Clinical Intelligence

Merck receives FDA approval of new HIV-1 treatment

Tuesday, May 30, 2017

Merck has announced that the U.S. Food and Drug Administration (FDA) has approved ISENTRESS® HD, a new 1200 mg once-daily dose of the company’s integrase inhibitor, ISENTRESS® (raltegravir), to be administered orally as two 600 mg film-coated tablets with or without food, in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults, and pediatric patients weighing at least 40 kg, who are treatment-naïve or whose virus has been suppressed on an initial regimen of ISENTRESS 400 mg given twice daily.

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Trovagene releases phase I study results supporting development of PCM-075 in AML

Monday, May 29, 2017

Trovagene, a precision medicine biotechnology company, announced summary data from a phase I safety study conducted by Nerviano Medical Sciences with PCM-075, a polo-like kinase 1 (PLK1) inhibitor. This data is supportive of a planned phase I/II clinical trial in patients with acute myeloid leukemia (AML) and is now being submitted for peer review publication by study investigators.

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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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FDA grants Biohaven’s trigriluzole Fast Track Designation

Wednesday, May 17, 2017

Biohaven Pharmaceutical announced that the FDA has granted the company Fast Track Designation for Biohaven’s product candidate trigriluzole (BHV-4157) for the potential treatment of Spinocerebellar Ataxia (SCA). Trigriluzole previously received Orphan Drug Designation from the FDA for the treatment of SCA in 2016. Biohaven is currently conducting a phase II/III clinical trial in patients with SCA, with topline results expected in 2018.

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