LONDON – A new national consortium of virologists has been set up to systematically assess how mutations in SARS-CoV-2 affect key outcomes such as effectiveness of vaccines and therapies, transmissibility of the virus and the severity of COVID-19 infections. Now is the critical time to do this, as the level of both natural and vaccine-conferred immunity that might drive natural selection is increasing, said Wendy Barclay, head of the department of infectious disease at Imperial College London, who is leading the G2P-UK (Genotype to Phenotype-UK) project.
LONDON – The U.K. has launched a nationwide free testing program to diagnose COVID-19 in people who are asymptomatic, in the latest attempt to stem the tide of infection. Through the program, all local authorities will provide rapid testing using lateral flow devices. In addition, companies will be provided with free tests to set up workplace screening. Initially, the focus of both strands will be on getting people who cannot work from home to come forward for regular checks.
LONDON – The 1,246 pages that make up the U.K./EU post-Brexit trade deal have “one paragraph we can build on,” said Steve Bates, chief executive of the Bioindustry Association (BIA), giving his initial reaction to the document published late on Dec. 24. That one paragraph refers to the setting up of a joint working group on medicinal products. It says the EU and the U.K. “shall endeavour to cooperate with a view to strengthening, developing and promoting adoption and implementation of internationally agreed scientific or technical guidelines.”
LONDON – The U.K. is to make treatment with interleukin-6 (IL-6) inhibitors standard of care for critically ill COVID-19 patients after a randomized trial found the arthritis drugs significantly improve survival.
LONDON – The EMA has recommended approval of Moderna Inc.’s COVID-19 vaccine, becoming the fourth western regulator to do so, after Israel approved the product on Jan. 5 and the FDA and Health Canada in December.
LONDON – Controversy has erupted over COVID-19 vaccines dosing after the U.K. said it is to prioritize giving as many people as possible a single dose of the two currently approved products, rather than two doses three or four weeks apart, as scheduled on their labels. The move prompted a sharp rebuke from FDA Commissioner Stephen Hahn and Peter Marks, director of FDA’s Center for Biologics Evaluation, who said any such change “is not rooted in the science.”
The medical device company Distalmotion SA has hit a regulatory milestone in the commercialization of its surgical robot, Dexter, earning a CE mark in Europe. The Dexter surgical robot is built with the aim of allowing surgeons to take a hybrid approach to minimally invasive surgery, using the robot for tasks such as suturing and complex dissections while switching to a laparoscopic approach for stapling and basic dissections.
DUBLIN – European biopharma, like the rest of the global industry, scaled new heights in 2020 from an investment perspective. European firms collectively raised $12.682 billion from the private and public equity markets, as well as substantial levels of debt and grant funding. It was a bumper year for both venture capital investment and for Europe’s growing cadre of listed companies.
LONDON – Family-owned Angelini Pharma is to buy Swiss startup Arvelle Therapeutics GmbH for $960 million, acquiring full European rights to the epilepsy drug cenobamate. The first tranche, of $610 million, will be paid following the EMA’s recommendation to approve cenobamate, which is expected at either the January or February meeting of the Committee for Medicinal Products for Human Use.
PARIS – Solvay SA is partnering with Printerprezz Inc. to develop 3D printing technology using Selective Laser Sintering (SLS) for implants and other medical devices.