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Chronological Index of : Regulatory

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  • Lusduna regulatory update

    EMA's CHMP recommended approval of Lusduna from Merck to treat diabetes in patients ages =2. The product is a biosimilar of Lantus insulin glargine, a synthetic sustained-release subcutaneous insulin analog from Sanofi…

    Published on 11/21/2016
  • Midostaurin regulatory update

    FDA accepted and granted Priority Review to an NDA from Novartis for midostaurin to treat newly diagnosed FMS-like tyrosine kinase 3 (FLT3; CD135) mutation-positive acute myelogenous leukemia (AML) and advanced systemic…

    Published on 11/21/2016
  • Nimenrix regulatory update

    EMAs CHMP recommended expanding the label of Nimenrix from Pfizer for immunization against invasive meningococcal diseases caused by Neisseria meningitidis groups A, C, W-135 and Y to include patients ages =6 weeks. The…

    Published on 11/21/2016
  • Nyxoid regulatory update

    Mundipharma submitted an MAA to EMA for Nyxoid intranasal naloxone spray for the emergency reversal of opioid overdose. The company said data from an open-label crossover trial in 38 volunteers showed that single doses …

    Published on 11/21/2016
  • Oral solithromycin regulatory update

    FDAs Antimicrobial Drugs Advisory Committee (AMDAC) voted 7-6 that efficacy results of solithromycin from Cempra outweigh the risks for treatment of community-acquired bacterial pneumonia (CABP). The committee voted …

    Published on 11/21/2016
  • Parsabiv regulatory update

    The European Commission approved an MAA from Amgen for Parsabiv etelcalcetide to treat secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis. In August, FDA issued a complete response…

    Published on 11/21/2016
  • Ryanodex regulatory update

    Eagle began submission of a rolling NDA to FDA for Ryanodex dantrolene to treat exertional heat stroke. Eagle said the first part of the NDA includes data from an open-label, Saudi Arabian Phase II trial in which IV …

    Published on 11/21/2016
  • Stelara regulatory update

    The European Commission approved an expanded label for Stelara ustekinumab from Johnson & Johnsons Janssen Biotech Inc. unit to include treatment of moderately to severely active Crohns disease (CD). The drug is …

    Published on 11/21/2016
  • Subcutaneous rituximab regulatory update

    FDA accepted for review a BLA from Roches Genentech unit for subcutaneous Rituxan rituximab to treat multiple blood cancers. Roche declined to specify the indications. The PDUFA date is June 26, 2017. Biogen and …

    Published on 11/21/2016
  • Suliqua regulatory update

    EMA's CHMP recommended approval of Suliqua lixisenatide/insulin glargine from Sanofi to treat Type II diabetes. The pharma is seeking approval of the product to improve glycemic control in combination with metformin …

    Published on 11/21/2016
  • Trailblaze Pharos regulatory update

    Ignyta said it received CE Mark approval for its Trailblaze Pharos companion diagnostic to identify patients who have solid tumors with neurotrophic tyrosine kinase receptor 1 (TrkA; NTRK1), TrkB, TrkC, c-ros proto-…

    Published on 11/21/2016
  • Translarna regulatory update

    EMAs CHMP recommended renewal of the conditional marketing authorization for Translarna ataluren to treat nonsense mutation Duchenne muscular dystrophy (DMD) in ambulatory patients ages =5. CHMP said available data …

    Published on 11/21/2016
  • Tresiba regulatory update

    Novo Nordisk submitted a Type II variation application to EMA for Type I and II diabetes drug Tresiba insulin degludec to include data from the double-blind Phase IIIb SWITCH 1 and 2 trials. Data from SWITCH 1 in Type I…

    Published on 11/21/2016
  • Vemlidy regulatory update

    EMA's CHMP recommended approval of once-daily oral Vemlidy tenofovir alafenamide fumarate (TAF) from Gilead to treat chronic HBV infection in patients ages =12 with a body weight of =35 kg. The product is approved in …

    Published on 11/21/2016
  • Vimpat regulatory update

    EMAs CHMP recommended expanding the label of Vimpat lacosamide from UCB to include its use as monotherapy to treat partial-onset seizures in patients ages =16. The company expects a decision from the European Commission…

    Published on 11/21/2016
  • Vyndaqel regulatory update

    Brazil approved Vyndaqel tafamidis from Pfizer to treat early or intermediate-stage transthyretin (TTR) familial amyloid polyneuropathy (FAP). The small molecule that stabilizes the TTR protein and prevents its …

    Published on 11/21/2016
  • XaraColl regulatory update

    Innocoll submitted an NDA to FDA for XaraColl bupivacaine collagen-matrix implants to treat postsurgical pain. The NDA is based on data from the Phase III MATRIX-1 and MATRIX-2 trials (see BioCentury, May 30). XaraColl …

    Published on 11/21/2016
  • Adcetris regulatory update

    FDA granted breakthrough therapy designation to Adcetris brentuximab vedotin from Seattle Genetics to treat CD30-positive mycosis fungoides and primary cutaneous anaplastic large cell lymphoma (ALCL) in patients who …

    Published on 11/14/2016
  • DPP Zika IgM/IgG Assay regulatory update

    Brazil approved Chembios DPP Zika IgM/IgG Assay to diagnose Zika virus. The product is a point-of-care assay that uses Dual Path Platform (DPP) technology to detect Zika virus antibodies from a fingerstick sample. …

    Published on 11/14/2016
  • Enbrel regulatory update

    FDA approved an sBLA for Enbrel etanercept from Amgen to treat chronic moderate to severe plaque psoriasis in patients ages 4-17 who are candidates for systemic therapy or phototherapy. Enbrel is approved in adults for …

    Published on 11/14/2016
  • FDA regulatory update

    FDA approved labeling changes for all prescription testosterone products and anabolic androgenic steroids to warn of their risks associated with abuse and dependence. The labels will include information about serious …

    Published on 11/14/2016
  • Human anti-rabies IgG therapy regulatory update

    FDA accepted for review a BLA from Kamada for its human anti-rabies IgG therapy as post-exposure treatment of rabies infection. The PDUFA date is Aug. 29, 2017. Kedrion Group S.p.A. (Barga, Italy) has exclusive rights …

    Published on 11/14/2016
  • iDTECT Blood test regulatory update

    Business: DiagnosticPathoQuest received CE mark approval for its iDTECT Blood test to detect bacteria and viruses in blood from patients with suspected infections. The next-generation sequencing (NGS)-based metagenomics…

    Published on 11/14/2016
  • KTE-C19 regulatory update

    Kite said it plans to begin by year end the submission of a rolling BLA to FDA for KTE-C19 to treat non-Hodgkin's lymphoma (NHL). The company plans to complete the submission by the end of next quarter and launch the …

    Published on 11/14/2016
  • Myl-1401O regulatory update

    Mylan and Biocon said Mylan submitted a BLA to FDA for Myl-1401O, a biosimilar of Herceptin trastuzumab, to treat HER2-positive breast and gastric cancers. In August, EMA accepted for review an MAA for Myl-1401O (see …

    Published on 11/14/2016

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