PharmaShots Weekly Snapshot (January 27-31, 2020)

  1. ProQR’s QR-421a Receives FDA’s Rare Pediatric Disease Designation for Retinitis Pigmentosa

Published: Jan 30, 2020 | Tags: ProQR, QR-421a, Receives, FDA, Rare Pediatric Disease Designation, Retinitis Pigmentosa

2. Eli Lilly’s Fast-Acting Insulin Lispro Receives CHMP’s Positive Opinion in Patients with Diabetes

Published: Jan 31, 2020 | Tags: Eli Lilly, Fast Acting Insulin Lispro, Receives, CHMP, Positive Opinion, Patients, Diabetes

3. Alnylam’s Givlaari (givosiran) Receives CHMP’s Positive Opinion to Treat Acute Hepatic Porphyria in Adults and Adolescents

Published: Jan 31, 2020 | Tags: Alnylam, Givlaari, givosiran, Receives, CHMP, Positive Opinion, Treat, Acute Hepatic Porphyria, Adults, Adolescents

4. Accenture Collaborates with Google Cloud to Support Life Sciences Companies Advancing Research and Development of Innovative Therapies

Published: Jan 30, 2020 | Tags: Accenture, Collaborates, Google Cloud, Support, Life Sciences Companies, Research, Development, Innovative Therapies

5. Microsoft Launches $40M AI Program to Accelerate Health Initiatives Globally

Published: Jan 29, 2020 | Tags: Microsoft, Launches, $40M, AI Program, Accelerate, Health Initiatives, Globally

6. Abbott’s Tendyne Receives CE Mark as the World’s First Transcatheter Mitral Valve Implantation System in Europe

Published: Jan 30, 2020 | Tags: Abbott, Tendyne, Receives, CE Mark, World, First, Transcatheter Mitral Valve Implantation System, Europe

7. Inovio Collaborates with Beijing Advaccine to Advance the Development of INO-4800 Vaccine Targeting Coronavirus in China

Published: Jan 30, 2020 | Tags: Inovio, Collaborates, Beijing Advaccine, Advance, Development, INO-4800, Vaccine, Targeting Coronavirus, China

8. Spring Bank Discontinues the Development of Inarigivir to Treat Patients with Chronic Hepatitis B Virus

Published: Jan 29, 2020 | Tags: Spring Bank, Discontinues, Development, Inarigivir, Chronic Hepatitis B Virus

9. Bayer Report Result of Nubeqa (darolutamide) + ADT in P-III ARAMIS Study for Non-Metastatic Castration-Resistant Prostate Cancer

Published:  Jan 30, 2020 | Tags: Bayer, Report, Result, Nubeqa, darolutamide, ADT, P-III, ARAMIS Study, Non-Metastatic Castration-Resistant Prostate Cancer

10. Janssen Receives EC’s Approval for Expanded Use of Erleada (apalutamide) to Treat Metastatic Hormone-Sensitive Prostate Cancer

Published: Jan 29, 2020 | Tags: Janssen, Receives, EC, Approval, Expanded Use, Erleada, apalutamide, Metastatic, Hormone-Sensitive Prostate Cancer

11. Sorrento Collaborates with Celularity to Initiate the Development of Emergency Allogeneic Natural Killer Cell Therapy for Coronavirus Infection

Published: Jan 30, 2020 | Tags: Sorrento, Collaborates, Celularity, Initiate, Development, Emergency, Allogeneic Natural Killer Cell Therapy, Coronavirus Infection

12. Astellas Reports Submission of sNDA to MHLW for Evrenzo (roxadustat) to Treat Anemia Associated with Chronic Kidney Disease in Non-Dialysis Dependent Patients in Japan

Published: Jan 30, 2020 | Tags: Astellas, Reports, Submission, sNDA, MHLW, Evrenzo, roxadustat, Anemia; Associated; Chronic Kidney Disease, Non-Dialysis Dependent, Patients, Japan

13. Sanofi Reports Results of Olipudase alfa in Two Studies for Acid Sphingomyelinase Deficiency in Adults and Pediatric Patients

Published: Jan 30, 2020 | Tags: Sanofi, Reports, Results, Olipudase alfa, Two Studies, Acid Sphingomyelinase Deficiency, Adults, Pediatric Patients

14. Johnson & Johnson Initiates the Development of Vaccines Against Coronavirus

Published: Jan 29, 2020 | Tags: Johnson & Johnson, Initiates, Development, Vaccines, Coronavirus

15. Akcea and Ionis Report Results of AKCEA-ANGPTL3-LRx in P-II Study for Patients with Cardiovascular and Metabolic Diseases

Published: Jan 28, 2020 | Tags: Akcea, Ionis, Report, Results, AKCEA-ANGPTL3-LRx, P-II, Study, Patients, Cardiovascular, Metabolic Diseases

16. Verastem Reports Dosing of Copiktra (duvelisib) in CPSC’s Chinese Study for Relapsed or Refractory Follicular Lymphoma

