Due to fraudulent clinical trials from a contract research organization, the EMA’s expert committee, the CHMP, is now suspending marketing approval authorizations for around 100 generic drugs on the market.
Morten Søgaard is leaving Pfizer to join Astellas, where he will be in charge of 100 employees. Going from one of the world largest pharmaceutical firms to a considerably smaller one will be a challenge, he says.
Drug-resistant bacteria kill hundreds of thousands of people every year, and national regulatory forces across the world are now coming together to ensure a uniform approach to clinical trials for antibiotics.
International antibiotic alliance Carb-X has received commitments of up to USD 370m to accelerate the development of new antibiotics to combat a future shortage. The news is welcomed by several players on the AMR field.
Almirall is launching psoriasis cream Wynzora in Denmark. The treatment has been inlicensed from Danish firm MC2 Therapeutics, where the CEO says ”it is a special feeling” to see Wynzora launched in its home country.
During this month’s meeting of the CHMP, the EMA’s expert committee, a total of nine new drugs have been recommended while six drugs have had indication extensions accepted. Two treatments have been rejected.
After a turbulent time for Ambu under Juan Jose Gonzalez’s reign, new chief executive appointee Britt Meelby Jensen aims to rebuild the trust in the medtech firm, which has downgraded its expectations seven times over the past three years.