PharmaShots Weekly Snapshot (August 05 – 09, 2019)

  1. Ziopharm Oncology’s Controlled IL-12 Platform Receives EMA’s COMP Positive Recommendation for Orphan Drug Designation to Treat Glioma

Published: Aug 08, 2019 | Tags: COMP, Controlled, IL-12, EMA, Glioma, Orphan Drug Designation Platform, Positive, Receives, Recommendation, Treat, Ziopharm Oncology

Eli Lilly Reports the Availability of Verzenio (abemaciclib) for Metastatic Breast Cancer in Canada

2. Eli Lilly Reports the Availability of Verzenio (abemaciclib) for Metastatic Breast Cancer in Canada

Published: Aug 08, 2019 | Tags: Abemaciclib, Availability, Canada, Eli Lilly, Metastatic, Breast, Cancer Reports, Verzenio   

AstraZeneca Reports Updated Positive Results of Tagrisso (osimertinib) in P-III FLAURA Study for 1L EGFR-Mutated Non-Small Cell Lung Cancer

3. AstraZeneca Reports Updated Positive Results of Tagrisso (osimertinib) in P-III FLAURA Study for 1L EGFR-Mutated Non-Small Cell Lung Cancer

Published: Aug 09, 2019 | Tags: 1L, AstraZeneca, EGFR, FLAURA, Mutated, Non-Small Cell Lung Cancer, osimertinib, P-III, Positive, Results, Reports, Study, Tagrisso, Updated

Takeda Reports Submission of NDA to MHLW for Vedolizumab SC to Treat Moderately to Severely Active Ulcerative Colitis in Japan

4. Takeda Reports Submission of NDA to MHLW for Vedolizumab SC to Treat Moderately to Severely Active Ulcerative Colitis in Japan

Published: Aug 08, 2019 | Tags: Active, Japan, MHLW, Moderately, NDA, Reports, SC, Severely, Submission, Takeda, Treat, Ulcerative Colitis, Vedolizumab

Eli Lilly with Evidation Health and Apple Report Results of Digital Alzheimer’s Study

5. Eli Lilly with Evidation Health and Apple Report Results of Digital Alzheimer’s Study

Published: Aug 07, 2019 | Tags: Alzheimer, Study, Apple, Digital, Eli Lilly, Evidation, Health, Report, Result

Bayer to Acquire BlueRock Therapeutics for its Cell Therapies

6. Bayer to Acquire BlueRock Therapeutics for its Cell Therapies

Published: Aug 08, 2019 | Tags: Acquire, Bayer, BlueRock Therapeutics, Cell Therapies, CELL+GENE, platform, iPSC technology, Versant Ventures

Gilead Sciences Receives the US FDA Advisory Committee’s Recommendation on Approval of Descovy for PrEP

7.Gilead Sciences Receives the US FDA Advisory Committee’s Recommendation on Approval of Descovy for PrEP  

Published: Aug 08, 2019 | Tags: Advisory, Committee, approval, Descovy, Gilead Sciences, PrEP, Receives, Recommendation, the US FDA

Myriad to File sPMA to the US FDA of BRACAnalysis CDx as a Companion Diagnostic for Lynparza (olaparib) to Treat Metastatic Castrate-Resistant Prostate Cancer in Men

8. Myriad to File sPMA to the US FDA of BRACAnalysis CDx as a Companion Diagnostic for Lynparza (olaparib) to Treat Metastatic Castrate-Resistant Prostate Cancer in Men

Published: Aug 07, 2019 | Tags: olaparib, BRACAnalysis CDx, Companion, Diagnostic, File, Lynparza, Men, Metastatic Castrate-Resistant Prostate Cancer, Myriad, sPMA, Treat, US FDA

Mitsubishi Tanabe’s Edaravone Receives NMPA’s Approval for Amyotrophic Lateral Sclerosis (ALS)

9. Mitsubishi Tanabe’s Edaravone Receives NMPA’s Approval for Amyotrophic Lateral Sclerosis (ALS)

Published: Aug 08, 2019 | Tags: ALS, Amyotrophic Lateral Sclerosis, Approval, Edaravone, Mitsubishi Tanabe, NMPA, Receives

Akcea Therapeutics and Ionis Pharmaceutical Launch Waylivra (volanesorsen) for Familial Chylomicronemia Syndrome in EU

10. Akcea Therapeutics and Ionis Pharmaceutical Launch Waylivra (volanesorsen) for Familial Chylomicronemia Syndrome in EU

Published: Aug 08, 2019 | Tags: Akcea Therapeutics, EU, Familial Chylomicronemia Syndrome, Ionis Pharmaceutical, Launch, Volanesorsen, Waylivra

Stoke Therapeutics’ STK-001 Receives FDA’s Orphan Drug Designation for Dravet Syndrome

11. Stoke Therapeutics’ STK-001 Receives FDA’s Orphan Drug Designation for Dravet Syndrome

Published: Aug 06, 2019 | Tags: Dravet Syndrome, FDA, Orphan Drug Designation, Receives, Stk-001, Stoke Therapeutics

