United States

FDA approves Alkermes ARISTADA treatment for schizophrenia

Wednesday, June 7, 2017

Alkermes announced that the FDA has approved two-month ARISTADA (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA is now FDA-approved in four doses and three dosing duration options (441mg, 662mg or 882mg once monthly, 882mg once every six weeks and 1064mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers. The new two-month dose is expected to be available in mid-June.

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FDA approves new hemophilia treatment

Thursday, June 1, 2017

Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application for REBINYN® (Coagulation Factor IX (Recombinant), GlycoPEGylated) for the treatment of adults and children with hemophilia B.

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Three Questions: David Izard, Chiltern

Tuesday, May 30, 2017

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Sony Salzman spoke with David Izard, senior director, Clinical Data Standards at Chiltern. He co-authored the white paper “The Case For Embracing The FDA’s Endorsed Data Standards.”

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Genentech’s Actemra FDA approved for giant cell arteritis

Friday, May 26, 2017

Genentech, a member of the Roche Group, announced that the FDA has approved Actemra (tocilizumab) subcutaneous injection for the treatment of giant cell arteritis (GCA), a chronic and severe autoimmune condition. Actemra is the first therapy approved by the FDA for the treatment of adult patients with GCA. This is the sixth FDA approval for Actemra since the medicine was launched in 2010.

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Otsuka, Proteus Digital Health resubmit FDA application for first digital medicine

Tuesday, May 23, 2017

Otsuka Pharmaceutical and Proteus Digital Health announced that the FDA has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

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