PharmaShots Weekly Snapshot (December 03 – 07, 2018)

1.Genentech’s Tecentriq Receives FDA Approval a Combination Therapy, for mNon-Sq NSCLC with No EGFR or ALK Genomic Tumor Aberrations

Published: 6 Dec, 2018 | Tags: Genentech, Tecentriq, Receives, FDA, Approval, Combination Therapy, Treat, mNon-Sq, NSCLC, No EGFR, ALK, Genomic Tumor Aberrations

  1. Novartis Expands its Cell Therapy Collaboration with Intellia Therapeutics for CRISPR/Cas9-Based Therapy

Published: 6 Dec, 2018 | Tags: Novartis, Reports, Results, BYL719, (alpelisib), fulvestrant, P-III, SOLAR-1, HR+/HER2- Advanced Breast Cancer

  1. Biogen Exercises Exclusive Worldwide Option to Develop & Commercialize Ionis’s BIIB067 (IONIS-SOD1RX) for Amyotrophic Lateral Sclerosis (ALS)

Published: 6 Dec, 2018 | Tags: Biogen, Exercises, Option, Develop, Commercialize, Ionis, BIIB067, (IONIS-SOD1RX), Amyotrophic Lateral Sclerosis (ALS), SOD1 mutations

  1. Novartis Reports Results of BYL719 (alpelisib) + fulvestrant in P-III SOLAR-1 trial for HR+/HER2- Advanced Breast Cancer

Published: 6 Dec, 2018 | Tags: Novartis, Reports, Results, BYL719, (alpelisib), fulvestrant, P-III, SOLAR-1, HR+/HER2- Advanced Breast Cancer

  1. Subtle an AI based Medical Device SubtlePET Receives FDA’s 510(K) Clearance

Published: 6 Dec, 2018 | Tags: Subtle, AI, based, Medical Device, SubtlePET, Receives, FDA, 510(K) Clearance

  1. Roche Collaborates with Icagen for the Development of Drug Candidates for Neurological Disorders

Published: 5 Dec, 2018 | Tags: Roche, Collaborates, Icagen, Development, Drug, Candidates, Neurological Disorders

  1. Roche Reports Results of Kadcyla (trastuzumab emtansine) in P-III KATHERINE Study for HER2-positive Early Breast Cancer (eBC)

Published: 6 Dec, 2018 | Tags: Roche, Reports, Results, Kadcyla, (trastuzumab emtansine), Herceptin, (trastuzumab) P-III, KATHERINE Study, HER2-positive Early Breast Cancer (eBC)

8.NeuroPace Reports Positive Results of Next-Gen RNS System for Refractory Epilepsy in the US

Published: 5 Dec, 2018 | Tags: NeuroPace, Reports, Positive, Results, Next-Gen RNS System, Refractory, Epilepsy, the US

  1. Innovate and Massachusetts General Hospital Collaborates to Develop Larazotide for Alcoholic Liver Disease

Published: 5 Dec, 2018 | Tags: Innovate, Massachusetts General Hospital, Collaborates, Develop, Alcoholic Liver Diseases, Celiac Disease

  1. Domain Therapeutics Signs Research and License Agreement with Boehringer Ingelheim (BI) for G-Protein Coupled Receptors (GPCRs)

Published: 5 Dec, 2018 | Tags: Domain Therapeutics, Signs, Research, License, Agreement, Boehringer Ingelheim (BI) , G-Protein Coupled Receptors (GPCRs)

  1. Celltrion Reports Results of CT-P10 (rituximab, biosimilar) in P-III for Advance Follicular Lymphoma (AFL)

Published: 5 Dec, 2018 | Tags: Celltrion, Reports, Results, CT-P10, (rituximab, biosimilar), P-III, Advance Follicular Lymphoma, Rituxan

  1. Gilead’s Descovy (Emtricitabine, Tenofovir Alafenamide) Receives NMPA ‘s (CFDA) Approval for HIV-1 Infection

Published: 5 Dec, 2018 | Tags: Gilead, Descovy, (Emtricitabine, Tenofovir Alafenamide), Receives, NMPA, CFDA, Approval, HIV-1 Infection

13.Crown Laboratories Acquires Rights for GSK’s Five OTC Drugs

Published: 30 Nov, 2018 | Tags: Crown Laboratories, Acquires, Rights, GSK’s, Five, OTC Drugs

  1. Kite Reports Results of Yescarta (axicabtagene ciloleucel) in ZUMA-1 trial for Refractory Large B-Cell, Lymphoma, Presented at ASH 2018

Published: 2 Dec, 2018|Tags: Kite, Reports, Results, Yescarta, (axicabtagene ciloleucel), ZUMA-1, Refractory, Large B-Cell, Lymphoma

  1. Cilag Acquires Exclusive Worldwide Rights of Argenx’s Cusatuzumab (ARGX-110) for $1.6B

Published: 4 Dec, 2018|Tags: Cilag Acquired Exclusive Worldwide Rights of Argenx’s Cusatuzumab (ARGX-110) for $1.6B

  1. AbbVie Signs a Worldwide Non-Exclusive License Agreement for Humira’s (adalimumab) Patent Rights with Pfizer

Published: 4 Dec, 2018|Tags: AbbVie, Signs, Worldwide, Non-Exclusive, License, Agreement, Humira, (adalimumab), Patent, Rights, Pfizer

  1. GSK to Acquire Tesaro for its Zejula (niraparib) for $5.1B (£4.0 billion)

Published: 3 Dec, 2018|Tags: GSK, Acquire, Tesaro, Zejula, (niraparib), $5.1B,(£4.0 billion), Ovarian, Prostate, Lung

  1. Pfizer Reports Results of PF-05280586 (rituximab biosimilar) in REFLECTIONS B328-06 study for CD20-Positive Non-Hodgkin Lymphoma

Published: 3 Dec, 2018|Tags: Pfizer, Reports, Results, PF-05280586, (rituximab biosimilar), REFLECTIONS B328-06 study, CD20-Positive Non-Hodgkin Lymphoma

  1. Bluebird Bio and Celgene Reports Results of bb21217 in P-I (CRB-402) study for 3L+ r/r Multiple Myeloma

Published: 3 Dec, 2018|Tags: Bluebird Bio, Celgene, Reports, Results, bb21217, P-I, (CRB-402), 3L+, r/r, Multiple Myeloma

  1. Shire’s Takhzyro IV (lanadelumab) Receives EU’s Approval for Hereditary Angioedema

Published: 3 Dec, 2018 | Tags: Shire, Takhzyro, IV, (lanadelumab), Receives, EU, Approval, Hereditary Angioedema