PharmaShots Weekly Snapshot (Sept 21-25, 2020)

1. Philips Launches QuickClear Mechanical Thrombectomy System for Blood Clot Removal

Published: Sept 25,2020 | Tags: Philips, Launches, QuickClear Mechanical Thrombectomy System, Blood Clot Removal

2. BMS Reports Results of Opdivo (nivolumab) in P-III CheckMate -274 Study for Patients with High-Risk Muscle-Invasive Urothelial Carcinoma

Published: Sept 25,2020 | Tags: BMS, Reports, Results, Opdivo, (nivolumab), P-III, CheckMate -274 Study, Patients, High-Risk, Muscle-Invasive Urothelial Carcinoma

3. Medtronic Evaluates Insertable Cardiac Monitor to Identify Patients at High Risk of Worsening Heart Failure

Published: Sept 25,2020 | Tags: Evaluates, Heart Failure, High Risk, Identify, Insertable Cardiac Monitor, Medtronic, Worsening

4. Roche’s Polivy (polatuzumab vedotin) Receives Health Canada’s Approval For R/R Diffuse Large B Cell Lymphoma

Published: Sept 25, 2020 | Tags:  Polatuzumab vedotin, approval, Diffuse Large B Cell Lymphoma, Health Canada, Polivy, r/r, receives, Roche

5. Novavax Initiates P-III Study of its COVID-19 Vaccine in the UK

Published: Sept 25, 2020 | Tags:  COVID-19, Initiates, Novavax, P-III study, UK, vaccine

6. Accord Launches Zercepac (biosimilar, trastuzumab) in the UK

Published: Sept 25, 2020 | Tags:   Accord, Biosimilar, Launches, trastuzumab, UK, Zercepac

7. IDEAYA and Pfizer Expand CTC and Supply Agreement for Solid Tumors Harboring GNAQ or GNA11 Mutations

Published: Sept 24, 2020 | Tags: Collaboration, Expand, GNAQ, Harboring, IDEAYA, Pfizer, Solid Tumors Supply

8. Verona Initiates P-III ENHANCE Studies Evaluating Nebulized Ensifentrine for the Maintenance Treatment of COPD

Published: Sept 24, 2020 | Tags: Verona, Initiates, P-III, ENHANCE Studies, Evaluating, Nebulized Ensifentrine, Maintenance Treatment, COPD

9. Pear Therapeutics Reports the Availability of its Prescription Digital Therapeutics to Wellpath Community Care Centers

Published: Sept 24, 2020 | Tags:   Cognitive Behavioral Therapy, Opioid Use Disorder, Pear Therapeutics, Prescription Digital Therapeutics, RESET, reSET-O, Substance Use Disorder, Us FDA, Wellpath Community Care Centers  

10. Genentech and AC Immune’s Semorinemab Flounders in P-II TAURIEL Study for Early Alzheimer’s Disease

Published: Sept 24, 2020 | Tags:   Genentech, AC Immune, Semorinemab, Flounders, P-II, TAURIEL Study, Early Alzheimer’s Diseas

11. Novartis and Siemens Collaborate to Develop Blood Tests for Multiple Sclerosis

Published: Sept 24, 2020 | Tags: Blood Tests, Collaborate, Develop, Multiple Sclerosis, Novartis, Siemens

12. J&J Initiates Global P-III Clinical Study of its COVID-19 Vaccine

Published: Sept 24, 2020 | Tags: Ad26.COV2. S, Clinical Study, COVID-19, Global, Initiates, J&J, JNJ-78436735, P-III, vaccine

13. Pfizer Reports the US FDA’s Acceptance of Xalkori’s (crizotinib) sNDA for Pediatric Patients with R/R Systemic ALCL

Published: Sept 23, 2020 | Tags:  Biomarker-Driven Therapy, Metastatic NSCLC, Pediatric ALK-Positive Anaplastic Large Cell Lymphoma, Pfizer, Supplemental New Drug Application, Tyrosine Kinase Inhibitor, Us FDA, Xalkori

14. Sanofi’s Supemtek Receives CHMP’s Positive Opinion for Approval to Prevent Influenza

Published: Sept 23, 2020 | Tags:  Approval, CHMP, Influenza, Positive Opinion, Sanofi, Supemtek

15. Micreos Initiates P-I/IIa Study Evaluating XZ.700 as the World’s First Endolysin Therapy for Atopic Dermatitis

Published: Sept 23, 2020 | Tags: Atopic Dermatitis, Cutaneous T-cell Lymphoma, Diabetic Wound Infections, Dosing, Endolysin, Micreos, MRSA, S. aureus, XZ.700

