Vancouver, BC – 16 Nov 2017: IBM (NYSE: IBM) today announced that Vancouver-based company Fusion Genomics selected IBM’s cloud capabilities to help advance Fusion’s ability to detect pandemics before they happen. Fusion Genomics has developed disruptive DNA and RNA technology that it believes can positively identify infectious diseases and enhance the surveillance of emerging pathogens […]
ABILIFY MYCITE (aripiprazole tablets with sensor) is a drug-device combination product comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. The ABILIFY MYCITE System includes: ABILIFY MYCITE, the MYCITE® Patch (wearable sensor); the MYCITE APP (a smartphone application); and web-based portals for healthcare providers and caregivers1 The system records medication […]
LONDON, UK – September, 27 2017 – GSK announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Benlysta (belimumab) for the treatment of adult patients with systemic lupus erythematosus (SLE) who are inadequate responders to existing therapies. Benlysta is for use as an add-on therapy in autoantibody positive SLE patients. […]
Company Expects to Complete Submission for Fast Track Designated Medicine by Year-End 2017 DUBLIN–(BUSINESS WIRE)–Aug. 21, 2017– Alkermes plc (NASDAQ:ALKS) today announced the initiation of its rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking marketing approval of ALKS 5461, a once-daily, oral investigational medicine with a […]
LYNPARZA’s New Tablet Formulation Approved as Maintenance Treatment for Women With Platinum-Sensitive Recurrent Ovarian Cancer Regardless of BRCA-Mutation Status LYNPARZA Tablets Also Indicated in BRCA-Mutated Ovarian Cancer Beyond the Third-Line Setting Newly-Approved Tablet Formulation Means Improved Patient Convenience August 17, 2017 KENILWORTH, N.J.–(BUSINESS WIRE)–AstraZeneca and Merck & Co., Inc. (NYSE:MRK), known as MSD outside the […]
BESPONSA is the first and only CD22-directed antibody-drug conjugate indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia NEW YORK – August 17, 2017 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BESPONSA® (inotuzumab ozogamicin) for the treatment of adults with relapsed […]
NEW YORK, August 3, 2017 – Pfizer Inc. announced today that the United States Food and Drug Administration’s (FDA) Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend approval of the proposed dose of tofacitinib for the treatment of adult patients with active psoriatic arthritis (PsA). Pfizer submitted supplemental new drug applications (sNDAs) for […]
Collaboration Aims to Maximize the Potential of PARP and MEK Inhibitors in Combination with PD-L1/PD-1 Medicines, Based on Growing Scientific Evidence That These Combinations Offer New Potential for the Treatment of a Range of Tumor Types AstraZeneca and Merck Will Independently Develop and Commercialize LYNPARZA and Potential Medicine Selumetinib in Combinations with Companies’ Respective PD-L1/PD-1 […]
Results demonstrate equivalence in objective response rate in patients with advanced non-squamous non-small cell lung cancer NEW YORK, July 24, 2017 – Pfizer Inc. (NYSE:PFE) today announced that the REFLECTIONS B7391003 study, a comparative, confirmatory safety and efficacy study of PF-06439535 versus Avastin® (bevacizumab), met its primary objective. PF-06439535 is being developed by Pfizer as […]
Once-Daily, Oral Product Candidate Demonstrated Antipsychotic Efficacy Statistically Superior to Placebo and Similar to Olanzapine in ENLIGHTEN-1 Study Management to Hold Conference Call Today at 4:30 p.m. ET DUBLIN–(BUSINESS WIRE)–Jun. 29, 2017– Alkermes plc (NASDAQ: ALKS) today announced positive preliminary topline results from ENLIGHTEN-1, the first of two key phase 3 studies in the ENLIGHTEN […]