PharmaShots Weekly Snapshot (July 08 – 12, 2019)

1.Eli Lilly Reports Results of Emgality (galcanezumab-gnlm) in Three P-III Studies for Chronic and Episodic Migraine

Published: Jul 12, 2019 | Tags: Eli Lilly, Reports, Results, Emgality, galcanezumab-gnlm, Three, P-III, Studies, Chronic, Episodic Migraine

2. Valeo Launches Onstryv (safinamide tablet) for the Treatment of Parkinson’s Disease in Canada

Published: Jul 10, 2019 | Tags: Valeo, Launches, Onstryv, safinamide tablet, Treatment, Parkinson, Disease, Canada

3. Ono Pharmaceutical Signs an Exclusive License Agreement with FortySeven to Develop and Commercialize 5F9 in Selected Asian Countries

Published: Jul 11, 2019 | Tags: Ono Pharmaceutical, Signs, Exclusive, License Agreement, Forty Seven, Develop, Commercialize, 5F9, Selected, Asian Countries, Japan, South Korea, Taiwan

4. Abbott’s Alinity S System Receives FDA’s Approval for Blood and Plasma Screening in the US

Published: Jul 11, 2019 | Tags: Abbott, Alinity S System, Receives, FDA, Approval, Blood, Plasma, Screening, US

5. Novartis, Amgen and Banner Alzheimer’s Institute Terminate Two P-II/III Studies of CNP520 (umibecestat) for the Prevention of Alzheimer’s Disease

Published: Jul 11, 2019 | Tags: Novartis, Amgen, Banner Alzheimer’s Institute, Terminate, Two, P-II/III, Studies, CNP520, umibecestat, Prevention, Alzheimer’s Disease

6. I-Mab Signs an Exclusive License Agreement with MacroGenics to Develop and Commercialize Enoblituzumab in Greater China

Published: Jul 10, 2019 | Tags: I-Mab, Signs, Exclusive, License, Agreement, MacroGenics, Develop, Commercialize, Enoblituzumab, Greater China

7. Eli Lilly Reports Results of Emgality (galcanezumab-gnlm) in P-III Study for Episodic Cluster Headache Published: Jul 11, 2019 | Tags:Eli Lilly, Reports, Results, Emgality, galcanezumab-gnlm, P-III, Study, Episodic Cluster Headache

8. Amazon’s AI-Powered Alexa to Deliver NHS Health Advice in the UK

Published: Jul 10, 2019 | Tags: NHS, Collaborates, Amazon, Alexa, Deliver, NHS, Health Advice, UK

9. Takeda’s Vyvanse (lisexamfetamine dimesylate) Chewable Tablet Receives Health Canada’s Approval for the Treatment of Patients with Attention-Deficit/Hyperactivity Disorder Aged≥ 6yrs.

Published: Jul 10, 2019 | Tags: Takeda, Vyvanse, lisexamfetamine dimesylate, Chewable Tablet, Receives, Health Canada, Approval, Treatment, Patients, Attention Deficit/Hyperactivity Disorder, Aged≥ 6yrs.

10. Torrent Signs a Non-Exclusive License Agreement with Glenmark to Co-Commercialize Remogliflozin Etabonate for Type 2 Diabetes in India

Published: Jul 11, 2019 | Tags: Torrent, Signs, Non-Exclusive, License Agreement, Glenmark, Co-Commercialize, Remogliflozin Etabonate, India

11. Celgene’s Pomalyst (pomalidomide)-Based Triple Regimen Receive Health Canada’s Approval for Multiple Myeloma

Published: Jul 10, 2019 | Tags: Celgene, Pomalyst, pomalidomide, Triple Regimen, Receive, Health Canada, Approval, Multiple Myeloma

12. Sandoz Launches Pre-Filled Epinephrine Injection for Type 1 Allergic Reactions in the US

Published: Jul 10, 2019 | Tags: Sandoz, Launches, Pre-Filled, Epinephrine, Injection, Type 1, Allergic Reactions, US

13. Jazz Pharmaceuticals Acquires Redx Pharma’s Pre-clinical Pan-RAF Inhibitor Program for RAF and RAS Mutant Tumors

Published: Jul 10, 2019 | Tags:  Jazz Pharmaceuticals, Acquires, Redx Pharma, Pre-clinical, Pan-RAF Inhibitor Program, RAF, RAS, Mutant Tumors

