PharmaShots Weekly Snapshot (Sept 07 -11, 2020)

1. Janssen's Tremfya (guselkumab) Receives the US FDA's Approval as the First Selective IL-23 Inhibitor for Active Psoriatic Arthritis

Published: Sept 10, 2020 | Tags: Janssen, Tremfya, Guselkumab, Biologic, US FDA, Selective, IL-23 inhibitor, Active Psoriatic Arthritis, Severe Plaque Psoriasis, human mAb

2. Janssen Reports sBLA Submission to the US FDA for Darzalex Faspro (daratumumab and hyaluronidase-fihj) to Treat Patients with Light Chain (AL) Amyloidosis

Published: Sept 10, 2020 | Tags: Janssen, Reports, sBLA, Submission, US, FDA, Darzalex Faspro, daratumumab, hyaluronidase-fihj, Treat, Patients, Light Chain, (AL), Amyloidosis

3. Chugai and Takeda Collaborate to Evaluate the Combination Therapy for Multiple Tumor Types in Japan

Published: Sept 10, 2020 | Tags: Chugai, Takeda, Collaborate, Evaluate, Combination Therapy, Multiple Tumor Types, Japan

4. GSK and Innoviva's Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA's Approval for Asthma and COPD

Published: Sept 10, 2020 | Tags: GSK, Triple Therapy, Trelegy Ellipta, US FDA, Asthma, COPD, sNDA, Lung function, Acute Bronchospasm

5. Roche to Present New Data of Ocrevus (ocrelizumab) for Relapsing-Remitting Multiple Sclerosis at MSVirtual2020

Published: Sept 11, 2020 | Tags: Roche, Present, New Data, Ocrevus, (ocrelizumab), Relapsing-Remitting, Multiple Sclerosis, MSVirtual2020

6. Henlius Reports NMPA's Acceptance of NDA for HLX04 (biosimilar, bevacizumab)

Published: Sept 10, 2020 | Tags: Henlius , Reports, NMPA, Acceptance, NDA, HLX04, biosimilar, bevacizumab

7. Takeda Reports Results of Ninlaro (ixazomib) in a P-III Clinical Study for Newly Diagnosed Multiple Myeloma

Published: Sept 10, 2020 | Tags: Takeda, Reports, Results, Ninlaro, (ixazomib), P-III, Clinical Study, Newly Diagnosed, Multiple Myeloma

8. Jazz Collaborates with Redx Pharma to Develop Two Targeted Cancer Therapies

Published: Sept 09, 2020 | Tags: Jazz, Collaborates, Redx Pharma, Develop, Two, Targeted, Cancer Therapies

9. Genentech to Present New Data of Enspryng (satralizumab-mwge) for Neuromyelitis Optica Spectrum Disorder at MSVirtual2020

Published: Sept 10, 2020 | Tags: Genentech, Present, New Data, Enspryng, (satralizumab-mwge), for Neuromyelitis Optica Spectrum Disorder, MSVirtual2020

10. Pfizer and BioNTech to Supply 200M Doses of it COVID-19 Vaccine in the EU

Published: Sept 09, 2020 | Tags: Pfizer, BioNTech, Supply, 200M Doses, COVID-19 Vaccine, EU

11. AstraZeneca Reports Results of Fasenra (benralizumab) in P-III OSTRO Study for Chronic Rhinosinusitis with Nasal Polyps

Published: Sept 10, 2020 | Tags: AstraZeneca, Reports, Results, Fasenra, (benralizumab), P-III, OSTRO Study, Chronic Rhinosinusitis with Nasal Polyps

12. Bayer Collaborates with Recursion to Fortify Digital Drug Discovery for Fibrotic Diseases

Published: Sept 09, 2020 | Tags: Bayer, Collaborates, Recursion, Fortify, Digital Drug Discovery, Fibrotic Diseases

13. Sanofi to Present New Data of its Neurology Portfolio at MSVirtual2020

Published: Sept 10, 2020 | Tags: Sanofi, Present, New Data, Neurology Portfolio, MSVirtual2020

14. Regenxbio Reports First Patients Dosing in its P-II AAVIATE Study of RGX-314 for Wet AMD

Published: Sept 09, 2020 | Tags: Regenxbio, Reports, First Patients Dosing, P-II, AAVIATE Study, RGX-314, Wet AMD

15. Merck Reports Results of Gefapixant (45mg) in Two P-III Studies for the Treatment of Refractory or Unexplained Chronic Cough

