PharmaShots Weekly Snapshot (March 09-13, 2020)

1. I-Mab to Initiate the Development of TJM2 for Treating Cytokine Release Syndrome Associated with COVID-19

Published: Mar 13, 2020 | Tags: I-Mab, Initiate, Development, TJM2, Treating, Cytokine Release Syndrome, COVID-19

2. EMD Serono and Pfizer to Terminate P-III JAVELIN Head and Neck 100 Study Evaluating Bavencio + CRT for Squamous Cell Carcinoma of the Head and Neck

Published: Mar 13, 2020 | Tags: EMD Serono, Pfizer, Terminate, P-III, JAVELIN, Head and Neck 100, Study, Bavencio, CRT, Squamous Cell Carcinoma of the Head and Neck

3. Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) Receives the US FDA’s Fast Track Designation for Chronic Kidney Disease

Published: Mar 12, 2020 | Tags: Boehringer Ingelheim, Eli Lilly, Jardiance, empagliflozin, Receives, US, FDA, Fast Track Designation, Chronic Kidney Disease

4. AstraZeneca and MSD Report Results of Cediranib + Lynparza in P-III GY004 Study for Patients with Platinum-Sensitive Relapsed Ovarian Cancer

Published: Mar 12, 2020 | Tags: AstraZeneca, MSD, Reports, Results, Cediranib, Lynparza, P-III, GY004 Study, Platinum-Sensitive, Relapsed Ovarian Cancer

5. Roche’s cobas SARS-CoV-2 Test Receives the US FDA’s Emergency Use Authorization to Identify Corona Virus

Published: Mar 13, 2020 | Tags: Roche, cobas SARS-CoV-2 Test, Receives, US, FDA, Emergency Use Authorization, Identify, Corona Virus

6. AbCellera and Eli Lilly Collaborate to Co-develop Antibody Therapies Targeting COVID-19

Published: Mar 12, 2020 | Tags: AbCellera, Eli Lilly, Collaborate, Co-develop, Antibody Therapies, Targeting, COVID-19

7. Thermo Fisher Scientific Collaborates with Janssen to Co-Develop CDx for Multiple Cancer Indications

Published: Mar 12, 2020 | Tags: Thermo Fisher Scientific, Collaborates, Janssen, Co-Develop, CDx, Multiple, Cancer Indications

8. AbbVie’s Dual Regimen Receives EC’s Approval for Patients with Previously Untreated Chronic Lymphocytic Leukemia

Published: Mar 12, 2020 | Tags: AbbVie, Dual Regimen, Receives, EC, Approval, Patients, Previously Untreated, Chronic Lymphocytic Leukemia

9. Novavax and Serum Institute of India Collaborate to Develop and Commercialize Vaccines for Malaria

Published: Mar 11, 2020 | Tags: Novavax, Serum Institute of India, Collaborate, Develop, Commercialize Vaccines, Malaria

10. Teva’s Ajovy (fremanezumab) Receives NICE Positive Recommendation for Prevention of Migraine in Adults

Published: Mar 12, 2020 | Tags: Teva, Ajovy, fremanezumab, Receives, NICE Positive Recommendation, Prevention, Migraine, Adults

11. Henlius Reports the NMPA’s Acceptance of IND for HLX14 (biosimilar, denosumab)

Published: Mar 09, 2020 | Tags: Henlius, Reports, NMPA, Acceptance, IND, HLX14, biosimilar, denosumab

12. Vir Biotechnology Collaborates with NIH Vaccine Research Center to Advance the Development of mAbs Against Coronavirus

Published: Mar 11, 2020 | Tags: Vir Biotechnology, Collaborates, NIH Vaccine Research Center, Advance, Development, mAbs, Against Coronavirus

13. BMS’ Opdivo (nivolumab) + Yervoy (ipilimumab) Receive the US FDA’s Approval for Patients with Hepatocellular Carcinoma Prior Treated with Sorafenib

Published:  Mar 11, 2020 | Tags: BMS, Opdivo, nivolumab, Yervoy, ipilimumab, Receive, US, FDA, Approval, Patients, Hepatocellular Carcinoma

14. Takeda Reports Results of Ninlaro (ixazomib) in P-III TOURMALINE-MM2 Study for Transplant Ineligible Patients with Multiple Myeloma

Published: Mar 10, 2020 | Tags: Takeda, Reports, Results, Ninlaro, ixazomib, P-III, TOURMALINE-MM2, Study, Transplant Ineligible, Patients, Multiple Myeloma

15. Janssen’s JNJ-6372 Receives the US FDA’s Breakthrough Therapy Designation for Non-Small Cell Lung Cancer

Published: Mar 11, 2020 | Tags: Janssen, JNJ-6372, Receives, US, FDA, Breakthrough Therapy Designation, Non-Small Cell Lung Cancer

