PharmaShots Weekly Snapshot (December 09-13, 2019)

1.  Pfizer’s Amsparity (biosimilar, adalimumab) Receives CHMP’s Positive Opinion for Inflammatory and Autoimmune Disorders

Published: Dec 12, 2019 | Tags: Pfizer, Amsparity, biosimilar, adalimumab, Receives, CHMP, Positive Opinion, Inflammatory, Autoimmune Disorders

2.  Janssen’s Darzalex (daratumumab) Combination Regimen Receives CHMP’s Positive Opinion for Transplant Eligible Patients with Newly Diagnosed Multiple Myeloma

Published: Dec 13, 2019 | Tags: Janssen, Darzalex, daratumumab, Combination Regimen, Receives, CHMP, Positive Opinion, Transplant Eligible Patients, Newly Diagnosed Multiple Myeloma

3.  ViiV Healthcare Reports Regulatory Submission to the US FDA and EMA for Dispersible Formulation of Tivicay (dolutegravir)

Published: Dec 13, 2019 | Tags: ViiV Healthcare, Reports, Regulatory Submission, US, FDA, EMA, Dispersible Formulation, Tivicay, dolutegravir

4. Pfizer’s Xeljanz XR (tofacitinib) Receives the US FDA’s Approval for Ulcerative Colitis

Published: Dec 12, 2019 | Tags: Pfizer, Xeljanz XR, tofacitinib, Receives, US, FDA, Approval, Ulcerative Colitis

5.  Equillium Expands its Exclusive Licensing Agreement with Biocon for Itolizumab

Published: Dec 12, 2019 | Tags: Equillium, Expands, Exclusive, Licensing Agreement, Biocon, Itolizumab

6.  Roche Reports Results of Triple Combination Regimen in P-III IMspire150 Study for Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma

Published: Dec 13, 2019 | Tags: Roche, Reports, Results, Triple Combination Regimen, P-III, IMspire150 Study, Previously Untreated, BRAF V600 Mutation-Positive Advanced Melanoma

7.  PerkinElmer’s Screening Kit Receives the FDA’s Approval as the First Test to Aid in Newborn Screening for Duchenne Muscular Dystrophy

Published: Dec 12, 2019 | Tags: PerkinElmer, FDA, Approval, First Test, Aid, Newborn Screening, Duchenne Muscular Dystrophy

8. iTeos Therapeutics Collaborates with Merck to Evaluate EOS100850 + Keytruda (pembrolizumab) for Solid Tumors

Published:  Dec 12, 2019 | Tags: iTeos Therapeutics, Collaborates, Merck, Evaluate, EOS100850, Keytruda, pembrolizumab, Solid Tumors

9. Alvogen to Acquire Assertio’s Gralise (gabapentin) for $127.5M

Published: Dec 12, 2019 | Tags: Alvogen, Acquire, Assertio, Gralise, gabapentin, $127.5M

10. AstraZeneca’s Imfinzi (durvalumab) Receives NMPA’s Approval for Unresectable Stage III Non-Small Cell Lung Cancer

Published: Dec 05, 2019 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, NMPA, Approval, Unresectable, Stage III, Non-Small Cell Lung Cancer

11. AstraZeneca and Daiichi Sankyo Report Result of Trastuzumab Deruxtecan in P-II DESTINY-Breast01 Study for HER2 Positive Metastatic Breast Cancer

Published: Dec 12, 2019 | Tags: AstraZeneca, Daiichi Sankyo, Report, Result, Trastuzumab Deruxtecan, P-II, DESTINY-Breast01, Study, HER2 Positive Metastatic Breast Cancer

12. Amgen and UCB’s Evenity (romosozumab) Receive EC’s Approval to Treat Severe Osteoporosis in Postmenopausal Women at High Risk of Fracture

Published: Dec 11, 2019 | Tags: Amgen, UCB, Evenity, romosozumab, Receive, EC, Approval, Treat, Severe, Osteoporosis, Postmenopausal Women, Fracture

