PharmaShots Weekly Snapshot (January 13-17, 2020)

1. Arena’s APD418 Receives FDA’s Fast Track Designation to Treat Patients with Decompensated Heart Failure

Published: Jan 17, 2020 | Tags: Arena, APD418, Receives, FDA, Fast Track Designation, Treat, Patients, Decompensated Heart

2. Charles River Collaborates with Fios Genomics for Bioinformatics-Driven Drug Discovery and Safety Assessment

Published: Jan 16, 2020 | Tags: Charles River, Collaborates, Fios Genomics, Bioinformatics-Driven, Drug Discovery, Safety Assessment

3. Launches Digital Wound Management Solution to Treat Chronic Wounds

Published: Jan 15, 2020 | Tags:, Launches, Digital Wound Management Solution, Evaluate, Chronic Wounds

4.  Just – Evotec Signs a Development and Manufacturing Agreement with OncoResponse for OR2805

Published: Jan 16, 2020 | Tags: Just – Evotec, Signs, Development, Manufacturing, Agreement, OncoResponse, OR2805

5. Novo Nordisk’s Ozempic (semaglutide) Receives the US FDA’s Approval for Reduction in MACE in Patients with Type 2 Diabetes

Published: Jan 16, 2020 | Tags: Novo Nordisk, Ozempic, semaglutide, Receives, US, FDA, Approval, Reduction, MACE, Patients, Type 2 Diabetes

6.  BioNTech To Acquire Neon to Bolster its Immunotherapy Pipeline

Published: Jan 16, 2020 | Tags: BioNTech, Acquire, Neon, Bolster, Immunotherapy Pipeline

7. Sun Pharma Signs a License Agreement with Rockwell Medical for Triferic in India

 Published:  Jan 15, 2020 | Tags: Sun Pharma, Signs, License Agreement, Rockwell Medical, Triferic, India 

8. BMS Reports the US FDA Acceptance of sBLA for Opdivo (nivolumab) + Yervoy (ipilimumab) as 1L Treatment for Non-Small Cell Lung Cancer

Published: Jan 15, 2020 | Tags: BMS, Reports, US, FDA, Acceptance, sBLA, Opdivo, nivolumab, Yervoy, ipilimumab, 1L, Treatment, Non-Small Cell Lung Cancer

9.  UCB’s Cimzia (certolizumab pegol) Receives Health Canada Approval for Non-Radiographic Axial Spondyloarthritis

Published: Jan 15, 2020 | Tags: UCB, Cimzia, certolizumab pegol, Receives, Health Canada Approval, Non-Radiographic Axial Spondyloarthritis

10.  Wuxi Biologic to Acquire Bayer’s Production Facility in Germany

Published: Jan 16, 2020 | Tags: Wuxi Biologic, Acquire, Bayer, Production Facility, Germany

11.  Livongo to Integrate Dexcom’s G6 CGM System into its Applied Health Signals Platform

Published: Jan 13, 2020 | Tags: Livongo, Integrate, Dexcom, G6 CGM System, Applied, Health Signals Platform

12. JT Signs an Exclusive License Agreement with Dermavant to Develop and Commercialize Tapinarof in Japan

Published: Jan 15, 2020 | Tags: JT, Signs, Exclusive, License Agreement, Dermavant, Develop, Commercialize, Tapinarof, Japan

13. Galapagos Signs an Exclusive Option to License Agreement with Fibrocor to Expand their Existing 2019 Partnership for Fibrosis

Published: Jan 15, 2020 | Tags: Galapagos, Expands, Existing, 2019, Collaboration, Fibrocor, Fibrosis

14. BioLineRx’s Motixafortide (BL-8040) Receives EC’s ODD to Treat Pancreatic Cancer in Europe

Published: Jan 14, 2020 | Tags: BioLineRx, Motixafortide, BL-8040, Receives, EC, ODD, Treat, Pancreatic Cancer, Europe

15. Kymera Signs a DNA-Encoded Library Based Drug Discovery Research Agreement with HitGen

Published: Jan 15, 2020 | Tags:  Kymera, Signs, DNA-Encoded Library, Drug Discovery, Research Agreement, HitGen

16.  Alexion to Initiate P-III CHAMPION-ALS Study Evaluating Ultomiris (ravulizumab) in Amyotrophic Lateral Sclerosis

Published: Jan 14, 2020 | Tags: Alexion, Initiate, P-III, CHAMPION-ALS, Study, Evaluating, Ultomiris, ravulizumab, Amyotrophic Lateral Sclerosis

17. JAMP Signs an Agreement with Alvotech to Commercialize Five Biosimilars in Canada

Published: Jan 14, 2020 | Tags: JAMP, Signs, Agreement, Alvotech, Commercialize, Five Biosimilars, Canada

18.  Insilico Collaborates with Pfizer to Explore Novel Data and AI System for Target Discovery

Published: Jan 14, 2020 | Tags: Insilico, Collaborates, Pfizer, Explore, Novel Data, AI System, Target Discovery

19.  ViiV Healthcare’s Dovato (dolutegravir/lamivudine) Receives MHLW’s Approval to Treat HIV 1 Infection

Published: Jan 15, 2020 | Tags: ViiV Healthcare, Dovato, dolutegravir/lamivudine, Receives, MHLW, Approval, HIV 1 Infection

