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Chronological Index of : Regulatory

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  • Arymo ER morphine sulfate extended-release regulatory update

    Egalet Corp. (NASDAQ:EGLT), Wayne, Pa. Product: Arymo ER morphine sulfate extended-release (formerly Egalet-001) Business: Neurology Egalet said it received notice from FDA that the agency would not meet the Oct. 14 …

    Published on 10/24/2016
  • EBV-CTL regulatory update

    Atara Biotherapeutics Inc. (NASDAQ:ATRA), Brisbane, Calif. Memorial Sloan Kettering Cancer Center, New York, N.Y. Product: EBV-CTL Business: Cancer EMA granted PRIority MEdicines (PRIME) designation to EBV-CTL from …

    Published on 10/24/2016
  • Harmony Prenatal Test regulatory update

    Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Harmony Prenatal Test Business: Diagnostic Roche received CE Mark approval for the second-generation Harmony Prenatal Test to screen for Down syndrome and other …

    Published on 10/24/2016
  • Lartruvo olaratumab regulatory update

    Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Lartruvo olaratumab (IMC-3G3, LY3012207) Business: Cancer FDA granted accelerated approval to Lartruvo olaratumab from Eli Lilly in combination with doxorubicin …

    Published on 10/24/2016
  • Lucentis ranibizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Novartis AG (NYSE:NVS; SIX:NOVN), Basel, Switzerland Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Lucentis ranibizumab (RG3645) Business: Ophthalmic EMAs CHMP …

    Published on 10/24/2016
  • NiCord regulatory update

    Gamida Cell Ltd., Jerusalem, Israel Product: NiCord Business: Cancer FDA granted breakthrough therapy designation to NiCord from Gamida Cell as a graft modality for bone marrow transplantation in patients with high-risk…

    Published on 10/24/2016
  • Ocaliva obeticholic acid regulatory update

    Intercept Pharmaceuticals Inc. (NASDAQ:ICPT), New York, N.Y. Product: Ocaliva obeticholic acid (DSP-1747) (formerly INT-747, 6ECDCA, OCA) Business: Hepatic EMAs CHMP recommended conditional approval of Ocaliva …

    Published on 10/24/2016
  • Onivyde irinotecan regulatory update

    Merrimack Pharmaceuticals Inc. (NASDAQ:MACK), Cambridge, Mass. PharmaEngine Inc. (TPEx:4162), Taipei, Taiwan Shire plc (LSE:SHP; NASDAQ:SHPG), Dublin, Ireland Product: Onivyde irinotecan (MM-398) Business: Cancer The …

    Published on 10/24/2016
  • 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 EMAs CHMP recommended expanding the …

    Published on 10/24/2016
  • Sodium zirconium cyclosilicate regulatory update

    AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Sodium zirconium cyclosilicate (ZS-9) Business: Hematology FDA accepted for review a resubmitted NDA from AstraZenecas ZS Pharma subsidiary for ZS-9 to treat …

    Published on 10/24/2016
  • Tecentriq atezolizumab regulatory update

    Genentech Inc., South San Francisco, Calif. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Tecentriq atezolizumab (Anti-PDL1) (MPDL3280A, RG7446) Business: Cancer FDA approved Tecentriq atezolizumab from …

    Published on 10/24/2016
  • Translarna ataluren regulatory update

    PTC Therapeutics Inc. (NASDAQ:PTCT), South Plainfield, N.J. Product: Translarna ataluren (formerly PTC124) Business: Musculoskeletal PTC said FDA denied the companys first appeal of the refusal to file letter the agency…

    Published on 10/24/2016
  • Trisenox arsenic trioxide regulatory update

    Teva Pharmaceutical Industries Ltd. (NYSE:TEVA), Petah Tikva, Israel Product: Trisenox arsenic trioxide Business: Cancer EMAs CHMP recommended expanding the label of Trisenox arsenic trioxide from Teva to include …

