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.
MDxHealth has announced that results from a study published in The Prostate further validated ConfirmMDx for Prostate Cancer and showed that the test can provide treating urologists with deeper insights into a patient`s risk for aggressive prostate cancer.
C. R. Bard and Becton, Dickinson have announced the results of Bard’s special meeting of shareholders, held on August 8, 2017 and at which a quorum was present, for Bard shareholders to consider and vote upon the proposed merger of Bard with BD.
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.
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.
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.
Nordic Nanovector has appointed Dr. Reza Safaei, MD as Head of Medical Affairs to lead the development and execution of Nordic Nanovector’s medical affairs strategy for Betalutin.
CTI BioPharma completes enrollment in the Phase 3 trial of aggressive B-cell non-Hodgkin lymphoma drug
CTI BioPharma has completed enrollment in the Phase 3 PIX306 trial of PIXUVRI (pixantrone).
Onxeo has sold of two products Sitavig and Loramyc to Vectans Pharma, a private pharmaceutical company which develops and markets innovative therapeutics in oral pathologies.
Cardinal Health has completed the acquisition of Medtronic’s Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency business for $6.1 billion.