16. BMS and bluebird bio Report the US FDA’s Acceptance of Idecabtagene Vicleucel’s BLA for Priority Review to Treat Multiple Myeloma

Published: Sept 23, 2020 | Tags:  Acceptance, BLA, Bluebird Bio, BMS, FDA, Idecabtagene Vicleucel, Multiple Myeloma, Priority Review, Report

17. Novartis to Initiate Pivotal Confirmatory Study of AVXS-101 Intrathecal Formulation in Older Patients with SMA

Published: Sept 23, 2020 | Tags:  Novartis, Initiate, Pivotal Confirmatory Study, AVXS-101, Intrathecal Formulation, Patients with SMA

18. UCB Reports the FDA’s and EMA’s Acceptance of BLA and MAA for Bimekizumab to Treat Moderate to Severe Plaque Psoriasis

Published: Sept 23, 2020 | Tags: Acceptance, EMA, Bimekizumab, BLA, FDA, MAA, Moderate, Plaque Psoriasis, UCB

19. BMS’ Inrebic (fedratinib) Receives Health Canada’s Approval for Patients with Myelofibrosis

Published: Sept 22, 2020 | Tags: Fedratinib, Approval, BMS, Health Canada, Inrebic, Myelofibrosis      

 20. Illumina to Acquire GRAIL for ~$8B

Published: Sept 22, 2020 | Tags: Acquire, GRAIL, Illumina, $8B

21. Alexion’s Ultomiris (ravulizumab) Receives the CHMP’s Positive Opinion for its New Advanced Formulation

Published: Sept 22, 2020 | Tags: Ravulizumab, Alexion, CHMP, New Advanced Formulation, Positive Opinion, Ultomiris

22. Genentech Collaborates with Scenic Biotech to Develop Novel Therapies Targeting Genetic Modifiers

Published: Sept 22, 2020 | Tags: Collaborates, Develop, Genentech, Genetic Modifiers, Novel Therapies, Scenic Biotech, Targeting

23. Novartis’ Kisqali (ribociclib) Receives Highest Score on the ESMO Magnitude of Clinical Benefit Scale

Published: Sept 22, 2020 | Tags: Novartis, Kisqali, (ribociclib), Receives, Highest Score, ESMO Magnitude of Clinical Benefit Scale, MONALEESA-7, MONALEESA-3, CDK 4/6 inhibitor

24. Lilly’s Olumiant (baricitinib) Receives CHMP’s Positive Opinion for Moderate to Severe Atopic Dermatitis

Published: Sept 21, 2020 | Tags: Baricitinib, Atopic Dermatitis, CHMP, Lilly, Moderate to Severe, Olumiant, Positive Opinion, Receives

25. Roche Presents New P-III Data of Tecentriq in Triple-Negative Breast Cancer at ESMO Virtual Congress 2020

 Published: Sept 21, 2020 | Tags: Roche, Presents, New, P-III, Data, Tecentriq, Triple-Negative Breast Cancer, ESMO Virtual Congress 2020

26. Bausch Health Acquires Option to Purchase Allegro’s Ophthalmology Assets

Published: Sept 21, 2020 | Tags: Acquires, Allegro, Bausch Health, Ophthalmology Assets, Option to Purchase

27. AstraZeneca and MSD’s Lynparza (Olaparib) Receives the CHMP’s Positive Opinion as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Sept 21, 2020 | Tags: Olaparib, Advanced Ovarian Cancer, AstraZeneca, CHMP’s Positive Opinion, HRD-Positive, Lynparza, Maintenance Treatment, MSD

28. Roche Acquires Inflazome for ~$450M

Published: Sept 21, 2020 | Tags: Roche, Acquire, Inflazome, $450M

29. Takeda Collaborates with Foundation Medicine for Lung Cancer CDx

Published: Sept 21, 2020 | Tags: Takeda, Collaborates, Foundation Medicine, Lung Cancer, CDx

30. AstraZeneca Reports the Results of Tagrisso (osimertinib) in P-III ADAURA Study for the Adjuvant Treatment of Patients Early-Stage EGFR-Mutated Lung Cancer

Published: Sept 21, 2020 | Tags: ADAURA Study, Adjuvant, AstraZeneca, Early-Stage, EGFR-Mutated, Lung Cancer, Osimertinib, P-III, Patients, Reports, Results, Tagrisso, Treatment