1. Profound Medical’s TULSA-PRO Receives the US FDA’s 510(k) Clearance for Ablation of Prostate Tissue

Published: Aug 16, 2019 | Tags: 510(k), Ablation, Clearance, Profound Medical, Prostate Tissue, Receives, TULSA-PRO, The US FDA

2. Mallinckrodt Reports Positive Results of Terlipressin in P-III CONFIRM Study for Hepatorenal Syndrome Type 1

Published: Aug 16, 2019 | Tags: CONFIRM, Hepatorenal Syndrome Type 1, Mallinckrodt, P-III, Positive, Reports, Results, Terlipressin

3. Baxter Collaborates with Cosmed to Commercialize Q-NRG+ Indirect Calorimetry Device to Support Global Clinical Nutrition

Published: Aug 15, 2019 | Tags: Baxter, Calorimetry, Clinical Nutrition, Collaborates, Commercialize, Cosmed, Device, Globally, Indirect, Q-NRG+, Support

4. Gilead and Galapagos Reports the Validation of EMA’s MAA for Filgotinib to Treat Rheumatoid Arthritis

Published: Aug 15, 2019 | Tags: EMA, Filgotinib, Galapagos, Gilead, MAA, Reports, Treat, Validation

5. Ultragenyx Enters into a Partnership and Option to Acquire Agreement with GeneTx to Develop its GTX-102 for Angelman Syndrome  

Published: Aug 16, 2019 | Tags: Agreement, Angelman Syndrome, Develop, GeneTx, GTX-102, Signs, Ultragenyx

6. Roche’s Rozlytrek (entrectinib) Receives the US FDA Approval for ROS1-Positive Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors  

Published: Aug 16, 2019 | Tags: Approval, Entrectinib, FDA, Genentech, Metastatic Non-Small Cell Lung Cancer, NTRK, Gene, Fusion-Positive, Solid, Tumors, Receives, ROS1-Positive, Rozlytrek US

7. Regeneron Reports Positive Results of Evinacumab in P-III Study for Homozygous Familial Hypercholesterolemia

Published: Aug 14, 2019 | Tags: Evinacumab, Homozygous Familial Hypercholesterolemia, P-III, Positive, Regeneron, Reports, Results, Study

8. Regeneron’s Eylea (aflibercept) Receives the US FDA’s Approval as a Prefilled Syringe

Published: Aug 14, 2019 | Tags: Aflibercept, Approval, EYLEA, FDA, Prefilled, Receives, Regeneron, Syringe, the US

9. AstraZeneca and MSD Report Results of Lynparza in P-III PAOLA-1 Study as 1L Maintenance Therapy for Advanced Ovarian Cancer

Published: Aug 14, 2019 | Tags: 1L, Advanced, AstraZeneca, Lynparza, Maintenance Therapy, MSD, Ovarian Cancer, P-III, PAOLA-1, Report, Results, Study

10. Leo Pharma Enters into a Sub-Licensing Agreement with Bausch Health to Develop and Commercialize Brodalumab for Moderate-to-Severe Psoriasis Outside Europe

Published: Aug 13, 2019 | Tags: Agreement, Bausch Health, Brodalumab, Commercialize, Develop, Enters, Europe, Leo Pharma, Moderate, Outside, Psoriasis, Severe, Sub-Licensing

11. AstraZeneca’s Calquence (acalabrutinib) Receives the US FDA’s Breakthrough Therapy Designation for Chronic Lymphocytic Leukemia

Published: Aug 13, 2019 | Tags: Acalabrutinib, AstraZeneca, Breakthrough Therapy Designation, Calquence, Chronic Lymphocytic Leukemia, FDA, Receives, US

12. Janssen’s Imbruvica (ibrutinib) Receives European Commission Approval for Chronic Lymphocytic Leukaemia and Waldenstrom’s Macroglobulinemia in Adults

Published: Aug 13, 2019 | Tags: Adults, Approval, Chronic, European Commission, Ibrutinib, Imbruvica, Janssen, Lymphocytic Leukaemia, Receives, Waldenstrom's Macroglobulinemia

13.Roche’s Tecentriq (atezolizumab) Receives Health Canada’s Approval for 1L Extensive-Stage Small Cell Lung Cancer in Adults

Published: Aug 13, 2019 | Tags: 1L, Adults, Approval, atezolizumab, ES-SCLC, Extensive-Stage, Small Cell Lung Cancer, Health Canada, Receives, Roche, Tecentriq

14. Eli Lilly Reports Superiority Results of Taltz (ixekizumab) in P-IV IXORA-R Study for Patients with Moderate to Severe Plaque Psoriasis  

Published: Aug 13, 2019 | Tags: Eli Lilly, ixekizumab, IXORA-R Study, Moderate-to-Severe, P-IV, Patients, Plaque Psoriasis, Report, Results, Superiority, Taltz

15. Jazz Pharmaceutical to Acquire Cavion for the Expansion of its Sleep and Neurology Portfolio

Published: Aug 13, 2019 | Tags: Acquire, Cavion, Expansion, Jazz Pharmaceutical, Neurology, Portfolio, Sleep

16. Pharming Signs an Exclusive Development and Commercialization Agreement with Novartis for its CDZ173 to Treat Activated Phosphoinositide 3-kinase Delta Syndrome

Published: Aug 13, 2019 | Tags: Activated Phosphoinositide 3-kinase Delta Syndrome, Agreement, CDZ173, Commercialization, Development, Exclusive, Novartis, Pharming, Signs, Treat

17. Baxter’s PrisMax System Receives Health Canada’s Approval for Maximizing Treatment in the Intensive Care Unit

Published: Aug 12, 2019 | Tags: Approval, Baxter, Health Canada, Maximizing, PrisMax System, Receives, Treatment

18. Boehringer Ingelheim Signs a Multi-Year Agreement with University of Texas for the Advancement of Cancer Therapies  

Published: Aug 12, 2019 | Tags: Advancement, Agreement, Boehringer Ingelheim, Cancer, Multi-Year, Signs, Therapies, University of Texas

19. Zai Lab and Novocure’s Optune Receive NMPA’s Innovative Medical Device Designation for its Tumor Treating Field Delivery System

Published: Aug 12, 2019 | Tags: Innovative, Medical Device Designation, NMPA, Novocure, Optune, Receive, Treating, Field, Delivery System, Tumor, Zai Lab

20. Oncologie and Merck Collaborate to Evaluate Bavituximab + Keytruda for Treatment of Advanced Gastric or Gastroesophageal Cancer

Published: Aug 12, 2019 | Tags: Advanced, Bavituximab, Cancer, Collaborate, Evaluate, Gastric Gastroesophageal, Keytruda, Merck, Oncologie, Treatment

21. Atricure to Acquire SentreHEART for Expansion of Therapie s to Treat Atrial Fibrillation

Published: Aug 12, 2019 | Tags: Acquire, Atricure, Expansion, SentreHEART ,Therapies, Treat

22. SMS-Oncology Signs a Clinical Trial Collaboration with Cytovation to Treat Solid Tumors

Published: Aug 12, 2019 | Tags: Clinical, Collaboration, Cytovation, Signs, SMS- Oncology, Solid, Treat, Trial, Tumors

23. Gilead’s Biktarvy (Bictegravir, Emtricitabine and Tenofovir Alafenamide) Receives NMPA’s Approval for Treatment of HIV-1 Infection

Published: Aug 09, 2019 | Tags: Approval, , Biktarvy, CHMP, Emtricitabine, Gilead, Receives, Tenofovir Alafenamide, Treatment