PERTH, Australia – On the heels of scoring a CE mark for its Novosorb biodegradable temporizing matrix (BTM) in the EU, Melbourne-based Polynovo Ltd. crossed its first AU$2 million (US$1.3 million) month in December sales for its initial commercial product.

PARIS – Quantum Surgical SAS, of Montpellier, France, has been awarded development aid amounting to $2.25 million in grants and repayable loans from Bpifrance bank, as part of the French Deeptech program.

Keystone Heart Ltd., of Caesarea, Israel and Tampa, Fla., scored a win in Europe after obtaining the CE mark for the Triguard 3 cerebral embolic protection (CEP) device. It is designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation (TAVI) and other transcatheter heart procedures. According to the company, the device is the only product with a CE mark designed to cover and protect all three major cerebral aortic arch vessels.

LONDON – The U.K. life sciences sector has stepped into “a new reality” following publication of the government’s negotiating mandate on the future trading relationship with the EU. “Plan A is no longer on the table,” said Steve Bates, chief executive of the Bioindustry Association, who has spent three long years lobbying for a favorable deal for the industry.

LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.

LONDON – The EU launched a “Corona” response team, bringing together oversight of all the separate strands put in place to control the virus, as the infection spread to 18 of 27 member states, with 2,100 confirmed cases and 31 deaths.

DUBLIN – The EMA’s Committee for Medicinal Products for Human Use (CHMP) diverged from the FDA on a key decision at its monthly meeting, which concluded Feb. 28. It refused to back an application from Eli Lilly and Co. for a line extension to its migraine prevention drug, Emgality (galcanezumab), which would have authorized the drug for preventing attacks during an episode of cluster headaches.

LONDON – The COVID-19 epidemic has reached a “decisive point” as the number of new cases in the rest of the world exceeded the number of new cases in China, and seven countries reported infections for the first time.

PARIS – Vygon SA, of Ecouen, France, has acquired Advanced Perfusion Diagnostics SA (APD), a startup based in Lyon, France, that has developed Ikorus, a device that detects changes in visceral microvascular blood flow in the most critically ill hospital patients. Vygon did not disclose the financial details behind the agreement.

LONDON – The COVID-19 outbreak appears to be sliding toward pandemic status, with the virus spreading to four more countries and confirmed cases and deaths mounting in infection hotspots in Italy, Iran and South Korea. Parts of northern Italy are in lockdown, with 200-plus cases and seven deaths. Austria and Switzerland are reported to be considering closing their borders with Italy, and the EU has responded with a €232 million (US$252 million) package of aid, including €90 million for development of a vaccine and €10 million for therapeutics and diagnostics.