PharmaShots Weekly Snapshot (September 16-20, 2019)

1.Boehringer Ingelheim Enters into an Agreement with Inflammasome Therapeutics to Co-Develop Therapies for Retinal Diseases

Published: Sept 20, 2019 | Tags: Boehringer Ingelheim, Agreement, Inflammasome Therapeutics, Co-Develop, Therapies, Retinal Disease

2. Astellas and FibroGen's Evrenzo (roxadustat) Receives MHLW's Approval for Anemia Associated with Chronic Kidney Disease in Dialysis Patients

Published: Sept 20, 2019 | Tags: Astellas, FibroGen, Evrenzo, roxadustat, Receives, MHLW, Approval, Anemia Associated with Chronic Kidney Disease, Dialysis Patients

3. Eli Lilly's Trulicity (dulaglutide) Receives CHMP Recommendation for Label Update to Include Results from REWIND Study

Published: Sept 20, 2019 | Tags: Eli Lilly, Trulicity, dulaglutide, Receives, CHMP Recommendation, Label Update, REWIND Study

4.Roche's cobas Babesia Blood Test Receives the US FDA's Approval for Donor Screening

Published: Sept 20, 2019 | Tags: Roche, cobas Babesia Test, Receives, US FDA, Approval, Donor Screening

5.Takeda and Lundbeck's Trintellix (vortioxetine) Receives MHLW's Approval for Major Depressive Disorder in Japan

Published: Sept 20, 2019 | Tags: Takeda, Lundbeck, Trintellix, vortioxetine, Receives, MHLW, Approval, Major Depressive Disorder, Japan

6. Merck KGaA Signs a License Agreement with Y-Trap to Develop Antibody-Ligand Traps for Immuno-Oncology

Published: Sept 19, 2019 | Tags: Merck KGaA, Signs, License Agreement, Y-Trap, Develop, Antibody-Ligand Traps, Immuno-Oncology

7.Novartis Reports the Reimbursement of Kisqali as 1L Treatment for Metastatic Breast Cancer in Quebec

Published: Sept 19, 2019 | Tags: Novartis, Reports, Reimbursement, Kisqali, Quebec, 1L, Treatment, Metastatic Breast Cancer

8. Novo Nordisk Reports Results of Tresiba (insulin degludec) in CONCLUDE Study for Type 2 Diabetes

Published: Sept 19, 2019 | Tags: Novo Nordisk, Reports, Results, Tresiba, insulin degludec, CONCLUDE Study, Type 2 Diabetes

9. Biogen to Initiate P-II/III DEVOTE Study Evaluating the Higher Doses of Spinraza (nusinersen) for Spinal Muscular Atrophy

Published: Sept 18, 2019 | Tags: Biogen, Initiate, P-II/III, DEVOTE Study, Evaluating, Higher Doses, Spinraza, Nusinersen, Spinal Muscular Atrophy

10. Novartis Reports Results of Galvus (vildagliptin) Combination Therapy in P-IV VERIFY Study for Type 2 Diabetes Mellitus

Published: Sept 18, 2019 | Tags: Novartis, Reports, Results, Galvus, vildagliptin, Combination Therapy, P-IV, VERIFY Study, Type 2 Diabetes Mellitus

11. Roche Renews its Support to the Phelophepa Healthcare Trains in South Africa Marking the 25th Anniversary

Published: Sept 19, 2019 | Tags: Roche, Renews, Support, Phelophepa Healthcare Trains, South Africa, 25th Anniversary

12. Novigenix Collaborates with BioLizard to Develop AI-Based Diagnostic Algorithm for Detecting Colon Cancer

Published: Sept 19, 2019 | Tags: Novigenix, Collaborates, BioLizard, Develop, AI, Diagnostic Algorithm, Colon Cancer Detection

13. Merck's Keytruda (pembrolizumab) + Eisai's Lenvima (lenvatinib) Receives FDA's Approval for Certain Types of Endometrial Carcinoma

Published: Sept 17, 2019 | Tags: Merck, Keytruda, pembrolizumab, Eisai, Lenvima, lenvatinib, Receives, FDA, Approval, Endometrial Carcinoma, Project Orbis

14.The US FDA Initiates its First Step Towards Project Orbis for Concurrent Review of Cancer Therapies

Published: Sept 17, 2019 | Tags: US, FDA, First Initiative, Project Orbis, Concurrent Review, Cancer Therapies, TGA, Health Canada