Aevi Genomic Medicine Signs an Option and License Agreement with AstraZeneca for its MEDI2338

12. Aevi Genomic Medicine Signs an Option and License Agreement with AstraZeneca for its MEDI2338

Published: Aug 06, 2019 | Tags: Aevi Genomic, Medicine, Agreement, Astrazeneca, License, Medi2338, Option, Signs

Newsoara Biopharma Signs a Licensing Agreement with Zenith Epigenetics for its ZEN-3694Newsoara Biopharma Signs a Licensing Agreement with Zenith Epigenetics for its ZEN-3694

13. Newsoara Biopharma Signs a Licensing Agreement with Zenith Epigenetics for its ZEN-3694

Published: Aug 06, 2019 | Tags: BioPharma, Licensing, Agreement, Newsoara, Signs, ZEN-3694, Zenith Epigenetics

NIH Launches LUCA Biologics to Develop Live Biotherapeutics for Women’s Health

14. NIH Launches LUCA Biologics to Develop Live Biotherapeutics for Women’s Health

Published: Aug 06, 2019 | Tags: NIH, Develop, Launches, Live Biotherapeutics, LUCA Biologics, Women’s Health

ADC Therapeutics and Sophia Genetics Collaborate to Identify Biomarkers in Clinical Study

15. ADC Therapeutics and Sophia Genetics Collaborate to Identify Biomarkers in Clinical Study

Published: Aug 06, 2019 | Tags: ADC Therapeutics, Biomarkers, Clinical Study, Collaborate, Sophia Genetics

AstraZeneca and MSD’s Report Results of Lynparza in P-III PROfound Study for Metastatic Castration-Resistant Prostate Cancer with Homologous Recombination Repair Gene Mutation

16. AstraZeneca and MSD’s Report Results of Lynparza in P-III PROfound Study for Metastatic Castration-Resistant Prostate Cancer with Homologous Recombination Repair Gene Mutation

Published: Aug 07, 2019 | Tags: AstraZeneca, Homologous Recombination Repair Gene Mutation, Lynparza, Metastatic Castration-Resistant Prostate Cancer, MSD P-III, PROfound, Reports, Results, Study

Spring Bank Signs a Research Agreement with University of Texas Southwestern Medical School to Evaluate STING Antagonist Compounds

17. Spring Bank Signs a Research Agreement with the University of Texas Southwestern Medical School to Evaluate STING Antagonist Compounds

Published: Aug 07, 2019 | Tags: Compounds, Evaluate, Research, Agreement, Signs, Spring Bank, STING Antagonist University, Texas, Southwestern Medical School

Allergan Reports the Acceptance of EMA’s MAA for Abicipar to Treat Neovascular Age-Related Macular Degeneration

18. Allergan Reports the Acceptance of EMA’s MAA for Abicipar to Treat Neovascular Age-Related Macular Degeneration

Published: Aug 06, 2019 | Tags: Abicipar, Acceptance,, Allergan, EMA, MAA, Neovascular Age-Related Macular Degeneration, Reports

Astellas Initiates P-III BRIGHT SKY Clinical Program for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms

19. Astellas Initiates P-III BRIGHT SKY Clinical Program for Fezolinetant in Postmenopausal Women with Vasomotor Symptoms

Published: Aug 06, 2019 | Tags: Astellas, BRIGHT SKY, Clinical, Program, Fezolinetant, Initiates, P-III, Postmenopausal Vasomotor Symptoms, Women

GSK and Sabin Signs an Exclusive Agreement to Advance the Development of Ebola and Marburg VaccinesGSK and Sabin Signs an Exclusive Agreement to Advance the Development of Ebola and Marburg Vaccines

20. GSK and Sabin Signs an Exclusive Agreement to Advance the Development of Ebola and Marburg Vaccines

Published: Aug 06, 2019 | Tags: Advance, Agreement, Development, Ebola, Exclusive, GSK, Marburg, Sabin, Signs, Vaccines

Innovent and Shenogen Enter into a Collaboration to Evaluate the Combination of Tyvyt (sintilimab injection) + SNG1005 for Advanced Cancer Innovent and Shenogen Enter into a Collaboration to Evaluate the Combination of Tyvyt (sintilimab injection) + SNG1005 for Advanced Cancer

21. Innovent and Shenogen Enter into a Collaboration to Evaluate the Combination of Tyvyt (sintilimab injection) + SNG1005 for Advanced Cancer

Published: Aug 06, 2019 | Tags: Advanced, Cancer, Collaboration, combination, Enter, Evaluate, Innovent, Shenogen, Sintilimab, Injection, SNG1005, Tyvyt

AstraZeneca and MSD’s Report Results of Lynparza in P-III PROfound Study for Metastatic Castration-Resistant Prostate Cancer with Homologous Recombination Repair Gene Mutation

