MedWatch

Regulation

CHMP recommends six new drugs

The European Medicines Agency's committee has at its October meeting recommended six drugs for market approval in Europe. In addition, the authority recommends new uses for ten other drugs.

Former FDA head to make comeback under Biden, media reports

The US President is ready to announce his candidate for the head of the US Food and Drug Administration, the FDA, Politico reports. The agency has not had a permanent leader since January, and Biden's likely candidate has previously held the post.

EU Commision working on solution for IVDR bottlenecks

The new EU regulation (IVDR) strikes fear into the industry, as a lack of notified bodies could cause bottlenecks in the certification process of in vitro diagnostics tests (IVDs). The EU Commission is working on a solution, reports Danish Minister of Health Magnus Heunicke.

Pharmacosmos settles legal dispute with Vifor

Pharmacosmos is now withdrawing the press release that the Danish Medicines Agency has ruled was in breach of the Danish Medicines Act. The ruling was the root of the subsequent case which competitor Vifor brought against the company in the Maritime and Commercial High Court of Denmark.

CHMP recommends nine new drugs, rejects one

Roche and Biogen are among the companies that have received recommendation for approval from the European Medicines Agency's committee (CHMP) at its September meeting. One Pfizer drug was the sole candidate to be rejected.

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