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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 ...
EMA accepts regulatory submission for Takeda’s dengue vaccine candidate europeanpharmaceuticalreview
March 29, 2021
The submission is the first in a series that will include dengue-endemic countries, it includes long-term Phase III safety and efficacy data for the TAK-003 vaccine candidate.
EMA accepts Astellas/Seagen’s enfortumab vedotin for review pharmatimes
March 29, 2021
The European Medicines Agency (EMA) has accepted a marketing authorisation application (MAA) for Astellas and Seagen’s enfortumab vedotin.
EMA Approves BioNTech's COVID Vax Production at Marburg Site contractpharma
March 29, 2021
Largest mRNA vaccine manufacturing site in Europe has annual production capacity of up to one billion doses of its COVID-19 vaccine.
EMA advises against ivermectin use for Covid-19 outside clinical trials pharmaceutical-technology
March 24, 2021
The European Medicines Agency (EMA) has advised against the use of Merck’s anti-parasite drug ivermectin for the prevention or treatment of Covid-19 outside randomised clinical trials.
EMA clears use of COVID-19 Vaccine AstraZeneca europeanpharmaceuticalreview
March 22, 2021
The EMA’s drug safety committee concluded that the vaccine is not associated with an increased risk of thromboembolic events and that its benefits still outweigh its risks.
EMA review concludes AstraZeneca Covid-19 vaccine is “safe and effective” pharmaceutical-technology
March 19, 2021
The European Medicines Agency (EMA) has concluded that the AstraZeneca/Oxford University Covid-19 vaccine is “safe and effective” after an investigation into a potential link between the vaccine and blood clots in a small number of patients.
EMA approves fourth Covid-19 vaccine, J&J’s single-shot candidate pharmaceutical-technology
March 12, 2021
The European Medicines Agency (EMA) has recommended conditional marketing authorisation for Johnson & Johnson (J&J) subsidiary Janssen’s Covid-19 vaccine.
J&J gets positive CHMP opinion for single-shot COVID-19 vaccine candidate expresspharma
March 12, 2021
If granted conditional marketing authorisation by the EC, the J&J single-shot COVID-19 vaccine will be available in the EU.
EMA Issues Advice on bamlanivimab Alone, Administered Together with etesevimab for COVID-19 in EU americanpharmaceuticalreview
March 10, 2021
Eli Lilly and Company announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for bamlanivimab alone and bamlanivimab administered together with etesevimab.

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