As a part of EU's new health authority, the Commission has set aside millions of euros to reserve the capacities of European manufacturers in times of need. The investment will create an "ever-warm" network of medical countermeasures.
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.
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 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.
Although the price of Biogen's treatment Spinraza has been dropped yet again, the Danish Medicines Council will not expand the drug's approved patient group. It is the sixth time that the council has declined this application – and Roche's muscle wasting disease treatment is also expected to be rejected.
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.
With a budget potentially exceeding EUR 47.1bn (DKK 350bn), the EU Commission wants to establish a new agency to ward against future health crises. While the financial makeup is uncertain, good news for future clinical trials might be on the way.