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EMA confirms Janssen COVID-19 Vaccine benefits outweigh clotting risks europeanpharmaceuticalreview
April 22, 2021
The EMA’s drug safety committee has concluded that the Janssen COVID-19 Vaccine is safe for continued use, so Johnson & Johnson will resume shipments to the EU.
Amylyx Pharma plans to file ALS therapy with the EMA this year pharmatimes
April 16, 2021
Amylyx Pharmaceuticals has announced its intention to submit a marketing authorisation application for its investigational amyotrophic lateral sclerosis (ALS) therapy AMX0035 to the European Medicines Agency (EMA) by the end of 2021.
Highlights of the EMA’s drug safety committee April meeting europeanpharmaceuticalreview
April 14, 2021
In the April meeting the Pharmacovigilance Risk Assessment Committee began two new reviews of adverse events that could be caused by COVID-19 vaccines.
EMA initiates review of J&J’s Covid-19 vaccine over blood clot reports pharmaceutical-technology
April 13, 2021
The European Medicines Agency (EMA) has initiated review of Johnson & Johnson’s (J&J) single-shot Covid-19 vaccine over reports of rare blood clots in four individuals in the US.
Global Pharmacovigilance Observatory to aid pharma’s understanding of regulatory decisions europeanpharmaceuticalreview
April 09, 2021
The observatory will collate drug safety data, analyses and decisions into a single source to help pharma identify regional differences in decision-making.
AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis pharmaceutical-business-review
April 09, 2021
AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of ...
Gan & Lee receives EMA orphan drug designation for Phase I drug candidate GLR2007 for the treatment of glioma prnasia
April 07, 2021
announced that the European Medicine Gan & Lee Pharmaceuticals Co., Ltd. Agency (EMA) Committee for Orphan Medicinal Products granted orphan drug designation for the investigational compound GLR2007, for the treatment of glioma.
What strains should be in this year’s seasonal influenza vaccines? europeanpharmaceuticalreview
March 31, 2021
The European Medicines Agency has published its recommendations for 2021-2022 seasonal influenza vaccine composition.
EMA validates Gilead Sciences’ application for breast cancer therapy pharmaceutical-business-review
March 31, 2021
The European Medicines Agency (EMA) has validated Gilead Sciences’ marketing authorization application (MAA) for sacituzumab govitecan-hziy (SG) to treat advanced breast cancer.
BioNTech Provides Update on Vaccine Production Status at Marburg Manufacturing Site americanpharmaceuticalreview
March 30, 2021
BioNTech announced the European Medicines Agency (EMA) approved the manufacturing of the COVID-19 vaccine drug product at the facility in Marburg. As part of the process, EMA has approved the production of the drug substance, the mRNA, at the Marburg ...

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