PharmaShots Weekly Snapshot (April 08-12, 2019)

1.Omron Healthcare Receives FDA’s Approval for Complete a Blood Pressure Monitoring Device with ECG Facility

Published: April 12, 2019 | Tags: Omron Healthcare, Receives, FDA, Approval, Complete, Blood Pressure, Monitoring, Device, EKG, Facility

2.Gilead and Novo Nordisk Collaborate to Conduct a Combination Therapy Trial in NASH

Published: April 12, 2019 | Tags: Gilead, Novo Nordisk, Collaborate, Conduct, Combination Therapy, Trial, NASH

3. Moleculin Signs a Clinical Research Agreement with Emory University for Brain Tumor in Pediatric Patients

Published: April 12, 2019 | Tags: Moleculin, Signs, Clinical, Research, Agreement, Emory University, WP1066, Brain Tumor, Pediatric Patients

4. Evotec Signs a Research Agreement with Indivumed to Develop Precision Therapies for Colorectal Cancer (CRC)

Published: April 12, 2019 | Tags: Evotec, Sign, Research, Agreement, Indivumed, Develop, Precision, Therapies, Colorectal Cancer, CRC

5. Merck’s Keytruda (pembrolizumab) Receives FDA’s Expanded Monotherapy Label Approval for Patients with 1L Stage III Non-Small Cell Lung Cancer (NSCLC)

Published: April 12, 2019 | Tags: Merck, Keytruda, pembrolizumab, Receives, FDA, Expanded, Monotherapy, Label, Approval, Patients, 1L, Stage III, Non-Small Cell Lung Cancer, NSCLC

6. BioDelivery Sciences (BDSI) Signs a License Agreement with Shionogi to Commercialize Symproic (naldemedine) in the US

Published: April 11, 2019 | Tags: BioDelivery Sciences, BDSI, Signs, License, Agreement, Shionogi, Commercialize, Symproic, naldemedine, the US

7. Cognoa Signs an Exclusive License Agreement with Stanford for its Google Glass-based Technology for Children with Autism Spectrum Disorder (ASD)

Published: April 11, 2019 | Tags:Cognoa, Signs, Exclusive, License, Agreement, Stanford, Google Glass-based Technology, Children, Autism Spectrum Disorder, ASD

8.Sandoz Signs a Commercialization Agreement with Shionogi for Rizmoic (naldemedine) in Europe

Published: April 11, 2019 | Tags: Sandoz, Collaborates, Shionogi, Commercialize, Rizmoic, naldemedine

9. Shanghai Miracogen Signs a Non-Exclusive License Agreement with Synaffix for its ADC Technologies

Published: April 11, 2019 | Tags: Shanghai Miracogen, Signs, Non-Exclusive, License, Agreement, Synaffix, ADC Technologies

10. Astellas Collaborates with Concerto HealthAI on Real-World Evidence (RWE) Initiative for Acute Myeloid Leukemia (AML)

Published: April 11, 2019 | Tags: Astellas, Collaborates, Concerto HealthAI, Real-World Evidence, RWE, Initiative, Acute Myeloid Leukemia, AML

11.Shanghai Fosun Signs an Exclusive License Agreement with ReNeuron for its CTX and hRPC Cell Therapy in China

Published: April 10, 2019 | Tags: Shanghai Fosun, Signs, Exclusive, License, Agreement, ReNeuron, CTX, hRPC, Cell Therapy 

12. Alkermes’ Reports Results of Aristada (aripiprazole lauroxil) and Invega Sustenna (paliperidone palmitate) in P-IIIb ALPINE Study to Treat Schizophrenia

Published: April 10, 2019 | Tags: Alkermes, Reports, Results, Aristada, aripiprazole lauroxil, Invega Sustenna, paliperidone palmitate, P-IIIb, ALPINE Study, Treat, Schizophrenia

13. AstraZeneca and Merck’s Lynparza (olaparib) Receive EU’s Approval as a Monotherapy to Treat Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer

Published: April 10, 2019 | Tags: AstraZeneca, Merck, Lynparza, olaparib, Receives, EU, Approval, Monotherapy, Treat, Germline, BRCA-Mutated, HER2-Negative, Advanced, Breast Cancer

14. Xinhua Healthcare Signs an Exclusive License Agreement with ArcDia for its mariPOC Technology in China

Published: April 10, 2019 | Tags: Xinhua Healthcare, Signs, Exclusive, License, Agreement, ArcDia, mariPOC, technology, China

15. Amgen’s Evenity (romosozumab-aqqg) Receives FDA’s Approval for Osteoporosis in Postmenopausal Women at High Risk for Fracture

Published: April 10, 2019 | Tags: Amgen, Evenity, romosozumab-aqqg, Receives, FDA, Approval, Osteoporosis, Postmenopausal Women, High Risk, Fracture

16. BeiGene Signs a Worldwide Co-Development and Commercialization Agreement with BioAtla for BA3071 and Tislelizumab

Published: April 09, 2019 | Tags: BeiGene, Signs, Worldwide, Co-Development, Commercialization, Agreement, BioAtla, BA3071, Tislelizumab

17. Audentes Signs an Exclusive License Agreement with Nationwide Children’s Hospital (NCH) for the Expansion of its AAV Technology and Pipeline

Published: April 09, 2019 | Tags: Audentes, Collaborates, Nationwide Children’s Hospital, Expansion, AAV Technology, Pipeline

18. uniQure’s AMT-130 Receives FDA’s Fast Track Designation for Huntington’s Disease

Published: April 09, 2019 | Tags: uniQure, AMT-130, Receives, FDA, Fast Track Designation, Huntington’s Disease

19. ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives FDA’s Approval to Treat HIV-1 Infection in Adults

Published: April 09, 2019 | Tags: GSK, Dovato, dolutegravir/lamivudine, Receives, FDA, Approval, Treat, HIV-1, infection, Adults

20.Regeneron Collaborates with Alnylam to Discover, Develop and Commercialize RNAi Therapeutics for Ophthalmic and CNS Disorders

Published: April 09, 2019 | Tags: Regeneron, Collaborates, Alnylam, Discover, Develop, Commercialize, RNAi Therapeutics, Ophthalmic, CNS Disorders

21. Xoma Purchases Royalty Rights for Aronora’s Five Preclinical and Clinical Hematology Candidates

Published: April 08, 2019 | Tags: Xoma, Purchases, Aronora, Royalty, Rights, Five, Hematology Candidates

22.Sanofi and Alnylam Exercise Research and Option Phase Collaboration for its 2014 Deal

Published: April 08, 2019 | Tags: Sanofi, Alnylam, Exercise, Research, Option, Phase, Collaboration, Rare Diseases, 2014

23.Celgene and Acceleron Pharma Submit Biologics License Application (BLA) to the US FDA for Luspatercept

Published: April 08, 2019 | Tags: Celgene, Acceleron, Submit, Biologics License Application, US FDA, Luspatercept

24. Avita Medical Reports Results of RECELL System in Investigational Device Exemption (IDE) Compassionate Use and Continued Access Studies for Third-Degree Burns in Pediatric Patients

Published: April 08, 2019 | Tags: AVITA Medical, Reports, Results, RECELL System, Investigational Device Exemption, IDE, Compassionate Use, Continued Access Studies, Third-Degree Burns, Pediatric Patients