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Novartis’ lymphoma treatment receives FDA breakthrough therapy designation

19 April 2017 | By Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Novartis’ CTL019, an investigational chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of adult patients with relapsed and refractory (r/r) diffuse large B-cell lymphoma (DLBCL), who have failed two or more prior therapies. This is…

Enzyvant receives FDA designation for investigational therapy

19 April 2017 | By Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has granted Enzyvant’s RVT-802, an investigational tissue-based therapy for the treatment of complete DiGeorge Syndrome (cDGS), breakthrough therapy designation as well as regenerative medicine advanced therapy (RMAT) designation. Both designations confer special access to the Office of Tissues and Advanced Therapies for development…

Amarantus forms Elto Pharma for CNS disorders and MANF Therapeutics for ophthalmology

18 April 2017 | By Niamh Marriott, Junior Editor

Amarantus Bioscience has formed a wholly-owned subsidiary named Elto Pharma for the purpose of creating investment vehicles focused exclusively on the further development of Eltoprazine, Amarantus' mid-stage central nervous system (CNS) symptomatic treatment for Adult Attention Deficit and Hyperactivity Disorder (Adult ADHD), Alzheimer's Aggression and Parkinson's disease Levodopa-induced Dyskinesia (PD-LID).

FDA approves first drug to treat tardive dyskinesia

12 April 2017 | By Niamh Marriott, Junior Editor

The US Food and Drug Administration (FDA) has approved Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.   Tardive dyskinesia is a neurological disorder characterised by repetitive involuntary movements, usually of the jaw, lips and tongue, such as…