RFPi’s iCertainty Receives FDA 510(k) Clearance Approval for Blood Flow in Surgeries

Published: 10 Jan, 2019 |Tags: iCertainty, Approval, Blood Flow Clearance, FDA, 510(k), Receives, RFPi, Surgeries

2. Rafael Pharmaceuticals’ Devimistat (CPI-613) Receives EMA’s ODD for R/R Acute Myeloid Leukemia (AML) and Metastatic Pancreatic Cancer (mPC)

Published: 10 Jan, 2019 |Tags: Rafael Pharmaceuticals, (AML), (CPI-613), (mPC), Devimistat, EMA, Metastatic, Pancreatic Cancer, ODD, R/R, Acute, Myeloid Leukemia, Receives

3.  Yuhan Signs an Exclusive License Agreement with Glenmark for its Ryaltris

Published:10 Jan, 2019 |Tags: Agreement, Exclusive, Glenmark, License, Ryaltris, Signs, Yuhan

4. Sumitomo Dainippon Reports Results of Lurasidone Hydrochloride (lurasidone) in P-III JEWEL Study in Patients with Schizophrenia

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

7. Elevian and Insilico Medicine Collaborates to Develop Therapies Targeting Aging

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

9.  Janssen (J&J) Reports Filing of Stelara’s (ustekinumab) in Group Type II Variation Application to EMA for Moderately to Severely Active Ulcerative Colitis (UC)

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