August 24, 2017
Karo Pharma to buy Weifa for €138M
Karo Pharma will launch voluntary cash offer to acquire the entire issued share capital of Weifa for € 3.78 per share in cash.
Pharmaceuticals, Biotechnology and Life Sciences
Category: Regions
August 24, 2017
EC approves Novartis’s metastatic breast cancer drug
European Commission (EC) approved Novartis’s Kisqali (ribociclib) in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.
August 11, 2017
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.
August 10, 2017
ConfirmMDx study provides further validation of epigenetic risk profile
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.
August 9, 2017
Bard shareholders approve proposed merger with Becton, Dickinson
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.
August 4, 2017
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.
August 4, 2017
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.
August 2, 2017
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.
August 2, 2017
Nordic Nanovector appoints Reza Safaei as head of medical affairs
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.
August 2, 2017
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).