14.Janssen Signs an Agreement with Celsius Therapeutics to Identify Response Biomarkers for Ulcerative Colitis

Published: Jul 09, 2019 | Tags: Janssen, Signs, Agreement, Celsius Therapeutics, Identify, Response Biomarkers, Ulcerative Colitis

15. Mirati Signs a Non-Exclusive Clinical Collaboration with Novartis to Evaluate the Combination of MRTX849 and TNO155 for Solid Tumors

Published: Jul 09, 2019 | Tags: Mirati, Signs, Non-Exclusive, Agreement, Novartis, Evaluate, Combination, MRTX849, TNO155, Solid Tumors

16. ViiV Healthcare Reports Results of Dual-Drug Regimen in P-III TANGO Study for HIV-1 Infection

Published: Jul 10, 2019 | Tags: ViiV Healthcare, Reports, Results, Dual-Drug Regimen, P-III, TANGO, Study, HIV-1 Infection

17. Sanofi Reports FDA’s Acceptance of BLA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma

Published: Jul 10, 2019 | Tags: Sanofi, Reports, FDA, Acceptance, BLA, Review, Isatuximab, Relapsed/Refractory, Multiple Myeloma

18. Boehringer Ingelheim Reports Results of Pradaxa (dabigatran etexilate mesylate) for the Management of Venous Thromboembolism in Children

Published: Jul 08, 2019 | Tags: Boehringer Ingelheim, Reports, Results, Pradaxa, dabigatran etexilate mesylate, Management, Venous Thromboembolism, Children

19.Merck Reports FDA’s Acceptance of sBLA of Keytruda (pembrolizumab) with Six-Week Dosing Schedule for Multiple Indications

Published: Jul 09, 2019 | Tags: Merck, Reports, FDA, Acceptance, sBLA, Keytruda, pembrolizumab, Six-Week, Dosing Schedule, Multiple Indications

20. The US Department of Defense Awarded Contract to SIGA for Expanded Indication of TPOXX (tecovirimat) for $19.5M

Published: Jul 08, 2019 | Tags: The US Department of Defense, Awarded, Contract, SIGA, Expanded Indication, TPOXX, tecovirimat, $19.5M

21. Roche Reports Updated Results of Hemlibra (emicizumab) in P-III HAVEN and P-IIIb STASEY Studies for Hemophilia A

Published: Jul 09, 2019 | Tags: Roche, Reports, Updated, Results, Hemlibra, emicizumab, P-III, HAVEN, P-IIIb, STASEY, Studies, Hemophilia A

22. Bayer Reports Results of Xarelto (rivaroxaban) in P-III EINSTEIN-Jr. Study for Venous Thromboembolism

Published: June 08, 2019 | Tags: Bayer, Reports, Results, Xarelto, rivaroxaban, P-III, EINSTEIN-Jr., Study, Venous Thromboembolism

23.ViiV Healthcare Initiates CUSTOMIZE Study of Dual-Drug Injectable Regimen for the Treatment of HIV

Published: Jul 08, 2019 | Tags: ViiV Healthcare, Initiates, CUSTOMIZE, Study, Dual-Drug, Injectable Regimen, Treatment, HIV

24. Takeda Reports Updated Results of Adynovate in P-IIIb/IV PROPEL Study for Personalized Prophylaxis in Patients with Severe Hemophilia A

Published: Jul 08, 2019 | Tags: Takeda, Reports, Updated, Results, Adynovate, P-IIIb/IV, PROPEL, Study, Personalized Patients, Severe, Hemophilia A

25. Novo Nordisk Reports Results of Refixia (nonacog beta pegol) in Two P-III Studies for Hemophilia B in Children

Published: Jul 08, 2019 | Tags: Novo Nordisk, Reports, Results, Refixia, nonacog beta pegol, Two, P-III, Studies, Hemophilia B, Children

26. Isansys Lifecare Develops Patient Status Engine Wearable Body Patch for the Detection of Sepsis

Published: Jul 05, 2019 | Tags: Isansys Lifecare, Develops, Patient Status Engine, Wearable, Body Patch, Detection, Sepsis

27. BeiGene’s Tislelizumab Receives NMPA’s Priority Review to sNDA for Urothelial Carcinoma in China

Published: Jul 07, 2019 | Tags: BeiGene, Tislelizumab, Receives, NMPA, Priority Review, sNDA, Urothelial Carcinoma, China