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Chronological Index of : Regulatory

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  • APPY1 regulatory update

    Venaxis Inc. (NASDAQ:APPY), Castle Rock, Colo. Product: APPY1 (formerly AppyScore) Business: Diagnostic Venaxis said FDA provided the company with questions and requested information as part of the agencys review of a …

    Published on 7/28/2014
  • Aptiom eslicarbazepine acetate regulatory update

    Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Bial-Portela & Ca. S.A., S. Mamede do Coronado, Portugal Product: Aptiom eslicarbazepine acetate (BIA 2-093, SEP-0002093) (formerly Stedesa) Business: …

    Published on 7/28/2014
  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion said EMA accepted and granted accelerated assessment to an MAA for asfotase alfa to …

    Published on 7/28/2014
  • 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 Roche and its …

    Published on 7/28/2014
  • Bendamustine RTD regulatory update

    Eagle Pharmaceuticals Inc. (NASDAQ:EGRX), Woodcliff Lake, N.J. Product: Bendamustine RTD (EP-3102) Business: Cancer Eagle said FDA granted Orphan Drug designation to EP-3102 to treat chronic lymphocytic leukemia (CLL) …

    Published on 7/28/2014
  • Breast Cancer Index regulatory update

    bioMerieux S.A. (Euronext:BIM), Marcy lEtoile, France Product: Breast Cancer Index (BCI) Business: Diagnostic bioMerieuxs bioTheranostics Inc. company said the New York State Department of Health approved the companys …

    Published on 7/28/2014
  • Breo Ellipta regulatory update

    Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Breo Ellipta (Relvar - EU) fluticasone furoate/vilanterol (Relvar/Breo) (GW685698/GW64244) (…

    Published on 7/28/2014
  • CombiSNP Array for Pediatric Analysis regulatory update

    CombiMatrix Corp. (NASDAQ:CBMX), Irvine, Calif. Product: CombiSNP Array for Pediatric Analysis Business: Diagnostic CombiMatrix said the New York Department of Health granted conditional approval for CombiSNP Array for …

    Published on 7/28/2014
  • CRS-207 regulatory update

    Aduro BioTech Inc., Berkeley, Calif. Product: CRS-207 Business: Cancer Aduro said FDA granted breakthrough therapy designation to the combination of CRS-207 and GVAX Pancreas cancer vaccine to treat pancreatic cancer. …

    Published on 7/28/2014
  • Deoxycholic acid regulatory update

    Kythera Biopharmaceuticals Inc. (NASDAQ:KYTH), Calabasas, Calif. Product: Deoxycholic acid (ATX-101) Business: Other Kythera said FDA accepted for review an NDA for ATX-101 to reduce submental (under chin) fat. The …

    Published on 7/28/2014
  • ENMD-2076 regulatory update

    CASI Pharmaceuticals Inc. (NASDAQ:CASI), Rockville, Md. Product: ENMD-2076 Business: Cancer CASI (formerly EntreMed Inc.) said FDA granted Orphan Drug designation to ENMD-2076 to treat hepatocellular carcinoma (HCC). …

    Published on 7/28/2014
  • EpiFix regulatory update

    MiMedx Group Inc. (NASDAQ:MDXG), Marietta, Ga. Product: EpiFix Business: Dermatology MiMedx said a Medicare contractor responsible for about 5 million beneficiaries in Texas, Oklahoma, Louisiana, New Mexico, Colorado, …

    Published on 7/28/2014
  • FoundationOne regulatory update

    Foundation Medicine Inc. (NASDAQ:FMI), Cambridge, Mass. Product: FoundationOne Business: Diagnostic Foundation Medicine said it received final approval from the New York State Department of Health for 2 laboratory-…

    Published on 7/28/2014
  • Iclusig ponatinib regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Product: Iclusig ponatinib (formerly AP24534) Business: Cancer Ariad said EMAs Pharmacovigilance Risk Assessment Committee (PRAC) requested additional …

    Published on 7/28/2014
  • Imbruvica ibrutinib regulatory update

    Pharmacyclics Inc. (NASDAQ:PCYC), Sunnyvale, Calif. Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Imbruvica ibrutinib (PCI-32765) Business: Cancer EMAs CHMP issued a positive opinion recommending approval …

    Published on 7/28/2014
  • Imnovid regulatory update

    Celgene Corp. (NASDAQ:CELG), Summit, N.J. Product: Imnovid (Pomalyst) pomalidomide (CC-4047) Business: Cancer Celgene said Sweden, Spain and Switzerland approved reimbursement for Imnovid pomalidomide for multiple …

    Published on 7/28/2014
  • Intercept Blood System for platelets regulatory update

    Cerus Corp. (NASDAQ:CERS), Concord, Calif. Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY), Bad Homburg, Germany Product: Intercept Blood System for platelets Business: Hematology Cerus submitted the third and final …

    Published on 7/28/2014
  • Isentress raltegravir regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Product: Isentress raltegravir (formerly MK-0518) Business: Infectious EMAs CHMP recommended expanding the label for Mercks Isentress raltegravir to treat HIV-1 …

    Published on 7/28/2014
  • Naloxone nasal spray regulatory update

    AntiOp Inc., Lexington, Ky. Reckitt Benckiser Group plc (LSE:RB), Slough, U.K. Product: Naloxone nasal spray Business: Neurology AntiOp said FDA granted Fast Track designation for AntiOps naloxone nasal spray to aid in …

    Published on 7/28/2014
  • Natpara regulatory update

    NPS Pharmaceuticals Inc. (NASDAQ:NPSP), Bedminster, N.J. Product: Natpara (Preotact) (NPSP558 (PTH 1-84) Business: Endocrine/Metabolic FDAs Endocrinologic and Metabolic Drugs Advisory Committee will meet on Sept. 12 to …

    Published on 7/28/2014
  • NIFTY prenatal genetic test regulatory update

    BGI, Shenzhen, China Product: NIFTY prenatal genetic test Business: Diagnostic BGI said the China Food and Drug Administration (CFDA) approved the companys NIFTY prenatal genetic test to detect the risk of fetal …

    Published on 7/28/2014
  • Nintedanib regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Nintedanib (BIBF 1120) Business: Pulmonary Boehringer Ingelheim said FDA granted breakthrough therapy designation to nintedanib to treat idiopathic pulmonary …

    Published on 7/28/2014
  • Octagam 10% regulatory update

    Octapharma AG, Lachen, Switzerland Product: Octagam 10% Business: Autoimmune FDA approved Octagam 10% human IV Ig to treat adults with chronic immune thrombocytopenic purpura (ITP). Octapharmas Octapharma USA subsidiary…

    Published on 7/28/2014
  • OmniSeq Target regulatory update

    Roswell Park Cancer Institute, Buffalo, N.Y. Product: OmniSeq Target Business: Diagnostic Roswell Park said the New York State Department of Health approved the companys OmniSeq Target test as a genomic test for cancer …

    Published on 7/28/2014
  • Pirfenex pirfenidone regulatory update

    InterMune Inc. (NASDAQ:ITMN), Brisbane, Calif. Shionogi & Co. Ltd. (Tokyo:4507), Osaka, Japan Product: Pirfenex pirfenidone (Esbriet, Pirespa) (S-7701) Business: Pulmonary InterMune said FDA granted breakthrough therapy…

    Published on 7/28/2014

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