PharmaShots Weekly Snapshot (December 23-27, 2019)

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PharmaShots Weekly Snapshot (December 23-27, 2019)

1. Luye Pharma Reports Submission of NDA to the US FDA for LY03005

Published: Dec 26, 2019 | Tags: FDA, Luye Pharma, LY03005, NDA, reports, Submission, US

2. Immunomedics Reports the US FDA’s Acceptance of BLA for Sacituzumab Govitecan to Treat Metastatic Triple-Negative Breast Cancer

Published: Dec 26, 2019 | Tags: Acceptance, BLA, FDA, Immunomedics, Metastatic Triple-Negative Breast Cancer, reports, Sacituzumab Govitecan, Treat, US

3.Chugai Receives MHLW’s Approval for the Expanded Use of FoundationOne CDx as a Companion Diagnostic of Rozlytrek (entrectinib)

Published: Dec 26, 2019 | Tags: Approval, Chugai, Companion Diagnostic, Entrectinib, Expanded Use, FoundationOne CDx, MHLW, receives, Rozlytrek

4. ONO and BMS Report Submission of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) in Japan

Published: Dec 26, 2019 | Tags: (BMS), (ipilimumab), (nivolumab), Japan, ONO, Opdivo, reports, sBLA, Submission, Yervoy

5. Kadmon and Meiji Collaborate to Form JV for the Development and Commercialization of KD025 in Japan

Published: Dec 27, 2019 | Tags: Collaborate, Commercialization, Development, Japan, JV, Kadmon, KD025, Meiji

6. Astellas Acquires Xyphos Biosciences for ~$665M

Published: Dec 26, 2019 | Tags: ~$665M, Acquires, Astellas, Xyphos Biosciences

7. OBI Pharma’s OBI-999 Receives the US FDA’s Orphan Drug Designation for Pancreatic Cancer

Published: Dec 26, 2019 | Tags: FDA, OBI Pharma, OBI-999, Orphan Drug Designation, Pancreatic cancer, receives, US

8. AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) Receive the FDA’s Accelerated Approval for HER-2 Positive Unresectable/ Metastatic Breast Cancer

Published: Dec 23, 2019 | Tags: Regulatory Accelerated Approval, AstraZeneca, Daiichi Sankyo, Enhertu, FDA, HER-2 Positive, Receive, Trastuzumab Deruxtecan, Unresectable/ Metastatic Breast Cancer

9. Pfizer Extends its Research and License Agreement with BioInvent to Develop Ab Targeting Tumor-Associated Myeloid Cells

Published: Dec 23, 2019 | Tags: Ab, BioInvent, Develop, Extends, License Agreement, Pfizer, Research, Targeting, Tumor-Associated Myeloid Cell

10. AstraZeneca’s Triple Combination Regimen Receives NMPA’s Approval as the Maintenance Treatment for COPD in China

Published: Dec 23, 2019 | Tags: Approval, AstraZeneca, China, COPD, Maintenance Treatment, NMPA, receives, Triple Combination Regimen

11. Allergan’s Ubrelvy (ubrogepant) Receives the US FDA’s Approval for Acute Treatment of Migraine with or without Aura in Adults  

Published: Dec 23, 2019 | Tags: Acute Treatment, Adults, Allergan, approval, Aura, FDA, Migraine, receives, Ubrelvy, Ubrogepant, US

12. Gilead Signs a Co-Promotion Agreement with Eisai for Filgotinib in Japan

Published: Dec 23, 2019 | Tags: Agreement, Co-Promotion, Eisai, Filgotinib, Gilead, Japan, Signs

13. Pfizer Signs a Worldwide License Agreement with Theravance BioPharma for its Pan-JAK Inhibitor Program  

Published: Dec 23, 2019 | Tags: License Agreement, Pan-JAK Inhibitor Program, Pfizer, Signs, Theravance BioPharma, Worldwide

14. Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) Receives NMPA’s Approval for Chronic Hepatitis C Infection Who Require Re-Treatment

Published: Dec 20, 2019 | Tags: Approval, Chronic, Gilead, Hepatitis C, Infection, NMPA, Receives, Sofosbuvir, Velpatasvir, Vosev, Voxilaprevir

15. Johnson & Johnson to Acquire TARIS Biomedical for its Drug Delivery Technology to Treat Bladder Cancer  

Published: Dec 20, 2019 | Tags: Acquire, Drug Delivery, Johnson & Johnson, TARIS Biomedical, Technology, Treat

16. Roche Signs an Exclusive Worldwide Option and License Agreement with Rheos Medicines to Develop and Commercialize Therapies for Immunometabolism

Published: Dec 20, 2019 | Tags: Agreement, Commercialize, Develop, Exclusive Worldwide, Immunometabolism, License, Option, Rheos Medicines, Roche, Signs, Therapies

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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