Published: Sept 08, 2020 | Tags: Merck, Reports, Results, Gefapixant, (45mg), Two, P-III, Studies, Treatment, Refractory, or Unexplained, Chronic Cough

16. Theranica's Nerivio Wearable Device Receives CE Mark for Acute Treatment of Migraine in the Europe

Published: Sept 08, 2020 | Tags: Theranica, Nerivio, Wearable Device, CE mark, Acute Migraine, Chronic Migraine

17. Takeda Divests its Select Non-Core Assets in EU and Canada to Cheplapharm for $562M

Published: Sept 09, 2020 | Tags: Takeda, Divests, its Select Non-Core Assets, EU, Canada, Cheplapharm, $562M

18. Roche Expands its MS Portfolio with the Initiation of P-III Clinical Program of Fenebrutinib and Ocrevus (ocrelizumab)

Published: Sept 09, 2020 | Tags: Roche, Expands, MS Portfolio, Initiation, P-III, Clinical Program, Fenebrutinib, Ocrevus, (ocrelizumab)

19. Janssen's Imbruvica (ibrutinib) + Rituximab Receives the EC's Marketing Authorization for Previously Untreated Patients with Chronic Lymphocytic Leukemia

Published: Sept 08, 2020 | Tags: Janssen, Imbruvica, (ibrutinib), Receives, EC, Marketing Authorization, Approval, Chronic Lymphocytic Leukaemia

20. Silence Therapeutics Highlights its R&D Pipeline and Initiates Dose Escalation Studies for SLN360

Published: Sept 08, 2020 | Tags: Silence Therapeutics, Highlights, Pipeline Portfolio, Provides, Research, Development, Update

21. Roche's cobas BKV Test Receives the US FDA's 510 (k) Clearance to Improve Treatment for Transplant Patients

Published: Sept 08, 2020 | Tags: Roche, cobas BKV Test, Receives, US, FDA, 510 (k) Clearance, Transplant Patients

22. Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA TRAVERSE OLE Study for Asthma

Published: Sept 07, 2020 | Tags: Sanofi, Reports, Results, Dupixent, dupilumab, P-III, LIBERTY ASTHMA TRAVERSE OLE, Study, for Asthma

23. Mylan to Acquire Aspen's Thrombosis Business in the EU for ~ $758M

Published: Sept 07, 2020 | Tags: Mylan, Acquire, Aspen, Thrombosis Business, EU, $758M

24. Boehringer Ingelheim and Pharmaxis Halt the Development of BI 1467335 for Diabetic Retinopathy

Published: Sept 08, 2020 | Tags: Boehringer Ingelheim, Pharmaxis, Halt, Development, BI 1467335, Diabetic Retinopathy

26. Project ALS' Prosetin Receives the US FDA's Orphan Drug Designation for Amyotrophic Lateral Sclerosis

Published: Sept 06, 2020 | Tags: Project ALS, Prosetin, Receives, US, FDA, Orphan Drug Designation, Amyotrophic Lateral Sclerosis

27. Grifols to Acquire Remaining Stake of Alkahest for ~$146M

Published: Sept 06, 2020 | Tags: BMS, Acquire, Forbius, Adding, TGF-beta Inhibitor, Portfolio

28. AstraZeneca to Present Results of Breztri Aerosphere in P-III ETHOS Study at ERS International Congress 2020

Published: Sept 07, 2020 | Tags: AstraZeneca, Present, Results, Breztri Aerosphere, P-III, ETHOS Study, ERS, International Congress 2020

29.Genentech Gavreto (pralsetinib) Receives the US FDA's Approval Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer

Published: Sept 07, 2020 | Tags: Genentech, Gavreto, (pralsetinib), Receives, US, FDA, Approval, Metastatic, Rearranged, During, Transfection, Fusion-Positive, Non-Small Cell Lung Cancer, Adults

30. Kite Reports sBLA Submission to the US FDA for Yescarta (axicabtagene ciloleucel) in Relapsed or Refractory Indolent Non-Hodgkin Lymphomas

Published: Sept 06, 2020 | Tags: Kite, Reports, sBLA, Submission, US, FDA for Yescarta, axicabtagene ciloleucel, Relapsed, Refractory, Indolent Non-Hodgkin Lymphomas

31. Chi-Med Initiates P-III FRESCO-2 Study of Fruquintinib in Metastatic Colorectal Cancer

Published: Sept 06, 2020 | Tags: Chi-Med, Initiates, P-III, FRESCO-2 Study, Fruquintinib, Metastatic Colorectal Cancer