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 FDAs 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
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 Pharmas OBI-999 Receives the US FDAs Orphan Drug Designation for Pancreatic Cancer
Published: Dec 26, 2019 | Tags: FDA, OBI Pharma, OBI-999, Orphan Drug Designation, Pancreatic cancer, receives, US
Published: Dec 23, 2019 | Tags: Regulatory Accelerated Approval, AstraZeneca, Daiichi Sankyo, Enhertu, FDA, HER-2 Positive, Receive, Trastuzumab Deruxtecan, Unresectable/ Metastatic Breast Cancer
Published: Dec 23, 2019 | Tags: Ab, BioInvent, Develop, Extends, License Agreement, Pfizer, Research, Targeting, Tumor-Associated Myeloid Cell
Published: Dec 23, 2019 | Tags: Approval, AstraZeneca, China, COPD, Maintenance Treatment, NMPA, receives, Triple Combination Regimen
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
Published: Dec 23, 2019 | Tags: License Agreement, Pan-JAK Inhibitor Program, Pfizer, Signs, Theravance BioPharma, Worldwide
Published: Dec 20, 2019 | Tags: Approval, Chronic, Gilead, Hepatitis C, Infection, NMPA, Receives, Sofosbuvir, Velpatasvir, Vosev, Voxilaprevir
Published: Dec 20, 2019 | Tags: Acquire, Drug Delivery, Johnson & Johnson, TARIS Biomedical, Technology, Treat
Published: Dec 20, 2019 | Tags: Agreement, Commercialize, Develop, Exclusive Worldwide, Immunometabolism, License, Option, Rheos Medicines, Roche, Signs, Therapies
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