PharmaShots Weekly Snapshot (September 09 – 13, 2019)

1. Eisai And Biogen to Terminate Two P-III Clinical Studies of Elenbecestat (E2609) for Early Alzheimer’s Disease

Published: Sept 13, 2019 | Tags: Eisai, Biogen, Terminate Two, P-III, Clinical Studies, Elenbecestat, E2609, Early Alzheimer’s Disease

2. GE Healthcare’s Critical Care Suite AI-Powered X-ray Device Receives FDA’s 510(k) Clearance to Identify Pneumothorax

Published: Sept 12, 2019 | Tags: GE Healthcare, Critical Care Suite, AI-Powered, X-ray Device, Receives, FDA, 510(k) Clearance, Identify, Pneumothorax

3. Celgene Reports Results of CC-486 in P-III QUAZAR AML-001 Study as Maintenance Therapy for Acute Myeloid Leukemia

Published: Sept 13, 2019 | Tags: Celgene, Reports, Results, CC-486, P-III, QUAZAR AML-001, Maintenance Therapy, Acute Myeloid Leukemia

4. GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11yrs.

Published: Sept 12, 2019 | Tags: GSK, Nucala, mepolizumab, Receives, US, FDA, Approval, First Biologic, Severe Eosinophilic Asthma, Children, Aged 6-11yrs.

5.Roche Reports Results of Perjeta (pertuzumab) Fixed Dose SC Combination Therapy in P-III FeDeriCa Study for HER2+ve Breast Cancer

Published: Sept 13, 2019 | Tags: Roche, Reports, Results, Fixed Dose, SC, Combination Therapy, P-III, FeDeriCa Study, HER2-positive Breast Cancer

6. Aytu BioScience to Acquire Innovus Pharmaceuticals for ~$24M

Published: Sept 12, 2019 | Tags: Aytu BioScience, Acquire, Innovus Pharmaceuticals, ~$24M

7. Vertex Signs an Access Agreement with Scottish Government for Orkambi (lumacaftor/ivacaftor) and Symkevi (tezacaftor/ivacaftor)

Published:  Sept 12, 2019 | Tags:  Vertex, Enters, Access Agreement, Scottish Government, Orkambi, lumacaftor/ivacaftor, Symkevi, tezacaftor/ivacaftor

8.Hansoh Enters into a Collaboration with Atomwise for AI-Based Drug Discovery

Published: Sept 11, 2019 | Tags: Hansoh, Enters, Collaboration, Atomwise, AI, Drug Discovery, $1.5B

9. Janssen Reports Results of Ponesimod in P-III OPTIMUM Study for Relapsing Multiple Sclerosis in Adults

Published: Sept 11, 2019 | Tags: Janssen, Reports, Results, Ponesimod, P-III, OPTIMUM, Study, Relapsing, Multiple Sclerosis, Adults

10.Zentiva to Acquire Sanofi’s Ankleshwar Manufacturing Facility in India

Published: Sept 11, 2019 | Tags: Zentiva, Acquire, Sanofi, Manufacturing Facility, Ankleshwar, India

11. Roche Reports Results of Satralizumab in Second P-III Study for Neuromyelitis Optica Spectrum Disorder

Published: Sept 12, 2019 | Tags: ¬Roche, Reports, Results, Satralizumab, Second, P-III, Study, Neuromyelitis Optica Spectrum Disorder

12. Teva Canada’s Herzuma (biosimilar, trastuzumab) Receives Health Canada Approval for Multiple Cancer Indications

Published: Sept 11, 2019 | Tags: ¬Teva Canada, Herzuma, biosimilar, trastuzumab, Receives, Health Canada, Approval, Multiple Cancer Indications

13. GSK to Acquire Sitari Pharmaceuticals for its Celiac Diseases Program

Published: Sept 11, 2019 | Tags: ¬GSK, Acquire, Sitari Pharmaceuticals, Celiac Diseases Program

14. Apple to Launch a Research App for Three Medical Studies Monitoring Health Issues

Published: Sept 10, 2019 | Tags: Apple, Launch, Research App, Three, Medical Studies, Monitoring, Health Issues 

15. Merck KGaA’s Tepotinib Receives FDA’s Breakthrough Therapy Designation for Metastatic NSCLC with METex14 Skipping Alterations

