PharmaShots Weekly Snapshot (April 20 -24, 2020)

1. Sanofi Receives the US FDA’s Approval for its MenQuadfi Meningococcal (MenACWY) Conjugate Vaccine

Published: Apr 23, 2020 | Tags: Sanofi, Receives, US, FDA, Approval, MenQuadfi, Meningococcal, MenACWY, Conjugate Vaccine

2.  Takeda to Divest Select OTC and Non-Core Assets in Europe to Orifarm for $670M

Published: Apr 24, 2020 | Tags: Takeda, Divest, Select OTC and Non-Core Assets, Orifarm, $670M

3.  AstraZeneca and MSD Report Results of Lynparza in P-III PROfound Study for BRCA1/2 or ATM-Mutated Metastatic Castration-Resistant Prostate Cancer

Published: Apr 24, 2020 | Tags: AstraZeneca, MSD, Report, Results, Lynparza, P-III, PROfound Study, BRCA1/2, ATM-Mutated, Metastatic, Castration-Resistant, Prostate Cancer

4. Merck & Co. Reports the Resubmission of sBLA to the US FDA for Keytruda (pembrolizumab) Six-Week Dosing Schedule

Published: Apr 23, 2020 | Tags: Merck & Co., Reports, Resubmission, sBLA, US, FDA, Keytruda, pembrolizumab, Six-Week, Dosing Schedule

5.  Janssen Collaborates with Emergent BioSolutions to Accelerate the Manufacturing of its Vaccine Against COVID-19

Published: Apr 23, 2020 | Tags: Janssen, Collaborates, Emergent BioSolutions, Accelerate, Manufacturing, Vaccine, Against, COVID-19

6. Theravance Reports First Patient Dosing in P-I Study with TD-0903 to Treat Patients with Acute Lung Injury Associated with COVID-19

Published: Apr 23, 2020 | Tags: Theravance, Reports, First Patient, Dosing, P-I Study, TD-0903, Treat, Patients, Acute Lung Injury, Associated, COVID-19

7.  Mobidiag Receives Emergency Use Authorization for its Automated COVID-19 Test in Finland

Published: Apr 22, 2020 | Tags: Mobidiag, Receives, Emergency Use Authorization, Automated, COVID-19 Test, Finland

8. LabCorp Receives the US FDA’s Emergency Use Authorization for its COVID-19 At-Home Test Kit

Published: Apr 21, 2020 | Tags: LabCorp, Receives, US, FDA, Emergency Use Authorization, COVID-19, At-Home Test Kit

9. AstraZeneca and Saint Luke’s Mid America Heart Institute to Initiate P-III DARE-19 Evaluating Farxiga Against COVID-19

Published: Apr 23, 2020 | Tags: AstraZeneca, Signs, Clinical Trial Agreement, Saint Luke’s Mid America Heart Institute, Initiate, P-III, DARE-19, Evaluating, Farxiga, Against, COVID-19

10. The European Commission Approves the Merger of Mylan and Upjohn with Conditions

Published: Apr 23, 2020 | Tags: European Commission, Approves, Merger, Mylan, Upjohn, Conditions

11. Valneva and Dynavax Collaborate to Advance the Development of Vaccine Against COVID-19

Published: Apr 22, 2020 | Tags: Valneva, Dynavax, Collaborate, Advance, Development, VLA 2001, Against, COVID-19

12. Sobi’s Affiliate Florio GmbH Launches a Digital Platform to Improve the Lives of Patients with Hemophilia

Published: Apr 22, 2020 | Tags: Sobi, Affiliate, Florio GmbH, Launches, Digital Platform, Improve, Lives, Patients, Hemophilia

13. Pfizer and BioNTech to Commence Clinical Study for COVID-19 in Germany

Published: Apr 22, 2020 | Tags: Pfizer, BioNTech, Commence, Clinical Study, COVID-19, Germany

14. Hope Biosciences Reports its Third US FDA’s Approval for Clinical Trial in COVID-19

Published:  Apr 22, 2020 | Tags: Hope Biosciences, Reports, Third, US, FDA, Approval, Clinical Trial, COVID-19

15. Novartis’ Kymriah (tisagenlecleucel) Receives the US FDA’s Regenerative Medicine Advanced Therapy Designation for Follicular Lymphoma

Published: Apr 22, 2020 | Tags: Novartis, Kymriah, tisagenlecleucel, Receives, US, FDA, Regenerative Medicine Advanced Therapy Designation, Follicular Lymphoma