13. Roche Reports Results of Fixed-Dose SC Combination of Perjeta (pertuzumab) and Herceptin (trastuzumab) in P-III FeDeriCa Study for HER2-Positive Breast Cancer

Published: Dec 12, 2019 | Tags: Roche, Reports, Results, Fixed-Dose, SC, Perjeta, pertuzumab, Herceptin, trastuzumab, P-III, FeDeriCa Study, HER2-Positive Breast Cancer

14. Almirall to Accelerate Drug Discovery Process Utilizing Iktos’ AI Technology

Published: Dec 12, 2019 | Tags: Almirall, Deploy, Iktos, AI, Technology, Accelerate, Drug Discovery

15. Novartis Signs Worldwide License Agreement with Forendo Pharma to Discover Therapies Targeting Chronic Liver Diseases

 Published: Dec 11, 2019 | Tags: Novartis, Signs, WW, License Agreement, Forendo Pharma, Discover, Therapies, Targeting, Chronic Liver Diseases

16. Kite Reports Submission of BLA to the US FDA for its Second CAR T Cell Therapy

Published: Dec 11, 2019 | Tags:  Kite, Reports, Submission, BLA, US, FDA, Second, CAR T Cell Therapy

17.  Kite and Kiniksa Collaborate to Evaluate the Combination of Yescarta (axicabtagene ciloleucel) and Mavrilimumab for R/R Large B-Cell Lymphoma

Published: Dec 11, 2019 | Tags: Kite, Kiniksa, Collaborate, Evaluate, Combination, Yescarta, axicabtagene ciloleucel, Mavrilimumab, R/R Large B-Cell Lymphoma

18. Amgen Reports Results of KYPROLIS (carfilzomib) and DARZALEX (daratumumab) in P-III CANDOR study for Patients with Relapsed or Refractory Multiple Myeloma

Published: Dec 10, 2019 | Tags: Myovant Sciences, Reports, Results, Relugolix, P-III, HERO Study, Men, Advanced Prostate Cancer

19.  Dermira‘s Lebrikizumab Receives the US FDA’s Fast Track Designation to Treat Atopic Dermatitis

Published: Dec 10, 2019 | Tags: Eris Lifesciences, Acquires, Novartis, Zomelis, vildagliptin, India, $13M

20. AffaMed Therapeutics’ AMT901 (biosimilar, trastuzumab) Receives NMPA’s Approval to Initiate P-III Clinical Study in China

Published: Dec 10, 2019 | Tags: AffaMed Therapeutics, AMT901, biosimilar, trastuzumab, Receives, NMPA, Approval, Initiate, P-III, Clinical Study, China

21. Vertex’s Kalydeco (ivacaftor) Receives EC’s Approval for Infants with Cystic Fibrosis with CFTR Gene Mutation Aged 6 to <12mos.

Published: Dec 10, 2019 | Tags: Vertex, Kalydeco, ivacaftor, Receives, EC, Approval, Infants,Cystic Fibrosis, CFTR, Gene Mutation, Aged, 6 to <12mos.

22.  Roche and Novartis Report the US FDA’s Acceptance of sBLA for Xolair (omalizumab) to Treat Nasal Polyps

Published: Dec 11, 2019 | Tags: Roche, Reports, FDA, Acceptance, sBLA, Xolair, omalizumab, Treat, Nasal Polyps, Novartis

23.  Sanofi and Regeneron to Restructure its Collaboration for Kevzara (sarilumab) and Praluent (alirocumab)

Published: Dec 11, 2019 | Tags: Sanofi, Regeneron, Restructure, Collaboration, Kevzara, sarilumab, Praluent, alirocumab

24.  Sanofi Divulges its Strategic Framework to Drive Innovation and Growth

Published: Dec 10, 2019 | Tags:  Sanofi, Divulges, Strategic Framework, Drive, Innovation, Growth

