PharmaShots Weekly Snapshot (Aug 17 -21 2020)

1. BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Published: Aug 20, 2020 | Tags:  BioMarin, Reports, NDA, Submission, US, FDA, Vosoritide, Children, Achondroplasia

2. Junshi and Impact to Establish Joint Venture for Senaparib (IMP4297) in China

Published: Aug 20, 2020 | Tags:  Junshi, Impact, Establish, Joint Venture, Senaparib, IMP4297, China

3. The US FDA Approves Kyprolis (carfilzomib) + Darzalex (daratumumab) + Dexamethasone in Two Dosing Regimens for R/R MM

Published: Aug 20, 2020 | Tags: US, FDA, Approves, Kyprolis, carfilzomib, Darzalex, (daratumumab), Dexamethasone, Two Dosing, Regimens, RRMM

4. AstraZeneca’s Imfinzi (durvalumab) Receives MHLW’s Approval for Extensive-Stage Small Cell Lung Cancer

Published: Aug 21, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, MHLW, Approval, Extensive-Stage, Small Cell lung Cancer

5.  Pfizer and BioNTech Plan for Regulatory Review of its COVID-19 Vaccine in October 2020

Published: Aug 20, 2020 | Tags: Pfizer, BioNTech, Regulatory Review, COVID-19, Vaccine,  October, 2020

6. Novartis’ Kesimpta (ofatumumab) Receives the US FDA’s Approval as the First Self-Administered Therapy for Relapsing Multiple Sclerosis 

Published: Aug 20, 2020 | Tags: Novartis, Kesimpta, (ofatumumab), Receives, US ,FDA, Approval, First, Self-Administered Therapy, Relapsing, Multiple Sclerosis

7. Evotec and Centogene Expand their Collaboration to Target Gaucher Disease

Published: Aug 20, 2020 | Tags: Evotec, Centogene, Expand, Collaboration, Target, Gaucher Disease

8. BioSymetrics Signs an Agreement with Janssen and Sema4 to Utilize AI for the Prediction of COVID-19

Published: Aug 19, 2020 | Tags: BioSymetrics, Signs, Agreement, Janssen, Sema4, Utilize AI, COVID-19

9. Precision BioSciences Receives the US FDA’s Fast Track Designation for PBCAR0191 to Treat Advanced B-cell Precursor Acute Lymphoblastic Leukemia

Published: Aug 19, 2020 | Tags:  Precision BioSciences, Receives, US, FDA, Fast Track Disease Designation, PBCAR0191, Treat, Advanced, B-cell Precursor Acute Lymphoblastic Leukemia

10. Qiagen Launches QIAseq SARS-CoV-2 Primer Panel for Tracking COVID-19 Mutations and Strains

Published: Aug 18, 2020 | Tags:  Qiagen, Launches, QIAseq SARS-CoV-2, Primer Panel, Tracking, COVID-19, Mutations, Strains

11. Sorrento Files IND for STI-1499 (COVI-GUARD) in Patients Hospitalized with COVID-19

Published: Aug 19, 2020 | Tags:  Sorrento, Files, IND, STI-1499, COVI-GUARD, Patients, Hospitalized, COVID-19

12. Fitbit Reports Results of its COVID-19 Study for Early Detection of Diseases

Published: Aug 19, 2020 | Tags: Fitbit, Report, Results, COVID-19, Study, Early, Detection, Diseases

13. Roche’s Tecentriq + Bevacizumab Receive Health Canada’s Approval as 1L Treatment for Unresectable or Metastatic Hepatocellular Carcinoma

Published: Aug 19, 2020 | Tags: Roche, Tecentriq, Bevacizumab, Receive, Health Canada, Approval, 1L, Treatment,  Unresectable,  Metastatic, Hepatocellular Carcinoma

14. The US FDA Rejects Gilead’s Filgotinib Due to Toxicity Issues   

Published: Aug 19, 2020 | Tags: The US, FDA, Rejects, Gilead, Filgotinib, Toxicity Issues

