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Chronological Index of BioCentury, Week in Review: Regulatory

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  • Aclidinium bromide regulatory update

    Almirall S.A. (Madrid:ALM), Barcelona, Spain Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Kyorin Pharmaceutical Co. Ltd. (Tokyo:4569), Tokyo, Japan Product: Aclidinium bromide Business: Pulmonary FDA's Pulmonary-…

    Published on 1/30/2012
  • Adasuve staccato loxapine regulatory update

    Alexza Pharmaceuticals Inc. (NASDAQ:ALXA), Mountain View, Calif. Product: Adasuve staccato loxapine, (formerly AZ-004) Business: Neurology FDA extended the PDUFA date by 3 months for an NDA from Alexza for inhaled …

    Published on 1/30/2012
  • Alere Influenza A&B Test regulatory update

    Alere Inc. (NYSE:ALR), Waltham, Mass. Product: Alere Influenza A&B Test Business: Diagnostic FDA granted a CLIA waiver to the Alere Influenza A&B Test. The product uses antibodies to detect influenza types A and B …

    Published on 1/30/2012
  • Avastin bevacizumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Genentech Inc., South San Francisco, Calif. Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Eli Lilly and Co.…

    Published on 1/30/2012
  • Bosutinib regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Bosutinib (SKI-606, PF-5208763, PF-05208763) Business: Cancer FDA accepted for review an NDA for Pfizer's bosutinib to treat previously treated Philadelphia chromosome-…

    Published on 1/30/2012
  • Bydureon regulatory update

    Alkermes plc (NASDAQ:ALKS), Dublin, Ireland Amylin Pharmaceuticals Inc. (NASDAQ:AMLN), San Diego, Calif. Product: Bydureon (Exenatide once weekly) Business: Endocrine/Metabolic FDA approved once-weekly Bydureon …

    Published on 1/30/2012
  • Daxas regulatory update

    Forest Laboratories Inc. (NYSE:FRX), New York, N.Y. Mitsubishi Tanabe Pharma Corp. (Tokyo:4508; Osaka:4508), Osaka, Japan Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Daxas (Daliresp - U.S.) …

    Published on 1/30/2012
  • Denosumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Daiichi Sankyo Co. Ltd. (Tokyo:4568; Osaka:4568), Tokyo, Japan Product: Denosumab (Prolia, Xgeva, Ranmark) (AMG 162) Business: Musculoskeletal Amgen said FDA accepted for …

    Published on 1/30/2012
  • Durezol regulatory update

    Senju Pharmaceutical Co. Ltd., Osaka, Japan Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Durezol (ST-601) difluprednate Business: Ophthalmic Novartis disclosed in its 4Q11 earnings that it submitted an …

    Published on 1/30/2012
  • Eliquis apixaban regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Eliquis apixaban Business: Cardiovascular The U.K.'s NICE issued final guidance recommending the use of Eliquis …

    Published on 1/30/2012
  • Everolimus regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Everolimus (Afinitor, Certican, Zortress, Votubia) (RAD001) Business: Cancer Novartis disclosed in its 4Q11 earnings that it submitted regulatory …

    Published on 1/30/2012
  • Everolimus regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Everolimus (Afinitor, Certican, Zortress, Votubia) (RAD001) Business: Transplant Novartis disclosed in its 4Q11 earnings that it submitted regulatory …

    Published on 1/30/2012
  • Everolimus regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Everolimus (Afinitor, Certican, Zortress, Votubia) (RAD001) Business: Cancer, Transplant Novartis disclosed in its 4Q11 earnings that Japan approved …

    Published on 1/30/2012
  • Exjade deferasirox regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Exjade deferasirox (ICL670) Business: Hematology Novartis disclosed in its 4Q11 earnings that it submitted a regulatory application in the EU for Exjade …

    Published on 1/30/2012
  • Fabrazyme agalsidase beta regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Fabrazyme agalsidase beta Business: Endocrine/Metabolic Sanofi's Genzyme Corp. unit said FDA approved its Framingham, Mass., manufacturing facility for the …

    Published on 1/30/2012
  • Glivec regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Glivec (Gleevec - U.S.) imatinib (QTI571) Business: Cancer EMA's CHMP issued a positive opinion to expand the label of Glivec imatinib from Novartis to …

    Published on 1/30/2012
  • Inhaled nitric oxide regulatory update

    Ikaria Inc., Hampton, N.J. Product: Inhaled nitric oxide (NO) with the INOpulse DS drug-delivery system (IK-7001) Business: Cardiovascular FDA granted Orphan Drug designation for the use of inhaled NO with the INOpulse …

    Published on 1/30/2012
  • Inlyta axitinib regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Inlyta axitinib (formerly AG-013736) Business: Cancer FDA approved Inlyta axitinib from Pfizer to treat advanced renal cell carcinoma after failure of 1 prior systemic …

    Published on 1/30/2012
  • Keppra regulatory update

    UCB Group (Euronext:UCB), Brussels, Belgium Product: Keppra (E Keppra) levetiracetam Business: Neurology FDA approved an expanded label for Keppra levetiracetam tablets and oral solution from UCB to include adjunctive …

    Published on 1/30/2012
  • LuViva Advanced Cervical Scan regulatory update

    Guided Therapeutics Inc. (OTCBB:GTHP), Norcross, Ga. Product: LuViva Advanced Cervical Scan (formerly LightTouch Cervical Scanner) Business: Diagnostic FDA issued a not approvable letter for a PMA from Guided …

    Published on 1/30/2012
  • MabThera rituximab regulatory update

    Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: MabThera rituximab (Rituxan) (R105, RG105) Business: Cancer The U.K.'s …

    Published on 1/30/2012
  • Metyrapone regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Metyrapone (Metopirone) Business: Other Novartis disclosed in its 4Q11 earnings that Japan approved Metopirone metyrapone to treat Cushing's syndrome. The …

    Published on 1/30/2012
  • Naturaferon interferon alfa-n3 regulatory update

    Hemispherx Biopharma Inc. (NYSE-A:HEB), Philadelphia, Pa. Product: Naturaferon interferon alfa-n3 (Alferon N Injection) Business: Infectious Hemispherx Biopharma said Argentina approved a regulatory application from …

    Published on 1/30/2012
  • NBI-98854 regulatory update

    Neurocrine Biosciences Inc. (NASDAQ:NBIX), San Diego, Calif. Product: NBI-98854 Business: Neurology FDA granted Fast Track designation for Neurocrine's NBI-98854 to treat neuroleptic-induced tardive dyskinesia. The …

    Published on 1/30/2012
  • Nepafenac regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Nepafenac (Nevanac) Business: Ophthalmic Novartis disclosed in its 4Q11 earnings that it submitted an NDA to FDA for once-daily Nevanac nepafenac to treat …

    Published on 1/30/2012

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