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Chronological Index of : Regulatory

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  • Abilify Maintena regulatory update

    H. Lundbeck and Otsuka said FDA accepted for review an sNDA for once-monthly Abilify Maintena aripiprazole to treat bipolar I disorder. The PDUFA date is July 28, 2017. Abilify Maintena is approved to schizophrenia. It …

    Published on 12/5/2016
  • Actemra regulatory update

    Chugai submitted a regulatory application in Japan to expand the label of Actemra tocilizumab to include treatment of large vessel vasculitis. The humanized mAb against IL-6 is approved in Japan to treat Castleman's …

    Published on 12/5/2016
  • Avelumab regulatory update

    Merck and Pfizer said FDA accepted and granted Priority Review to a BLA for avelumab to treat metastatic Merkel cell carcinoma. The partners said the mAb against PD-L1 would be the first therapy approved in the U.S. to …

    Published on 12/5/2016
  • Biosimilar pegfilgrastim regulatory update

    EMA accepted for review an MAA from Coherus for CHS-1701, a biosimilar of neutropenia drug Neulasta pegfilgrastim. Amgen Inc. (NASDAQ:AMGN, Thousand Oaks, Calif.) markets Neulasta, a long-acting pegylated G-CSF. A BLA …

    Published on 12/5/2016
  • FluLaval Quadrivalent regulatory update

    FDA approved an sBLA from GlaxoSmithKline for FluLaval Quadrivalent influenza vaccine to prevent disease caused by influenza A subtype viruses and type B viruses in children ages 6-35 months. It is already approved in …

    Published on 12/5/2016
  • Guselkumab regulatory update

    Johnson & Johnson submitted an MAA to EMA for guselkumab to treat moderate to severe plaque psoriasis in adults. The submission includes data from the Phase III VOYAGE 1, VOYAGE 2 and NAVIGATE trials and the Phase …

    Published on 12/5/2016
  • Iclusig regulatory update

    FDA granted full approval to Iclusig ponatinib from Ariad to treat chronic, accelerated or blast phase chronic myelogenous leukemia (CML) or Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). In …

    Published on 12/5/2016
  • Ingrezza regulatory update

    FDA's Psychopharmacologic Drugs Advisory Committee will meet on Feb. 16, 2017, to discuss an NDA from Neurocrine for Ingrezza valbenazine to treat tardive dyskinesia. The NDA is under Priority Review with a PDUFA date …

    Published on 12/5/2016
  • ITCA 650 regulatory update

    Intarcia submitted an NDA to FDA for ITCA 650 to treat Type II diabetes. The submission triggered a $100 million milestone payment to Intarcia under a 2015 royalty deal (see BioCentury, June 8, 2015). ITCA 650 provides …

    Published on 12/5/2016
  • Keytruda regulatory update

    FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab from Merck to treat classical Hodgkins lymphoma (cHL) in patients who relapsed after =3 prior lines of therapy. The PDUFA date is March 15, …

    Published on 12/5/2016
  • Keytruda regulatory update

    Merck said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab to treat advanced microsatellite instability-high (MSI-H) cancer. Its PDUFA date is March 8, 2017. Merck is seeking accelerated …

    Published on 12/5/2016
  • Ninlaro regulatory update

    Takeda said the European Commission conditionally approved Ninlaro ixazomib in combination with Revlimid lenalidomide and dexamethasone to treat adults with multiple myeloma (MM) who received =1 prior therapy. FDA has …

    Published on 12/5/2016
  • Opdivo regulatory update

    The European Commission approved a label expansion for Opdivo nivolumab from Bristol-Myers Squibb to include treatment of relapsed or refractory classical Hodgkins lymphoma in adults after autologous stem cell …

    Published on 12/5/2016
  • Qapzola regulatory update

    FDA issued a complete response letter to Spectrum for Qapzola apaziquone to treat non-muscle invasive bladder cancer (NMIBC). Based on discussions with the agency, Spectrum is considering a new smaller study of Qapzola …

    Published on 12/5/2016
  • Shingrix regulatory update

    GlaxoSmithKline submitted an MAA to EMA for Shingrix to prevent shingles in people ages =50. In October, GSK submitted a BLA to FDA for the indication. The pharma plans to submit a regulatory application next year in …

    Published on 12/5/2016
  • Soliqua 100/33 regulatory update

    FDA approved an NDA from Sanofi for Soliqua 100/33 insulin glargine/lixisenatide to treat Type II diabetes. The pharma plans to launch the product in January 2017. Sanofi used a Priority Review voucher, for which it …

    Published on 12/5/2016
  • Tadalafil PharmFilm regulatory update

    MonoSol submitted an NDA to FDA for Tadalafil PharmFilm to treat erectile dysfunction (ED). The product is a film formulation of tadalafil, a phosphodiesterase-5 (PDE-5) inhibitor.MonoSol Rx LLC, Warren, N.J.Product: …

    Published on 12/5/2016
  • Veltassa regulatory update

    The Relypsa Inc. unit of Vifor Pharma Ltd. said FDA approved an sNDA that removes a black box warning from the label of Veltassa patiromer, a high-capacity oral potassium binder indicated to treat hyperkalemia. The …

    Published on 12/5/2016
  • VTS-270 regulatory update

    FDA granted rare pediatric disease designation to VTS-270 from Vtesse to treat Niemann-Pick type C1 (NPC1) disease in children. VTS-270 is in Phase IIb/III testing to treat NPC1. The product has breakthrough therapy …

    Published on 12/5/2016
  • Xultophy regulatory update

    FDA approved an NDA from Novo Nordisk for Xultophy IDegLira insulin degludec/liraglutide to treat adult Type II diabetics. The company plans to launch Xultrophy in the U.S. in 1H17. The once-daily, fixed-dose …

    Published on 12/5/2016
  • AGIL-AADC regulatory update

    FDA granted rare pediatric disease designation to Agilis AGIL-AADC to treat Aromatic L-Amino Acid Decarboxylase (AADC) deficiency. The product is an adeno-associated viral (AAV) vector encoding the dopa decarboxylase (…

    Published on 11/28/2016
  • Amphetamine XR oral suspension regulatory udpate

    Neos submitted an NDA to FDA for NT-0201 to treat ADHD. The product is an oral suspension extended-release amphetamine polistirex using Neos dynamic time release suspension (DTRS) technology.Neos Therapeutics Inc. (…

    Published on 11/28/2016
  • Darzalex regulatory update

    FDA approved an sBLA for Darzalex daratumumab in combination with dexamethasone plus either Revlimid lenalidomide or Velcade bortezomib to treat multiple myeloma (MM) in patients who have received =1 prior therapy. The …

    Published on 11/28/2016
  • Fluticasone furoate/umeclidinium/vilanterol regulatory update

    GlaxoSmithKline submitted an NDA to FDA for fluticasone furoate/umeclidinium/vilanterol to treat chronic obstructive pulmonary disease (COPD). GSK plans to submit an MAA to EMA by year end. The product is a combination …

    Published on 11/28/2016
  • Guselkumab regulatory update

    Johnson & Johnsons Janssen Research & Development LLC unit submitted a BLA to FDA for guselkumab to treat moderate to severe plaque psoriasis. The submission includes data from the Phase III VOYAGE 1 trial (see …

    Published on 11/28/2016

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