15. Johnson & Johnson to Acquire Momenta Pharmaceuticals for $6.5B

Published: Aug 19, 2020 | Tags: Johnson & Johnson, Acquire, Momenta Pharmaceuticals,  $6.5B

16. Sanofi’s Dupixent (dupilumab) Receives the Health Canada Approval for Severe Chronic Rhinosinusitis with Nasal Polyposis

Published: Aug 18, 2020 | Tags: Sanofi, Dupixent, dupilumab, Receives,  Health Canada, Approval,  Severe, Chronic Rhinosinusitis,  Nasal Polyposis

17. Novo Nordisk Collaborates with Evotec to Develop Therapies Targeting Chronic Kidney Disease 

Published: Aug 18, 2020 | Tags: Novo Nordisk, Collaborates, Evotec, Develop Therapies, Targeting, Chronic Kidney Disease

18. Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Published: Aug 19, 2020 | Tags: Regeneron, Collaborates, Roche, Improve, Global Supply, REGN-COV2, Against, COVID-19

19. Lilly and Innovent Report the Global Expansion of their Alliance for Tyvyt (sintilimab)

Published: Aug 18, 2020 | Tags: Lilly, Innovent, Report, Global Expansion, Alliance, Tyvyt, sintilimab

20. G1 Therapeutics Reports the US FDA Acceptance and Priority Review of NDA for Trilaciclib to Treat SCLC

Published: Aug 17, 2020 | Tags: G1 Therapeutics, Reports, US, FDA, Acceptance, Priority Review, NDA, Trilaciclib, SCLC

21.PTC Reports the EMA’s Acceptance of MAA for Evrysdi (risdiplam) to Treat SMA

Published: Aug 17, 2020 | Tags: PTC, Reports, EMA, Acceptance, MAA, Evrysdi, risdiplam, SMA

22. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B   

Published: Aug 17, 2020 | Tags: Gilead, Expand, Oncology Collaboration, Tango, $6.3B

23. AstraZeneca’s Imfinzi (durvalumab) Receives the US FDA’s Priority Review for Less Frequent Fixed-Dose Use in NSCLC and Bladder Cancer

Published: Aug 19, 2020 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, US, FDA, Priority Review, Less Frequent, Fixed-Dose Use, NSCLC, Bladder Cancer

24. AstraZeneca Collaborates with mAbxience to Produce COVID-19 Vaccine in Latin America

Published: Aug 17, 2020 | Tags: AstraZeneca, Collaborates, mAbxience, Produce, Covid-19, Vaccine, Latin America

26. Gilead Expands its Oncology Collaboration with Tango for ~$6.3B

Published: Aug 17, 2020 | Tags:  Gilead, Expand, Oncology Collaboration, Tango, Worth, ~$6.3B

27. Roche’s Enspryng (satralizumab-mwge) Receives the US FDA’s Approval for Neuromyelitis Optica Spectrum Disorder

Published: Aug 17, 2020 | Tags: Roche, Enspryng, (satralizumab-mwge), Receives,  US, FDA, Approval,  Neuromyelitis Optica Spectrum Disorder

28. Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Published: Aug 17, 2020 | Tags: Henlius, HLX02, Receives, NMPA, Approval, First, Trastuzumab, Biosimilar, China

29.Abeona Signs a License and Inventory Purchase Agreements with Taysha for ABO-202 to Treat CLN1 Disease (Infantile Batten disease)

Published: Aug 17, 2020 | Tags: Abeona Therapeutics, Signs, License, Inventory Purchase, Agreements, Taysha Gene Therapies, ABO-202, CLN1 Disease

30.BMS Signs an Exclusive Worldwide License Agreement with Dragonfly Therapeutics for DF6002

Published: Aug 17, 2020 | Tags:  BMS, Signs, Exclusive, Worldwide, License Agreement, Dragonfly Therapeutics, DF6002

31. Sanofi to Acquire Principia Biopharma for ~$3.68B

Published: Aug 17, 2020 | Tags: Sanofi, Acquire, Principia Biopharma, $3.68B