PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

October 2, 2020 Auto Bot AbbVie, Alnylam, BMS, Boston, CSL behring, Henlius, Janssen, Junshi, Moderna, Pfizer, Regeneron, Sanofi, Sarepta, Sobi, Weekly Snapshot 0

  1. Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi

2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Published: Oct 1, 2020 | Tags: COVID-19, Moderna, mRNA-1273, P-l study

3. Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Published: Oct 1, 2020 | Tags:  Alnylam, ILLUMINATE-B, Lumasiran, P-III study, Primary Hyperoxaluria Type 1, reports, results

4. Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Published: Oct 1, 2020 | Tags: Janssen, NDA, Pulmonary Arterial Hypertension, reports, selexipag, Submission, Treat, UPTRAVI, USFDA

5. Henlius Signs an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 1, 2020 | Tags: Accord Healthcare Inc., Develop and Commercialize, Exclusive License Agreement, Henlius, HLX02

6.  Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Published: Oct 1, 2020 | Tags: (DTaP-IPV), India, Launches, Preschoolers, Sanofi, Tetraxim

7. Abbott’s FreeStyle Libre 3 System Receives CE Mark in Europe

Published: Sept 30, 2020 | Tags: Abbott, CE Mark, Europe, FreeStyle Libre 3 System, receives

8. Medtronic to Acquire Avenu Medical

Published: Sept 30, 2020 | Tags: Acquire, Avenu Medical, Ellipsys Vascular Access system, endovascular solutions, Medtronic

9. BMS’s Reblozyl (luspatercept) Receives Health Canada Approval for Beta Thalassemia

Published: Sept 30, 2020 | Tags: Beta Thalassemia, BMS, Health Canada Approval, Luspatercept, Reblozyl

10. Junshi Reports Results of Dual Regimen in P-III Jupiter-02 Study as 1L Therapy for Nasopharyngeal Carcinoma

Published: Sept 30, 2020 | Tags: 1L Therapy, Dual Regimen, Junshi Biosciences, Jupiter-02 Study, Nasopharyngeal Carcinoma (NPC), P-lll

11. Galapagos Reports First Patients Dosing with GLPG3970 (Toledo Compound) for Psoriasis

Published: Sept 30, 2020 | Tags: First Patients Dosing, Galapagos, GLPG3970, LADYBUG study, ll CALOSOMA study, P-l/ll, Psoriasis, SEA TURTLE study

12. Regeneron’s REGN-COV2 Demonstrate Reduction in Viral Load and Improve Symptoms in Non-Hospitalized Patients with COVID-19

Published: Sept 30, 2020 | Tags: COVID-19, Demonstrate, Improve Symptoms, Non-Hospitalized, patients, Reduction, Regeneron, REGN-COV2, Viral Load

13. Boston Scientific Launches ACURATE neo2 Aortic Valve System in Europe

Published: Sept 29, 2020 | Tags: ACURATE neo2 Aortic Valve System, Boston Scientific Corporation, Europe, Launches

14. Inovio Reports FDA’s Partial Clinical Hold on P-II/III Trial of INO-4800 Against COVID-19

Published: Sept 29, 2020 | Tags: COVID-19, FDA’s, INO-4800, Inovio, P-ll/lll Study

15. CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

Published: Sept 29, 2020 | Tags: CSL behring, HAE, Haegarda, Hereditary Angioedema, Pediatric Patients, US FDA’s Approval

16. Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 29, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, approval, FDA, receives, tofacitinib, US, XELJANZ

17. AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and Fast Track Designation for Spinal Cord Injury

Published: Sept 29, 2020 | Tags: AbbVie, Elezanumab, FDA, FT, ODD, Spinal Cord Injury, US

18. Sarepta Reports Two-Year Follow Up Results of SRP-9001 for Duchenne Muscular Dystrophy

Published: Sept 29, 2020 | Tags: Duchenne Muscular Dystrophy, reports, results, Sarepta, SRP-9001, Two-Year Follow Up

19. Innovent Report Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020 | Tags: 1L Therapy, Byvasda, Hepatocellular Carcinoma (HCC), Innovent Biologics, Tyvyt

20. Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the Collaboration with Sosei Heptares

Published: Sept 28, 2020 | Tags: Candidate, Clinical Study, Collaboration, Emerges, Initiates, Pfizer, Sosei Heptares, Under

21. Roche Reports Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA

Published: Sept 28, 2020 | Tags: (risdiplam), Data, Evrysdi, Infants, reports, Roche, Two-Year, Type 1 SMA

22. GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as the First Treatment for Hypereosinophilic Syndrome

Published: Sept 28, 2020 | Tags: (mepolizumab), approval, FDA, GSK, Hypereosinophilic Syndrome, Nucala, receives, US

23. Chugai’s Tecentriq (atezolizumab) and Avastin (bevacizumab) Receive MHLW’s Approval as 1L Treatment for Unresectable Hepatocellular Carcinoma

Published: Sept 28, 2020 | Tags: (atezolizumab), (bevacizumab), 1L, approval, Avastin, Chugai, MHLW, Receive, Tecentriq, Treatment, Unresectable Hepatocellular Carcinoma

24. Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis in Japan

Published: Sept 28, 2020 | Tags: Filgotinib, Gilead, JAK1 Inhibitor, Jyseleca, MHLW Approval, Rheumatoid Arthritis, Structural Joint Damage

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