Europe’s drug regulator is evaluating South Korean drugmaker Celltrion’s Covid-19 antibody treatment, the third such drug against the disease to go under real-time review in the region.
The U.S. Food and Drug Administration accepted for priority review a Biologics License Application (BLA) for Merck’s 15-valent pneumococcal conjugate vaccine V114.
U.S. firm Johnson & Johnson is likely to apply for EU approval for the company’s Covid-19 vaccine candidate in February, a top lawmaker said.
U.S. drugmaker Pfizer and the company’s German partner BioNTech said documents related to development of their Covid-19 vaccine were “unlawfully accessed” in a cyberattack on Europe’s medicines regulator.
Pfizer received positive top-line results from the Phase III JADE REGIMEN study, examining the investigational oral once-daily Janus kinase 1 (JAK1) inhibitor abrocitinib for the treatment of severe atopic dermatitis.
The UK government’s Covid-19 Vaccine Taskforce and the contract research company Open Orphan announced a $13 million (£10 million) plan to test investigational vaccines in volunteers who are then intentionally exposed to SARS-CoV-2, the virus that causes Covid-19.
The European health regulator started reviewing data on AstraZeneca and Oxford University’s potential Covid-19 vaccine in real time, the first of such moves aimed at speeding up any approval process in the region for a vaccine.
Novartis announced results from a post-hoc analysis of pooled data from the Phase III ORION-10 and -11 trials evaluating the individual responses of patients on low-density lipoprotein cholesterol (LDL-C) reduction with inclisiran, a first-in-class investigational treatment for hyperlipidemia in adults.
Roche company Genentech has released data from a long-term clinical trial of Ocrevus (ocrelizumab) in multiple sclerosis. The U.S. FDA and the European Medicines Agency accepted Novartis’ marketing applications for siponimod (BAF312) to treat secondary-progressive multiple sclerosis in adults.
Vertex Pharmaceuticals selected two next-generation cystic fibrosis drugs to advance into late-stage testing of triple-combination therapies that could eventually treat up to 90 percent of patients.