The team behind Sputnik V has attacked what it calls “fake news and provocations” in the EU as political arguments over the vaccine claim another ministerial scalp.
Amid renewed concern over COVID-19 vaccine supplies following warnings by European regulators about the risk of rare blood clots with the Oxford/AstraZeneca PLC vaccine, EU countries are increasingly eyeing up the pros and cons of using Russia’s Sputnik V. But the vaccine is at the eye of a growing political storm.
Sputnik V is undergoing a rolling review at the European Medicines Agency pending the filing of a marketing authorization application...
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
Following EU approval of the first disease-modifying treatment for Alzheimer’s disease, and with a second expected soon, the European Medicines Agency plans to update its guidance to support the design of state-of-the-art clinical trials for the disease and enhance drug development.
The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.
The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.
