PharmaShots Weekly Snapshot (November 24 – 29, 2018)

  1. Novartis’ Gilenya (fingolimod) Receives EU’s Approval for Relapsing-Remitting Forms of Multiple Sclerosis (RRMS)

Published: 29 Nov, 2018 | Tags: Novartis, Gilenya, (fingolimod), Receives, EU, Approval, Relapsing-Remitting, Forms, Multiple Sclerosis (RRMS), 10 to <18 yrs, PARADIGMS study, P-III

  1. NTU Singapore & TTSH Develops AI based Smart Medical Device for Early Detection of Congestive Heart Failure

Published: 29 Nov, 2018 | Tags: NTU Singapore, TTSH, Develops, AI based, Medical Device, Early, Detection, Congestive Heart Failure

  1. Vertex’s Kalydeco (ivacaftor) Receives FDA’s Expanded Label Approval for Cystic Fibrosis (CF) Aged 12 to < 24 Months

Published: 29 Nov, 2018 | Tags: Vertex, Kalydeco, (ivacaftor), Receives, FDA’s, Expanded, Label, Approval , Cystic Fibrosis (CF), Aged 12 to < 24 Months

  1. Astellas’ Xospata (gilteritinib) Receives FDA ‘s Approval for 1L R/R Acute Myeloid Leukemia (AML) in Adults

Published: 29 Nov, 2018 | Tags: Astellas, Xospata, gilteritinib, Receives, FDA ‘s, Approval, Treatment, Relapsed/Refactory Acute Myeloid Leukemia, (AML), Adults

  1. ElectroCore’s gammaCore (nVNS) Receives FDA’s 510(k) Approval, a Novel Therapy for Cluster Headache in Adults

Published: 28 Nov, 2018 | Tags: ElectroCore, GammaCore (nVNS), Receives, FDA, 510(k), Approval, Cluster Headache, Adults


  1. Q BioMed Acquires Rights of Metastron from GE Healthcare

Published: 28 Nov, 2018 | Tags: Q BioMed, Acquires,Rights, Metastron, GE Healthcare

  1. Merck’s Delstrigo (doravirine / lamivudine / tenofovir disoproxil fumarate) & Pifeltro (doravirine) Receives EU’s Approval for the Treatment of HIV-1 Infection

Published: 28 Nov, 2018 | Tags: Merck, Delstrigo, (doravirine / lamivudine / tenofovir disoproxil fumarate), Pifeltro, (doravirine), Receives, EU, Approval, Treatment, HIV-1 Infection

  1. Genentech Acquires Jecure Therapeutics for its Preclinical Stage NLRP3 inhibitors

Published: 28 Nov, 2018 | Tags: Genentech, Acquires, Jecure Therapeutics, Preclinical Nlrp3 Inhibitors, Nash, Liver Fibrosis, Autoimmune, Inflammatory

  1. Mesa Biotech’s Accula RSV Test Receives FDA’s 510(K) Clearance and CLIA Waiver for Respiratory Infections

Published: 27 Nov, 2018 | Tags: Mesa Biotech, Accula RSV Test, Receives, FDA’s 510(K) Clearance, CLIA Waiver, Respiratory Infections


  1. Beigene Signs Exclusive License and Development Agreement with Zymeworks (ZW)

Published: 27 Nov, 2018 | Tags: Beigene, Signs, Exclusive, License, Development, Agreement, Zymeworks, ZW25, ZW49, Azymetric platform, Efect platforms

  1. Novo Nordisk Reports Improved Results of Oral Semaglutide in PIONEER 9 Study in Patients with Type-2 Diabetes (T2D)

Published: 27 Nov, 2018 | Tags: Novo, Reports, Improved, Results, Oral Semaglutide, PIONEER 9 Study, T2D, Victoza

  1. Loxo’s Vitrakvi (larotrectinib) Receives the US FDA Approval for the Treatment of Solid Tumors in Adults and Pediatric Patients

Published: 27 Nov, 2018 | Tags: Loxo, Vitrakvi, (larotrectinib), Receives, the US FDA, Approval, Treatment, Solid Tumors, Adults, Pediatric Patient

  1. Genentech’s ACTpen Receives FDA’s Approval for Actemra (tocilizumab) to Treat Rheumatoid Arthritis (RA), Giant Cell Arteritis (GCA) and Two Forms of Juvenile Arthritis

Published: 26 Nov, 2018 | Tags: Genentech, ACTpen, Receives, FDA’s, Approval, Actemra (tocilizumab), Treat, RA, Giant Cell Arteritis, Two Forms of Juvenile Arthritis

  1. Sandoz’s Ziextenzo (pegfilgrastim) Receives EU Approval for Reduction in Duration of Neutropenia

Published: 27 Nov, 2018 | Tags: Sandoz’s, Ziextenzo, (pegfilgrastim), Receives, EU, Approval, Reduction, Duration, Neutropenia, Eighth, Approval, Febrile Neutropenia

  1. RegenxBio and Rocket Signs Exclusive Worldwide License Agreement for NAV AAV9 Vector

Published: 26 Nov, 2018 | Tags: RegenxBio, Rocket, Signs, Exclusive, Worldwide, License, Agreement, NAV AAV9 Vector


  1. Bristol-Myers’ Opdivo and Yervoy Combination Couldn’t Meet OS as Maintenance Therapy in esSCLC Patients Post 1L Chemo

Published: 26 Nov, 2018 | Tags: Bristol-Myers, Reports, Unmet, Results, P-III Checkmate-451 Study, Patients, 1L, Extensive-Stage SCLC

  1. Novartis Receives EU Approval for Gene Therapy Luxturna (voretigene neparvovec) in Patients with Rare Inherited Retinal Disease

Published: 23 Nov, 2018 | Tags: Novartis, Receives, EU, Approval, One-Time Gene Therapy, Luxturna, Control group, Vision improvement, Retinal Disease

  1. Mundipharma Receives EU Approval for Pelmeg (Pegfilgrastim, Biosimilar)

Published: 23 Nov, 2018 | Tags: Mundipharma, Receives, EU approval, Pelmeg, Biosimilar, Neutropenia, Febrile neutropenia Cytotoxic CT, Malignancy, Neulasta, G-CSF, CHMP

  1. Indivior Receives Health Canada Approval for Sublocade (SC) (Buprenorphine Extended-Release) in Patients with Moderate to Severe Opioid Use Disorder (OUD)

Published: 23 Nov, 2018 | Tags: Indivior, Receives, Health Canada, Approval, Sublocade, Moderate to Severe, Opioid Use Disorder(OUD), Clinical Trials, Injection



Shiwani Sharma

Shiwani Sharma is a Senior Editor at PharmaShots. She has in-depth knowledge of lifesciences industry including pharma and biotech sectors. She also covers news in field of Digital Health, Medtech and regulatory approvals from the US FDA, EU, and other global regulatory bodies in the industry. Additionally, she also writes Whitepapers, analysis reports, blogs on pharma and biotech industry. She is graduate in Biotechnology. She can be contacted on

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