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FDA grants priority review designation to Gilead Sciences’s HIV drug

The U.S. Food and Drug Administration (FDA) has granted priority review for the company’s New Drug Application (NDA) for Gilead Sciences’s investigational, fixed-dose combination of bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection.

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Bristol-Myers Squibb strengthens its oncology pipeline – buys IFM Therapeutics

Bristol-Myers Squibb and IFM Therapeutics have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.

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Portola Pharmaceuticals resubmits biologics license application for AndexXa

Portola Pharmaceuticals has resubmitted its Biologics License Application (BLA) to the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) for AndexXa (andexanet alfa), a reversal agent for Factor Xa inhibitors.

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FDA OK’s Gilead Sciences’s hepatitis C drug

The U.S. Food and Drug Administration (FDA) has approved updated labeling for Gilead Sciences’s Epclusa (sofosbuvir 400mg/velpatasvir 100mg), the first all-oral, pan-genotypic, once-daily single tablet regimen (STR) for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV.

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Strong FDA workforce for patients’ benefits, scientists invited to join

The new efforts the FDA is making will provide a solid foundation for recruitment and for responsibly managing our user fee resources, Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration said at the beginning of the week.

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Diplomat to distribute Puma Biotechnology’s new cancer drug

Diplomat Pharmacy will distribute Puma Biotechnology’s new product, Nerlynx, a kinase inhibitor approved by the US Food and Drug Administration (FDA).

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FDA accepts new IND to expand in U.S. IFNalpha kinoid clinical development program in dermatomyositis

The U.S. Food and Drug Administration (FDA) has cleared Neovacs’s Investigational New Drug (IND) application for IFNalpha Kinoid in the treatment of dermatomyositis, which allows the Company to initiate in the US its Phase IIa clinical trial already on-going in European countries.

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FDA OK’s Puma Biotechnology’s cancer drug

The U.S. Food and Drug Administration has approved Puma Biotechnology’s neratinib for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.

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Novartis confirms 5 year data for first and only fully-human IL-17A inhibitor Cosentyx reinforcing sustained efficacy and safety profile in psoriasis

Novartis has confirmed positive 5 year efficacy and safety results for Cosentyx from a Phase III long-term extension study in patients with moderate-to-severe plaque psoriasis.

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Janssen Biotech’s psoriasis drug wins FDA’s approval

The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Tremfya (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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