22. AstraZeneca and MSD’s Report Results of Lynparza in P-III PROfound Study for Metastatic Castration-Resistant Prostate Cancer with Homologous Recombination Repair Gene Mutation

Published: Aug 07, 2019 | Tags: Astrazeneca, Homologous, Recombination, Repair, Gene, Mutation, Lynparza, Metastatic, Castration-Resistant Prostate Cancer, MSD, P-III, Profound, Reports, Results, Study 

MannKind Enter into an Agreement with One Drop to Combine Bluetooth-Connected Inhaler with Dose Detection into the One Drop Platform

23. MannKind Enter into an Agreement with One Drop to Combine Bluetooth-Connected Inhaler with Dose Detection into the One Drop Platform

Published: Aug 05, 2019 | Tags: Agreement, Bluetooth-Connected, Inhaler, Combine, Dose, Detection, Enter, MannKind, One Drop ,One Drop Platform

LifeOmic Launches AI- Based LIFE Extend App to Expand Healthcare and Enable People to Adopt Five Health Pillars

24. LifeOmic Launches AI-Based LIFE Extend App to Expand Healthcare and Enable People to Adopt Five Health Pillars

Published: Aug 05, 2019 | Tags: Adopt, AI, Enabling, Five Health, Pillars, Launches, LIFE, Extend, App, LifeOmic, People

Sanofi’s Dupixent Receives European Commission Approval for Moderate-To-Severe Atopic Dermatitis in Adolescents

25. Sanofi and Regeneron’s Dupixent Receives European Commission Approval for Moderate-To-Severe Atopic Dermatitis in Adolescents

Published: Aug 06, 2019 | Tags: Adolescents, Approval, Atopic Dermatitis, Dupixent, European Commission, Moderate, Receives, Sanofi, Severe

Eli Lilly Reports Results of Emgality (galcanezumab-gnlm) in P-III CONQUER Study for Chronic and Episodic Migraine

26. Eli Lilly Reports Results of Emgality (galcanezumab-gnlm) in P-III CONQUER Study for Chronic and Episodic Migraine

Published: Aug 05, 2019 | Tags: (galcanezumab-gnlm), Chronic, CONQUER, Eli Lilly, Emgality, Episodic, Migraine, P-III, Reports, Results, Study

NUST MISIS Laboratory Develops an Ultrasound Tomography System for the Diagnosis of Cancer

27. NUST MISIS Laboratory Develops an Ultrasound Tomography System for the Diagnosis of Cancer

Published: Aug 05, 2019 | Tags: Develops, Diagnosis, Cancer, NUST MISIS Laboratory, Ultrasound, Tomography System

Pfizer Reports Results of Rivipansel in P-III RESET Study for Sickle Cell Disease with Vaso-Occlusive Crisis

28. Pfizer Reports Results of Rivipansel in P-III RESET Study for Sickle Cell Disease with Vaso-Occlusive Crisis

Published: Aug 02, 2019 | Tags: P-III, Pfizer, reports, RESET, results, Rivipansel, Sickle Cell Disease, study, Vaso-Occlusive Crisis

AstraZeneca Reports Label Update with Positive Cardiovascular Outcomes and Renal Data for Forxiga (dapagliflozin) in EU

29. AstraZeneca Reports Label Update with Positive Cardiovascular Outcomes and Renal Data for Forxiga (dapagliflozin) in EU

Published: Aug 05, 2019 | Tags: AstraZeneca, Cardiovascular, Outcomes, Dapagliflozin, EU, Forxiga, Label, Positive, Renal Data, Reports, Update

Takeda Signs an Exclusive Multi-Target Research Agreement with Sosei Heptares to Develop and Commercialize Therapies Modulating GPCR

30. Takeda Signs an Exclusive Multi-Target Research Agreement with Sosei Heptares to Develop and Commercialize Therapies Modulating GPCR

Published: Aug 05, 2019 | Tags: Agreement, Commercialize, Develop, Exclusive, GPCR, Modulating, Multi-Target, Research, Signs, Sosei, Heptares Takeda, Therapies

Roche Reports Results of Tecentriq in P-III IMvigor130 Study for Previously Untreated Advanced Bladder Cancer

31. Roche Reports Results of Tecentriq in P-III IMvigor130 Study for Previously Untreated Advanced Bladder Cancer

Published: Aug 05, 2019 | Tags: Advanced, Bladder Cancer, IMvigor130, P-III, Previously, Report, Results, Roche, Study, Tecentriq, Untreated

Daiichi Sankyo’s Turalio (pexidartinib) Receives the US FDA’s Approval for the Symptomatic Tenosynovial Giant Cell Tumor

32. Daiichi Sankyo’s Turalio (pexidartinib) Receives the US FDA’s Approval for the Symptomatic Tenosynovial Giant Cell Tumor

Published: Aug 02, 2019 | Tags: Approval, Daiichi Sankyo, FDA, pexidartinib, Receives, Symptomatic Tenosynovial Giant Cell Tumor, Turalio, US