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.
bluebird bio announced that it expected to file three applications for regulatory approval by the end of 2019.
Daiichi Sankyo Europe GmbH informed Nektar Therapeutics that it was terminating a collaboration and licensing deal, which becomes effective Feb. 4, 2018. All rights and licenses that Daiichi acquired in the deal will revert to Nektar.
Novartis’ generics division Sandoz said new immunology data from four clinical studies supported its proposed biosimilars adalimumab for treating psoriasis and cancer drug rituximab.