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