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
Published: Sept 20, 2019 | Tags: Astellas, FibroGen, Evrenzo, roxadustat, Receives, MHLW, Approval, Anemia Associated with Chronic Kidney Disease, Dialysis Patients
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
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
Published: Sept 18, 2019 | Tags: Biogen, Initiate, P-II/III, DEVOTE Study, Evaluating, Higher Doses, Spinraza, Nusinersen, Spinal Muscular Atrophy
Published: Sept 18, 2019 | Tags: Novartis, Reports, Results, Galvus, vildagliptin, Combination Therapy, P-IV, VERIFY Study, Type 2 Diabetes Mellitus
Published: Sept 19, 2019 | Tags: Roche, Renews, Support, Phelophepa Healthcare Trains, South Africa, 25th Anniversary
Published: Sept 19, 2019 | Tags: Novigenix, Collaborates, BioLizard, Develop, AI, Diagnostic Algorithm, Colon Cancer Detection
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
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
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
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
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
31. Lundbeck to Acquire Alder BioPharmaceuticals for $1.95B
Published: Sept 16, 2019 | Tags: Lundbeck, Acquire, Alder Bio Pharmaceuticals, $1.95B, Eptinezumab, ALD1910
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