The European Medicines Agency (EMA) said on April 7 it had found a possible link between AstraZeneca’s coronavirus vaccine and reports of very rare cases of blood clots in people who had received the shot.
The European Commission granted Amarin Corporation Plc’s fish-oil derived heart drug Vazkepa marketing authorization in the European Union, the drugmaker said on March 30.
Copenhagen, Denmark-based Orphazyme announced the company’s Phase II/III clinical trial of arimoclomal for inclusion body myositis (IBM) failed to hit primary and secondary endpoints.
GSK and Vir Biotechnology filed an application to U.S. regulators for emergency use authorization of their antibody therapy to treat early-stage Covid-19 infections, the drugmakers said on March 26.
Scientists are exploring several possibilities that might explain at least 18 reports of extremely rare blood clots in the brain that occurred in individuals in the days and weeks after receiving the AstraZeneca COVID-19 vaccine.
A World Health Organization (WHO) vaccine safety panel said on March 17 that it considers that the benefits of the AstraZeneca Covid-19 vaccine outweigh its risks and recommends that vaccinations continue.
AstraZeneca Plc said on March 14 a review of safety data of people vaccinated with the company’s Covid-19 vaccine has shown no evidence of an increased risk of blood clots.
The European Union’s drugs regulator on March 11 approved Johnson & Johnson’s single dose Covid-19 vaccine, as the bloc seeks to speed up a stuttering inoculation campaign and boost its supplies.
The European Union was asked to allow an extra dose of the Covid-19 vaccine developed by Pfizer and BioNTech to be taken from each vial, a practice allowed elsewhere that would make scarce supplies go further.
The European Medicines Authority (EMA) will most likely not be able to approve the Covid-19 vaccine developed by drug maker AstraZeneca and the University of Oxford in January 2021, the watchdog’s Deputy Executive Director Noel Wathion said.