The convergence of life science and information technology has received further validation with the launch of a new €250 million fund called Endeavour Medtech Growth LP to support medical device and digital health companies in Europe and the US.
The US Food and Drug Administration has asked Newron Pharmaceuticals SpA to provide more information on the potential for abuse of its candidate drug for Parkinson’s disease safinamide. The FDA is withholding approval pending further information.
The US Food and Drug Administration has turned down a proposed new indication for the anti-depressant Brintellix (vortioxetine) saying that more clinical data is required. Discovered by H. Lundbeck A/S, the drug was being assessed for cognitive dysfunction.
France-based Gecko Biomedical SAS has obtained €22.5 million in equity financing from Sofinnova Partners, Bpifrance and others in order to advance its medical device for tissue reconstruction, which is based on proprietary biopolymers.
Onxeo SA, which was formed from the 2014 merger of BioAlliance Pharma SA of France and Topotarget A/S of Denmark, has completed the acquisition of DNA Therapeutics SA of France in a move that will strengthen its expertise in rare cancers.
The failure of the anti-platelet agent Brilinta (ticagrelor) to perform better than aspirin in a late-stage stroke trial has dashed expectations, at least for the time being, of expanding the approved indications for the drug.
Mercia Technologies Plc, which provides seed and follow-on funding to UK technology companies, has expanded the geographical penetration of its operations with the acquisition of Enterprise Ventures Group Ltd, a company located in the north of England.
In keeping with the trend toward global drug development, regulatory consultancies from Sweden and the US have merged, creating a network of more than 1,000 experts with knowledge of medical technology, science and US and European regulatory procedures.
GlaxoSmithKline Plc has signed an agreement with a service company in Germany to gain access to technology for industrialising cell and gene therapies. The two parties will also discover new chimeric antigen-receptor T (CAR T) cell therapies.
UK-based Adaptimmune Therapeutics Plc has decided to align its financial year with the calendar year as part of a move to make its reporting practices more compatible with those in the US. This follows the company’s listing on Nasdaq and an expansion of its operations in Philadelphia.