Rapid progress on MDD (Medical Devices Directive) review at Council and Parliament levels
This article was originally published in Clinica
Swift progress is already being made at the European Council on discussions on the proposed review of the Medical Devices Directive. A meeting, scheduled for February 20, will allow the Council to complete its first preliminary review of the text, before a second round of discussions is launched. This review at the Council is allowing major issues to be identified where there is not full agreement. It gives the EU presidency, currently held by Austria, as well as expert working groups or committees that have been set up by member states on particular subjects, an opportunity to contribute to the debate. The Commission can also propose some redrafting where necessary. In parallel, there have also been developments at the European Parliament. The EP has decided is to consult the European Economics and Social Committee (Ecosoc) over the text. And Ecosoc has appointed Paolo Braghin, of Italian industry association Confindustria, as rapporteur.
You may also be interested in...
Public Company Edition: Lixte’s small uplisting was the only biopharma initial public offering in the US during Thanksgiving week, but IPOs are ramping up again. Also, LifeSci launched its second SPAC and in follow-on offerings Reata brought in $281m and Intellia grossed $175m.
Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Results of Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia “should prompt reconsideration of [OTC] mixed omega-3 fatty acid products for [atherosclerotic cardiovascular disease] prevention,” say cardiologists in an editorial published with JAMA study.