PharmaShots Weekly Snapshot (December 16-20, 2019)

1. Merck’s Ervebo Vaccine Receives the US FDA’s Approval for Prevention of Ebola Virus  

Published: Dec 20, 2019 | Tags: Sage Therapeutics, Reports, Results, SAGE-217, P-III, MOUNTAIN Study, Major Depressive Disorders

2. Novo Nordisk Signs a Five-Year Agreement with UVA Center for Diabetes Technology for Type 2 Diabetes

Published: Dec 20, 2019 | Tags: Sage Therapeutics, Reports, Results, SAGE-217, P-III, MOUNTAIN Study, Major Depressive Disorders

3. AstraZeneca to Sell Commercialization Rights of its Two Oncology Candidates to Juvise Pharmaceuticals

Published: Dec 20, 2019 | Tags: AstraZeneca, Candidates, Commercialization, Juvisé Pharmaceuticals, Oncology, Rights, Sell Two

4. Gilead Reports Submission of Filgotinib’s NDA Under Priority Review to the US FDA for Rheumatoid Arthritis Treatment

Published: Dec 20, 2019 | Tags: Filgotinib, Gilead, NDA, Priority Review, Reports, Rheumatoid Arthritis, Submission, Unde, US FDA

5. Smith Medical Recalls Medfusion 4000 Syringe Pump Due to its Software Failure

Published: Dec 20, 2019 | Tags: 4000 Syringe, Pump, Due, Failur,  Medfusion, Recalls, Smith Medical, Software

6. Amgen and Allergan Report Submission of BLA to the US FDA for its ABP 798 (biosimilar, rituximab)

Published: Dec 20, 2019 | Tags: ABP 798, Allergan, Amgen, Biosimilar, BLA, Report, Rituximab, Submission, US FDA

7.       Genmab and CureVac Collaborate to Develop mRNA-based Antibody Therapeutics

Published: Dec 20, 2019 | Tags: Antibody Therapeutics, Collaborate, CureVac, Develop, Genmab, mRNA

8. Exelixis Signs a Clinical Trial Collaboration with Roche for Patients with Solid Tumors

Published: Dec 12, 2019 | Tags: Clinical, Collaboration, Exelixis, patients, Roche, Signs, Solid Tumors, Trial

9. Biogen Signs an Exclusive License Agreement with Ionis for IONIS-MAPTRx

Published: Dec 12, 2019 | Tags: Agreement, Biogen, Exclusive, Ionis, IONIS-MAPTRx, License, Signs

10. Novartis Terminates its Agreement with Akcea for AKCEA-APOCIII-LRx

Published: Dec 12, 2019 | Tags: 2017, Agreement, Akcea, AKCEA-APOCIII-LRx, Novartis, Terminates

11. AbbVie’s RINVOQ (upadacitinib) Receives the EC’s Approval for the Treatment of Adults with Moderate to Severe Active Rheumatoid Arthritis

Published: Dec 19, 2019 | Tags: AbbVie, Active, Adults, approval, EC, Moderate, receives, Rinvoq, Severe, Treatment, Upadacitinib

12. Specialised Therapeutics Signs an Exclusive License Agreement with Onconova Therapeutics for Rigosertib

Published: Dec 19, 2019 | Tags: Agreement, Exclusive, License, Onconova Therapeutics, Rigosertib, Signs, Specialised Therapeutics

13. GSK Reports Results of Benlysta (belimumab, IV) in P-III BLISS-LN Study for Patients with Active Lupus Nephritis  

Published: Dec 19, 2019 | Tags: Active Lupus Nephritis, belimumab, Benlysta, BLISS-LN Study, GSK, IV, P-III, patients, reports, results

14. Chondrial Therapeutics Signs a Reverse Merger Agreement with Zafgen

Published: Dec 18, 2019 | Tags: Chondrial Therapeutics, Reverse Merger Agreement, Zafgen

15.   Eisai Signs a Research Collaboration with BioArctic to Characterize BAN2401’s Mechanism of Action

Published: Dec 18, 2019 | Tags: BAN2401, BioArctic, Collaboration, Eisai, Evaluate, Research, Signs

16.   AstraZeneca and Merck Receive the US FDA Advisory Committee’s Recommendation on Approval of Lynparza (olaparib) as 1L Maintenance Treatment for Germline BRCA-Mutated Metastatic Pancreatic Cancer

Published: Dec 18, 2019 | Tags: (olaparib), 1L, Advisory Committee, approval, AstraZeneca, FDA, Germline BRCA-Mutated Metastatic Pancreatic Cancer, Lynparza, Maintenance Treatment, Merck, Receive, Recommendation, US  

17.   BioInvent Collaborates with MSD to Evaluate BI-1206 in Combination with Keytruda (pembrolizumab) for Advanced Solid Tumors  

