PharmaShots Weekly Snapshot (Jul 06 – 10, 2020)

1. LEO Reports the US FDA’s Acceptance of BLA for Tralokinumab to Treat Adults with Moderate to Severe Atopic Dermatitis

Published Date: Jul 10, 2020 | Tags: LEO, Reports, US, FDA, Acceptance, BLA, Tralokinumab, Treat, Adults, Moderate to Severe, Atopic Dermatitis

2. Philips Collaborates with BioIntelliSense to Enhance Remote Patient Monitoring

Published Date:  Jul 10, 2020 | Tags: Philips, Collaborates, BioIntelliSense, Enhance, Remote Patient Monitoring

3. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Published Date: Jul 10, 2020 | Tags: AstraZeneca, Collaborates, Design, Novel Peptide, Therapeutics, ProteinQure

4. Bayer Reports Results of Finerenone P-III FIDELIO-DKD Renal Outcomes Study in Patients with Chronic Kidney Disease and Type 2 Diabetes

Published Date: Jul 10, 2020 | Tags: Bayer, Reports, Results, Finerenone, P-III, FIDELIO-DKD Renal Outcomes Study, Patients, Chronic Kidney Disease, Type 2 Diabetes

5. Sanofi Signs an Agreement with Kymera to Advance Novel Protein Degrader Therapies Worth Up to $2.1B

Published Date: Jul 10, 2020 | Tags: Sanofi, Signs, Agreement, Kymera, Advance, Novel Protein Degrader Therapies, Worth, Up to, $2.1B

6. Cipla Launches Cipremi at $53.34 per Vial in India

Published Date: Jul 10, 2020 | Tags: Cipla, Launches, Cipremi, $53.34, Vial, India  

7. Mylan and Fujifilm Kyowa Kirin Receive the US FDA’s Approval for its Hulio (biosimilar, adalimumab)

Published Date: Jul 10, 2020 | Tags: Mylan, Fujifilm Kyowa Kirin, Receive, US, FDA, Approval, Hulio, biosimilar, adalimumab

8. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Published Date: Jul 09, 2020 | Tags: European Commission, Signs, Agreement, Roche, Merck, Supply, COVID-19 Therapies, EU

9. AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Priority Review for Reducing Stroke in Patients with Acute Ischemic Stroke or Transient Ischemic Attack

 Published Date: Jul 09, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US, FDA, Priority Review, Reducing Stroke, Patients, Acute Ischemic Stroke, Transient Ischemic Attack

10. Roche and Reverie Labs Collaborate to Advance Kinase Drug Discovery Programs

Published Date: Jul 09, 2020 | Tags: Roche, Reverie Labs, Collaborate, Advance, Kinase Drug Discovery, Programs

11. Biogen and Eisai Complete the Submission of BLA to the US FDA for Aducanumab to Treat Alzheimer’s Disease

 Published Date: Jul 09, 2020 | Tags: Biogen, Eisai, Complete, Submission, BLA, US, FDA, Aducanumab, Treat, Alzheimer’s Disease

12. Merck Collaborates with Foghorn to Develop Oncology Therapies Against Transcription Factor Target

Published Date: Jul 09, 2020 | Tags: Merck, Collaborates, Foghorn, Develop, Oncology Therapies, Against, Transcription Factor Target, $425M

13. AstraZeneca and MSD’s Lynparza (olaparib) Receives EC’s Approval for BRCA-Mutated Metastatic Pancreatic Cancer

Published Date: Jul 08, 2020 | Tags:AstraZeneca, MSD, Lynparza, Olaparib, Receives, EC, Approval, BRCA-Mutated, Metastatic Pancreatic Cancer

14. Zai Lab Signs an Exclusive License Agreement with Turning Point Therapeutics for Repotrectinib in Greater China

Published Date: Jul 08, 2020 | Tags: Zai Lab, Signs, Exclusive, License Agreement, Turning Point Therapeutics, Repotrectinib, Greater China

15. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Published Date: Jul 08, 2020 | Tags: Angion, Commences, P-II, ANG-3777, Patients, Acute Lung Injury, Associated, COVID-19 Pneumonia, Brazil

16. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

 Published Date: Jul 08, 2020 | Tags: GSK, Medicago, Initiate, P-I, Trial, COVID-19, Vaccine, July 2020

17. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Published Date: Jul 08, 2020 | Tags: Regeneron, Signs, Agreement, BARDA, US, Department of Defense, REGN-COV2, Worth, $450M

18. Daiichi Reports EMA’s Validation of MAA and Accelerated Assessment for Trastuzumab Deruxtecan to Treat HER2 Positive Metastatic Breast Cancer

Published Date: Jul 08, 2020 | Tags: Accelerated Assessment, Breast Cancer, Daiichi, Reports, EMA, HER2, MAA, Metastatic, Positive, Trastuzumab Deruxtecan, Treat, Validation

19. Novartis’ Enerzair Breezhaler Receives the EC’s Approval as a Maintenance Treatment of Asthma in Adult Patients Uncontrolled with LABA/ICS

 Published Date: Jul 07, 2020 | Tags: Adult, Approval, Asthma, Enerzair Breezhaler, Maintenance, Novartis, Patients, Receives, the EC, Treatment, Uncontrolled

20. Abbott’s Gallant ICD and CRT-D Devices Receives the US FDA’s Approval for Heart Rhythm Disorder with Bluetooth Connectivity

Published Date: Jul 07, 2020 | Tags: Abbott, Gallant ICD, CRT-D, Devices, Receives, the US FDA, Approval, Heart Rhythm Disorder, with Bluetooth Connectivity

21. BMS Signs an Exclusive Option to License Agreement with Dragonfly Therapeutics to Develop Novel Therapies for Multiple Sclerosis and Neuro-inflammation Targets

 Published Date: Jul 07, 2020 | Tags: BMS, Signs, Exclusive, License, Agreement, Dragonfly Therapeutics, Develop, Novel, Therapies, Multiple Sclerosis, Neuro-inflammation Targets

22. Becton Dickinson Receives the US FDA’s EUA for its Third Point-Of-Care SARS-CoV-2 Diagnostic Test to Detect COVID-19

Published Date: Jul 07, 2020 | Tags: Becton Dickinson, Receives, the US FDA, EUA, Point-Of-Care, SARS-CoV-2, Diagnostic Test, Detect, COVID-19

23. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19

 Published Date: Jul 07, 2020 | Tags: Emergent, Signs, Five-Year, Manufacturing, Services, Agreement, Janssen, Ad26.COV2-S, Treat, COVID-19

24. EspeRare’s ER-004 Receives the US FDA’s Breakthrough Therapy Designation for Prenatal Treatment of XLHED

Published Date: Jul 07, 2020 | Tags: Breakthrough Therapy Designation, ER-004, EspeRare, Prenatal, Receives, the US FDA, Treatment, XLHED

25. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19

 Published Date: Jul 06, 2020 | Tags: Regeneron, Signs, Agreement, BARDA, US, Department of Defense, REGN-COV2, Worth, $450M

26. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India

 Published Date: Jul 06, 2020 | Tags: Mylan, Remdesivir Lyophilized Powder, Injection, Receives, the DCGI, Accelerated Approval, Restricted Emergency Use, COVID-19, Patients, India

27. MSD Signs a Clinical Trial Collaboration with Ascentage Pharma for Solid Tumors

Published Date: Jul 06, 2020 | Tags:  MSD, Signs, Clinical Trial, Collaboration, Ascentage Pharma, Solid Tumors

28. CytoDyn Signs an Agreement with American Regent for Leronlimab to Treat COVID-19 Patients in the US

Published Date: Jul 06, 2020 | Tags: CytoDyn, Signs, Agreement, American Regent, Leronlimab, Treat, COVID-19, Patients, the US

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