PharmaShots Weekly Snapshot (May 18-22, 2020)

1. BMS Reports EMA’s Validation of MAA for Idecabtagene Vicleucel (Ide-cel, bb2121) and CC-486

Published: May 22, 2020 | Tags: bb2121, BMS ,CC-486, EMA, ide-cel Idecabtagene, Vicleucel MAA

2. Gilead Plans to Submit MAA to CDSCO for its Remdesivir to Treat COVID-19 in India

Published: May 21, 2020 | Tags: Gilead, Plans, Submit, MAA, CDSCO, Remdesivir, COVID-19, India

3. Bayer Reports Submission of MAA to the MHLW for Larotrectinib to Treat Solid Tumors with NTRK Gene Fusion

Published: May 21, 2020 | Tags: Bayer, Reports, Submission, MAA, MHLW, Larotrectinib, TRK Fusion Cancer

4. Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Orphan Drug Designation for Gastric Cancer

Published: May 22, 2020 | Tags: Daiichi Sankyo, AstraZeneca, Enhertu, (fam-trastuzumab deruxtecan-nxki), Receive, US, FDA, Orphan Drug Designation, Gastric Cancer

5. GSK Collaborates with Samsung Biologics for Large Scale Biopharmaceutical Manufacturing

Published: May 22, 2020 | Tags: GSK, Collaborates, Samsung Biologics, Large Scale Biopharmaceutical, Manufacturing

6. Roche Acquires Stratos Genomics to Advance the Development of Nanopore Sequencer

Published: May 22, 2020 | Tags: Roche, Acquires, Stratos Genomics, Advance, Development, Nanopore Sequencer

7. Gilead and Galapagos Report Results of Filgotinib in P-IIb/III SELECTION Study for Moderately to Severely Active Ulcerative Colitis

Published: May 20, 2020 | Tags: Gilead, Galapagos, Reports, Results, Filgotinib, P-IIb/III, SELECTION Study, Moderately, Severely, Active, Ulcerative Colitis

8. Synlogic Terminates its Agreement with AbbVie for Synthetic Biotic Medicines to Treat Inflammatory Bowel Disease

Published: May 20, 2020 | Tags: Synlogic, Terminates, Agreement, AbbVie, Synthetic Biotic Medicines, Treat, Inflammatory Bowel Disease

9. AstraZeneca Receives First Supply Agreement for University of Oxford’s ChAdOx1 nCoV-19 Vaccine Against COVID-19

Published: May 21, 2020 | Tags: AstraZeneca, Receives, First Commitments, Oxford University, ChAdOx1 nCoV-19 Vaccine, Against, COVID-19

10. Apple and Google Launch COVID-19 Exposure Notification System to Support Health Agencies

Published: May 20, 2020 | Tags: Apple, Google, Launch, COVID-19 Exposure Notification System, Support, Health Agencies

11. Eiger BioPharmaceuticals Reports the US FDA’s Acceptance of NDA for Zokinvy (lonafarnib) to Treat Progeria and Progeroid Laminopathies  

Published: May 20, 2020 | Tags: Eiger BioPharmaceuticals, Reports, US, FDA, Acceptance, NDA, Zokinvy, lonafarnib, Treat, Progeria, Progeroid Laminopathies

12.Roche Launches Elecsys Anti-SARS-CoV-2 Antibody Blood Test in the US

Published: May 20, 2020 | Tags: Roche, Launches, Elecsys, Anti-SARS-CoV-2, Antibody Blood Test, US

13. AveXis Receives EC’s Conditional Approval and Activates “Day One” Access Program for Zolgensma (onasemnogene abeparvovec) to Treat Spinal Muscular Atrophy

Published: May 19, 2020 | Tags: AveXis, Receives, EC, Conditional Approval, Activates, “Day One”, Access Program, Zolgensma, onasemnogene abeparvovec, Treat, Spinal Muscular Atrophy

14. Innovent Biologics and MD Anderson Collaborate to Co-develop TYVYT (sintilimab) in Rare Cancer Indications in the US  

Published: May 19, 2020 | Tags: Co-develop, Collaborate, Innovent Biologics, MD Anderson, Rare Cancer, Indications, Sintilimab, Tyvyt, US

15. Roche Signs an Exclusive Worldwide Option and License Agreement with Vividion Focusing on Novel E3 Ligases

Published: May 19, 2020 | Tags: Roche, Signs, Exclusive, Worldwide, Option, License Agreement, Vividion, Focusing, Novel E3 Ligases

16. Samsung Bioepis Reports Results of SB11 (proposed biosimilar ranibizumab) in P-III Study for Neovascular Age-Related Macular Degeneration

Published: May 18, 2020 | Tags: Samsung Bioepis, Reports, Results, SB11, proposed biosimilar ranibizumab, P-III, Study, for Neovascular Age-Related Macular Degeneration

17. Teva’s Austedo (deutetrabenazine) Receives the NMPA’s Approval to Treat Chorea Associated with Huntington’s Disease and Tardive Dyskinesia in Adults

Published: May 19, 2020 | Tags: Teva, Austedo, deutetrabenazine, Receives, the NMPA, Approval, Treat, Chorea, Associated, Huntington’s Disease, Tardive Dyskinesia, Adults

18. Moderna Reports Positive Interim P-I Data of mRNA-1273 Against COVID-19

Published: May 19, 2020 | Tags: Moderna, Reports, Positive Interim, P-I Data, mRNA-1273, Against, COVID-19

19. Roche’s Tecentriq Receives the US FDA’s Approval as 1L Monotherapy for Patients with Metastatic Non-Small Cell Lung Cancer

Published: May 19, 2020 | Tags: Roche, Tecentriq, Receives, US, FDA, Approval, 1L, Monotherapy, Patients, Metastatic Non-Small Cell Lung Cancer

20. EMA to Grant Initial Authorization to Gilead’s Remdesivir for COVID-19 is Imminent

Published: May 18, 2020 | Tags: EMA, Grant, Initial Authorization, Gilead, Remdesivir, COVID-19, Coming Days

21. AstraZeneca’s Bevespi Aerosphere (glycopyrronium/formoterol fumarate) Receives NMPA’s Approval for Patients with COPD

Published: May 19, 2020 | Tags: AstraZeneca, Bevespi Aerosphere, glycopyrronium/formoterol fumarate, Receives, NMPA, Approval, Patients, COPD

22. Daiichi Sankyo and AstraZeneca’s Enhertu (fam-trastuzumab deruxtecan-nxki) Receive the US FDA’s Breakthrough Therapy Designation for HER2 Mutant Metastatic Non-Small Cell Lung Cancer

Published: May 18, 2020 | Tags: AstraZeneca, Bevespi Aerosphere, glycopyrronium/formoterol fumarate, Receives, NMPA, Approval, Patients, COPD