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.
As a direct consequence of new EU regulation for the medtech industry, firms have started to launch in the US before Europe, which wasn’t always the case previously, says the chief executive of industry association Medtech Europe.
The aim of the European Health Data Space (EHDS) is to strengthen cross-border access to health data in Europe.
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.
European regional differences are too large in regard to the time it takes for drugs to reach individual EU countries post approval, says European lobby organization EFPIA, which is launching a new initiative to reduce inequalities in the area.
When the Danish Medicines Council meets with representatives from the Danish Regions in April, the possibility of implementing a fast-track scheme in the country may be on the agenda.
Roche and Novartis have been behind almost 10 percent of all application submissions to the Danish Medicines Council since 2017. In a column, representatives from both firms point out three problems and make concrete proposals for how to improve the council’s work.
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.
An EU directive aiming to put concrete target figures on corporate boards in order to fight gender inequality is one step closer to becoming reality.
The European Medicine Agency’s new role in European crisis preparedness was tested during the Covid-19 pandemic, and has now been made permanent.
13 new treatments have received a positive opinion from the CHMP’s February monthly meeting, while seven drugs have been approved in new indications.
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.
Two Danish researchers are the first out of the gate to make use of an EU portal for the registration of clinical trials, which launched at the same time as the EU’s new Clinical Trials Regulation in January.
This year, Europe’s new Health Emergency Preparedness and Response Authority will channel many millions of euros into R&D, for instance going to pre-clinical therapies for diseases with unmet medical needs, documents reveal.
The Danish Chamber of Commerce is urging the Danish government to promote the establishing of a reference laboratory in Denmark, as the EU’s new rules concerning in vitro diagnostic equipment near.
From Monday, pharmaceutical companies and researchers will be able to register clinical trials in one centralized place within the EU and the European Economic Area (EEA).
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.
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.
After concerns with finding employees for notified bodies were brought to the European Commission, the authority will now put the problem on its agenda.
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.
Another clinical trial of TAK-721 is needed, says the US Food and Drug Administration, which has rejected the drug.
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.
Amgen has received approval for its plan to expand the usage of psoriasis drug Otezla.
Ministers from EU member countries agree to give nations and companies, including life science firms, an additional sixth months for the implementation of the extensive cybersecurity directive, NIS2. "The stakes are high," says Slovenian Minister.
It is appropriate to consider obligatory Covid-19 jabs, says EU Commission President Ursula von der Leyen.
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