In the wake of towering freight rates and massive delays, the European Commission has commenced an investigation of liner companies’ special exemption from the union’s competition rules. Industry players will have the opportunity to submit documents ”relevant to the evaluation,” spokesperson says.
The life science sector will have a central role in a comprehensive revision of the EU’s industry policy, but a new presidency of the European Council could slow down the process, warns a Think Tank Europa representative.
Experiences from Danish climate partnerships are among the tools that can be leveraged when Novo Nordisk CEO Lars Fruergaard begins stepping up efforts in the life science sector’s central organs in Brussels. ”I’ve been fired up by the intimacy and shared vision we could see in Denmark,” he tells MedWatch.
The EU Commission is concerned that Vifor Pharma might have abused a ”dominant position” by spreading false safety information about its closest European competitor on the IV iron treatment market, Pharmacosmos.
During a good clinical practice inspection at Leo Pharma last year, the Danish Medicines Agency struggled to gain access to data related to two clinical eczema studies. The next step would have been ”regulatory action.”
On Wednesday, pharmaceutical firms can apply to a trial scheme in Denmark where the public health system and private firms join forces to share the financial risks of expanding certain drug reimbursements.
Due to fraudulent clinical trials from a contract research organization, the EMA’s expert committee, the CHMP, is now suspending marketing approval authorizations for around 100 generic drugs on the market.
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 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.
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.