Published: Dec 18, 2019 | Tags: (pembrolizumab), Advanced Solid Tumors, BI-1206, BioInvent, Collaborates, combination, Evaluate, KEYTRUDA, MSD

18.   Takeda Collaborates with Cerevance to Develop New Therapies for Gastrointestinal Disorders  

Published: Dec 18, 2019 | Tags: Cerevance, Collaborates, Develop, GastroIntestinal Disorders, New Therapies, Takeda  

19.   Merck Receives the US FDA Advisory Committee’s Recommendation on Approval of Keytruda (pembrolizumab) for Patients with High-Risk Non-Muscle Invasive Bladder Cancer

Published: Dec 18, 2019 | Tags: (pembrolizumab), Advisory Committee, approval, FDA, High-Risk, KEYTRUDA, Merck, patients, receives, Recommendation, US

20.   Medtronic Acquires Klue to Bolster its Personalized Closed Loop Technology for Diabetes Management

Published: Dec 18, 2019 | Tags: Acquires, Bolster, Klue, Medtronic, Personalized Closed Loop Technology

21.   Sangamo Highlights its Genomic Medicine Pipeline at R&D Day 2019

Published: Dec 18, 2019 | Tags: Genomic Medicine Pipeline, Highlights, R&D DAY 2019, Sangamo

22. Xiangxue Signs an Exclusive License Agreement with Athenex to Expand their Existing Partnership

Published: Dec 18, 2019 | Tags: Athenex, Exclusive, Existing, Expand, License Agreement, Partnership, Signs, Xiangxue

23. Janssen’s Erleada (apalutamide) Receives Health Canada’s Approval for Metastatic Castration-Sensitive Prostate Cancer

Published: Dec 17, 2019 | Tags: Apalutamide, Approval, Erleada, Health Canada, Janssen, Receives

24. BeiGene Report Results of Brukinsa (zanubrutinib) in P-III ASPEN Study for Waldenström’s Macroglobulinemia

Published: Dec 17, 2019 | Tags: ASPEN Study, BeiGene, Brukinsa, P-III, Report, results, Waldenstrom’s Macroglobulinemia, Zanubrutinib 

25. Eagle Pharmaceuticals’ Ryanodex (dantrolene sodium) Receives the US FDA’s ODD for the Treatment of Organophosphate Exposure

Published: Dec 17, 2019 | Tags: dantrolene sodium, Eagle Pharmaceuticals, FDA, ODD, Organophosphate Exposure, receives, Ryanodex, Treatment, US 

26. Medtronic and ChristianaCare Collaborate to Deploy Value-Based Healthcare Initiatives in Delaware

Published: Dec 17, 2019 | Tags: ChristianaCare, Collaborate, Delaware, Deploy, Medtronic, Value-Based Healthcare Initiatives

27. Charles River to Acquire HemaCare Corporation for $380M

Published: Dec 16, 2019 | Tags: Acquire, Charles River, HemaCare Corporation

28. Lilly Collaborates with DexCom to Utilize Dexcom CGM in its Personalized Diabetes Management System 

Published: Dec 16, 2019 | Tags: Collaborates, DexCom, Dexcom CGM, Diabetes Management System, Lilly, Personalized, Utilize

29. SanBio and Sumitomo Dainippon Pharma Terminate Joint Development and License Agreement for SB623 in North America

Published: Dec 16, 2019 | Tags: Joint Development, License Agreement, North America, SanBio, SB623, Sumitomo Dainippon Pharma, Terminate

30. Boehringer Ingelheim and Lilly Report Results of Jardiance (empagliflozin) in P-III EMPERIAL Studies for Chronic Heart Failure 

Published: Dec 16, 2019 | Tags: (empagliflozin), Boehringer Ingelheim, Chronic Heart Failure, EMPERIAL Studies, Jardiance, Lilly, P-III, Report, Result

31. Novartis Terminates Clinical Development of Fevipiprant (AW039) in P-III LUSTER Studies for Patients with Uncontrolled GINA 4/5 Asthma

Published: Dec 16, 2019 | Tags: AW039, Fevipiprant, GINA 4/5 Asthma, LUSTER Studies, Novartis, P-III, patients, reports, results, Uncontrolled

32. Tandem’s Predictive Insulin Pump Software Receives the US FDA’s Approval to Deliver Accurate Doses of Insulin in Patients Utilizing t:slim X2 Insulin Pump

Published: Dec 16, 2019 | Tags: Accurate, approval, Deliver, FDA, Insulin, Predictive Insulin Pump Software, receives, t:slim X2 Insulin Pump, Tandem, US

33. Roche Launches cobas Zika Blood Screening Test to Detect Zika Virus RNA

Published: Dec 16, 2019 | Tags: Cobas, Zika Blood Screening Test, Detect, Launches, Roche, Zika Virus RNA