Skip to main content
Home > Week in Review > Regulatory

Chronological Index of : Regulatory

 Current Issue
  • AbobotulinumtoxinA regulatory update

    Ipsen Group (Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Product: AbobotulinumtoxinA (Dysport) (formerly Reloxin) Business: Musculoskeletal FDA approved an sBLA from Ipsen for Dysport to treat upper limb …

    Published on 7/27/2015
  • Ameluz regulatory update

    Biofrontera AG (Xetra:B8F), Leverkusen, Germany Product: Ameluz (BF-200 ALA) Business: Dermatology Biofrontera submitted an NDA to FDA for Ameluz and BF-RhodoLED to treat actinic keratosis. Ameluz is a photodynamic …

    Published on 7/27/2015
  • BMS-663068 regulatory update

    Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: BMS-663068 Business: Infectious FDA granted breakthrough therapy designation to Bristol-Myers BMS-663068 to treat HIV-1 infection in combination with other …

    Published on 7/27/2015
  • Envarsus tacrolimus regulatory update

    Veloxis Pharmaceuticals A/S (CSE:VELO), Horsholm, Denmark Product: Envarsus tacrolimus (Envarsus XR) (formerly LCP-Tacro) Business: Transplant FDA approved an NDA from Veloxis for Envarsus tacrolimus XR for the …

    Published on 7/27/2015
  • Fluad regulatory update

    Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Fluad Business: Infectious FDAs Vaccines and Related Biological Products Advisory Committee will meet on Sept. 15 to discuss and make recommendations on the …

    Published on 7/27/2015
  • Granisetron extended release regulatory update

    Heron Therapeutics Inc. (NASDAQ:HRTX), Redwood City, Calif. Product: Granisetron extended release (Sustol) (APF530) Business: Gastrointestinal Heron resubmitted an NDA to FDA for Sustol granisetron extended release to …

    Published on 7/27/2015
  • Herpes Simplex Virus regulatory update

    Theranos Inc., Palo Alto, Calif. Product: Herpes Simplex Virus, Type 1 test (HSV1 86695) Business: Diagnostic FDA granted 510(k) clearance and a CLIA waiver to Theranos Herpes Simplex Virus, Type 1 test to screen for or…

    Published on 7/27/2015
  • Keytruda pembrolizumab regulatory update

    Merck & Co. Inc. (NYSE:MRK), Kenilworth, N.J. Product: Keytruda pembrolizumab (MK-3475) (formerly lambrolizumab) Business: Cancer The European Commission approved an MAA from Merck for Keytruda pembrolizumab as …

    Published on 7/27/2015
  • Opdivo nivolumab regulatory update

    Ono Pharmaceutical Co. Ltd. (Tokyo:4528), Osaka, Japan Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Opdivo nivolumab (ONO-4538, MDX-1106, BMS-936558) Business: Cancer The European Commission approved …

    Published on 7/27/2015
  • Praluent alirocumab regulatory update

    Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), Tarrytown, N.Y. Sanofi (Euronext:SAN; NYSE:SNY), Paris, France Product: Praluent alirocumab (SAR236553, REGN727) Business: Endocrine/Metabolic EMAs CHMP recommended approval…

    Published on 7/27/2015
  • Qinprezo regulatory update

    Sumitomo Dainippon Pharma Co. Ltd. (Tokyo:4506), Osaka, Japan Sunesis Pharmaceuticals Inc. (NASDAQ:SNSS), South San Francisco, Calif. Product: Qinprezo (vosaroxin) (AG-7352) (formerly voreloxin, SNS-595) Business: …

    Published on 7/27/2015
  • Repatha evolocumab regulatory update

    Amgen Inc. (NASDAQ:AMGN), Thousand Oaks, Calif. Product: Repatha evolocumab (AMG 145) Business: Endocrine/Metabolic The European Commission approved an MAA from Amgen for Repatha evolocumab to treat several groups of …

    Published on 7/27/2015
  • RTS regulatory update

    GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: RTS,S vaccine (Mosquirix) (GSK257049) Business: Infectious EMAs CHMP recommended approval of Mosquirix from GlaxoSmithKline for active immunization of …

    Published on 7/27/2015
  • Xiaflex regulatory update

    BioSpecifics Technologies Corp. (NASDAQ:BSTC), Lynbrook, N.Y. Endo International plc (NASDAQ:ENDP; TSX:ENL), Dublin, Ireland Asahi Kasei Pharma Corp., Tokyo, Japan Product: Xiaflex ( Xiapex - EU) collagenase clostridium…

    Published on 7/27/2015
  • Arzerra ofatumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Product: Arzerra ofatumumab (HuMax-CD20) Business: Cancer Novartis submitted an application to EMA to expand …

    Published on 7/20/2015
  • Daratumumab regulatory update

    Genmab A/S (CSE:GEN; OTCBB:GMXAY), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Daratumumab (HuMax-CD38) Business: Cancer Genmab said Johnson & Johnsons Janssen Biotech Inc. unit …

    Published on 7/20/2015
  • DX-2930 regulatory update

    Dyax Corp. (NASDAQ:DYAX), Burlington, Mass. Product: DX-2930 Business: Inflammation FDA granted breakthrough therapy designation to DX-2930 from Dyax to prevent hereditary angioedema (HAE) attacks. The human mAb against…

    Published on 7/20/2015
  • Evotaz atazanavir/cobicistat regulatory update

    Gilead Sciences Inc. (NASDAQ:GILD), Foster City, Calif. Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Evotaz atazanavir/cobicistat Business: Infectious The European Commission approved an MAA from Bristol…

    Published on 7/20/2015
  • Iressa gefitinib regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Iressa gefitinib Business: Cancer FDA approved an NDA from AstraZeneca for Iressa gefitinib for the first-line treatment of patients with metastatic non-small …

    Published on 7/20/2015
  • Ixazomib regulatory update

    Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Ixazomib (MLN9708) Business: Cancer Takeda submitted an NDA to FDA for ixazomib to treat relapsed and/or refractory multiple myeloma (MM). The company …

    Published on 7/20/2015
  • MCNA regulatory update

    Telesta Therapeutics Inc. (TSX:TST; Pink:BNHLF), Belleville, Ontario Product: MCNA (EN3348) (formerly Urocidin) Business: Cancer Telesta submitted a BLA to FDA for MCNA to treat high-risk non-muscle invasive bladder …

    Published on 7/20/2015
  • Perjeta pertuzumab regulatory update

    Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Perjeta pertuzumab (R1273, RG1273) Business: Cancer EMAs CHMP recommended expanding the label of Perjeta pertuzumab …

    Published on 7/20/2015
  • Rexulti brexpiprazole regulatory update

    H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Rexulti brexpiprazole (OPC-34712) Business: Neurology FDA approved an NDA from Otsuka for Rexulti brexpiprazole to …

    Published on 7/20/2015
  • Therascreen EGFR RGQ Plasma PCR Kit regulatory update

    Qiagen N.V. (Xetra:QIA; NASDAQ:QGEN), Venlo, the Netherlands AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Therascreen EGFR RGQ Plasma PCR Kit, therascreen EGFR RGQ PCR Kit Business: Diagnostic FDA approved…

    Published on 7/20/2015
  • Voncento regulatory update

    CSL Ltd. (ASX:CSL), Melbourne, Australia Product: Voncento, Humate-P Business: Hematology EMAs CHMP recommended extending the indication of Voncento from CSL to include prophylaxis and treatment of hemorrhage or …

    Published on 7/20/2015

< 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