PharmaShots Weekly Snapshot (February 10-14, 2020)

1. Epizyme Reports the US FDA Acceptance of NDA for Tazverik (tazemetostat) to Treat Follicular Lymphoma

Published: Feb 14, 2020 | Tags: Epizyme, Reports, US, FDA, Acceptance, NDA, Tazverik, tazemetostat, Follicular Lymphoma

2. Soligenix’s RiVax Receives the US FDA’s Fast Track Designation for the Prevention of Ricin Poisoning

Published: Feb 13, 2020 | Tags: Soligenix, RiVax, Receives, FDA, Fast Track Designation, Prevention, Ricin Poisoning

3. Codagenix Collaborates with Serum Institute of India to Co-Develop a Live-Attenuated Vaccine Against Coronavirus (COVID-19)

Published: Feb 13, 2020 | Tags: Codagenix, Collaborates, Serum Institute of India, Co-Develop, Live-Attenuated, Vaccine, COVID-19

4. Orthofix’s STIM onTrack 2.1 Mobile App Receives the US FDA’s Approval for Bone Growth Stimulators

Published: Feb 13, 2020 | Tags: Orthofix, STIM onTrack 2.1 Mobile App, Receives, US, FDA, Approval, Bone Growth Stimulators

5. Roche’s Tecentriq (atezolizumab) + CT Receive NMPA’s Approval as 1L Treatment for Extensive-Stage Small Cell Lung Cancer

Published: Feb 14, 2020 | Tags: Roche, Tecentriq, atezolizumab, CT, Receive, NMPA, Approval, 1L, Treatment, Extensive-Stage Small Cell Lung Cancer

6. Thermo Fisher Collaborates with NanoPin to Facilitate Infectious Diseases Diagnosis

Published: Feb 13, 2020 | Tags: Thermo Fisher, Collaborates, NanoPin, Facilitate, Infectious Diseases Diagnosis

7. BMS Receives FDA’s Priority Review Acceptance of Lisocabtagene Maraleucel’s BLA for Patients with Relapsed or Refractory Large B-Cell Lymphoma

Published: Feb 13, 2020 | Tags: BMS, Receives, FDA, Priority Review, Acceptance, Lisocabtagene Maraleucel, BLA, Relapsed, Refractory, Large B-Cell Lymphoma

8. Amgen Receives Health Canada’s Marketing Authorization Transfer of Otezla for Moderate to Severe Plaque Psoriasis and Psoriatic Arthritis

Published: Feb 12, 2020 | Tags: Amgen, Receives, Health Canada, Marketing Authorization Transfer, Otezla, Moderate to Severe, Plaque Psoriasis, Psoriatic Arthritis

9. Medtronic to Acquire Digital Surgery to Bolster its Robotic-Assisted Surgery Platform and AI Capabilities

Published:  Feb 13, 2020 | Tags: Medtronic, Acquire, Digital Surgery, Bolster, Robotic Assisted Surgery Platform, AI Capabilities

10. BenevolentAI Collaborates with UC San Diego to Develop Non-Invasive Therapies for Cerebral Cavernous Malformations

Published: Feb 12, 2020 | Tags: BenevolentAI, Collaborates, UC San Diego, Develop, Non-Invasive Therapies, Cerebral Cavernous Malformations

11.  Medtronic Recalls its MiniMed 600 Series Insulin Pumps Due to Incorrect Insulin Dosing

Published: Feb 12, 2020 | Tags: Medtronic, Recalls, MiniMed 600 Series Insulin Pumps, Incorrect Insulin Dosing

12. Deciphera Reports the US FDA’s Acceptance of NDA and Priority Review for Ripretinib to Treat Patients with Advanced Gastrointestinal Stromal Tumors

Published: Feb 12, 2020 | Tags: Deciphera, Reports, US, FDA, Acceptance, NDA, Priority Review, Ripretinib, Advanced Gastrointestinal Stromal Tumors

13. Dr. Reddy’s to Acquire Wockhardt’s Select Business Divisions for ~$259M in India

Published: Feb 12, 2020 | Tags: Dr. Reddy’s, Acquire, Wockhardt’s, Select Business Divisions, ~$258M, India

14. Merck & Co. Reports Results of Keytruda (pembrolizumab) + CT in P-III KEYNOTE-355 Study as 1L Treatment for Metastatic Triple-Negative Breast Cancer

Published: Feb 12, 2020 | Tags: Merck & Co., Reports, Results, Keytruda, pembrolizumab, CT, P-III, KEYNOTE-355, Study, 1L, Treatment, Metastatic Triple-Negative Breast Cancer

15. Astellas and Pfizer Report Results of Xtandi (enzalutamide) in P-III PROSPER Study for Non-Metastatic Castration-Resistant Prostate Cancer

Published: Feb 12, 2020 | Tags: Astellas, Pfizer, Report, Results, Xtandi, enzalutamide, P-III, PROSPER, Study, Non-Metastatic Castration-Resistant Prostate Cancer

