Skip to main content
Home > Week in Review > Regulatory

Chronological Index of : Regulatory

 Current Issue
  • Actimmune interferon gamma-1b regulatory update

    Horizon Pharma plc (NASDAQ:HZNP), Dublin, Ireland Product: Actimmune interferon gamma-1b Business: Neurology FDA granted Fast Track designation to Horizons Actimmune interferon gamma-1b to treat Friedreichs ataxia. This…

    Published on 4/20/2015
  • Aethlon Hemopurifier regulatory update

    Aethlon Medical Inc. (OTCQB:AEMD), San Diego, Calif. Product: Aethlon Hemopurifier Business: Infectious Aethlon said it submitted a Humanitarian Use Device (HUD) application to FDA for Aethlon Hemopurifier to treat …

    Published on 4/20/2015
  • Alere q HIV-1/2 Detect regulatory update

    Alere Inc. (NYSE:ALR), Waltham, Mass. Product: Alere q HIV-1/2 Detect Business: Diagnostic Alere received CE Mark approval for Alere q HIV-1/2 Detect assay to detect and identify and distinguish between HIV-1 subgroup M…

    Published on 4/20/2015
  • Bendamustine RTD regulatory update

    Eagle Pharmaceuticals Inc. (NASDAQ:EGRX), Woodcliff Lake, N.J. Product: Bendamustine RTD (EP-3102) Business: Cancer FDA accepted for review an NDA for EP-3102 to treat chronic lymphocytic leukemia (CLL) and indolent B …

    Published on 4/20/2015
  • Bryostatin-1 regulatory update

    Blanchette Rockefeller Neurosciences Institute, Morgantown, W.Va. Neurotrope Inc. (OTCQB:NTRP), Newark, N.J. Product: Bryostatin-1 Business: Neurology Neurotrope said FDA granted Orphan Drug designation to bryostatin-1 …

    Published on 4/20/2015
  • Celution System regulatory update

    Cytori Therapeutics Inc. (NASDAQ:CYTX; Xetra:XMPA), San Diego, Calif. Product: Celution System Business: Transplant The China Food and Drug Administration (CFDA) approved Cytoris Celution System for autologous re-…

    Published on 4/20/2015
  • CUDC-907 regulatory update

    Curis Inc. (NASDAQ:CRIS), Lexington, Mass. Product: CUDC-907 Business: Cancer FDA granted Orphan Drug designation to CUDC-907 from Curis to treat diffuse large B cell lymphoma (DLBCL). Next half, Curis plans to begin a …

    Published on 4/20/2015
  • Eklira Genuair aclidinium bromide regulatory update

    Actavis plc (NYSE:ACT), Dublin, Ireland Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Eklira Genuair aclidinium bromide (Bretaris Genuair, Tudorza …

    Published on 4/20/2015
  • Glatopa glatiramer acetate regulatory update

    Momenta Pharmaceuticals Inc. (NASDAQ:MNTA), Cambridge, Mass. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Glatopa glatiramer acetate (M356) Business: Autoimmune FDA approved an ANDA from Novartis Sandoz…

    Published on 4/20/2015
  • Kengreal Cangrelor regulatory update

    The Medicines Co. (NASDAQ:MDCO), Parsippany, N.J. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Kengreal Cangrelor (Kengrexal) (formerly AR-C69931MX) Business: Cardiovascular FDAs Cardiovascular and Renal …

    Published on 4/20/2015
  • Nesina alogliptin regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Nesina alogliptin (SYR-322) Business: Endocrine/Metabolic FDAs Endocrinologic and Metabolic Drugs Advisory Committee recommended that the agency add …

    Published on 4/20/2015
  • Onglyza saxagliptin regulatory update

    Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Onglyza saxagliptin (BMS-477118, OPC-262) Business: Endocrine/Metabolic FDAs Endocrinologic and Metabolic Drugs …

    Published on 4/20/2015
  • Pradaxa dabigatran etexilate regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Pradaxa dabigatran etexilate (Pradax, Prazaxa) Business: Cardiovascular FDA accepted for review an sNDA from Boehringer for Pradaxa dabigatran etexilate to prevent…

    Published on 4/20/2015
  • Procoralan ivabradine regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Servier, Neuilly-sur-Seine, France Product: Procoralan ivabradine (Corlanor) (ONO-1162) (formerly (S-16257)) Business: Cardiovascular FDA approved an NDA from Amgen…

    Published on 4/20/2015
  • Riboflavin ophthalmic solution regulatory update

    Avedro Inc., Waltham, Mass. Product: Riboflavin ophthalmic solution (VibeX) Business: Ophthalmic FDA issued a complete response letter to Avedro for an NDA for VibeX to treat progressive keratoconus or corneal ectasia …

    Published on 4/20/2015
  • RSV mAb regulatory update

    AIMM Therapeutics B.V., Amsterdam, the Netherlands AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: RSV mAb (D25, MEDI8897) Business: Infectious AstraZenecas MedImmune LLC unit said FDA granted Fast Track …

    Published on 4/20/2015
  • Soliris eculizumab regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Soliris eculizumab Business: Hematology The European Commission approved an expanded label for Soliris eculizumab from Alexion to include transfusion…

    Published on 4/20/2015
  • Vectibix panitumumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Vectibix panitumumab Business: Cancer The European Commission approved an expanded label for Vectibix …

    Published on 4/20/2015
  • Viaskin Peanut regulatory update

    DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT), Bagneux, France Product: Viaskin Peanut (DBV-712) Business: Inflammation FDA granted breakthrough therapy designation to Viaskin Peanut from DBV to treat peanut allergy…

    Published on 4/20/2015
  • Allplex Respiratory Panel 5 assay regulatory update

    Seegene Inc. (KOSDAQ:096530), Seoul, South Korea Product: Allplex Respiratory Panel 5 assay Business: Diagnostic Seegene said Health Canada approved Allplex Respiratory Panel 5 assay to identify influenza virus A and B,…

    Published on 4/13/2015
  • Androxal enclomiphene regulatory update

    Repros Therapeutics Inc. (NASDAQ:RPRX), The Woodlands, Texas Product: Androxal enclomiphene Business: Endocrine/Metabolic FDA accepted for review an NDA for Androxal enclomiphene from Repros to treat secondary …

    Published on 4/13/2015
  • Avastin bevacizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Avastin bevacizumab (RG435) Business: Cancer The European …

    Published on 4/13/2015
  • AXS-02 regulatory update

    Axsome Therapeutics Inc., New York, N.Y. Product: AXS-02 Business: Neurology FDA granted Fast Track designation to Axsomes AXS-02 to treat complex regional pain syndrome (CRPS). The oral, non-opioid candidate is in …

    Published on 4/13/2015
  • Catena idebenone regulatory update

    Santhera Pharmaceuticals Holding AG (SIX:SANN), Liestal, Switzerland Product: Catena idebenone (Sovrima - EU, Raxone - EU) (SNT-MC17) Business: Musculoskeletal FDA granted Fast Track designation to Catena idebenone from…

    Published on 4/13/2015
  • CLT-28643 regulatory update

    Clanotech AB, Solna, Sweden Product: CLT-28643 Business: Ophthalmic FDA granted Orphan Drug designation to CLT-28643 from Clanotech to prevent scarring following glaucoma surgery. The integrin alpha(5)beta(1) antagonist…

    Published on 4/13/2015

< Previous   1  2  3  4  5  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993