PharmaShots Weekly Snapshot (January 07 -11, 2019)

  1. Published: 10 Jan, 2019 |Tags: iCertainty, Approval, Blood Flow Clearance, FDA, 510(k),
    Receives, RFPi, Surgeries
    Published: 10 Jan, 2019 |Tags: Rafael Pharmaceuticals, (AML), (CPI-613), (mPC),
    Devimistat, EMA, Metastatic, Pancreatic Cancer, ODD, R/R, Acute, Myeloid
    Leukemia, Receives
    Published:10 Jan, 2019 |Tags: Agreement, Exclusive, Glenmark, License, Ryaltris, Signs,
    Yuhan
    Published: 10 Jan, 2019 |Tags: (lurasidone), JEWEL Study, Lurasidone, Hydrochloride,
    P-III, Reports, Results, Schizophrenia, Sumitomo, Dainippon
    5.  Empatica’s Embrace an AI Smartwatch Receives FDA’s 510(K) Clearance Approval in Pediatric
    Patients Aged ≥6 yrs.
    Published: 09 Jan, 2019 |Tags: Embrace, Empatica, FDA’s, 510(K), Pediatric, Receives,
    Smartwatch, Aged, AI Approval, Clearance
    6.  ONO Pharmaceutical Reports Results of Opdivo (nivolumab) in P-III ATTRACTION-3
    Study in Patients with Unresectable or Recurrent Esophageal Cancer
    Published: 09 Jan, 2019 |Tags: ATTRACTION-3, Esophageal Cancer, ONO Pharmaceutical,
    Opdivo, P-III, Recurrent, Reports, Results, Unresectable
    Published: 09 Jan, 2019 |Tags: Collabortaes, Develop, Elevian, Insilico, Medicine,
    Therapies, Targeting, Aging
    8.  Sanofi Reports Results of Cablivi (caplacizumab) in P-III HERCULES study in Patients
    with Rare Blood Clotting Disorder, Published in NEJM
    Published: 09 Jan, 2019 |Tags: (caplacizumab), Cablivi, HERCULES study, NEJM, P-III,
    Published, Rare Blood, Clotting, Disorder, Reduction, Reports, Results, Sanofi
    Published: 07 Jan, 2019 |Tags: J&J, Janssen, Reports, Stelara, UC, Ulcerative Colitis,
    Variation, (ustekinumab) Application, EMA, Moderately to Severely, Active,
    Filing, Group, Type II
    10. ImmunoGen to Sell Residual Royalty Rights for Kadcyla (ado-trastuzumab emtansine) to
    OMERS
    Published: 08 Jan, 2019 |Tags: ImmunoGen, (ado-trastuzumab emtansine), Kadcyla, OMERS,
    ImmunoGen, Residual, Rights, Royalty Sell
    11. Exelixis and Daiichi Sankyo’s Minnebro (Esaxerenone) Receives MHLW Marketing Approval in
    Patients with Hypertension in Japan
    Published: 08 Jan, 2019 |Tags: Daiichi Sankyo, Exelixis, Hypertension, (Esaxerenone),
    Japan, Marketing, Approval, MHLW, Minnebro, Patients, Receives
    12. Astellas and Amgen Astellas’ Evenity (romosozumab) Receives MHLW Approrval for Patients
    with Osteoporosis at High Risk of Fracture in Japan
    Published: 08 Jan, 2019 |Tags: Evenity, (romosozumab), Amgen, Astellas, Fracture,
    High-Risk, Japan, MHLW, Osteoporosis, Patients, Receives
    13. Novartis’s SEG101(crizanlizumab) receives FDA’s Breakthrough Therapy(BT) designation for
    sickle cell disease
    Published: 08 Jan, 2019 |Tags: Novartis, (crizanlizumab), Breakthrough Therapy
    Designation, FDA, Receives, SEG101, Sickle Cell Disease, (BT)
    14. 3SBio Signs a License Agreement with Samsung Bioepis for its Biosimilars
    Published: 08 Jan, 2019 |Tags: 3SBio, Agreement, Biosimilars, License, Samsung Bioepis,
    Signs
    15. Sandoz and Pear Therapeutics Launches reSET-O Mobile App for Opioid Use Disorder (OUD)
    Patients
    Published: 08 Jan, 2019 |Tags: (OUD), Launches, Mobile App, Opioid Use Disorde, Pear
    Therapeutics, reSET-O, Sandoz
    16. Eli Lilly to Acquire Loxo Oncology for $8B
    Published: 08 Jan, 2019 |Tags: Eli Lilly, Acquire, Loxo Oncology, LOXO-195, LOXO-292,
    LOXO-305, P-I/II, Vitrakvi, Bayer
    17. BlueBirdBio Signs an Exclusive License Agreement with Inhibrx for CAR T Cell Immunotherapies
    Published: 07 Jan, 2019 |Tags: BlueBirdBio, CAR T, Cell Immunotherapies, Exclusive,
    Inhibrx, License, Agreement, Signs
    18. Bruin Biometrics Receives FDA’s Marketing Approval for SEM Scanner for Patients with
    Pressure Ulcer
    Published: 07 Jan, 2019 |Tags: Bruin Biometrics, Approval, FDA, Marketing, Pressure,
    receives Scanner SEM Ulcer
    19. Gilead Signs an Agreement with Yuhan Corporation to Develop Novel Therapy for Patients
    with NASH (Nonalcoholic Steatohepatitis)
    Published: 06 Jan, 2019 |Tags: Gilead, (Nonalcoholic Steatohepatitis), Agreement, Develop,
    Nash, Republic of Korea, Signs, Therapies, Yuhan Corporation