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Chronological Index of : Regulatory

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  • ADS-5102 regulatory update

    Adamas said FDA accepted for review an NDA for ADS-5102 to treat levodopa-induced dyskinesia in patients with Parkinsons disease (PD). The PDUFA date is Aug. 24. ADS-5102 is an oral extended-release formulation of …

    Published on 1/16/2017
  • Adynovate regulatory update

    FDA approved Adynovate from Shire to treat patients ages <12 with hemophilia A and for use in perioperative management in adult and pediatric patients. The product is now approved in adults and children for on-demand…

    Published on 1/16/2017
  • Afstyla regulatory update

    The European Commission approved an MAA from CSL for Afstyla lonoctocog alfa for treatment and prophylaxis of bleeding in patients with hemophilia A. CSL plans to launch Afstyla in Europe in the coming months. The …

    Published on 1/16/2017
  • Arymo ER regulatory update

    FDA approved an NDA from Egalet for Arymo ER morphine sulfate extended-release tablets to manage pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate…

    Published on 1/16/2017
  • Cinvanti regulatory update

    Heron submitted an NDA to FDA for IV Cinvanti to prevent chemotherapy-induced nausea and vomiting (CINV). The company expects a decision in late 2017. Cinvanti is a polysorbate 80-free formulation of aprepitant, a …

    Published on 1/16/2017
  • Duzallo regulatory update

    Ironwood said FDA accepted for review an NDA for Duzallo lesinurad/allopurinol to treat hyperuricemia in patients with gout. The PDUFA date is in 2H17, with a launch slated for late this year. Under a 2016 deal, …

    Published on 1/16/2017
  • Eptacog beta regulatory update

    FDA accepted for review a BLA from LFB for eptacog beta to treat congenital hemophilia A or B in adolescents and adult congenital hemophilia A or B patients with inhibitors. HEMA Biologics LLC (Louisville, Ky.), a JV …

    Published on 1/16/2017
  • Ferritin IVD Capsule test regulatory update

    Abionic received CE mark approval for its Ferritin IVD Capsule test to diagnose iron deficiency. The company plans to launch the product early this year. The test measures ferritin levels in blood and runs on the …

    Published on 1/16/2017
  • Fiasp regulatory update

    The European Commission approved Fiasp insulin aspart from Novo Nordisk to treat diabetes in adults. Novo Nordisk plans to launch Fiasp, a faster-acting insulin aspart formulation, in Europe this half. Last year, FDA …

    Published on 1/16/2017
  • Immunoscore Colon regulatory update

    HalioDx launched its Immunoscore Colon diagnostic assay in Europe as an aid to assess prognosis of primary colon cancer. The product, which has CE Mark approval, is an in vitro diagnostic that measures the densities of …

    Published on 1/16/2017
  • Ingrezza regulatory update

    Neurocrine said FDA canceled a Feb. 16 meeting of its Psychopharmacologic Drugs Advisory Committee to discuss an NDA for Ingrezza valbenazine to treat tardive dyskinesia. The NDA is under Priority Review, with an April …

    Published on 1/16/2017
  • INOpulse regulatory update

    Bellerophon said FDA could approve INOpulse for pulmonary arterial hypertension (PAH) as early as 2020 after the agency accepted changes to INOpulses Phase III program. Bellerophon will now replace the planned Phase III…

    Published on 1/16/2017
  • IV rolapitant regulatory update

    FDA issued a complete response letter to Tesaro for an NDA for IV rolapitant to prevent chemotherapy-induced nausea and vomiting (CINV). At FDA's request during the NDA review, Tesaro provided in vitro data to …

    Published on 1/16/2017
  • Keytruda regulatory update

    FDA accepted and granted Priority Review to an sBLA for Merck's Keytruda pembrolizumab as first-line treatment of metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and…

    Published on 1/16/2017
  • Lucentis regulatory update

    FDA approved an sBLA from Roches Genentech unit for Lucentis ranibizumab to treat myopic choroidal neovascularization. The humanized mAb fragment against VEGF-A is also approved in the U.S. to treat wet age-related …

    Published on 1/16/2017
  • Myl-1401O regulatory update

    Biocon and Mylan said FDA accepted for review a BLA for Myl-1401O, a biosimilar of Herceptin trastuzumab, to treat HER2-positive metastatic breast cancer. The BsUFA date is Sept. 3. Roche (SIX:ROG; OTCQX:RHHBY, Basel, …

    Published on 1/16/2017
  • Opana ER regulatory update

    FDAs Drug Safety and Risk Management and Anesthetic and Analgesic Drug Products advisory committees will hold a joint meeting on March 13 to discuss safety issues of Endos pain drug Opana ER oxymorphone. The agency said…

    Published on 1/16/2017
  • Orthovisc-T regulatory update

    Anika received CE Mark approval for Orthovisc-T sodium hyaluronate to treat pain and restore function in tendons affected by chronic lateral epicondylosis (tennis elbow). The product comprises a biocompatible …

    Published on 1/16/2017
  • Pertagen regulatory update

    Thailand FDA approved an MAA from BioNet-Asia for Pertagen as an active booster immunization against pertussis in people ages =11. The company said it is the only recombinant monovalent pertussis vaccine in the world …

    Published on 1/16/2017
  • PSP IVD Capsule test regulatory update

    Abionic received CE mark approval for its PSP IVD Capsule test for sepsis risk assessment and management. The company plans to launch the product next year. The test measures pancreatic stone protein (PSP) in blood and …

    Published on 1/16/2017
  • Rhopressa regulatory update

    Aerie will delay an NDA submission to FDA for Rhopressa to treat intraocular pressure (IOP) in glaucoma and ocular hypertension patients to 1Q17. Aerie had planned to submit the application this month. In October, Aerie…

    Published on 1/16/2017
  • Soliris regulatory update

    Alexion submitted an sNDA to FDA and an MAA to EMA for Soliris eculizumab to treat refractory generalized myasthenia gravis in patients who are anti-acetylcholine receptor antibody positive. The humanized mAb targeting …

    Published on 1/16/2017
  • Tecentriq regulatory update

    FDA accepted and granted Priority Review to an sBLA from Roches Genentech unit for Tecentriq atezolizumab to treat locally advanced or metastatic urothelial carcinoma in patients who are ineligible for cisplatin therapy…

    Published on 1/16/2017
  • Aptima HIV-1 Quant Dx assay regulatory update

    FDA approved a PMA for Hologics Aptima HIV-1 Quant Dx assay for the quantitative detection of HIV-1 RNA from plasma. The in vitro nucleic acid amplification test is designed to run on the companys Panther system and has…

    Published on 1/9/2017
  • Betrixaban regulatory update

    FDA accepted and granted Priority Review to an NDA for betrixaban as extended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE. The PDUFA date is June 24. …

    Published on 1/9/2017

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