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Chronological Index of : Regulatory

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  • Cobas 4800 BRAF V600 Mutation Test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas 4800 BRAF V600 Mutation Test Business: Diagnostic Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) said Roche submitted an application last month …

    Published on 4/14/2014
  • Daclatasvir regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Daclatasvir (BMS-790052) Business: Infectious Bristol-Myers submitted a pair of NDAs to FDA for daclatasvir and asunaprevir (BMS-650032) to treat HCV genotype…

    Published on 4/14/2014
  • Gardasil regulatory update

    Merck & Co. Inc. (NYSE:MRK), Whitehouse Station, N.J. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Gardasil Business: Infectious The European Commission approved a 2-dose schedule of HPV vaccine Gardasil …

    Published on 4/14/2014
  • 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 Pharmacyclics submitted an sNDA to FDA for Imbruvica …

    Published on 4/14/2014
  • Intercept Blood System for plasma regulatory update

    Cerus Corp. (NASDAQ:CERS), Concord, Calif. Fresenius SE & Co. KGaA (Xetra:FRE; OTCQX:FSNUY), Bad Homburg, Germany Product: Intercept Blood System for plasma Business: Hematology Cerus submitted a medical device license …

    Published on 4/14/2014
  • Kalbitor ecallantide regulatory update

    Dyax Corp. (NASDAQ:DYAX), Burlington, Mass. Lee's Pharmaceutical Holdings Ltd. (HKSE:0950), Hong Kong, China Product: Kalbitor ecallantide (CB-500,929, DX-88) Business: Inflammation FDA approved an sBLA from Dyax for …

    Published on 4/14/2014
  • Latuda lurasidone regulatory update

    Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Latuda lurasidone (SM-13496) Business: Neurology Health Canada approved Latuda lurasidone …

    Published on 4/14/2014
  • Lemtrada alemtuzumab regulatory update

    BTG plc (LSE:BTG), London, U.K. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Lemtrada alemtuzumab (MabCampath, Campath) Business: Autoimmune Sanofi's Genzyme Corp. unit plans to resubmit an sBLA this quarter …

    Published on 4/14/2014
  • Mydicar regulatory update

    AmpliPhi Biosciences Corp. (OTCBB:APHB), Richmond, Va. Celladon Corp. (NASDAQ:CLDN), San Diego, Calif. Product: Mydicar (AAV1/SERCA2a) Business: Cardiovascular Celladon said FDA granted breakthrough therapy designation …

    Published on 4/14/2014
  • Niox Mino regulatory update

    Aerocrine AB (SSE:AERO), Solna, Sweden Product: Niox Mino; Niox Vero Business: Diagnostic The U.K.'s NICE issued final guidance recommending Niox Mino and Niox Vero from Aerocrine and NObreath from Bedfont Scientific …

    Published on 4/14/2014
  • NObreath regulatory update

    Bedfont Scientific Ltd., Kent, U.K. Product: NObreath Business: Diagnostic The U.K.'s NICE issued final guidance recommending Niox Mino and Niox Vero from Aerocrine AB (SSE:AERO, Solna, Sweden) and NObreath from Bedfont…

    Published on 4/14/2014
  • PA32540 regulatory update

    Pozen Inc. (NASDAQ:POZN), Chapel Hill, N.C. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: PA32540; PA8140 Business: Cardiovascular Pozen said it submitted final data to FDA from a Phase I trial comparing the …

    Published on 4/14/2014
  • Piccolo Xpress regulatory update

    Abaxis Inc. (NASDAQ:ABAX), Union City, Calif. Product: Piccolo Xpress Business: Diagnostic Abaxis said Health Canada reclassified the company's blood chemistry analyzer Piccolo Xpress and Piccolo Reagent Discs as a …

    Published on 4/14/2014
  • Pradaxa dabigatran etexilate regulatory update

    Boehringer Ingelheim GmbH, Ingelheim, Germany Product: Pradaxa dabigatran etexilate Business: Cardiovascular FDA approved an sNDA from Boehringer for Pradaxa dabigatran etexilate to treat deep vein thrombosis (DVT) and …

    Published on 4/14/2014
  • Revatio sildenafil regulatory update

    Pfizer Inc. (NYSE:PFE), New York, N.Y. Product: Revatio sildenafil Business: Cardiovascular FDA clarified a 2012 revised label warning against the use Revatio sildenafil from Pfizer in patients ages 1-17 years to treat …

    Published on 4/14/2014
  • Rytary regulatory update

    Impax Laboratories Inc. (NASDAQ:IPXL), Hayward, Calif. Product: Rytary (Patrome) (GSK587124, IPX066) Business: Neurology Impax resubmitted an NDA to FDA for Rytary extended-release carbidopa/levodopa for the symptomatic…

    Published on 4/14/2014
  • Safinamide regulatory update

    Newron Pharmaceuticals S.p.A. (SIX:NWRN), Bresso, Italy Zambon Co. S.p.A., Bresso, Italy Meiji Seika Pharma Co. Ltd., Tokyo, Japan Product: Safinamide (formerly PNU-151774E) Business: Neurology Newron and Zambon said …

    Published on 4/14/2014
  • Sofosbuvir regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Product: Sofosbuvir (GS-7977)/ledipasvir (GS-5885) Business: Infectious Gilead said FDA accepted and granted Priority Review for an NDA for an oral, once-daily, …

    Published on 4/14/2014
  • Vitaros alprostadil regulatory update

    Apricus Biosciences Inc. (NASDAQ:APRI), San Diego, Calif. Recordati S.p.A. (Milan:REC), Milan, Italy Product: Vitaros alprostadil Business: Genitourinary Apricus said Luxembourg's Ministry Health approved Vitaros …

    Published on 4/14/2014
  • Zelboraf vemurafenib regulatory update

    Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Zelboraf vemurafenib (PLX4032, R7204, RG7204, …

    Published on 4/14/2014
  • Adacel regulatory update

    Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Adacel Business: Infectious Sanofi said FDA approved an expanded label for Adacel to prevent tetanus, diphtheria and pertussis in persons 10-64 years of age. The …

    Published on 4/7/2014
  • Adempas riociguat regulatory update

    Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Adempas riociguat (BAY 63-2521) Business: Cardiovascular The European Commission approved Adempas riociguat from Bayer to treat pulmonary arterial hypertension (PAH) …

    Published on 4/7/2014
  • Afrezza regulatory update

    MannKind Corp. (NASDAQ:MNKD), Valencia, Calif. Product: Afrezza (formerly Afresa) Business: Endocrine/Metabolic FDA's Endocrinologic and Metabolic Drugs Advisory Committee said MannKind showed that Afrezza is safe and …

    Published on 4/7/2014
  • Aldoxorubicin regulatory update

    CytRx Corp. (NASDAQ:CYTR), Los Angeles, Calif. Product: Aldoxorubicin (formerly DOXO-EMCH, INNO-206) Business: Cancer The European Commission granted Orphan Drug designation for aldoxorubicin to treat advanced soft …

    Published on 4/7/2014
  • AmpliVue HSV 1+2 Assay regulatory update

    Quidel Corp. (NASDAQ:QDEL), San Diego, Calif. Product: AmpliVue HSV 1+2 Assay Business: Diagnostic Quidel said FDA granted 510(k) clearance for AmpliVue HSV 1+2 Assay to detect and differentiate herpes simplex virus …

    Published on 4/7/2014

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