    Published on 10/24/2016
  • Venclexta regulatory update

    Genentech Inc., South San Francisco, Calif. AbbVie Inc. (NYSE:ABBV), Chicago, Ill. Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Venclexta ( Venclyxto - EU) venetoclax (ABT-199, RG7601) (formerly GDC-0199) …

    Published on 10/24/2016
  • Zebinix eslicarbazepine acetate regulatory update

    Bial-Portela & Ca. S.A., S. Mamede do Coronado, Portugal Product: Zebinix eslicarbazepine acetate (Aptiom) (BIA 2-093, SEP-0002093) (formerly Stedesa) Business: Neurology EMAs CHMP recommended a label expansion for …

    Published on 10/24/2016
  • ADV6209 regulatory update

    Primex Pharmaceuticals AG, Zug, Switzerland Product: ADV6209 Business: Neurology Primex submitted an MAA for ADV6209 under the EUs decentralized procedure as moderate sedation prior to therapeutic or diagnostic …

    Published on 10/17/2016
  • Biosimilar pegfilgrastim regulatory update

    Coherus BioSciences Inc. (NASDAQ:CHRS), Redwood City, Calif. Product: Biosimilar pegfilgrastim (CHS-1701) Business: Hematology FDA accepted for review a BLA from Coherus for CHS-1701, a biosimilar of neutropenia drug …

    Published on 10/17/2016
  • Cetirizine regulatory update

    Nicox S.A. (Euronext:COX), Sophia Antipolis, France Product: Cetirizine (AC-170) Business: Inflammation FDA issued a complete response letter to Nicox for AC-170 to treat ocular itching associated with allergic …

    Published on 10/17/2016
  • Darzalex daratumumab regulatory update

    Genmab A/S (CSE:GEN), Copenhagen, Denmark Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Darzalex daratumumab (HuMax-CD38) Business: Cancer FDA accepted for review an sBLA from Johnson & Johnsons Janssen …

    Published on 10/17/2016
  • Faster-acting insulin aspart regulatory update

    Novo Nordisk A/S (CSE:NVO; NYSE:NVO), Bagsvaerd, Denmark Product: Faster-acting insulin aspart, FIAsp (NN1218) Business: Endocrine/Metabolic FDA issued a complete response letter to Novo Nordisk for faster-acting …

    Published on 10/17/2016
  • Flu A regulatory update

    BioGX Inc., Birmingham, Ala. Product: Flu A, Flu B, RSV assay Business: Diagnostic BioGX received CE mark approval for its Flu A, Flu B, RSV assay to detect influenza A and B and respiratory syncytial viruses from …

    Published on 10/17/2016
  • Flublok Quadrivalent regulatory update

    Protein Sciences Corp., Meriden, Conn. Product: Flublok Quadrivalent Business: Infectious FDA approved an sBLA from Protein Sciences for Flublok Quadrivalent to prevent 2 influenza A subtype viruses and 2 type B viruses…

    Published on 10/17/2016
  • Iclusig ponatinib regulatory update

    Ariad Pharmaceuticals Inc. (NASDAQ:ARIA), Cambridge, Mass. Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Iclusig ponatinib (formerly AP24534) Business: Cancer Japan approved an NDA from Otsuka for Iclusig …

    Published on 10/17/2016
  • IV carnexiv carbamazepine regulatory update

    Ligand Pharmaceuticals Inc. (NASDAQ:LGND), La Jolla, Calif. H. Lundbeck A/S (CSE:LUN), Copenhagen, Denmark Product: IV carnexiv carbamazepine Business: Neurology FDA approved an NDA from H. Lundbeck for IV Carnexiv …

    Published on 10/17/2016
  • Kazano regulatory update

    Allergan plc (NYSE:AGN), Dublin, Ireland Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Kazano ( Vipdomet - EU) alogliptin/metformin (Inisync) Business: Endocrine/Metabolic Japan approved an NDA from…

    Published on 10/17/2016

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