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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on

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