PharmaShots Weekly Snapshot (August 12-16, 2019)


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

Mallinckrodt, Reports, Positive, Results, Terlipressin, P-III, CONFIRM, Study, 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

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

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  

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  

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

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

Regeneron’s Eylea (aflibercept) Injection 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

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

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

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

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

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  

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

Jazz Pharmaceuticals Reports Results of JZP-258 in P-III Study for Narcolepsy Patients with Cataplexy and Excessive Daytime Sleepiness

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

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

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  

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

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

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

Atricure to Acquire SentreHEART for Expansion of Therapies 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

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

Gilead to Raise Stake in Galapagos with ~$5.1B Deal

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