PharmaShots Weekly Snapshot (Jun 29 – Jul 03, 2020)

1. Medivir’s MIV-818 Receives EC’s Orphan Medicinal Product Designation to Treat Hepatocellular Carcinoma

Published: Jul 03, 2020 | Tags: EC, Hepatocellular Carcinoma, Medivir, Miv-818, Orphan, Medicinal Product Designation, Receives

2. ViiV Healthcare’s Rukobia (fostemsavir) Receives the US FDA’s Approval for HIV in Patients with Limited Treatment Options

Published: Jul 03, 2020 | Tags: Approval, FDA, Fostemsavir, HIV, Limited, Treatment, Options, Patients, Receives, Rukobia, US, Viiv Healthcare

3. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Published: Jul 03, 2020 | Tags: COVID-19, Fails, Kevzara, P-III, Patients, Regeneron, Sanofi, Sarilumab, Study, US

4. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Published: Jul 03, 2020 | Tags: Zydus, Initiate, Clinical Trials, Evaluating, ZyCoV-D, Vaccine, Against, COVID-19, July 2020

5. Sarepta Signs an Exclusive Worldwide License with Hansa to Develop Imlifidase for Duchenne Muscular Dystrophy and Limb-Girdle Muscular Dystrophy

Published: Jul 03, 2020 | Tags: Sarepta, Signs, Exclusive, Worldwide, License, Hansa, Develop, Imlifidase, Duchenne Muscular Dystrophy, Limb-Girdle Muscular Dystrophy

6. Helsinn and MEI Terminate its P-III Study of Pracinostat for Patients with AML

Published: Jul 03, 2020 | Tags: Helsinn, MEI, Terminate, P-III, Study, Pracinostat, Patients, AML

7. Biogen Signs a License Agreement with Massachusetts Eye and Ear to Develop Treatment for Inherited Retinal Disorder

Published: Jul 02, 2020 | Tags: Biogen, Signs, License Agreement, Massachusetts Eye and Ear, Develop, Treatment, Inherited Retinal Disorder

8. Yuhan Collaborates with GI Innovation for its Allergy Treatment Worth up to $1.2B

Published: Jul 02, 2020 | Tags: Yuhan, Collaborates, GI Innovation, Allergy Treatment, Worth, $1.2B

9. Janssen Receives EC’s Approval for its Ebola Vaccine Dual Regimen

Published: Jul 02, 2020 | Tags: Janssen, Receives, EC, Approval, Ebola Vaccine, Dual Regimen

10. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Published: Jul 02, 2020 | Tags: Sorrento, Selects, T-VIVA-19, Targeted, Protein Vaccine Candidate, COVID-19

11. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan  

Published: Jul 02, 2020 | Tags: Dr. Reddy’s, GRA, Collaborate, Fujifilm, Avigan, Favipiravir, Treat, COVID-19, Outside, Japan

12. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Published: Jul 02, 2020 | Tags: Pfizer, BioNTech, Report, Results, BNT162b1, mRNA-Based Vaccine, P-I/II, Study, Against, COVID-19

13. QurAlis Signs a License Agreement with Eli Lilly for its ALS Therapeutic Candidates

Published: Jul 02, 2020 | Tags: QurAlis, Signs, License Agreement, Eli Lilly, ALS, Therapeutic Candidates   

14. Boston Scientific Receives the US FDA’s 510(k) Clearance for its LUX-Dx Insertable Cardiac Monitor System

Published: Jul 01, 2020 | Tags: Boston Scientific, Receives, US, FDA, 510(k) Clearance, LUX-Dx Insertable, Cardiac Monitor System

15. Merck KGaA and Pfizer’s Bavencio (avelumab) Receive the US FDA’s Approval as a 1L Treatment for Locally Advanced or Metastatic Urothelial Carcinoma

Published: Jul 01, 2020 | Tags: Merck KGaA, Pfizer, Bavencio, avelumab, Receives, US, FDA, Approval, 1L, Treatment, Locally Advanced, Metastatic Urothelial Carcinoma

16. Samsung Bioepis Reports the Initiation of P-III Study for SB15 Proposed Biosimilar to Eylea (aflibercept)

Published: Jul 01, 2020 | Tags: Aflibercept, Eylea, Initiation P-III, Proposed Biosimilar, Reports, Samsung Bioepis, Sb15, Study

