PharmaShots Weekly Snapshot (December 09-13, 2019)
Published: Dec 12, 2019 | Tags: Pfizer, Amsparity, biosimilar, adalimumab, Receives, CHMP, Positive Opinion, Inflammatory, Autoimmune Disorders
Published: Dec 13, 2019 | Tags: Janssen, Darzalex, daratumumab, Combination Regimen, Receives, CHMP, Positive Opinion, Transplant Eligible Patients, Newly Diagnosed Multiple Myeloma
Published: Dec 13, 2019 | Tags: ViiV Healthcare, Reports, Regulatory Submission, US, FDA, EMA, Dispersible Formulation, Tivicay, dolutegravir
?4. Pfizers Xeljanz XR (tofacitinib) Receives the US FDAs 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
Published: Dec 13, 2019 | Tags: Roche, Reports, Results, Triple Combination Regimen, P-III, IMspire150 Study, Previously Untreated, BRAF V600 Mutation-Positive Advanced Melanoma
7. ?? PerkinElmers Screening Kit Receives the FDAs 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
Published: Dec 12, 2019 | Tags: iTeos Therapeutics, Collaborates, Merck, Evaluate, EOS100850, Keytruda, pembrolizumab, Solid Tumors
9. Alvogen to Acquire Assertios Gralise (gabapentin) for $127.5M
Published: Dec 12, 2019 | Tags: Alvogen, Acquire, Assertio, Gralise, gabapentin, $127.5M
Published: Dec 05, 2019 | Tags: AstraZeneca, Imfinzi, durvalumab, Receives, NMPA, Approval, Unresectable, Stage III, Non-Small Cell Lung Cancer
Published: Dec 12, 2019 | Tags: AstraZeneca, Daiichi Sankyo, Report, Result, Trastuzumab Deruxtecan, P-II, DESTINY-Breast01, Study, HER2 Positive Metastatic Breast Cancer
Published: Dec 11, 2019 | Tags: Amgen, UCB, Evenity, romosozumab, Receive, EC, Approval, Treat, Severe, Osteoporosis, Postmenopausal Women, Fracture
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
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
Published: Dec 10, 2019 | Tags: Myovant Sciences, Reports, Results, Relugolix, P-III, HERO Study, Men, Advanced Prostate Cancer
19. ? Dermiras Lebrikizumab Receives the US FDAs Fast Track Designation to Treat Atopic Dermatitis
Published: Dec 10, 2019 | Tags: Eris Lifesciences, Acquires, Novartis, Zomelis, vildagliptin, India, $13M
Published: Dec 10, 2019 | Tags: AffaMed Therapeutics, AMT901, biosimilar, trastuzumab, Receives, NMPA, Approval, Initiate, P-III, Clinical Study, China
Published: Dec 10, 2019 | Tags: Vertex, Kalydeco, ivacaftor, Receives, EC, Approval, Infants,Cystic Fibrosis, CFTR, Gene Mutation, Aged, 6 to <12mos.
Published: Dec 11, 2019 | Tags: Roche, Reports, FDA, Acceptance, sBLA, Xolair, omalizumab, Treat, Nasal Polyps, Novartis
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
Published: Dec 10, 2019 | Tags: Engitix, Morphic, Collaborate, Detect, ECM-Related Targets, Fibrostenotic Inflammatory Bowel Disease
26. AbbVie to Deploy Adaptives 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
Published: Dec 09, 2019 | Tags: Merck, Collaborates, Seven and Eight BioPharmaceuticals, Evaluate, BDB001 + Keytruda (pembrolizumab), Advanced Solid Tumors
Published: Dec 09, 2019 | Tags: AbbVie, Signs, Exclusive, Agreement, Scripps Research, Develop, New Therapies, Targeting, Multiple Therapeutic Areas
Published: Dec 10, 2019 | Tags: Roche, Accu-Chek SugarView App, Receives, CE Mark Approval, Non-Insulin-Dependent, Type 2 Diabetes, Pre-Diabetes
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
Published: Dec 07, 2019 | Tags: AstraZeneca, Reports, Results, Calquence, acalabrutinib, P-III, ELEVATE TN, Study, Previously Untreated, Chronic Lymphocytic Leukemia
Published: Dec 06, 2019 | Tags: Amgen, Avsola, biosimilar, infliximab, Receives, US, FDA, Approval, Remicade
Published: Dec 09, 2019 | Tags: Boehringer Ingelheim, Collaborates, Healx, Identify, New Treatments, Rare Neurological Diseases
Published: Dec 08, 2019 | Tags: Dova Pharmaceutical, Reports, Results, Online Survey, Highlighting, Disease Burden, Impact, Immune Thrombocytopenia
36. Janssen to Acquire XBiotechs 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
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