PharmaShots Weekly Snapshot (May 06-10, 2019)

1.AstraZeneca Reports Results of Roxadustat in Global Phase III Programme for Cardiovascular Safety in Patients with Chronic Kidney Disease

Published: May 10, 2019 | Tags:  AstraZeneca, Reports, Results, Roxadustat, Global, Phase III, Programme, Cardiovascular Safety, Chronic Kidney Disease

2.Boston Scientific to Acquire Vertiflex for its Superion Indirect Decompression System

Published: May 10, 2019 | Tags: Boston Scientific, Acquire, Vertiflex, Superion Indirect Decompression System

3.Takeda Reports FDA’s Acceptance of BLA for Entyvio (Vedolizumab SC) as a Maintenance Therapy in Moderate to Severe Active Ulcerative Colitis

Published: May 10, 2019 | Tags: US FDA, Accepts, Takeda, BLA, Entyvio, Vedolizumab, SC, Maintenance Therapy, Moderate, Severe, Active, Ulcerative Colitis

4.Medtronic To Acquire Titan Spine for its Portfolio of Implants and nanoLock Surface Technology

Published: May 10, 2019 | Tags: Medtroni, Acquire, Titan Spine, Portfolio, Implants, nanoLock Surface Technology

5.BMS Report Results of Opdivo + Radiation in P-III CheckMate -498 Study in Patients with Newly Diagnosed MGMT-Unmethylated Glioblastoma Multiforme

Published: May 10, 2019 | Tags: Boston Scientific,Acquire, Vertiflex, Superion Indirect Decompression System

6.Takeda Signs a Licensing Agreement with Curadev for Stimulator of Interferon Genes (STING) Agonist

Published: May 10, 2019 | Tags: Takeda, Signs, Licensing, Agreement, Curadev, Stimulator, Interferon Genes (STING) Agonist

7.Ethicon Acquires Rights of Takeda’s TachoSil Fibrin Sealant Patch for ~$400M

Published: May 10, 2019 | Tags: ~$400M, Acquires, Ethicon, Rights, TachoSil Fibrin Sealant Patch, Takeda

8. Gilead Collaborates with Goldfinch Bio to Develop and Commercialize Therapies for Kidney Disorders

Published: May 09, 2019 | Tags: Collaborates, Commercialize, Develop, Gilead, Goldfinch Bio, Kidney Disorders, Therapies

9.Janssen (J&J) Expands its PTG-200 Collaboration with Protagonist for Second Generation Oral IL-23 Receptor Antagonists

Published: May 08, 2019 | Tags: Collaboration, Expands, IL-23, Janssen, Oral, Protagonist, PTG-200, Receptor, Antagonists, Second Generation

10. Medtronic Reports Results of MiniMed 640G System in the SMILE Study for Reducing Hypoglycemia in Patients with Type 1 Diabetes

Published: May 08, 2019 | Tags: Hypoglycemia, Medtronic, MiniMed 640G System, Reducing, reports, results, SMILE study, Type 1Diabetes

11. Novartis Acquires Worldwide Rights of Takeda’s Xiidra (lifitegrast ophthalmic solution) for $5.3B

Published: May 09, 2019 | Tags: Acquires, lifitegrast ophthalmic solution, Novartis, Rights, Takeda, Worldwide, Xiidra

12.Pfizer to Acquire Therachon for the Expansion of its Rare Disease Portfolio

Published: May 08, 2019 | Tags: Acquire, Expansion, Pfizer, Rare disease, Therachon

13.FDA Issues an Alert on Medtronic’s Pacemaker or Cardiac Resynchronization Therapy Pacemaker for its Premature Battery Depletion

Published: May 08, 2019 | Tags: Alert, FDA, Issues, Medtronic, Pacemaker, Premature, Battery, Depletion

14.AstraZeneca and Daiichi Report Results of Trastuzumab Deruxtecan (DS-8201) in P-II DESTINY-Breast01 Study for Refractory HER2+ Metastatic Breast Cancer

Published: May 08, 2019 | Tags: (DS-8201), AstraZeneca, Daiichi, DESTINY-Breast01, Refractory, HER2+ Metastatic Breast Cancer, P-II, Results, Trastuzumab, Deruxtecan

15. Sanofi’s Dupixent (dupilumab) Receives European Commission Approval for Severe Asthma with Type 2 Inflammation

Published: May 07, 2019 | Tags: Approval, Asthma, dupilumab, Dupixent, European Commission, Receives, Sanofi, Severe Type 2 Inflammation

16. Roche Reports Results of Ocrevus (ocrelizumab) in Three P-III Studies for Relapsing and Primary Progressive Multiple Sclerosis

Published: May 08, 2019 | Tags: Ocrelizumab, Ocrevus, P-III, Primary Progressive Multiple Sclerosis Relapsing, Reports, Results, Roche, Studies, Three

17.AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III ASCEND Study for R/R Chronic Lymphocytic Leukaemia

Published: May 08, 2019 | Tags: Acalabrutinib, ASCEND, AstraZeneca, Calquence, Chronic Lymphocytic Leukaemia, P-III, r/r, Reports, Results, Study

18.Novartis Reports Results of MS Progression Discussion Tool in a Validation Study for Patients with Multiple Sclerosis

Published: May 07, 2019 | Tags: MS Progression, Discussion, Tool, Multiple Sclerosis, Novartis, Patients, Reports, Results, Study, Validation

19.Takeda Collaborates with Skyhawk Therapeutics to Develop RNA Splicing Modifiers for Neurodegenerative Diseases

Published: May 06, 2019 | Tags: Collaborates, Develop, Modifiers, Neurodegenerative Diseases, RNA, Skyhawk Therapeutics, Splicing, Takeda

20.BioMarin’s Palynziq (pegvaliase injection) Receives European Commission’s MAA Approval for Phenylketonuria

Published: May 06, 2019 | Tags: Approval, BioMarin, European Commission, MAA, Palynziq, pegvaliase injection, Phenylketonuria, Receives

21.Roche Reports Results of Risdiplam in FIREFISH and SUNFISH Studies for Spinal Muscular Atrophy

Published: May 07, 2019 | Tags: FIREFISH, Reports, Results, Risdiplam, Roche, Studies, SUNFISH

22.Eli Lilly Reports Results of Emgality (galcanezumab-gnlm) in Two P-III Studies to Treat Low- and High-Frequency Episodic Migraine

Published: May 06, 2019 | Tags: (galcanezumab-gnlm) Eli Lilly Emgality Episodic Migraine Frequency High Low P-III reports results Studies Treat

23. Pfizer’s Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) Receive FDA’s Approval for Transthyretin Amyloid Cardiomyopathy

Published: May 06, 2019 | Tags: Approval, FDA Pfizer Receive Tafamidis tafamidis meglumine Vyndamax Vyndaqel

24. Astellas Reports Results of Mirabegron in P-IV PLUS Study to Reduce Overactive Bladder Symptoms in Men

Published: May 06, 2019 | Tags: Astellas, Men, Mirabegron, Overactive Bladder, Symptoms, P-IV, PLUS, Reduce

25.Lundbeck to Acquire Abide Therapeutics for $400M

Published: May 06, 2019 | Tags: Abide Therapeutics, Acquires, Lundbeck, $400M

26.Roche’s Kadcyla (trastuzumab emtansine) Receives FDA’s Expanded Approval as an Adjuvant Treatment for HER2+ Early Breast Cancer in the US

Published: May 06, 2019 | Tags: (trastuzumab emtansine), Adjuvant, Approval, Early, Breast Cancer, Expanded, FDA, HER2, Kadcyla, Receives, Roche, Treatment, US