Published: Sept 11, 2019 | Tags: Merck KGaA, Tepotinib, Receives, FDA, Breakthrough Therapy Designation, Metastatic, NSCLC, METex14 Skipping Alterations

16. Samsung Bioepis Reports the Availability of Brenzys (biosimilar, etanercept) in Brazil

Published: Sept 10, 2019 | Tags: Samsung Bioepis, Reports, Availability, Brenzys, biosimilar, etanercept, Brazil

17.Google Collaborates with Mayo Clinic for Healthcare Innovation Utilizing AI and Cloud Computing

Published: Sept 10, 2019 | Tags: Google, Collaborates, Mayo Clinic, Healthcare Innovation, AI, Cloud Computing

18. Xeris’ GVOKE (glucagon) Receives FDA’s Approval as The First Ready-To-Use Stable Liquid Glucagon for Severe Hypoglycemia

Published: Sept 10, 2019 | Tags: Xeris, GVOKE, glucagon, Receives, FDA, Approval, Ready-To-Use Stable Liquid Glucagon, Severe Hypoglycemia

19.Sanofi Terminates its Four Years Alliance with Lexicon for Zynquista (sotagliflozin)

Published: Sept 10, 2019 | Tags: Sanofi, Terminates, Four Years, Alliance, Settlement, Lexicon, Zynquista, sotagliflozin

20. Baxter to Acquire Cheetah Medical for ~$230M

Published: Sept 10, 2019 | Tags: Baxter, Acquire, Cheetah Medical, ~$230M

21.Mallinckrodt to Divest its Subsidiary BioVectra for $250M

Published: Sept 10, 2019 | Tags: Mallinckrodt, Divest, Subsidiary, BioVectra, $250M

22.BMS Reports Pooled Five Year Results of Opdivo (nivolumab) in Two P-III Studies for Advanced Non-Small Cell Lung Cancer

Published: Sept 10, 2019 | Tags: BMS, Reports, Pooled Five Year, Results, Opdivo, nivolumab, Two, P-III, Studies, Advanced, Non-Small Cell Lung Cancer23

23. Alexion Enters into an Exclusive License Agreement with Eidos to Develop and Commercialize AG10 in Japan   

Published: Sept 10, 2019 | Tags: Alexion, Enters, Exclusive, License Agreement, Eidos, Develop, Commercialize, AG10, Japan

24.Genmab Signs an Agreement with Tempus to Develop Novel Targets and Biomarkers for Cancer Indications

Published: Sept 09, 2019 | Tags: Genmab, Signs, Agreement, Tempus, Develop, Novel Targets, Biomarkers, Cancer Indications

25.Medtronic’s MiniMed 670G Insulin Pump System Receives Reimbursement for Patients with T1D in Germany

Published: Sept 09, 2019 | Tags: Medtronic, MiniMed 670G Insulin Pump System, Receives, Reimbursement, Germany

26. Allergan and Molecular Partners Report Acceptance of FDA’s BLA and Validation of EMA’s MAA for Abicipar Pegol

Published: Sept 09, 2019 | Tags: Allergan, Molecular Partners, Report, Acceptance, FDA, BLA, Validation, EMA, MAA, Abicipar Pegol

27. Abbott to Initiate World’s First Study to Evaluate its TriClip Transcatheter Tricuspid Valve Repair System in the US

Published: Sept 05, 2019 | Tags: Abbott, World, First, Study, Evaluate, TriClip Transcatheter Tricuspid Valve Repair System, US

28. AstraZeneca Reports Results of Imfinzi (durvalumab) in P-III CASPIAN Study for 1L Extensive-Stage Small Cell Lung Cancer

Published: Sept 09, 2019 | Tags: AstraZeneca, Reports, Results, Imfinzi, durvalumab, P-III, CASPIAN Study, 1L, Extensive-Stage Small Cell Lung Cancer

29. Eli Lilly Signs an Agreement with Thermo Fisher to Develop CDx for its Selpercatinib (LOXO-292)

Published: Sept 09, 2019 | Tags: Eli Lilly, Signs, Agreement, Thermo Fisher, Develop, CDx, Selpercatinib, LOXO-292

30. Sumitomo Dainippon and Roivant Signs a Memorandum of Understanding to Form $3B Alliance

Published: Sept 05, 2019 | Tags: Eli Lilly, Signs, Agreement, Thermo Fisher, Develop, CDx, Selpercatinib, LOXO-292