16. Cognoa Collaborates with Autism Learning Partners for Screening App to Accelerate Early Diagnosis of Autism

Published: Feb 11, 2020 | Tags:  Cognoa, Collaborates, Autism Learning Partners, Enable, Early Interventions, Screening App

17. Eli Lilly’s Taltz (ixekizumab) Receives Health Canada’s Approval for Active Ankylosing Spondylitis

Published: Feb 11, 2020 | Tags: Eli Lilly, Taltz, ixekizumab, Receives, Health Canada, Approval, Active Ankylosing Spondylitis

18. Novo Nordisk Launches Esperoct [antihemophilic factor (recombinant), glycopegylated-exei] to Treat Hemophilia A in the US

Published: Feb 10, 2020 | Tags: Novo Nordisk, Launches, Esperoct, [antihemophilic factor (recombinant), glycopegylated-exei], Treat, Hemophilia A, US

19. Pfizer Terminates its License Agreement with GlycoMimetics Signed in 2011

Published: Feb 10, 2020 | Tags: Pfizer, Terminates, License Agreement, GlycoMimetics, 2011

20. Janssen Collaborates with BARDA to Facilitate the Development of Corona Virus Vaccine

Published: Feb 11, 2020 | Tags: Janssen, Collaborates, BARDA, Facilitate, Development, Corona Virus Vaccine

21. Caption Health’s Caption Guidance Receives FDA’s Marketing Authorization as the First AI-Guided Image Acquisition System

Published: Feb 07, 2020 | Tags: Caption Health, Caption Guidance, FDA, Marketing Authorization, First, AI-Guided Image Acquisition System

22. Janssen Reports Submission of sBLA to the US FDA for Darzalex (daratumumab) based Combination Regimen for Relapsed/Refractory Multiple Myeloma

Published: Feb 10, 2020 | Tags: Janssen, Reports, Submission, sBLA, US, FDA, Darzalex, daratumumab, Combination Regimen, Relapsed/Refractory, Multiple Myeloma

23. Bayer and Nuvisan Collaborate to Establish a New Research Entity in Berlin

Published: Feb 11, 2020 | Tags: Bayer, Nuvisan, Collaborate, Establish, New Research Entity, Berlin

24. Novartis’ Capmatinib (INC280) Receives FDA’s Priority Review for METex14 Mutated Advanced Non-Small Cell Lung Cancer

Published: Feb 11, 2020 | Tags: Novartis, Capmatinib, INC280, Receives, FDA, Priority Review, METex14, Mutated, Advanced, Non-Small Cell Lung Cancer

25. Eagle’s Pemfexy (pemetrexed for injection) Receives Final FDA’s Approval to Treat Nonsquamous Non-Small Cell Lung Cancer

Published: Feb 10, 2020 | Tags: Eagle, Pemfexy, pemetrexed for injection, Receives, Final, FDA, Approval, Nonsquamous Non-Small Cell Lung Cancer

26. Kite’s KTE-X19 Receives the US FDA’s Priority Review for Relapsed or Refractory Mantle Cell Lymphoma

Published: Feb 10, 2020 | Tags: Kite, KTE-X19, Receive, US, FDA, Priority Review, Relapsed, Refractory, Mantle Cell Lymphoma

27. Sapphire Biotech Collaborates with Arizona State University to Develop Metastatic Cancer Inhibitor

Published: Feb 10, 2020 | Tags: Sapphire Biotech, Collaborates, Arizona State University, Develop, Metastatic Cancer Inhibitor

28. BioIntelliSense’s BioSticker Receives FDA’s 510 (k) Clearance for Month-Long Vitals Monitoring

Published: Jan 28, 2020 | Tags: BioIntelliSense, BioSticker, Receives, FDA, 510 (k) Clearance, Month-Long Vitals Monitoring

29. Roche Reports Results of Gantenerumab in P-II/III DIAN-TU-001 Study for Autosomal Dominant Alzheimer’s Disease

Published: Feb 10, 2020 | Tags: Roche, Reports, Results, Gantenerumab, P-II/III, DIAN-TU-001 Study, Autosomal Dominant Alzheimer Disease

30. Bayer Plans Two P-III Studies to Evaluate Aflibercept 8mg Formulation

Published: Feb 10, 2020 | Tags: Bayer, Plans, Two, P-III, Studies, Evaluate, Aflibercept 8mg Formulation

31. Zealand Pharma to Acquire Valeritas’ Business and Retain its Employees

Published: Feb 09, 2020 | Tags: Zealand Pharma, Acquire, Valeritas Business, Retain Employees

32. Regeneron Reports Results of Eylea (aflibercept) in P-III PANORAMA Study for Patients with Diabetic Retinopathy

Published: Feb 08, 2020 | Tags: Regeneron, Reports, Results, Eylea, aflibercept, P-III, PANORAMA Study, Patients, Diabetic Retinopathy

33. Eli Lilly Reports Results of Solanezumab in P-II/III DIAN-TU Study for Dominantly Inherited Alzheimer’s Disease

Published: Feb 10, 2020 | Tags: Eli Lilly, Reports, Results, Solanezumab, P-II/III, DIAN-TU, Study, Dominantly Inherited Alzheimer’s Disease