MedWatch

Regulation

Danish Medicines Council makes five recommendations after April meeting

The council has processed five drug applications at this month’s meeting, including proposals from Bristol Meyers Squibb and Novartis, which received thumbs-up for treatments for cancer and spinal arthritis, respectively. Sanofi’s application was rejected and Merck/Pfizer’s combination pitch was not approved, despite new data.

EMA management board elects new chair

The European Medicines Agency’s management board has found a new chair in the chief executive of the Irish health authority, Lorraine Nolan. With Emer Cooke, executive director at the EMA, there are now two women guiding the European agency.

New EMA powers have come into force

The European Medicine Agency’s new role in European crisis preparedness was tested during the Covid-19 pandemic, and has now been made permanent.

CHMP approves 13 new drugs

13 new treatments have received a positive opinion from the CHMP’s February monthly meeting, while seven drugs have been approved in new indications.

Janssen puzzled by Denmark's refusal of antidepressant nasal spray

The Danish Medicines Council has once again refused to approve Janssen’s nasal spray for treatment-resistant depression, dubbed Spravato. The decision surprises Julie Brooker, Janssen’s country director for Denmark, as other European countries have given conditional approvals.

Overwhelming majority passes new EMA powers

The European Parliament has adopted regulation that strengthens the EMA's ability to monitor drug and medical equipment shortages in Europe. New EMA groups will be impartial, they say, effectively shutting the door on representatives from the medical industry at large.

Ten EMA initiatives will strengthen clinical research in Europe

The framework conditions for clinical research in Europe have proved challenging and difficult, the EMA says. With ten new initiatives, the European health authority wants to change how trials are designed, initiated and conducted. Industry association Lif welcomes the changes.

Danish notified body expected approved in 2023

More than a year will pass before Denmark will once again have a notified body for the approval of medtech products. Industry association Medicoindustrien warns of a ”huge capacity crisis,” which will only grow – particularly affecting one part of the industry.

Gradual IVDR implementation backed by EU

New regulation on in vitro medical equipment will now have a longer implementation period after the proposal was backed by the bloc's Commission, Council and Parliament.

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