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.
PARIS – Aleva Neurotherapeutics SA reported the first successful implantation of its Directstim directional deep brain stimulation (DBS) system into a patient suffering from Parkinson’s disease. The procedure involving this new generation of active brain device was performed by neurosurgeon Stephan Sobottka, from the Clinic for Neurosurgery at the University Hospital Carl Gustav Carus in Dresden, Germany.
LONDON – The message that COVID-19 is a disease of the elderly needs to change, according to U.K. researchers who have analyzed complications suffered by 73,197 patients admitted to 302 hospitals in the first wave of the pandemic last year.
Hoping to get Germany to drop its opposition to a proposed World Trade Organization (WTO) waiver of intellectual property (IP) rights, several U.S. lawmakers have asked to meet with German Chancellor Angela Merkel when she’s in Washington for a July 15 summit with President Joe Biden.
DUBLIN – Poolbeg Pharma plc raised £25 million (US$35 million) in an IPO on London’s Alternative Investment Market (AIM) to pursue development of antiviral drugs. The company priced the offering at 10 pence per share, which implies a valuation of £50 million. Shares are due to commence trading on Monday, July 19.
It’s more than 20 years since the tobacco firm Philip Morris International Inc. commissioned a controversial research paper, “Public Finance Balance of Smoking in the Czech Republic,” which infamously argued that smokers cut state health care expenditure by dying early. The paper was considered an outrage and led to a high-profile apology from the company, after being widely derided by politicians and commentators internationally. The company’s July 9 proposal to buy the respiratory diseases firm Vectura Group plc for $1.2 billion is already looking just as provocative according to U.K. politicians and anti-smoking groups, who are calling for the government to intervene to stop it going ahead.