PharmaShots Weekly Snapshot (November 23-27, 2019)

1. ONO Reports Submission of MAA to MHLW for Tirabrutinib Hydrochloride to Treat Waldenstrom Macroglobulinemia and Lymphoplasmacytic Lymphoma

Published: Nov 29, 2019 | Tags: Lymphoplasmacytic Lymphoma, MAA, MHLW, ONO, reports, Submission, Tirabrutinib Hydrochloride, Waldenstrom Macroglobulinemia

2. AstraZeneca Collaborates with JVP to Invest in Digital Health Program in Israel

 Published: Nov 27, 2019 | Tags: AstraZeneca, Collaborates, Digital Health, Program, Invest, Israel, JVP

3. AstraZeneca Reports the US FDA Acceptance of sBLA and Granted Priority Review for Imfinzi (durvalumab) to Treat Patients with Extensive-Stage Small Cell Lung Cancer

Published: Nov 29, 2019 | Tags: (durvalumab), Acceptance, AstraZeneca, Extensive-Stage Small Cell Lung Cancer, Granted, Imfinzi, Priority Review, Reports, sBLA, US FDA

4. WuXi ATU and GeneMedicine Collaborate to Develop and Manufacture Oncolytic Virus Products  

Published: Nov 28, 2019 | Tags: Collaborate, Develop, GeneMedicine, Manufacture, Oncolytic Virus Products, WuXi ATU

5. Roche’s Kadcyla (trastuzumab emtansine) Receives Health Canada’s Approval for The Treatment of HER2-Positive Early Breast Cancer After Surgery

Published: Nov 28, 2019 | Tags: Trastuzumab emtansine, Approval, Health Canada, HER2-Positive Early Breast Cancer, After, Surgery, Kadcyla, Receives, Roche

6. Avion Signs an Exclusive License Agreement with ImmuPharma to Develop and Commercialize Lupuzor

Published: Nov 29, 2019 | Tags: Avion, Commercialize, Develop, Exclusive, ImmuPharma, License Agreement, Lupuzor, Signs

7. Octavus Consulting Collaborates with IBCI for Delivering of Professional Educational Programs in India from 2020

 Published: Nov 28, 2019 | Tags: 2020, Collaborates, Educational Programs, Expand, IBCI, India, Octavus Consulting

8. JW Pharma Acquires C&C Research Laboratories a Joint Venture with Chugai  

Published: Nov 27, 2019 | Tags: C&C Research Laboratories, Chugai, Collaborate, Establish, Joint Venture, JW Pharma

9. Simcere Signs an Exclusive Regional Licensing Agreement with GI Innovation for its GI-101 Candidate

Published: Nov 28, 2019 | Tags: Agreement, Candidate, Exclusive, GI Innovation, GI-101, Licensing, Regional, Signs, Simcere

10. Boehringer Ingelheim’s Ofev (nintedanib) Receives Health Canada’s Approval as the First Therapy to Treat SSc-ILD in Canada  

Published: Nov 27, 2019 | Tags: Approval, Boehringer Ingelheim, Canada, First Therapy, Health Canada, Nintedanib, Ofev, Receives, Ssc-Ild, Treat

11. Chugai Launches Tecentriq Intravenous Infusion 840mg as an Optimal Formulation to Treat PD-L1+ Triple-Negative Breast Cancer in Japan

Published: Nov 27, 2019 | Tags: Chugai, Japan, Launches, Optimal Formulation, PD-L1, Tecentriq Intravenous Infusion 840 mg, Treat, Triple-Negative Breast Cancer

12. Mochida Launches Teriparatide Biosimilar for the Treatment of Osteoporosis in Japan

Published: Nov 27, 2019 | Tags: Japan, Launches, Mochida, Osteoporosis, Teriparatide Biosimilar

13. AbbVie UK Collaborates with NorthWest EHealth to Generate Real World Evidence for Exploring Autoimmune Conditions

Published: Nov 27, 2019 | Tags: AbbVie UK, Autoimmune Conditions, Collaborates, Exploring, Generate, NorthWest EHealth, Real-World Evidence

14. Incyte Reports Acceptance and Priority Review of NDA for Pemigatinib to Treat Patients with Cholangiocarcinoma

Published: Nov 27, 2019 | Tags: Acceptance, Cholangiocarcinoma, Incyte, NDA, patients, Pemigatinib, Priority Review, reports, Treat

15. Astellas’ Xtandi (enzalutamide) Receives NMPA’s Approval for Metastatic Castration-Resistant Prostate Cancer in Men

Published: Nov 26, 2019 | Tags: Enzalutamide, Approval, Astellas, Castration-Resistant Prostate Cancer Men Metastatic, NMPA, Receives, Xtandi