16. Bridge Biotherapeutics Signs an AI-Based Research Agreement with Atomwise to Expand its Pellino Inhibitor Portfolio

Published: Mar 11, 2020 | Tags: Bridge Biotherapeutics, Signs, AI-Based, Research Agreement, Atomwise, Expand, Pellino Inhibitor Portfolio

17. Roche’s CINtec PLUS Cytology Receives the US FDA’s Approval as the First Biomarker-Based Triage Test to Improve the Prevention of Cervical Cancer

Published: Mar 11, 2020 | Tags: Roche, CINtec PLUS Cytology, Receives, US, FDA, Approval, First, Biomarker-Based, Triage Test, Improve, Prevention, Cervical Cancer 

18. CEPI Expands its Investment in the Development of Vaccine Against COVID-19

Published: Mar 10, 2020 | Tags: CEPI, Expands, Investment, Development, Vaccine, Against, COVID-19

19. Bora Pharmaceuticals to Acquire GSK’s Facility in Canada

Published: Mar 09, 2020 | Tags:  Bora Pharmaceuticals, Acquire, GSK, Facility, Canada

20. Novo Nordisk’s Fiasp (insulin aspart injection) Receives Health Canada’s Approval for Children with Diabetes

Published: Mar 10, 2020 | Tags:  Novo Nordisk, Fiasp, insulin aspart injection, Receives, Health Canada, Approval, Children, Diabetes

21. Boehringer Ingelheim’s Ofev (nintedanib) as the First Treatment for Chronic Fibrosing ILDs with Progressive Phenotype

Published: Mar 09, 2020 | Tags: Boehringer Ingelheim, Ofev, nintedanib, First Treatment, Chronic Fibrosing ILDs, Progressive Phenotype

22. ViiV Healthcare Renews its 2015 Collaboration with UNC-Chapel Hill to Discover a Cure for HIV

Published: Mar 09, 2020 | Tags: ViiV Healthcare, Renews, 2015, Collaboration, UNC-Chapel Hill, Five Years

23. Celltrion Reports Submission of MAA to EMA for CT-P17 (biosimilar, adalimumab)

Published: Mar 10, 2020 | Tags: Celltrion, Reports, Submission, MAA, EMA, CT-P17, biosimilar, adalimumab

24. AbbVie Collaborates with Global Health Authorities to Investigate its Kaletra/Aluvia (lopinavir/ritonavir) Against COVID-19

Published: Mar 09, 2020 | Tags: AbbVie, Collaborates, Global Health Authorities, Investigate, Kaletra/Aluvia, lopinavir/ritonavir, Against, COVID-19

25. Biocon and Mylan Report the US FDA Acceptance of BLA for Proposed Biosimilar of Avastin (bevacizumab)

Published: Mar 09, 2020 | Tags: Biocon, Mylan, Report, US, FDA, Acceptance, BLA, Proposed Biosimilar, Avastin, bevacizumab

26. BMS Reports Results of Triple Regimen in P-III ELOQUENT-1 Study for Patients with Newly Diagnosed Untreated Multiple Myeloma

Published: Mar 09, 2020 | Tags: BMS, Reports, Results, Triple Regimen, P-III, ELOQUENT-1, Study, Patients, Newly Diagnosed, Untreated Multiple Myeloma

27. Zydus Signs a License Agreement with XOMA to Advance IL-2- Based Immuno-Oncology Therapy

Published: Mar 09, 2020 | Tags: Zydus, Signs, License Agreement, XOMA, Advance, IL-2-Based Immuno-Oncology Therapy

28. AbbVie’s Maviret (glecaprevir/pibrentasvir) Receives EC’s Marketing Authorization as Eight-Week Regimen for Treatment-Naïve Chronic HCV Patients with Genotype 3 and Compensated Cirrhosis

Published: Mar 06, 2020 | Tags: Abbvie, Maviret, glecaprevir/pibrentasvir, Receives, EC, Marketing Authorization, Eight-Week Regimen, Treatment-Naïve, Chronic HCV Patients, Genotype 3, Compensated Cirrhosis

29. Novartis’ Isturisa (osilodrostat) Receives the US FDA’s Approval for Cushing’s Disease

Published: Mar 06, 2020 | Tags: Novartis, Isturisa, osilodrostat, Receives, US, FDA, Approval, Cushing’s Disease

30. Tetra Therapeutics and Shionogi Expand their Existing 2018 Collaboration to Develop and Commercialize BPN14770

Published: Mar 09, 2020 | Tags: Tetra Therapeutics, Shionogi, Expand, Existing, 2018, Collaboration, Develop, Commercialize, BPN14770