20. Astellas’ Xospata (gilteritinib) Receives Health Canada Approval for Relapsed or Refractory Acute Myeloid Leukemia with a FLT3 Mutation

Published: Jan 14, 2020 | Tags: Astellas, Xospata, gilteritinib, Receives, Health Canada, Approval, Relapsed, Refractory, Acute Myeloid Leukemia, FLT3 Mutation

21. Genome & Company Signs a Clinical Trial Agreement with Merck KGaA and Pfizer to Evaluate the Combination Therapy

Published: Jan 13, 2020 | Tags: Genome & Company, Signs, Clinical Trial Agreement, Merck KGaA, Pfizer, Evaluate, Combination Therapy

22.  Takeda Collaborates with Charles River to Identify and Develop Preclinical Candidates

Published: Jan 13, 2020 | Tags: Takeda, Collaborates, Charles River, Identify, Develop, Preclinical Candidates

23. Bayer Signs an Exclusive Option to License Agreement with Dare Biosciences to Commercialize Ovaprene in the U

Published: Jan 13, 2020 | Tags:  Bayer, Dare Biosciences, Signs, Exclusive, Option to License, Agreement, Commercialize, Ovaprene, US

24.  Axsome In-Licenses Pfizer’s Reboxetine and Esreboxetine in the US

Published: Jan 13, 2020 | Tags: Axsome, In-Licenses, Pfizer, Reboxetine, Esreboxetine, US

25. Amgen Collaborates with Guardant Health and Qiagen to Expand Molecular Testing for Patients with Non-Small Cell Lung Cancer

Published: Jan 14, 2020 | Tags: Amgen, Collaborates, Guardant Health, Qiagen, Expand, Molecular Testing, Patients, Non-Small Cell Lung Cancer

26.  Astellas and Adaptimmune Signs Co-Exclusive Agreement for Universal Donor Cell Platform and Stem-Cell Derived Allogeneic CAR-T and TCR T-Cell Therapies

Published: Jan 14, 2020 | Tags: Astellas, Adaptimmune, Collaborate, Co-Develop, Co-Commercialize, Stem-Cell Derived Allogeneic, CAR-T, TCR, T-Cell Therapies

27. Roche Collaborates with Illumina to Expand the Adoption of NGS Based Testing in Oncology

Published: Jan 13, 2020 | Tags: Roche, Collaborates, Illumina, Broaden, Adoption, NGS Based Testing, Oncology

28. MSD Signs a Multiyear Agreement with Just – Evotec Biologics for Gaining Access to J.POD Facility

Published: Jan 14, 2020 | Tags: MSD, Signs, Multiyear Agreement, Just – Evotec Biologics, Gaining, Access, J.POD Facility

29. Coherus Signs a License Agreement with Innovent Biologics to Commercialize Biosimilar of Avastin (bevacizumab) in the US and Canada

Published: Jan 14, 2020 | Tags: Coherus, Signs, License Agreement, Innovent Biologics, Commercialize, Biosimilar, Avastin, bevacizumab, US, Canada

30. BeiGene Collaborates with EUSA Pharma to Develop and Commercialize Sylvant (siltuximab) and Qarziba (dinutuximab beta) in Greater China

Published: Jan 13, 2020 | Tags: BeiGene, Collaborates, EUSA Pharma, Develop, Commercialize, Sylvant, siltuximab, Qarziba, dinutuximab beta, Greater China

31. Biogen to Acquire Pfizer’s PF-05251749 to Bolster its Neurological Pipeline

Published: Jan 13, 2020 | Tags: Biogen, Acquire, Pfizer, PF-05251749, Bolster, Neurological Pipeline

32. Mundipharma Collaborates with Samsung Bioepis to Commercialize Multiple Biosimilar Candidates in Hong Kong and Taiwan

Published: Jan 12, 2020 | Tags: Mundipharma, Collaborates, Samsung Bioepis, Commercialize, Multiple, Biosimilar Candidates, Hong Kong, Taiwan

33. Roche Signs a Technology License Agreement with Amunix Pharmaceutical to Develop Non-Oncology Therapies

Published: Jan 10, 2020 | Tags: Roche, Signs, Technology, License Agreement, Amunix Pharmaceutical, Develop, Non-Oncology Therapeutics

34. Incyte Signs a Worldwide License Agreement with MorphoSys for Tafasitamab

Published: Jan 13, 2020 | Tags: Incyte, Signs, Worldwide, License Agreement, MorphoSys, Tafasitamab

35. AstraZeneca’s Lynparza (olaparib) + Bevacizumab Receive the US FDA’s Priority Review for 1L Treatment of Advanced Ovarian Cancers

Published: Jan 13, 2020 | Tags: AstraZeneca, Lynparza, olaparib, Bevacizumab, Receive, US, FDA, Priority Review, 1L, Treatment, Advanced Ovarian Cancers

36. Iovance Signs a License Agreement with Novartis to Develop and Commercialize IOV-3001

Published: Jan 12, 2020 | Tags: Iovance, Signs, License Agreement, Novartis, Develop, Commercialize, IOV-3001