Pfizer and BioNTech announced today that European authorities approved storage of their COVID-19 vaccine at a new temperature. Based on data showing stability in standard pharmaceutical freezers, the European Medicines Agency (EMA) approved storage of the vaccine at -25°C to -15°C for a total of two weeks. The FDA’s requirements include two-week storage at the same temperatures, […]
European Medicines Agency (EMA)
BREAKING: Pfizer’s COVID-19 vaccine receives European authorization
Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that they received conditional authorization from European regulators. The European Commission confirmed that it granted a conditional marketing authorization for the vaccine developed by the two companies, making it the first available COVID-19 vaccine in the European Union. The news follows an earlier announcement that the companies had received […]
Acorda’s Parkinson’s device moves closer to E.U. approval
Acorda Therapeutics (NSDQ:ACOR) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of its Inbrija device for the intermittent treatment of “off” episodes in people with Parkinson’s disease. The self-administered, inhaled therapy is designed for people experiencing a re-emergence of Parkinson’s symptoms. These “off” episodes are caused by low […]
Report: French commission calls for massive medtech regulation overhaul
A French parliamentary body is calling for a significant overhaul of medical device regulations in the country and across Europe, calling the existing system “massively dysfunctional,” according to a new report from the International Consortium of Investigative Journalists’ Implant Files. A French Specially Convened Commission on Medical Devices, composed of parliamentarians Julein Borowczyk and Pierre […]
France, Germany deny reports they’ll split EU regulatory agencies
France and Germany this week dismissed rumors that they would split the EU banking and medicines agencies between the 2 countries as the groups are relocated out of London due to the Brexit. Rumors emerged from the German Magazine WirtschaftsWoche this week that the countries, being the 2 largest in the EU, would split the […]
European regulators recommend suspension of Medtronic’s Inductos
European regulators today recommended the suspension of Medtronic‘s (NYSE:MDT) Inductos bone growth product after inspections in July found problems with a U.S. plant that makes part of the implant. The European Medicines Agency recommended that the suspension be put in place until the problems are resolved. Dutch and Spanish inspectors found that the sponge manufacturer “did […]
