Looking to turn around the decline of clinical trials within its borders, the U.K. government appointed James O’Shaughnessy, a former health minister, board member of Health Data Research UK and a senior partner at Newmarket Strategy, to conduct an independent review of the country’s commercial clinical trial landscape.
More than two months after a voluntary recall by Zimmer Biomet Holdings Inc. (ZBio), the U.K. Medicines and Healthcare products Agency (MHRA) issued an alert confirming the U.K. National Joint Registry has identified that there are higher revision rates for certain of the company’s total knee replacement prostheses, as compared to all other knee replacements in the registry.
Previa Medical SA will begin clinical trials later this year of its artificial intelligence software designed for early detection of sepsis after it raised €2.1 million (US $2.2 million) in seed funds.
Royal Philips NV released a grim annual report for 2022 that showed a little willingness to share the pain of an unabashedly awful year for the health tech company, which has been plagued by a recall fiasco that has bled into multiple years. Shareholders lost much of their investment with the company’s more than 60% drop in market value in 2022, 10,000 employees faced job loss and all current members of top management waived their annual incentive payouts. Notably, former CEO Frans van Houten, who was replaced in October and oversaw the ill-fated recall, did not waive his bonus of $208,370.
Herantis Pharma plc has received approval from the Finnish Medicines Agency, Fimea, and an ethics committee for a clinical trial application (CTA) to start clinical development of HER-096 for Parkinson's disease.
To restore hearing function in patients with hearing loss or deafness, cochlear implantation is seen as the only method that works, but insertion of the electrode array may cause direct mechanical injury to the cochlea, with the subsequent loss attributed to an inflammatory response driven by proinflammatory cytokines, reactive oxygen species and apoptotic signals.
The stage is set for a showdown between the pharma industry and national governments and public health experts over which policy the EU should grasp, as it bids to create a pan-European incentive scheme that will encourage innovation and get more antibiotics through to market. At issue is a proposal supported by the industry, under which companies getting approval for a new antibiotic would be given a voucher allowing them to extend market exclusivity of any different drug of their choice for one year.
The European Parliament (EP) has voted to affirm the proposal by the European Commission (EC) to extend the compliance timelines for the Medical Device Regulation (MDR) in an urgent vote that eliminated any chance of debate. The vote was a landslide, coming in at 564 votes in support and three nays.
Syntach AB has been awarded up to $17 million in equity financing by the European Innovation Council (EIC) for the development of its cardiac support system, a breakthrough device for heart failure patients. This approval follows the $2.67 million EIC grant announced in December 2021 constituting the equity portion of the $18.7 million of blended finance under the EIC accelerator program. “Thanks to this funding, we are on the way to offering our treatment on a global scale,” said Tor Peters, CEO of Syntach.
The U.K. government recently released its first ever medical technology strategy which aims to accelerate access to innovative medical technologies in the NHS. Although it was welcomed by the industry, and questions remain as to whether it goes far enough to address some of the challenges to the adoption of medical devices, eyes are on its implementation and whether it will achieve its aims.
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