Valneva SE confirmed that the European Medicines Agency accepted the filing of a marketing authorization application (MAA) for the specialty vaccine company’s inactivated, whole-virus COVID-19 vaccine candidate, VLA2001.
The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a negative trend vote on the Marketing Authorization Application for Biogen’s controversial Alzheimer’s drug Aduhelm (aducanumab).
The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).
Ipsen’s New Drug Application (NDA) for palovarotene – an oral, investigational, selective RARγ agonist for the prevention of heterotopic ossification (new bone formation) as a potential treatment option for people living with the progressive disabling and ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP) – was accepted by the U.S. Food and Drug Administration.
The European Commission granted Amarin Corporation Plc’s fish-oil derived heart drug Vazkepa marketing authorization in the European Union, the drugmaker said on March 30.
bluebird bio Inc. announced updated results from the clinical development program for the company’s investigational elivaldogene autotemcel (eli-cel, Lenti-D) gene therapy in patients with cerebral adrenoleukodystrophy (CALD), including long-term results from the Phase 2/3 Starbeam study and data from the Phase 3 ALD-104 study.
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.