LONDON – The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) stood by its view that the benefits of Astrazeneca plc’s COVID-19 vaccine “continue to outweigh the risks,” as it published the latest summary of reported adverse events.
LONDON – A new route to the approval of drugs promises to smooth the path from clinical trials to approval, reimbursement and commissioning in the National Health Service, through closer and earlier collaboration between the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and health technology assessment bodies.
HONG KONG – SK Biopharmaceuticals Co. Ltd. partner Arvelle Therapeutics GmbH, now part of Angelini Pharma, has received European Commission (EC) approval for Ontozry (cenobamate), a treatment for drug-resistant focal-onset seizures. The approval was granted for focal-onset seizures with or without secondary generalization in adults who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicines.
PARIS – Barely one year after its formation, startup company Quantiq SAS has just closed an $825,000 seed round, to develop its contactless medical diagnostics technology. French business angels from the medical, artificial intelligence and fintech worlds participated in this initial fundraising.
“Our position has not changed,” said Emer Cooke, executive director of the EMA, giving an update on the agency’s investigation into cases of the rare clotting disorder cerebral venous sinus thrombosis (CVST) in people vaccinated with Astrazeneca plc’s COVID-19 vaccine. “There is no evidence to support restricting use of the vaccine in any population,” she said.
LONDON – Inbrain Neuroelectronics Ltd. has raised €14.35 million (US$16.9 million) in a series A round to take nanoscale graphene implants it says have the potential to interface one-on-one with neurons, into clinical development later this year. The technology promises significant improvements on current implants used for deep brain stimulation to treat conditions including Parkinson’s disease, epilepsy, obsessive compulsive disorder and neuropathic pain.
LONDON – Getting a handle on the specificity and sensitivity of rapid COVID-19 antibody tests, how they compare to each other and how they should be applied in population screening to understand who has had the virus and how it has spread, has been a source of difficulty and dispute between manufacturers, clinicians and public health experts.
Debx Medical BV has advanced to the pre-launch phase for its new topical desiccant gel for the treatment of chronic infected and necrotic wounds. Two months after obtaining CE mark approval for Debrichem, the Rotterdam, Netherlands-based company is starting distribution of its class IIb medical device in Europe – in the Netherlands, Italy and Spain – as well as in Hong Kong, South Africa, New Zealand and Australia.
Vetex Medical Ltd.'s Revene thrombectomy catheter reduced symptoms and improved quality of life in all patients with iliofemoral vein thrombus in a European clinical study. The results were presented at Venous 2021, the annual meeting of the American Venous Forum.
Fluxergy Inc. said Thursday that it has won CE-IVD marking for its one-hour COVID-19 real-time polymerase chain reaction (RT-PCR) test. The automated, sample-to-action Fluxergy diagnostic testing system can run multiple assay types – such as molecular, immunochemistry, chemistry and cytometry – simultaneously on the same cartridge. The SARS-CoV2 RT-PCR test is the first CE-marked product for the Fluxergy diagnostic platform.
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