PharmaShots Weekly Snapshot (Aug 10 – 14, 2020)

1. Roche’s Evrysdi (risdiplam) Receives the US FDA’s Approval for SMA in Adults and Children

Published: Aug 10, 2020 | Tags: Roche, Evrysdi, risdiplam, Receives, US, FDA, Approval, SMA, Adults, Children

2. The US FDA Approves Guardant360 CDx as the First Liquid Biopsy NGS Assay to Identify EGFR Mutations in Non-Small Cell Lung Cancer

Published: Aug 07, 2020 | Tags: Guardant Health, Guardant360 CDx, Receives, US, FDA, Approval, First, Liquid Biopsy, NGS, Assay, Identify, EGFR, Mutations, Non-Small Cell Lung Cancer

3. Roche Report Mixed Results of Etrolizumab in P-III Studies for Patients with Moderately to Severely Active Ulcerative Colitis

Published: Aug 10, 2020 | Tags: Roche, Report, Mixed Results, Etrolizumab, P-III, Studies, Patients, Moderately, Severely, Active, Ulcerative Colitis

4. Boehringer Ingelheim Acquires GST to Boost its Stem Cell Capabilities in Animal Health

Published: Aug 10, 2020 | Tags: Boehringer Ingelheim, Acquires, GST, Boost, Stem Cell Capabilities, Animal Health

5. Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Published: Aug 11, 2020 | Tags: Gilead, Reports, NDA, Submission, US, FDA, Veklury, Remdesivir, Treat, COVID-19

6. Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic HER2-Overexpressing Breast Cancer in Brazil

Published: Aug 11, 2020 | Tags: Samsung Bioepis, Launches, Ontruzant, trastuzumab, biosimilar, Early, Metastatic, HER2-Overexpressing, Breast Cancer, Brazil

7. Olympus to Acquire Arc Medical Design for Expanding its Product Portfolio

Published: Aug 10, 2020 | Tags: Olympus, Acquire, Arc Medical Design, Expand, Portfolio

8. Bayer to Acquire KaNDy Therapeutics for Augmenting its Women’s Healthcare Portfolio

Published: Aug 11, 2020 | Tags: Bayer, Acquire, KaNDy Therapeutics, Augment, Women’s Healthcare, Portfolio

9. Ligand to Acquire Pfenex for $516M

Published: Aug 11, 2020 | Tags: Ligand, Acquire, Pfenex, $516M

10. Medtronic to Acquire Companion Medical for Adding Smart Insulin Pen to its Diabetes Unit

Published: Aug 11, 2020 | Tags: Medtronic, Acquire, Companion Medical, Smart Insulin Pen, Diabetes Unit

11. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) + CT Receive Health Canada Approval for Metastatic Non-Small Cell Lung Cancer

Published: Aug 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, CT, Receive, Health Canada, Approval, Metastatic, Non-Small Cell Lung Cancer

12. Sarepta Therapeutics Collaborates with University of Florida to Accelerate the Development of Therapies for Rare Genetic Diseases

Published: Aug 12, 2020 | Tags: Sarepta Therapeutics, Collaborates, University of Florida, Accelerate, Development, Therapies, Rare Genetic Diseases

13. Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Published: Aug 12, 2020 | Tags: Innovent, Eli Lilly, Report, sNDA, Acceptance, Tyvyt, sintilimab, Combination Regimen, 1L Therapy, in Squamous, Non-Small Cell Lung Cancer, China

14. Roche Collaborates with Celleron Therapeutics for Emactuzumab to Treat Patients with Tenosynovial Giant Cell Tumor

Published: Aug 12, 2020 | Tags: Roche, Collaborates, Celleron Therapeutics, Emactuzumab, Patients with Tenosynovial Giant Cell Tumor

15. Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Published: Aug 13, 2020 | Tags: Regeneron, Reports, US, FDA, Acceptance, Evinacumab, BLA, Priority Review, Treatment, Patients, HoFH

16. Roche Reports the US FDA’s Acceptance of sBLA for Xolair (omalizumab) Prefilled Syringe for Self-Administration Across All Indications

Published: Aug 13, 2020 | Tags: Roche, Reports, US, FDA, Acceptance, sBLA, Xolair, (omalizumab), Prefilled Syringe, Self-Administration, Across, All, Indications

17. Zydus Launches Cheapest Version of Remdesivir at $37.41 per Vial in India

Published: Aug 13, 2020 | Tags: Zydus, Launches, Remdac, (remdesivir), $37.41, Vial, India

18. Novo Nordisk Resumes P-III Study of Concizumab for Patients with Hemophilia A and B

Published: Aug 13, 2020 | Tags: Novo Nordisk, Resumes, P-III, Study, Concizumab, Patients, Hemophilia A and B

19. Alphabet’s Verily Establishes CLIA-Certified Lab Focusing on COVID-19 Testing

Published: Aug 11, 2020 | Tags: Alphabet, Verily, Establishes, CLIA-Certified, Lab, Focusing, COVID-19, Testing

20. Strata Oncology Collaborates with Mirati Therapeutics to Broaden Enrollment Clinical Trial of MRTX849 for Patients with Advanced Solid Tumors

Published: Aug 13, 2020 | Tags: Strata Oncology, Collaborates, Mirati Therapeutics, Broaden, Enrollment, Clinical Trial, MRTX849, Patients, Advanced Solid Tumors

21. AstraZeneca to Initiate Production of its COVID-19 Vaccine Early in 2021

Published: Aug 13, 2020 | Tags: AstraZeneca, Initiate, Production, COVID-19, Vaccine, Early, 2021

22. EC Concludes Exploratory Talks with J&J to Supply 200M Doses of COVID-19 Vaccine

Published: Aug 13, 2020 | Tags: Johnson & Johnson, EC, Supply, 200M, Doses, COVID-19, Vaccine

23. SK bioscience Collaborate with Novavax to Supply Antigen for COVID-19 Vaccine

Published: Aug 14, 2020 | Tags: Novavax, SK bioscience, Collaborate, NVX-CoV2373, Treat, COVID-19

24. Novavax Collaborates with UK Government to Supply 60M Doses of NVX-CoV2373 to Combat COVID-19

Published: Aug 14, 2020 | Tags: Novavax, Collaborates, UK Government, Supply, 60M, Doses, NVX-CoV2373, Combat, COVID-19

25. Solasia Signs a License Agreement with Isofol to Develop and Commercialize Arfolitixorin for mCRC in Japan

Published: Aug 13, 2020 | Tags: Solasia, Signs, License Agreement, Isofol, Develop, Commercialize, Arfolitixorin, mCRC, Japan