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.
“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 – Astrazeneca plc’s COVID-19 vaccine is safe and effective and the benefits well outweigh any risks, according to a review carried out by the EMA, following reports of blood clots in people who received the vaccine.
A large-scale metabolomics study of blood samples from 11,000 people has identified common biological links among a number of chronic non-communicable diseases, opening up the possibility of countering multiple diseases simultaneously.
What started with Austrian regulators suspending use of one batch of Astrazeneca plc’s COVID-19 vaccine has expanded into precautionary holds in Denmark and other EU countries as PRAC, the EMA’s safety committee, investigates whether blood clots, which have resulted in at least two deaths in Europe, are connected to the vaccine.
LONDON – The National Health Service (NHS) in the U.K. has agreed to reimburse Zolgensma, the one-off gene therapy treatment for spinal muscular atrophy billed as the most expensive drug in the world, after a confidential deal was struck with Novartis Gene Therapies.
The European Commission (EC) is investigating whether Teva Pharmaceutical Industries Ltd., of Petah Tikva, Israel, illegally delayed the launch and uptake of competitors to its blockbuster multiple sclerosis (MS) drug, Copaxone (glatiramer acetate).
LONDON – A further U.K. real-world study of COVID-19 vaccines has found a single dose dramatically reduces the chances of the most elderly and frail being admitted to the hospital as a result of serious infection.
DUBLIN – Sofinnova Partners closed out its crossover fund at €445 million (US$535 million), a total, it said, that makes it Europe’s largest crossover investor in biotech. It’s almost three years since Paris-based Sofinnova Partners completed an initial close at €275 million. “We didn’t set a bar – we thought between €250 million and €400 million would be great,” Antoine Papiernik, chairman and managing partner at Sofinnova, told BioWorld.