25.  Engitix and Morphic Collaborate to Detect ECM-Related Targets in Fibrostenotic Inflammatory Bowel Disease

Published: Dec 10, 2019 | Tags: Engitix, Morphic, Collaborate, Detect, ECM-Related Targets, Fibrostenotic Inflammatory Bowel Disease

26. AbbVie to Deploy Adaptive’s clonoSEQ Assay to Assess MRD Status Across Multiple Myeloma Studies

Published: Dec 09, 2019 | Tags: AbbVie, Adaptive, clonoSEQ Assay, Assess, MRD Status, Multiple Myeloma Studies

27.  Merck Collaborates with Seven and Eight BioPharmaceuticals to Evaluate the BDB001 + Keytruda (pembrolizumab) for Advanced Solid Tumors

Published: Dec 09, 2019 | Tags: Merck, Collaborates, Seven and Eight BioPharmaceuticals, Evaluate, BDB001 + Keytruda (pembrolizumab), Advanced Solid Tumors

28. AbbVie Signs an Exclusive Agreement with Scripps Research to Develop New Therapies Targeting Multiple Therapeutic Areas

Published: Dec 09, 2019 | Tags: AbbVie, Signs, Exclusive, Agreement, Scripps Research, Develop, New Therapies, Targeting, Multiple Therapeutic Areas

29.  Roche’s Accu-Chek SugarView App Receives CE Mark Approval for Non-Insulin-Dependent Patients with Type 2 Diabetes or Pre-Diabetes

Published: Dec 10, 2019 | Tags: Roche, Accu-Chek SugarView App, Receives, CE Mark Approval, Non-Insulin-Dependent, Type 2 Diabetes, Pre-Diabetes

30. AstraZeneca Collaborates with DeepMatter for Optimization of Compound Synthesis Leveraging AI and Machine Learning

Published: Dec 09, 2019 | Tags: AstraZeneca, Collaborates, DeepMatter, Optimization, Compound Synthesis, Leveraging, AI, Machine Learning

31. Merck to Acquire ArQule for $2.7B

Published: Dec 09, 2019 | Tags: Merck, Acquire, ArQule, $2.7B, ARQ 531

32. AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III ELEVATE TN Study for Previously Untreated Chronic Lymphocytic Leukemia

Published: Dec 07, 2019 | Tags: AstraZeneca, Reports, Results, Calquence, acalabrutinib, P-III, ELEVATE TN, Study, Previously Untreated, Chronic Lymphocytic Leukemia

33. Amgen’s Avsola (biosimilar, infliximab) Receives the US FDA’s Approval for the Same Indications as Remicade (infliximab)

Published: Dec 06, 2019 | Tags: Amgen, Avsola, biosimilar, infliximab, Receives, US, FDA, Approval, Remicade

34. Boehringer Ingelheim Collaborates with Healx to Identify New Treatments for Rare Neurological Diseases

Published: Dec 09, 2019 | Tags: Boehringer Ingelheim, Collaborates, Healx, Identify, New Treatments, Rare Neurological Diseases

35. Sobi’s Dova Pharmaceutical Reports Results of an Online Survey Highlighting Disease Burden and Impact for Patients with Immune Thrombocytopenia

Published: Dec 08, 2019 | Tags: Dova Pharmaceutical, Reports, Results, Online Survey, Highlighting, Disease Burden, Impact, Immune Thrombocytopenia

36. Janssen to Acquire XBiotech’s Bermekimab for $750M

Published: Dec 07, 2019 | Tags: Janssen, Acquire, XBiotech, Bermekimab, $750M

37. Sanofi to Acquire Synthorx for $2.5B

Published: Dec 09, 2019 | Tags: Sanofi, Acquire, Synthorx, $2.5B, THOR-707, Expanded Genetic Alphabet Platform, Immuno-Oncology