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.
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.
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.
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.
During its May meeting, the Danish Medicines Councils has rejected breast cancer drug Piqray, which is developed by Novartis, and has partly reversed a prior rejection of acute myeloid leukemia (AML) treatment Xospata, developed by Astellas Pharma.
In a phase III study of dasiglucagon, biotech firm Zealand Pharma has met its endpoint, reducing the need for children under 12 months with the rare disorder to undergo intensive hospital treatment by 55%.