16. Gilead and Kite Sign a Three Years Agreement with oNKo-innate to Discover Cancer Immunotherapies

Published: Apr 21, 2020 | Tags: Gilead, Kite, Sign, Three Years, Agreement, oNKo-innate, Discover, Cancer Immunotherapies

17.  Bayer Collaborates with the Population Health Research Institute to Identify Treatment for COVID-19

Published: Apr 21, 2020 | Tags: Bayer, Collaborates, Population Health Research Institute, Identify, Treatment, COVID-19

18. Novartis Reports Results of Mayzent (siponimod) in P-III EXPAND Study for Secondary Progressive Multiple Sclerosis

Published: Apr 21, 2020 | Tags: Novartis, Reports, Results, Mayzent, siponimod, P-III, EXPAND Study, Secondary Progressive Multiple Sclerosis

19. Sangamo Signs an Exclusive License Agreement with Mogrify for iPSC and ESC-Derived Regulatory T-Cells

Published: Apr 21, 2020 | Tags: Sangamo, Signs, Exclusive, License Agreement, Mogrify, iPSC, ESC-Derived, Regulatory T-Cells

20.  Noxopharm Anticipates the US FDA’s Approval for Evaluating Veyonda in a Clinical Study for COVID-19

Published:  Apr 21, 2020 | Tags:  Noxopharm, Anticipates, US, FDA, Approval, Evaluating, Veyonda, Clinical Study, COVID-19

21. Roche’s cobas HPV Test Receives the US FDA’s Approval for cobas 6800/8800 System to Identify Women at Risk for Cervical Cancer

Published: Apr 21, 2020 | Tags: Roche, cobas HPV Test, Receives, US, FDA, Approval, cobas 6800/8800 System, Identify Women, Risk, Cervical Cancer

22.  Cue Biopharma Signs Clinical Trial Collaboration with Merck to Evaluate CUE-101 + Keytruda (pembrolizumab) as 1L Treatment for HPV+ Recurrent/Metastatic Head and Neck Cancer

Published: Apr 20, 2020 | Tags: Cue Biopharma, Signs, Clinical Trial Collaboration, Merck, Evaluate, CUE-101, Keytruda, pembrolizumab, 1L, Treatment, HPV+, Recurrent/Metastatic, Head and Neck Cancer

23. RedHill Biopharma Collaborates with NIAID to Investigate RHB-107 (upamostat, WX-671) Against COVID-19

Published: Apr 20, 2020 | Tags: RedHill Biopharma, Collaborates, NIAID, RHB-107, upamostat, WX-671, Against, COVID-19

24.   Alexion to Initiate P-III Study of Ultomiris (ravulizumab-cwvz) in Hospitalized Patients with Severe COVID-19

Published: Apr 20, 2020 | Tags: Alexion, Initiate, P-III, Study, Ultomiris, ravulizumab-cwvz, Hospitalized Patients, Severe, COVID-19

25.  Otsuka Signs a Development and Commercialization Agreement with Esperion for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) in Japan

Published: Apr 20, 2020 | Tags: Otsuka, Signs, Development, Commercialization, Agreement, Esperion, Nexletol, bempedoic acid,  Nexlizet, bempedoic acid and ezetimibe, Japan

26. Fosun Pharma Receives the US FDA’s EUA for its COVID-19 RT-PCR Detection Kit

Published: Apr 19, 2020 | Tags: Fosun Pharma, Receives, US, FDA, EUA, COVID-19 RT-PCR Detection Kit

27. Incyte Initiates P-III RUXCOVID Study Evaluating Jakafi (ruxolitinib) to Treat Patients with COVID-19 Associated Cytokine Storm

Published: Apr 17, 2020 | Tags: Incyte, Initiates, P-III, RUXCOVID Study, Evaluating, Jakafi, ruxolitinib, Treat, Patients, COVID-19 Associated Cytokine Storm

28. Roche Reports the FDA and EMA’s Acceptance of sBLA for Ocrevus Shorter 2-Hour Infusion Time

Published: Apr 20, 2020 | Tags: Roche, Reports, FDA, EMA, Acceptance, sBLA, Ocrevus, Shorter 2-Hour, Infusion Time

29. Novartis Signs an Agreement with the US FDA to Evaluate Hydroxychloroquine in Patients with COVID-19

Published: Apr 20, 2020 | Tags: Novartis, Signs, Agreement, US, FDA, Evaluate, Hydroxychloroquine, Patients, COVID-19