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PharmaShots Weekly Snapshot (April 22-26, 2019)

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PharmaShots Weekly Snapshot (April 22-26, 2019)

  1. Novo Nordisk Files MAA for Semaglutide to the EMA for Type 2 Diabetes

Published: April 26,2019 | Tags: Novo Nordisk, Files, MAA, Semaglutide, European Medicines Agency, EMA, Type 2 Diabetes

2.Gilead Reports Results of Selonsertib in P-III STELLAR 3 Study for Bridging Fibrosis (F3) due to NASH

Published: April 25,2019 | Tags: Gilead, Reports, Results, Selonsertib, P-III, STELLAR 3, Study, Bridging Fibrosis, F3, NASH

3.Takeda Files NDA for Cabometyx (cabozantinib) to MHLW for Advanced Renal Cell Carcinoma in Japan

Published: April 25,2019 | Tags: Takeda, Files, NDA, Cabometyx, cabozantinib, MHLW, Advanced Renal Cell Carcinoma, Japan

4. Merck Reports Updated Results of Keytruda (pembrolizumab) in P-III KEYNOTE-062 Study as a Monotherapy for 1L Treatment of Advanced Gastric Cancer

Published: April 25,2019 | Tags: Merck, Reports, Updated, Results, Keytruda, pembrolizumab, P-III, KEYNOTE-062, Study, 1L, Treatment, Advance Gastric Cancer

5. Salix (Bausch Health) Signs an Exclusive License Agreement with Mitsubishi Tanabe for its MT-1303 (amiselimod)

Published: April 25,2019 | Tags: Salix (Bausch Health), Signs, License Agreement, Mitsubishi Tanabe Pharma, MT-1303, amiselimod, Inflammatory Bowel Disease, Ulcerative Colitis

6.B. Braun Launches its Heparin Sodium Prefilled Syringe in the US

Published: April 24,2019 | Tags: B. Braun, Launches, Ready-To-Use, Prefilled Syringe, Heparin Sodium Injection

7. Eli Lilly Facilitates the Withdrawal of Lartruvo (olaratumab) from the Global Market for Advanced Soft Tissue Sarcoma

Published: April 25,2019 | Tags: Eli Lilly, Facilitates, Withdrawal, Lartruvo, olaratumab, Global Market, Advanced Soft Tissue Sarcoma

8. ADC Therapeutics Signs a License Agreement with Adagene for its SAFEbody Technology

Published: April 24,2019 | Tags: ADC Therapeutics, Signs, License Agreement, Adagene, SAFEbody Technology

9.Perelman School of Medicine Signs a Research and Development Agreement with Sensus Healthcare for its Sculptura Intraoperative Radiation Therapy System

Published: April 24,2019 | Tags: Perelman School of Medicine, Signs, Research, Development, Agreement, Sensus Healthcare, Sculptura Intraoperative Radiation Therapy System

10.Takeda Signs a Licensing Option Agreement with Emendo Biotherapeutics for its OMNI Nuclease Program

Published: April 24,2019 | Tags: Takeda, Signs, Licensing Option Agreement, Emendo Biotherapeutics, OMNI Nuclease Program

11. Fulcrum Therapeutics Signs an Exclusive Worldwide License Agreement with GSK to Develop and Commercialize Losmapimod for Facioscapulohumeral Muscular Dystrophy

Published: April 23,2019 | Tags: GSK, Signs, Exclusive, Worldwide, License, Agreement, Fulcrum Therapeutics, Develop, Commercialize, Losmapimod, Facioscapulohumeral Muscular Dystrophy

12. AbbVie's Skyrizi (risankizumab-rzaa) Receives FDA's Approval for Moderate to Severe Plaque Psoriasis

Published: April 23,2019 | Tags: AbbVie, Skyrizi (risankizumab-rzaa), Receives, FDA, Approval, Moderate, Severe, Plaque Psoriasis

13. OncoSec Initiates a Triple Combination Immunotherapy Trial for Squamous Cell Head and Neck Cancer

Published: April 23,2019 | Tags: OncoSec, Initiates, Triple Combination, Study, Immunotherapies, Squamous Cell Head and Neck Cancer

14.Teva Discontinues its P-III ENFORCE Study of Fremanezumab for Episodic Cluster Headache

Published: April 23,2019 | Tags: Teva, Discontinues, P-III, ENFORCE Study, Fremanezumab, Episodic Cluster Headache

15. BAROnova's TransPyloric Shuttle Device Receives FDA's Approval for the Treatment of Obesity in Adult

Published: April 23,2019 | Tags: BAROnova, TransPyloric Shuttle, Receive, FDA, Approval, Treatment, Obesity, Adults

16.NuVasive Reports Results of Cohere Porous PEEK Implants for Degenerative Cervical Disc

Published: April 22,2019 | Tags: NuVasive, Reports, Results, Cohere Porous PEEK Implants, Study, Patients, Degenerative Cervical Disc

17. Alder BioPharmaceuticals Reports FDA's Acceptance of BLA for Eptinezumab to Prevent Migraine

Published: April 22,2019 | Tags: Alder BioPharmaceuticals, Reports, FDA, Acceptance, BLA, Eptinezumab, Prevent, Migraine

18 .Eli Lilly to Sell Rights for its Two Antibiotics and a Manufacturing Facility to Eddingpharm in China for $375M

Published: April 22,2019 | Tags: Eli Lilly, Sell, Chinese Rights, Antibiotics, Manufacturing Facility, Eddingpharm, $375M

19.Roche Launches Ventana HER2 Dual ISH CDx for the Identification of Breast and Gastric Cancer

Published: April 23,2019 | Tags: Roche, Launches, Ventana HER2 Dual ISH, CDx, Identification, Breast, Gastric Cancer

20. Lilly Reports Results of Taltz (ixekizumab) in P-III COAST-X Study for Non-Radiographic Axial Spondyloarthritis

Published: April 22,2019 | Tags: Lilly, Reports, Results, Taltz, ixekizumab, P-III, COAST-X, Study, Non-Radiographic Axial Spondyloarthritis

21. Merck's Keytruda (pembrolizumab) + Inlyta (axitinib) Receive FDA's Approval as 1L Treatment for Advanced Renal Cell Carcinoma

Published: April 22,2019 | Tags: Merck, Keytruda, pembrolizumab, Inlyta, axitinib, Receive, FDA, Approval, 1L, Treatment, Advanced Renal Cell Carcinoma, RCC

22. Lilly Signs a Global Research and Licensing Agreement with Avidity Biosciences to Develop Therapies in Immunology

Published: April 22,2019 | Tags: Lilly, Signs, Global, Research, Licensing, Agreement, Avidity Biosciences, Develop, New Therapies, Immunology

23. TELA Bio's Restella Reconstructive BioScaffolds Receives FDA's 510(k) Clearance for Reconstructive Surgery

Published: April 18,2019 | Tags: TELA Bio, Restella Reconstructive BioScaffolds, Receives, FDA, 510(k), Clearance, Reconstructive Surgery

24. Alvogen Voluntary Recalls Nationwide Two Lots of Fentanyl Transdermal System Due to Product Mislabeling

Published: April 19,2019 | Tags: Alvogen, Voluntary, Recalls, Two, Lots, Fentanyl Transdermal System, Product Mislabeling


Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

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