15. Regeneron and Sanofi Launch Educational Campaign Focusing on Patients Living with Moderate-To-Severe Atopic Dermatitis

Published: Sept 18, 2019 | Tags: Regeneron, Sanofi, Launch, Educational Campaign, Focusing, Moderate-To-Severe Atopic Dermatitis

16.Roche's Gazyva (obinutuzumab) Receives FDA's Breakthrough Therapy Designation for Lupus Nephritis

Published: Sept 18, 2019 | Tags: Roche, Gazyva, obinutuzumab, Receives, FDA, Breakthrough Therapy Designation, Lupus Nephritis

17. AstraZeneca Amends its Development and Commercialization Agreement with Ironwood for Linzess (linaclotide) Signed in 2012

Published: Sept 18, 2019 | Tags: AstraZeneca, Amends, Agreement, Ironwood, Developing, Commercializing, Linzess, linaclotide, China

18.Generium Launches First Biosimilar of Dornase Alfa Utilizing Selexis' SUREtechnology Platform

Published: Sept 17, 2019 | Tags: Generium, Launches, First, Biosimilar, Dornase Alfa, Selexis, SUREtechnology Platform

19. Mylan Launches Generic Faslodex Injection for the Expansion of its Oncology Portfolio in the US

Published: Sept 17, 2019 | Tags: Mylan, Launches, Generic Faslodex Injection, Expansion, Oncology Portfolio, US

20. Bayer Signs a License Agreement with Informed Data Systems to Utilize its One Drop Digital Therapeutics Platform

Published: Sept 17, 2019 | Tags: Bayer, Signs, License Agreement, Informed Data Systems, Utilize, One Drop Digital Therapeutics Platform

21. Merck Reports Acceptance of BLA to the US FDA for V920 Ebola Virus Vaccine

Published: Sept 17, 2019 | Tags: Merck, Reports, Acceptance, BLA, US, FDA, V920 Ebola Virus Vaccine

22. GBR 1342 Receives the US FDA's Orphan Drug Designation for Multiple Myeloma

Published: Sept 17, 2019 | Tags: Glenmark, GBR 1342, Receives, US, FDA, Orphan Drug Designation, Multiple Myeloma

23. Acceleron to Discontinue its P-II Study of ACE-083 for Facioscapulohumeral Muscular Dystrophy

Published: Sept 16, 2019 | Tags: Acceleron, Discontinue, P-II, Study, ACE-083, Facioscapulohumeral Muscular Dystrophy

24.Seattle Genetics and Astellas Report Acceptance of BLA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

?Published: Sept 16, 2019 | Tags: Seattle Genetics, Astellas, Report, Acceptance, BLA, Enfortumab Vedotin, Locally Advanced, Metastatic Urothelial Cancer

25.Janssen Reports Submission of sBLA to the US FDA for Tremfya (guselkumab) to Treat Active Psoriatic Arthritis

Published: Sept 17, 2019 | Tags: Janssen, Reports, Submission, sBLA, US, FDA, Tremfya, guselkumab, Treat, Active Psoriatic Arthritis

26. Medtronic's Envision Pro Continuous Glucose Monitoring System Receives CE Mark in Europe

Published: Sept 16, 2019 | Tags: Medtronic, Envision Pro Continuous Glucose Monitoring System, Receives, CE Mark Approval, Europe

27. Boehringer Ingelheim Signs an Exclusive Worldwide License Agreement with Oncoheroes Biosciences for Volasertib

Published: Sept 16, 2019 | Tags: Boehringer Ingelheim, Signs, Exclusive, Worldwide, License Agreement, Oncoheroes Biosciences, Volasertib

28.AstraZeneca's Farxiga (dapagliflozin) Receives FDA's Fast Track Designation to Treat Patients with Heart Failure

Published: Sept 16, 2019 | Tags: AstraZeneca, Farxiga, dapagliflozin, Receives, FDA, Fast Track Designation, Treat, Patients, Heart Failure

29. Medtronic and Novo Nordisk Collaborate to Deliver Integrated Digital Solutions Easing the Hassles of Diabetes Management

Published: Sept 16, 2019 | Tags: Medtronic, Novo Nordisk, Collaborates, Deliver, Integrated Digital Solutions, Diabetes Management

30. Sanofi and Abbott Collaborate to Assimilate Glucose Sensing and Insulin Delivery Technologies to Manage Diabetes

Published: Sept 16, 2019 | Tags: Sanofi, Abbott, Collaborated, Assimilate, Glucose Sensing, Insulin Delivery Technologies, Manage, Diabetes