NHS England has announced a new £340 million (US$481 million) Innovative Medicines Fund, as the country grapples with the issue of bringing ultra-pricey specialist medicines to patients on the country’s taxpayer-funded health care system.
Vivasure Medical Ltd. has designed a sutureless and absorbable venous vessel closure for use following percutaneous cardiovascular procedures, such as transcatheter mitral valve or tricuspid valve repair or replacement. The Perqseal Blue technology builds on the Galway, Ireland-based company’s Perqseal, which received the CE mark for vascular closure of femoral arteries in 2016.
LONDON – The U.K. Medicines and Healthcare products Agency (MHRA) has embarked on wide-ranging reforms that are designed to make the most of post-Brexit regulatory flexibility while capitalizing on the ‘spirit of the pandemic,’ which has seen it rise to the occasion in supporting rapid set up of large-scale randomized clinical trials and approvals of COVID-19 vaccines.
Sweden’s Calliditas Therapeutics AB has licensed its rare kidney disease therapy to Stada Arzneimittel AG in Europe to help it navigate the complexity of the region’s market, ahead of a potential European and U.S. approval in the coming months.
The U.K. National Institute for Health and Care Excellence (NICE) said devices used to repair paravalvular leak around replaced mitral or aortic valves should only be used in studies because of a limited set of data on efficacy.
The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.
Responding to the growing number of state-sponsored cyber threats to health care and other key sectors and to the compromise of the Microsoft Exchange Server, which was disclosed in March, Canada, the EU, U.K., U.S. and other NATO allies issued statements July 19 laying out expectations and markers for how responsible nations behave in cyberspace and specifically calling out China’s “malicious cyber activity.”
DUBLIN – Panakès Partners SGR SpA has raised €150 million (US$177 million) in a first close of its second fund and is looking to secure a final tally of €180 million by year-end. That would represent more than twice the size of its first fund of €80 million and reflects its move into therapeutics investing.
LONDON – U.K. rapid diagnostics specialist Mologic Ltd. has been acquired by a group of philanthropists led by George Soros’ Economic Development Fund and the Bill & Melinda Gates Foundation, and will be turned from a for-profit company to a social enterprise. The aim is to use the change in status to expand access to low-cost point-of-care testing for tropical diseases, including dengue, bilharzia and river blindness, as well at COVID-19. The name Mologic will be changed to Global Access Health (GAH), with the philanthropic owners saying they are to invest at least $41 million in the deal.
French biotech Pep-Therapy SAS is taking its potentially first-in-class cancer cell penetrating peptide technology into the clinic, after raising €5.4 million (US$6.4 million) in an extended series A funding round. The series A fundraiser initially brought in €2.6 million, but the extension brought in a further €1.6 million in equity from Anaxago, i&i Prague and Badge as well as a €1 million loan from Bpifrance.