PharmaShots Weekly Snapshot (November 11-15, 2019)

1. Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ eBC with Residual Invasive Disease After Neoadjuvant Treatment

Published: Nov 15, 2019 | Tags: Roche, Kadcyla, trastuzumab emtansine, Receives, CHMP, Recommendation, Approval, Adjuvant, Treatment, HER2+ Early Breast Cancer

2. Stanford Medicine Reports Results of Apple Heart Study for Detecting Atrial Fibrillation

Published: Nov 13, 2019 | Tags: Stanford Medicine, Reports, Results, Apple’s Wearable Technology, Detecting, Atrial Fibrillation

3. Sarepta Signs a License Agreement with Stride Bio to Develop In vivo AAV-Based Gene Therapies

Published: Nov 14, 2019 | Tags: Sarepta, Signs, License Agreement, Stride Bio, Develop, In vivo, AAV-Based, Gene Therapies

4. Shionogi’s Fetroja (cefiderocol) Receives the US FDA’s Approval for the Treatment of Complicated Urinary Tract Infections

Published: Nov 14, 2019 | Tags: Shionogi, Fetroja, cefiderocol, Receives, US FDA, Approval, Complicated Urinary Tract Infections

5. BeiGene’s Brukinsa (zanubrutinib) Receives the US FDA’s Accelerated Approval for Patients with Mantle Cell Lymphoma Who Received At least One Prior Therapy

Published: Nov 14, 2019 | Tags: BeiGene, Brukinsa, zanubrutinib, Receives, FDA, Accelerated Approval, Mantle Cell Lymphoma, One Prior Therapy

6. AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib in Patients with Neurofibromatosis Type 1

Published: Nov 14, 2019 | Tags: AstraZeneca, MSD, Report, FDA, Acceptance, NDA, Selumetinib, Patients, Neurofibromatosis Type 1           

7. Allergan Signs an Exclusive Option and License Agreement with Exicure to Discover and Develop SNA-based Therapies for Hair Loss Disorders

Published: Nov 14, 2019 | Tags: Allergan, Signs, Exclusive, Option, License Agreement, Exicure, Discover, Develop, SNA-based Therapies, Hair Loss Disorders

8. Bayer Collaborates with Dewpoint to Develop New Therapies Targeting Cardiovascular and Gynecological Diseases

Published:  Nov 14, 2019 | Tags: Bayer, Collaborates, Dewpoint, Develop, New Therapies, Targeting, Cardiovascular, Gynecological Diseases

9. Zambon Signs a License Agreement with Aquestive to Develop and Commercialize Riluzole Oral Film for Amyotrophic Lateral Sclerosis in EU

Published: Nov 13, 2019 | Tags: Zambon, Signs, License Agreement, Aquestive, Develop, Commercialize, Riluzole Oral Film, Amyotrophic Lateral Sclerosis, EU

10. Takeda Expands its Collaboration with Finch Therapeutics to Develop Microbiome Therapies Utilizing Human-First Discovery Platform

Published: Nov 13, 2019 | Tags: Takeda, Expands, Collaboration, Finch Therapeutics, Develop, Microbiome Therapies, Human-First Discovery Platform

11. Boehringer Ingelheim and Lilly Report FDA’s EMDAC Outcomes for Empagliflozin (2.5mg) as Adjunct to Insulin for T1D Patients     

Published: Nov 13, 2019 | Tags: Boehringer Ingelheim, Lilly, FDA, EMDAC, Empagliflozin, 2.5mg, Adjunct, Insulin, T1D

12. Pfizer Collaborates with Centogene to Access its Rare Disease Data

Published: Oct 13, 2019 | Tags: Pfizer, Collaborates, CENTOGENE, Access, Rare Disease Data

13. Merck Acquires Calporta Therapeutics for ~$576M

Published: Nov 13, 2019 | Tags: Merck, Acquires, Calporta Therapeutics, ~$576M

14. GSK Reports Results of Nucala (mepolizumab) in P-III Study for Hypereosinophilic Syndrome

Published: Nov 13, 2019 | Tags: GSK, Reports, Results, Nucala, mepolizumab, P-III, Study, Hypereosinophilic Syndrome

15. Boehringer Ingelheim and Lilly Commence P-III EMPULSE Study to Evaluate Jardiance in People Hospitalized for Acute Heart Failure Who Have Been Stabilized

Published: Nov 12, 2019 | Tags: Boehringer Ingelheim, Lilly, Commence, P-III, EMPULSE, Jardiance, Acute Heart Failure, Stabilized

 16. AbbVie Reports Results of Rinvoq (upadacitinib) in P-II/III SELECT-AXIS 1 Study for Patients with Ankylosing Spondylitis