17. G1 Therapeutics and Boehringer Ingelheim Collaborate to Co-Promote Trilaciclib for Small Cell Lung Cancer in the US and Puerto Rico

Published: Jul 01, 2020 | Tags: G1 Therapeutics, Boehringer Ingelheim, Collaborate, Co-Promote, Trilaciclib, Small Cell Lung Cancer, US, Puerto Rico

18. Takeda Collaborates with Carmine for Non-Viral Gene Therapies Worth Up to $900M

Published: Jul 01, 2020 | Tags: Takeda, Collaborates, Carmine, Non-Viral, Gene Therapies, $900M

19. Celltrion’s Remsima SC (biosimilar, infliximab) Receives CHMP’s Positive Opinion for an Additional Five Indications Including Inflammatory Bowel Disease and Ankylosing Spondylitis

Published: Jun 30, 2020 | Tags: Celltrion, Remsima SC, biosimilar, infliximab, Receives, CHMP, Positive Opinion, Additional, Five Indications, Inflammatory Bowel Disease, Ankylosing Spondylitis

20. Roche’s Phesgo (fixed-dose combination of Perjeta and Herceptin) Receives the US FDA’s Approval for Early and Metastatic Her2-Positive Breast Cancer

Published: Jun 30, 2020 | Tags: Roche, Phesgo, fixed-dose combination, Perjeta, Herceptin, Receives, US, FDA, Approval, Early, Metastatic, Her2-Positive Breast Cancer 

21. AstraZeneca and MSD’s Selumetinib Receive MHLW’s Orphan Drug Designation for Neurofibromatosis Type 1 in Japan  

Published: Jun 30, 2020 | Tags: AstraZeneca, MSD, Selumetinib, Receives, MHLW, Orphan Drug Designation, Neurofibromatosis Type 1, Japan

22. Bharat Biotech to Initiate Clinical Trials Evaluating Covaxin (India’s First COIVD-19 Vaccine) in July 2020

Published: Jun 30, 2020 | Tags: Bharat Biotech, Initiate, Clinical Trials, Evaluating, Covaxin, India, First, COIVD-19, Vaccine, July 2020

23. Abbott Integrates its CGM Technology with Tandem’s Insulin Delivery System for Improving Diabetes Management

Published: Jun 30, 2020 | Tags: Abbott, Integrate, CGM Technology, Tandem, Insulin Delivery System, Improving, Diabetes Management

24. Gilead Unveils the Price of Remdesivir as $390 per Vial in Developed Countries

Published: Jun 30, 2020 | Tags: Gilead, Unveils, Price, Remdesivir, $390, Vial, US, Developed Countries

25. Samsung Bioepis’ Aybintio (biosimilar, bevacizumab) Receives CHMP’s Positive Opinion to Treat Multiple Cancer Indications

Published: Jun 29, 2020 | Tags: Samsung Bioepis, Aybintio, biosimilar, bevacizumab, Receives, CHMP, Positive Opinion, Treat, Multiple, Cancer Indications

26. Kyowa Kirin’s FKB327 (biosimilar, adalimumab) Receives the MMA Approval in Japan

Published: Jun 29, 2020 | Tags: Kyowa Kirin, FKB32, biosimilar, adalimumab, Receives, the MMA, Approval, Japan

27. Roche’s Enspryng (satralizumab) Receives MHLW’s Approval for Neuromyelitis Optica Spectrum Disorder in Japan

Published: Jun 29, 2020 | Tags: Roche, Enspryng, satralizumab, Receives, MHLW, Approval, Neuromyelitis Optica Spectrum Disorder, Japan

28. Alexion’s Ultomiris (ravulizumab) Receives EC’s Approval for Atypical Hemolytic Uremic Syndrome

Published: Jun 29, 2020 | Tags: Alexion, Ultomiris, ravulizumab, Receives, EC, Approval, Atypical Hemolytic Uremic Syndrome

29. MHLW Approves Novartis’ Five New Therapies Expanding its Footprints in Japan

Published: Jun 29, 2020 | Tags: MHLW, Approves, Novartis, Five New, Therapies, Expanding, Footprints, Japan

30. Daiichi Sankyo in Talks with AstraZeneca for the Supply of AZD1222 to Combat COVID-19 in Japan

    Published: Jun 29, 2020 | Tags: Daiichi Sankyo, Talks, AstraZeneca, Supply, AZD1222, COVID-19,  Japan

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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