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