PharmaShots Weekly Snapshot (November 04-08, 2019)

1. Triumvira’s TAC01-CD19 Receives FDA’s Fast Track Designation for R/R Diffuse Large B-Cell Lymphoma

Published: Nov 07, 2019 | Tags: Triumvira, TAC01-CD19, Receives, FDA, Fast Track Designation, R/R, Diffuse Large B-Cell Lymphoma

2. Janssen Reports Submission of MAA to EMA for its Investigational Ebola Vaccine Regimen to Prevent Ebola Virus Disease

Published: Nov 07, 2019 | Tags: Janssen, Reports, Submission, MAA, EMA, Ebola Vaccine Regimen, Prevent, Ebola Virus Disease

3. Yuhan Pharmaceutical Collaborates with Cyclica to Enhance Drug Development Utilizing AI-Integrated Drug Discovery Platform

Published: Nov 07, 2019 | Tags: Yuhan Pharmaceutical, Collaborates, Cyclica, Enhance, Drug Development, Utilizing, AI-Integrated Drug Discovery Platform

4. Takeda Reports Results of Ninlaro (ixazomib) in P-III TOURMALINE-MM4 Study as 1L Treatment for Multiple Myeloma Patients Not Treated with Stem Cell Transplantation

Published: Nov 07, 2019 | Tags: Takeda, Reports, Results, Ninlaro, ixazomib, P-III, TOURMALINE-MM4 Study, 1L, Treatment, Multiple Myeloma, Stem Cell Transplantation 

5. Sierra Oncology Amends its Asset Purchase Agreement with Gilead for Momelotinib Signed in 2018

Published: Nov 07, 2019 | Tags: Sierra Oncology, Amends, Asset Purchase Agreement, Gilead, Momelotinib, Signed, 2018

6. AstraZeneca Reports Results of Roxadustat in P-III OLYMPUS and ROCKIES Studies for Chronic Kidney Disease Patients with Anaemia

Published: Nov 07, 2019 | Tags: AstraZeneca, Reports, Results, Roxadustat, P-III, OLYMPUS, ROCKIES, Studies, Chronic Kidney Disease, Anaemia

7.  Teva and Celltrion Reports the Availability of Truxima (biosimilar, Rituxan) in the US

Published: Nov 07, 2019 | Tags: Teva, Celltrion, Reports, Availability, Truxima, biosimilar, Rituxan, US

8. Bio Thera’s QLETLI (biosimilar, adalimumab) Receives NMPA’s Approval for Auto-Immune Diseases in China

Published:  Nov 07, 2019 | Tags: Bio Thera, QLETLI, biosimilar, adalimumab, Receives, NMPA, Approval, Auto-Immune Diseases, China

9. AstraZeneca to Invest $1B for the Transformation of Healthcare in China

Published: Nov 06, 2019 | Tags: AstraZeneca, Invest, $1B, Transformation, Healthcare, China

10.  STADA Signs an Exclusive Commercialization Agreement with Alvotech for Seven Biosimilars in Europe

Published: Nov 07, 2019 | Tags: STADA, Signs, Exclusive, Commercialization Agreement, Alvotech, Seven, Biosimilars, Europe

11.  Novo Nordisk Signs an Exclusive Worldwide License Agreement with UBE Industries for its UD-014

Published: Nov 07, 2019 | Tags: Novo Nordisk, Signs, Exclusive, Worldwide, License Agreement, UBE Industries, UD-014

12. Novartis Collaborates with Pliant Therapeutics to Develop Therapies for NASH and Fibrotic Diseases

Published: Oct 24, 2019 | Tags: Novartis, Collaborates, Pliant Therapeutics, Develop, Therapies, NASH, Fibrotic Diseases

13.  Promega Signs a Worldwide Agreement with Merck to Develop MSI Technology as CDx for Keytruda

Published: Nov 06, 2019 | Tags: Merck, Signs, Worldwide, Agreement, Promega, Develop, MSI Technology, CDx, Keytruda, pembrolizumab

14. Coherus Signs an Exclusive License Agreement with Bioeq for Biosimilar of Lucentis (ranibizumab) in the US

Published: Nov 06, 2019 | Tags: Coherus, Signs, Exclusive, License Agreement, Bioeq, Biosimilar, Lucentis, ranibizumab, US

15.  Biogen Signs an Exclusive Commercialization Agreement with Samsung Bioepis to Expand its Biosimilars Portfolio

Published: Nov 06, 2019 | Tags: Biogen, Signs, Commercialization Agreement, Samsung Bioepis, Expand, Biosimilars Portfolio

16.  Regeneron Signs a Research and Option to License Agreement with Vyriad for Oncolytic Virus-Based Therapies

Published: Nov 06, 2019 | Tags: Agreement, Oncolytic Virus-Based, Option To License, Regeneron, Research, Signs, Therapies, Vyriad

17. Eisai to Transfer Royalty Rights for Tazemetostat to Royalty Pharma Outside Japan

Published: Nov 06, 2019 | Tags: Eisai, Transfer, Royalty Rights, Royalty Pharma, Tazemetostat, Outside, Japan