Published: Jan 29, 2020 | Tags:  Verastem, Reports, Dosing, Copiktra, duvelisib, CPSC, Chinese Study, Relapsed, Refractory, Follicular Lymphoma

17. Eli Lilly’s Selpercatinib (LOXO-292) Receives Priority Review Status for the Treatment of RET-Driven Cancer Indications

Published: Jan 29, 2020 | Tags: Eli Lilly, Selpercatinib, LOXO-292, Receives, Priority Review Status, Treatment, RET-driven Cancer Indications

18. Kite Reports the Validation of EMA’s MAA for KTE-X19 to Treat Relapsed or Refractory Mantle Cell Lymphoma

Published: Jan 28, 2020 | Tags: Kite, Reports, Validation, EMA, MAA, KTE-X19, Treat, Relapsed, Refractory, Mantle Cell Lymphoma

19. Takeda Report Submission of NDA to MHLW for Cabometyx (cabozantinib) to Treat Advanced Hepatocellular Carcinoma in Japan

Published: Jan 29, 2020 | Tags: Takeda, Report, Submission, NDA, MHLW, Cabometyx, cabozantinib, Treat, Advanced Hepatocellular Carcinoma, Japan

20. Timber Pharmaceuticals Signs a Reverse Merger Agreement with BioPharmX

Published: Jan 28, 2020 | Tags: Timber Pharmaceuticals, Signs, Reverse Merger Agreement, BioPharmX

21. Alkermes Reports the US FDA Acceptance of NDA for ALKS 3831 to Treat Schizophrenia and Bipolar I Disorder

Published: Jan 28, 2020 | Tags: Alkermes, Reports, US, FDA, Acceptance, NDA, ALKS 3831, Treat, Schizophrenia, Bipolar I Disorder

22. Ningbo NewBay Medical Technology Signs an Exclusive License Agreement with Genentech to Develop and Commercialize GDC-0570

Published: Jan 27, 2020 | Tags: Ningbo NewBay Medical Technology, Signs, Exclusive, License Agreement, Genentech, Develop, Commercialize, GDC-0570

23. Bausch + Lomb Collaborates with TerraCycle to Launch First Contact Lens Recycling Program in Canada

Published: Jan 27, 2020 | Tags: Bausch + Lomb, Collaborates, TerraCycle, Launch, First, Contact Lens Recycling Program, Canada

24. Eli Lilly and Boehringer Ingelheim’s Triple Regimen Receive the US FDA’s Approval for Type 2 Diabetes

Published: Jan 27, 2020 | Tags:  Eli Lilly, Boehringer Ingelheim, Triple Regimen, Receive, US, FDA, Approval, Type 2 Diabetes

25. GSK Out Licenses its Tuberculosis Vaccine (M72/AS01E ) to Bill & Melinda Gates Medical Research Institute

Published: Jan 27, 2020 | Tags: GSK, Out Licenses, Tuberculosis Vaccine (M72/AS01E ), Bill & Melinda Gates Medical Research Institute

26. Sanofi and Regeneron Receive the US FDA’s Priority Review Acceptance for Dupixent’s sBLA to Treat Moderate-to-Severe Atopic Dermatitis in Children Aged 6 to 11 Years

Published: Jan 28, 2020 | Tags: Sanofi, Regeneron, Receive, FDA, Priority Review Acceptance, Dupixent, sBLA, Moderate-to-Severe Atopic Dermatitis, Aged 6 to 11 Years 

27. Merck & Co’s Dificid (fidaxomicin) Receives FDA’s Approval to Treat Clostridioides difficile in Children Aged Six Months and Older

Published: Jan 27, 2020 | Tags: Merck & Co’s, Dificid, fidaxomicin, Receives, FDA, Approval, Treat, Clostridioides difficile, Children, Aged, Six Months and Older

28. AstraZeneca Reports Results of Brilinta (ticagrelor) in P-III THALES Study for Patients with Minor Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Jan 27, 2020 | Tags: AstraZeneca, Reports, Results, Brilinta, ticagrelor, P-III, THALES Study, Patients, Minor Acute Ischemic Stroke, High-Risk Transient Ischemic Attack

29. Roche Reports Submission of sBLA to the US FDA for Tecentriq (atezolizumab) + Avastin (bevacizumab) to Treat Unresectable Hepatocellular Carcinoma

Published: Jan 27, 2020 | Tags: Roche, Reports, Submission, sBLA, US, FDA, Tecentriq, atezolizumab, Avastin, bevacizumab, Treat, Unresectable Hepatocellular Carcinoma

30. AstraZeneca to Divest its Hypertension Therapies to Atnahs Pharma

Published: Jan 27, 2020 | Tags: AstraZeneca, Divest, Hypertension Therapies, Atnahs Pharma

31. AbbVie to Divest Allergan’s Brazikumab and Zenpep (pancrelipase) to Gain the US FTC and EC’s Approval on Pending Allergan Acquisition

Published: Jan 27, 2020 | Tags: AbbVie, Divest, Allergan, Brazikumab, Zenpep, pancrelipase, Gain, US, FTC, EC, Approval, Pending Allergan Acquisition