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).
Paris-based GenSight Biologics reported the first group of data from Week 96 of the company’s RESCUE Phase III clinical trial.
Sanofi reported overall net sales increased by 5.5 percent for second-quarter 2019, driven by Sanofi Genzyme, Sanofi Pasteur and emerging markets.
San Rafael, Calif.-based BioMarin Pharmaceutical announced positive Phase III clinical trial results for the company’s gene therapy, valoctocogene roxaparvovec, for adults with hemophilia A.
Boehringer Ingelheim’s SENSCIS Phase III clinical trial met the primary endpoint for nintedanib in patients with SSc-ILD.
Pfizer announced plans to buy Therachon, a rare disease biotech company based in Basel, Switzerland.