18.  Evotec Collaborates with Vifor Pharma to Launch a Joint Venture to Discover and Develop Therapies for Nephrology

Published: Nov 06, 2019 | Tags: Evotec,  Collaborates, Vifor Pharma, Launch, Joint Venture, Discover, Develop, Therapies, Nephrology

19. Vela Diagnostics’ Sentosa SQ HIV-1 Genotyping Assay Receives the US FDA’s DE Novo Authorization for Detection of HIV-1 Genomic Drug Resistance Mutations (DRMs)

Published: Nov 05, 2019 | Tags: Vela Diagnostics, Sentosa SQ HIV-1 Genotyping Assay, Receives, US FDA, DE Novo Authorization, Detection, HIV-1 Genomic Drug Resistance Mutations, DRMs

20.  BioLineRx Reports Results of BL-8040 in Combination with Keytruda (pembrolizumab) in P-IIb Trial for Patients with Metastatic Pancreatic Cancer

Published: Nov 05, 2019 | Tags: BioLineRx, Reports, Results, BL-8040, Combination, Keytruda, pembrolizumab, P-IIb Trial, Patients, Metastatic Pancreatic Cancer

21.  Takeda Signs an Exclusive License and Research Agreement with MD Anderson for CAR NK Cell Therapies

Published: Nov 05, 2019 | Tags: Takeda, Signs, Exclusive, License, Research, Agreement, MD Anderson, CAR NK Cell, Therapies

22. BeiGene Signs an Exclusive Worldwide License Agreement with Seattle Genetics to Advance Preclinical Candidates Treating Cancer

Published: Nov 06, 2019 | Tags: BeiGene, Signs, Exclusive, Worldwide, License, Agreement, Seattle Genetics, Advance, Preclinical, Candidates, Treating, Cancer

23.  Stryker to Acquire Wright Medical for $5.4B

Published: Nov 04, 2019 | Tags: Stryker, Acquire, Wright Medical, $5.4B

24.  Henlius and Ascentage Pharma Collaborate to Evaluate the Combination Therapy for Chronic Lymphocytic Leukemia in China

Published: Nov 04, 2019 | Tags:  Henlius, Ascentage Pharma, Collaborate, Evaluate, Combination Therapy, Chronic Lymphocytic Leukemia, China

25.  Sanofi’s Fluzone High-Dose Quadrivalent (Influenza Vaccine) Receives the FDA’s Approval for Adults Aged≥ 65yrs.

Published: Nov 04, 2019 | Tags: Sanofi, Fluzone, High-Dose Quadrivalent, Influenza Vaccine, Receives, FDA, Approval, Adults, Aged≥ 65yrs.

26.  Takeda to Divest its Portfolio of Select OTC and Non-Core Assets to STADA for ~$660M

Published: Nov 05, 2019 | Tags: Takeda, Divest, Portfolio, Select OTC, Non-Core Assets, STADA, $660M

27.  Sandoz’s Ziextenzo (biosimilar, pegfilgrastim) Receives the US FDA’s Approval to Decrease the Incidence of Febrile Neutropenia

Published: Nov 05, 2019 | Tags: Sandoz, Ziextenzo, biosimilar, pegfilgrastim, Receives, US, FDA, Approval, Decrease, Incidence of Febrile Neutropenia

28. Boehringer Ingelheim and Lilly Restructure their Alliance to Emphasis Full Expertise and Investment on Jardiance

Published: Nov 04, 2019 | Tags: Boehringer Ingelheim, Lilly, Modernize, Alliance, Emphasis, Full, Expertise, Investment, Jardiance

29.  Halozyme to Discontinue its P-III HALO-301 Study of PEGPH20 for the Treatment of Metastatic Pancreatic Cancer

Published: Nov 04, 2019 | Tags: Halozyme, Discontinue, P-III, HALO-301 Study, PEGPH20, Treatment, Metastatic Pancreatic Cancer

30. Yas Holding to Acquire Stake in Alvotech and Signs an Exclusive Agreement for its Three Biosimilar Candidates

Published: Nov 04, 2019 | Tags: Yas Holding, Acquire, Stake, Alvotech, Signs, Exclusive, Partnership, Three, Biosimilar Candidates

31. Janssen Collaborates with Vifor Pharma to Co-commercialize Invokana (canagliflozin) for the Treatment of Diabetic Kidney Disease in the US

Published: Nov 04, 2019 | Tags: Janssen, Collaborates, Vifor Pharma, Co-commercialize, Invokana, canagliflozin, Treat, Diabetic Kidney Disease, US

32. Sanofi Reports Results of Toujeo (insulin glargine 300 Units/mL) in P-III EDITION JUNIOR Study in Children and Adolescents with Type 1 Diabetes

Published: Nov 04, 2019 | Tags: Sanofi, Reports, Positive Results, Toujeo, insulin glargine, 300 Units/mL, P-III, EDITION JUNIOR, Study, Children, Adolescents, Type 1 Diabetes

33. Google to Acquire Fitbit for ~$2.1B

Published: Nov 01, 2019 | Tags: Google, Acquire, Fitbit, ~2.1B