Medicines Agency’s (EMA) committee for Medicinal Products for Human Use (CHMP) recommended 15 new medicines for approval in its final meeting of the year.
Albireo submits rare liver disease med odevixibat to FDA and EMA pharmatimes
December 14, 2020
Albireo Pharma has submitted odevixibat to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), seeking approval for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC).
EMA Validates Application for Tepotinib for Advanced NSCLC americanpharmaceuticalreview
December 14, 2020
Merck announced the European Medicines Agency (EMA) has validated for review, the application for tepotinib for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene ...
EMA and HMA publish joint strategy on medicine regulation for next five years europeanpharmaceuticalreview
December 10, 2020
The EMA and HMA have published their joint strategy for the next five years, detailing how the regulatory network can continue the supply of safe and effective medicines.
Neurogene announces EMA grants orphan drug designation for aspartylglucosaminuria gene therapy pharmaceutical-business-review
December 09, 2020
Neurogene announces that the European Medicines Agency (EMA) has granted orphan drug designation (ODD) to its adeno-associated virus vector (AAV) with engineered transgene encoding the human AGA gene for patients diagnosed with aspartylglucosaminuria.
Moderna applies for regulatory authorisation for COVID-19 vaccine europeanpharmaceuticalreview
December 03, 2020
The company has submitted for Emergency Use Authorization in the US and Conditional Marketing Authorization in Europe for its mRNA-1273 vaccine against COVID-19.

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