The European Commission gave conditional approval for the use of remdesivir in severe COVID-19 patients following an accelerated review process, making the antiviral the region’s first authorized therapy to treat the virus.
London-based Freeline announced the closing of a $120 million extended Series C financing to advance the company’s gene therapy programs, and is considering additional capital fundraising options during 2020.
The U.S. Food and Drug Administration approved a drug to treat infants and children with HIV, with the drug having been developed by drugmaker GlaxoSmithKline’s HIV drugs division ViiV Healthcare.
The European health regulator is looking to fast-track approval of Gilead’s antiviral remdesivir as a potential COVID-19 treatment in Europe.
Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.
Swiss drugmaker Novartis won a key European recommendation for the company’s gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.
Germany’s drug assessment body said data provided by Bayer on the precision cancer drug Vitrakvi did not provide clear enough evidence of benefits, in a setback to the drugmaker in the company’s home market.
Pfizer Inc.’s rheumatoid arthritis drug Xeljanz could increase the risk of blood clots in the lungs and in deep veins, the European Medicines Agency (EMA) said.
Gilead Sciences Inc. and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib – an investigational, oral, selective JAK1 inhibitor for the treatment of moderately to severely active rheumatoid arthritis (RA) – are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier during 2019.
Shionogi & Co. Ltd. announced results from APEKS-NP, an international, double-blind, randomized Phase III clinical trial evaluating the efficacy and safety of the investigational antibiotic cefiderocol in patients with nosocomial pneumonia (NP).