Published: Nov 13, 2019 | Tags:  AbbVie, Reports, Results, Rinvoq, upadacitinib, P-II/III, SELECT-AXIS 1, Study, Ankylosing Spondylitis 

17. Celgene Signs an Exclusive Worldwide License Agreement with Skyhawk to Develop Therapies Modulating RNA Splicing

Published: Nov 12, 2019 | Tags: Celgene, Exclusive, Worldwide, License, Agreement, Skyhawk, Therapies, Modulating, RNA Splicing

18. Celgene Amends its Existing Collaboration with Editas to Develop and Commercialize Autologous and Allogeneic T Cell Medicines for Cancer and Autoimmune Diseases

Published: Nov 12, 2019 | Tags: Celgene, Amends, Existing, Collaboration, Editas, Develop, Commercialize, Autologous Allogeneic T Cell Medicines, Treatment, Cancer, Autoimmune Diseases

19. Mylan and Pfizer Names Viatris as the New Company for Mylan-Upjohn’s Combination

Published: Nov 12, 2019 | Tags: Mylan, Pfizer, Reports, Viatris, New Company Name, Mylan Upjohn Collaboration

20. Bluebird Bio Collaborates with Forty Seven to Evaluate Antibody Conditioning Regimen in Combination with Autologous Lentiviral Vector Hematopoietic Stem Cell Gene Therapy

Published: Nov 12, 2019 | Tags: Bluebird bio, Forty Seven, Collaborate, Evaluate, All Antibody Conditioning Regimen, Autologous Lentiviral Vector Hematopoietic, Stem Cell Gene Therapy

21. Janssen Reports Results of Tremfya (guselkumab) in P-III DISCOVER Studies for Active Psoriatic Arthritis

Published: Nov 11, 2019 | Tags: Janssen, Reports, Results, Tremfya, guselkumab, P-III, DISCOVER, Studies, Active Psoriatic Arthritis

22. BMS Reports Acceptance of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) for Patients with Previously Treated Advanced Hepatocellular Carcinoma

Published: Nov 11, 2019 | Tags: BMS, Reports, Acceptance, sBLA, Opdivo, nivolumab, Yervoy, ipilimumab, Patients, Previously, Treated, Advanced Hepatocellular Carcinoma

23. Lupin to Divest its Stake in Kyowa to Unison for ~$525M

Published: Nov 11, 2019 | Tags: Lupin, Divest, Stake, Kyowa, Unison, ~$525M

24. Merck’s Ervebo [Ebola Zaire Vaccine (rVSVΔG-ZEBOV-GP) live] Receives EC’s Conditional Approval to Prevent Ebola Virus Disease

Published: Nov 11, 2019 | Tags:  Merck, Ervebo, Ebola Zaire Vaccine, rVSVΔG-ZEBOV-GP, live, Receives, EC, Conditional Approval, Prevent, Ebola Virus Disease

25. Medtronic Reports Results of World’s Smallest Pacemaker in MARVEL 2 Study for Patients with Atrioventricular Block

Published: Nov 11, 2019 | Tags: Medtronic, Reports, Results, World, Smallest, Pacemaker, MARVEL 2, Study, Patients, Atrioventricular Block

26. Roche Reports Results of Gazyva (obinutuzumab) in P-II NOBILITY Study for Lupus Nephritis

Published: Nov 11, 2019 | Tags: Roche, Reports, Results, Gazyva, obinutuzumab, P-II, NOBILITY Study, Lupus Nephritis

27. Celgene’s Reblozyl (luspatercept–aamt) Receives FDA’s Approval as the First Therapy to Treat Patients with Rare Blood Disorder

Published: Nov 08, 2019 | Tags: Celgene, Reblozyl, luspatercept–aamt, Receives, FDA, Approval, First Therapy, Treat, Patients, Rare Blood Disorder

28. Roche Reports Results of Risdiplam in Pivotal SUNFISH Study for Patients with Type 2 or 3 Spinal Muscular Atrophy

Published: Nov 11, 2019 | Tags: Roche, Reports, Results, Risdiplam, Pivotal, SUNFISH, Study, Patients, Type 2 Or 3, Spinal Muscular Atrophy

29. AstraZeneca Reports Pooled Cardiovascular Safety and Efficacy Analyses of Roxadustat in P-III Program for CKD Patients with Anaemia

Published: Nov 08, 2019 | Tags: AstraZeneca, Reports, Pooled, Cardiovascular Safety, Efficacy, Analyses, Roxadustat, P-III, Program, CKD, Anaemia

 30. Sandoz to Acquire Aspen’s Japanese Operations and Associated Assets for ~$440M

Published: Nov 11, 2019 | Tags: Sandoz, Aspen, Japanese Operations, Associated, Assets, ~$440M