PharmaShots Weekly Snapshot (May 20-24, 2019)

1.BrightInsight Launches a CE-Marked Dosing Calculator for Emicizumab to Treat Patients with Hemophilia A

Published: May 23, 2019 | Tags: BrightInsight, Launches, CE-Marked, Dosing Calculator, Emicizumab, Treat, Patients, Hemophilia A

2. Roche’s Cobas TV/MG Test Receives FDA’s 510 (k) Clearance for the Detection of Sexually Transmitted Diseases

Published: May 23, 2019 | Tags: Roche, Cobas TV/MG Test, Receives, FDA, 510 (k), Clearance, Detection, Sexually Transmitted Diseases

3. Hologic & Cepheid’s Diagnostic Tests Receive 510(k) Clearance for Extragenital Testing in Chlamydia and Gonorrhea

Published: May 23, 2019 | Tags: Hologic, Cepheid, Diagnostic Tests, Receive, 510(k), Clearance, Extragenital Testing, Chlamydia, Gonorrhea

4. Celltrion’s Herzuma (trastuzumab, biosimilar) Receives ANVISA’s Approval for Breast and Gastric Cancer in Brazil

Published: May 23, 2019 | Tags: Celltrion, Herzuma, trastuzumab, biosimilar, Receives, ANVISA, Approval, Brazil

5. GSK’s Shingrix Receives NMPA’s Approval for the Prevention of Shingles in China

Published: May 24, 2019 | Tags: GSK, Shingrix, Receives, NMPA, Approval, Prevention, Shingles, China

6. Boston Scientific Initiates OPTION Study of Watchman FLX Device for Stroke Risk Reduction Post-AF Ablation

Published: May 22, 2019 | Tags: Boston Scientific, Initiates, OPTION, Study, Watchman FLX, Device, Stroke Risk Reduction, Post-AFib Ablation

7. Synlogic Collaborates with Roche to Evaluate the Combination of SYNB1891 and Tecentriq (atezolizumab) for Advanced Solid Tumors

Published: May 22, 2019 | Tags: Synlogic, Collaborates, Roche, Evaluate, Combination, SYNB1891, Tecentriq, atezolizumab, Advanced Solid Tumors

8. OncoSec Reports Result of Keytruda + TAVO in P-II KEYNOTE-890 Study for Refractory Metastatic Triple Negative Breast Cancer

Published: May 22, 2019 | Tags: OncoSec, Reports, Result, Keytruda, TAVO, P-II, KEYNOTE-890, Study, Refractory, Metastatic, Triple Negative Breast Cancer

9. Santhera Signs an Exclusive License Agreement with Chiesi to Develop and Commercialize Raxone for Leber’s Hereditary Optic Neuropathy

Published: May 23, 2019 | Tags: Santhera, Signs, License Agreement, Chiesi, Develop, Commercialize, Raxone, Leber’s Hereditary Optic Neuropathy

10. Takeda’s Entyvio (vedolizumab) Receives MHLW’s Approval for Moderate to Severely Active Crohn’s Disease in Japan

Published: May 22, 2019 | Tags: Takeda, Entyvio, vedolizumab, Receives, MHLW, Approval, Moderate, Severely, Active, Crohn, Disease, Japan

11. Biocon and Mylan’s Ogivri (trastuzumab, biosimilar) Receives Health Canada’s Approval for HER2-Positive Breast and Gastric Cancers

Published: May 22, 2019 | Tags: Biocon, Mylan, Ogivri, trastuzumab, biosimilar, Receives, Health Canada, Approval, HER2-Positive, Breast,Gastric Cancers

12. Medtronic Reports Results of Symplicity Renal Denervation System in Two Studies for Hypertensive Heart Diseases

Published: May 22, 2019 | Tags: Medtronic, Reports, Results, Symplicity Renal Denervation System, Two Studies, Hypertensive Heart Diseases

13. Abbott Reports Results of Minimally Invasive Device in TRILUMINATE Study for Tricuspid Heart Valve Leaks

Published: May 21, 2019 | Tags: Abbott, Reports, Results, Minimally Invasive Device, TRILUMINATE, Study, Tricuspid Heart Valve Leaks

14. Array BioPharma Reports Results of Combination Therapy in P-III BEACON CRC Study for BRAF(V600E)- Mutant Metastatic Colorectal Cancer

Published: May 21, 2019 | Tags: Array BioPharma, Reports, Results, Combination Therapy, P-III, BEACON, CRC, Study, BRAFV600E Mutant, Metastatic Colorectal Cancer

15. Verily Collaborates with Global Pharma Companies to Develop Clinical Research Program

Published: May 21, 2019 | Tags: Verily, Collaborates, Big Pharma, Companies, Develop, Clinical Research Program

16. Merck to Acquire Peloton Therapeutics for $2.2B

Published: May 21, 2019 | Tags: Merck, Acquire, Peloton Therapeutics, $2.2B

17.Clovis Oncology Reports Results of Rubraca (rucaparib) in P-III ARIEL3 Study for Advanced Ovarian Cancer

Published: May 21, 2019 | Tags: Clovis Oncology, Reports, Results, Rubraca, rucaparib, P-III, ARIEL3, Study, Advanced, Ovarian Cancer

18. AstraZeneca Reports Results of Symbicort Turbuhaler (budesonide/formoterol) in Novel START Study for Mild Asthma

Published: May 20, 2019 | Tags: AstraZeneca, Reports, Results, Symbicort Turbuhaler, budesonide, formoterol, Novel START Study, Mild Asthma

19. Merck Reports Results of Keytruda (pembrolizumab) in P-III KEYNOTE-119 Study for Metastatic Triple-Negative Breast Cancer

Published: May 20, 2019 | Tags: Merck, Reports, Results, Keytruda, pembrolizumab, P-III, KEYNOTE-119, Study, Metastatic, Triple-Negative Breast Cancer

20. Santhera Signs a Pre-Clinical Research Agreement with Biozentrum to Advance Gene Therapy for Congenital Muscular Dystrophy

Published: May 20, 2019 | Tags: Santhera, Signs, Pre-Clinical, Research, Agreement, Biozentrum, Advance, Gene Therapy, Congenital Muscular Dystrophy

21. UCB’s Nayzilam (midazolam) Receives FDA’s Approval for the Treatment of Seizure Cluster in Epilepsy in the US

Published: May 20, 2019 | Tags: UCB, Nayzilam, midazolam, Receives, FDA, Approval, Treatment, Seizure Cluster, Epilepsy

22. Takeda’s Gattex (teduglutide) Receives the US FDA’s Approval for Short Bowel Syndrome in Children

Published: May 17, 2019 | Tags: Takeda, Gattex, teduglutide, Receives, US FDA, Approval, Short Bowel Syndrome, Children

23. Ethicon (J&J) Recalls Endo-Surgery Intraluminal Staplers Due to Complete Staple Line Failure

Published: May 16, 2019 | Tags: Ethicon, J&J, Recalls, Endo, Surgery, Intraluminal Staplers, Complete, Staple, Line Failure

24. Takeda Reports Results of Entyvio (vedolizumab) in P-III VARSITY Study for Ulcerative Colitis

Published: May 19, 2019 | Tags: Takeda, Reports, Results, Entyvio, vedolizumab, P-III, VARSITY, Study, Ulcerative Colitis

25. AbbVie Reports Results of Depatux-M (depatuxizumab mafodotin) in P-III INTELLANCE-1 Study for Glioblastoma

Published: May 17, 2019 | Tags: AbbVie, Reports, Results, Depatux-M, depatuxizumab mafodotin, P-III, INTELLANCE-1, Study, Glioblastoma