16. Amazon’s Alexa Launches Medication Management Feature for Giant Eagle’s Clients

Published: Nov 26, 2019 | Tags: Alexa, Amazon, Giant Eagle’s Clients, Launches, Medication Management Feature

17. Elsevier Acquires 3D4Medical for ~$50M

Published: Nov 27, 2019 | Tags: ~50M, 3D4Medical, Acquires, Elsevier

18. Celltrion’s Remsima SC (biosimilar, infliximab) Receives EC’s Approval for Rheumatoid Arthritis

Published: Nov 26, 2019 | Tags: (infliximab), approval, Biosimilar, Celltrion, EC, receives, Remsima SC

19. Biocon Report the US FDA’s Approval of sBLA for Fulphila (biosimilar, pegfilgrastim) Manufactured at its New Facility in Bengaluru

Published: Nov 27, 2019 | Tags: approval, Bengaluru, Biocon, Biosimilar, FDA, Fulphila, Manufactured, Mylan, New Facility, Pegfilgrastim, Report, sBLA, US  

20. Novoheart Collaborates with AstraZeneca to Develop World’s First Heart-in-a-Jar Model of Heart Failure 

Published: Nov 26, 2019 | Tags: AstraZeneca, Collaborates, Develop, First, Heart Failure, Heart-in-a-Jar Model, Novoheart, World

21. Merck’s Keytruda (pembrolizumab) + CT Receives NMPA’s approval as 1L Treatment for Metastatic Squamous Non-Small Cell Lung Cancer

Published: Nov 26, 2019 | Tags: Pembrolizumab, 1L, Treatment, Approval, Ct, Keytruda, Merck, Metastatic Squamous Non-Small Cell Lung Cancer, NMPA, Receives

22. Yas Holding Collaborates with Alvogen to Commercialize its Generic Portfolio in MENA Region

Published: Nov 25, 2019 | Tags: Alvogen, Collaborates, Commercialize, Generic Portfolio, MENA Region, Yas Holding

23. Kyowa Kirin Signs Two Agreement with Ardelyx to Expand its Existing Partnership

Published: Nov 25, 2019 | Tags: Ardelyx, Existing, Expand, Kyowa Kirin, Partnership, Signs, Two Agreement

24. Bayer Reports Submission of MAA to EMA for Rivaroxaban to Treat Venous Thromboembolism in Children

Published: Nov 25, 2019 | Tags: Bayer, Children, EMA, MAA, Reports, Rivaroxaban, Submission, Treat, Venous, Thromboembolism

25. Zogenix Reports the US FDA Acceptance of NDA and Granted Priority Review for Fintepla (fenfluramine) to Treat Dravet Syndrome

Published: Nov 25, 2019 | Tags: Acceptance, Dravet Syndrome, FDA, fenfluramine, Fintepla, Granted, NDA, Priority Review, reports, US, Zogenix

26. Ferring and Blackstone Collaborate to Establish Joint Venture Focusing on the Development of Gene Therapy for Bladder Cancer

Published: Nov 25, 2019 | Tags: Blackstone, Bladder Cancer, Collaborate, Ferring, Focusing, Gene Therapy, Joint Venture

27. Takeda Reports Results of Alunbrig (brigatinib) in P-III ALTA-1L Study for Advanced Anaplastic Lymphoma Kinase Positive Non-Small Cell Lung Cancer

Published: Nov 23, 2019 | Tags: Advanced, ALTA-1L, Alunbrig, Anaplastic Lymphoma Kinase Positive, brigatinib, Non-Small Cell Lung Cancer, P-III, reports, results, study, Takeda

28. Roche Reports Results of Tecentriq (atezolizumab) + Avastin (bevacizumab) in P-III IMbrave150 for Unresectable Hepatocellular Carcinoma at ESMO Congress 2019  

Published: Nov 22, 2019 | Tags: Atezolizumab, Avastin, Bevacizumab, ESMO, Congress, 2019, Imbrave150, P-III, Reports, Results, Roche, Tecentriq, Unresectable, Hepatocellular Carcinoma

29. Takeda’s Takhzyro (lanadelumab injection) Receives CADTH’s CDEC Positive Opinion for the Routine Prevention of Hereditary Angioedema Attacks

Published: Nov 22, 2019 | Tags: CADTH’s CDEC, Hereditary Angioedema Attacks, lanadelumab injection, Positive Opinion, receives, Routine Prevention, Takeda, Takhzyro

30. Roche Reports the US FDA’s Acceptance of NDA for Risdiplam and Granted Priority Review to Treat Spinal Muscular Atrophy

Published: Nov 25, 2019 | Tags: Acceptance, FDA, Granted, NDA, Priority Review, reports, Risdiplam, Roche, Spinal Muscular Atrophy, Treat, US

31. Novartis to Acquire The Medicines Company for $9.7B

Published: Nov 24, 2019 | Tags: $9.7B, Acquire, Novartis, The Medicines Company