Skip to main content
Home > Week in Review > Regulatory

Chronological Index of : Regulatory

 Current Issue
  • Humira adalimumab regulatory update

    AbbVie Inc.(NYSE:ABBV), Chicago, Ill. Eisai Co. Ltd.(Tokyo:4523), Tokyo, Japan Product: Humira adalimumab Business: Autoimmune The U.K.s NICE issued a final guidance recommending 3 mAbs against tumor necrosis factor (…

    Published on 3/16/2015
  • Hydrocodone bitartrate ER regulatory update

    Teva Pharmaceutical Industries Ltd.(NYSE:TEVA), Petah Tikva, Israel Product: Hydrocodone bitartrate ER (CEP-33237) Business: Neurology Teva said FDA accepted for review an NDA for CEP-33237 to treat pain severe enough …

    Published on 3/16/2015
  • Insti HIV/Syphilis Multiplex Test regulatory update

    bioLytical Laboratories Inc., Richmond, B.C. Product: Insti HIV/Syphilis Multiplex Test Business: Infectious bioLytical received CE Mark approval for the Insti HIV/Syphilis Multiplex Test to simultaneously detect …

    Published on 3/16/2015
  • IV Captisol-enabled Melphalan regulatory update

    Ligand Pharmaceuticals Inc.(NASDAQ:LGND), La Jolla, Calif. Spectrum Pharmaceuticals Inc.(NASDAQ:SPPI), Henderson, Nev. Product: IV Captisol-enabled Melphalan Business: Transplant FDA accepted for review an NDA from …

    Published on 3/16/2015
  • Jinarc tolvaptan regulatory update

    Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan Product: Jinarc tolvaptan (Samsca) (formerly Samska) Business: Renal EMAs CHMP recommended approval of Jinarc tolvaptan from Otsuka to slow the progression of cyst …

    Published on 3/16/2015
  • Keytruda pembrolizumab regulatory update

    Merck & Co. Inc.(NYSE:MRK), Whitehouse Station, N.J. Product: Keytruda pembrolizumab (MK-3475) (formerly lambrolizumab) Business: Cancer Merck said melanoma therapy pembrolizumab will be the first product offered under …

    Published on 3/16/2015
  • Nuplazid pimavanserin regulatory update

    Acadia Pharmaceuticals Inc.(NASDAQ:ACAD), San Diego, Calif. Product: Nuplazid pimavanserin (formerly ACP-103) Business: Neurology Acadia said it will delay submission of an NDA to FDA to 2H15 from 1Q15 for Nuplazid …

    Published on 3/16/2015
  • Olysio simeprevir regulatory update

    Medivir AB(SSE:MVIR B), Huddinge, Sweden Johnson & Johnson(NYSE:JNJ), New Brunswick, N.J. Product: Olysio simeprevir (Sovriad, Galexos) (TMC435) (formerly TMC435350) Business: Infectious The U.K.s NICE issued final …

    Published on 3/16/2015
  • ReEBOV Antigen Rapid Test regulatory update

    Corgenix Medical Corp.(OTCBB:CONX), Broomfield, Colo. Product: ReEBOV Antigen Rapid Test Business: Diagnostic The World Health Organization (WHO) approved the ReEBOV Antigen Rapid Test from Corgenix to detect Ebola …

    Published on 3/16/2015
  • Remicade infliximab regulatory update

    Johnson & Johnson(NYSE:JNJ), New Brunswick, N.J. Merck & Co. Inc.(NYSE:MRK), Whitehouse Station, N.J. Product: Remicade infliximab (formerly TA-650) Business: Autoimmune The U.K.s NICE issued a final guidance …

    Published on 3/16/2015
  • SB2 regulatory update

    Biogen Idec Inc.(NASDAQ:BIIB), Cambridge, Mass. Samsung Group, Seoul, South Korea Product: SB2 Business: Autoimmune Samsung Bioepis Co. Ltd. submitted an MAA to EMA for SB2, a biosimilar of autoimmune drug Remicade …

    Published on 3/16/2015
  • Simponi golimumab regulatory update

    Johnson & Johnson(NYSE:JNJ), New Brunswick, N.J. Product: Simponi golimumab Business: Autoimmune The U.K.s NICE issued a final guidance recommending 3 mAbs against tumor necrosis factor (TNF) alpha to treat moderately …

    Published on 3/16/2015
  • Soliris eculizumab regulatory update

    Alexion Pharmaceuticals Inc.(NASDAQ:ALXN), Cheshire, Conn. Product: Soliris eculizumab Business: Hematology EMAs CHMP recommended approval of an expanded label for Orphan drug Soliris eculizumab from Alexion to treat …

    Published on 3/16/2015
  • Sovaldi sofosbuvir regulatory update

    Gilead Sciences Inc.(NASDAQ:GILD), Foster City, Calif. Product: Sovaldi sofosbuvir (GS-7977) (formerly PSI-7977) Business: Infectious The U.K.s NICE issued final guidance recommending Gileads Sovaldi sofosbuvir to treat…

    Published on 3/16/2015
  • Tecfidera dimethyl fumarate regulatory update

    Biogen Idec Inc.(NASDAQ:BIIB), Cambridge, Mass. Product: Tecfidera dimethyl fumarate (formerly BG-12) Business: Autoimmune The Drug Controller General of India (DCGI) approved Tecfidera dimethyl fumarate from Biogen …

    Published on 3/16/2015
  • Unituxin dinutuximab regulatory update

    United Therapeutics Corp.(NASDAQ:UTHR), Silver Spring, Md. Product: Unituxin dinutuximab (formerly Ch14.18) Business: Cancer FDA approved a BLA from United Therapeutics for Unituxin dinutuximab in combination with GM-…

    Published on 3/16/2015
  • Viekirax regulatory update

    Enanta Pharmaceuticals Inc.(NASDAQ:ENTA), Watertown, Mass. AbbVie Inc.(NYSE:ABBV), Chicago, Ill. Product: Viekirax (paritaprevir (ABT-450) plus ritonavir/ombitasvir (ABT-267)) Business: Infectious AbbVie submitted an …

    Published on 3/16/2015
  • Xtampza ER oxycodone extended-release regulatory update

    Collegium Pharmaceutical Inc., Canton, Mass. Product: Xtampza ER oxycodone extended-release Business: Neurology FDA accepted for review an NDA for oral Xtampza ER oxycodone extended-release from Collegium to treat …

    Published on 3/16/2015
  • Zalviso sufentanil regulatory update

    AcelRx Pharmaceuticals Inc.(NASDAQ:ACRX), Redwood City, Calif. Product: Zalviso sufentanil (ARX-01) (formerly Sufentanil NanoTab PCA System) Business: Neurology AcelRx delayed its resubmission of an NDA for Zalviso …

    Published on 3/16/2015
  • Adenuric febuxostat regulatory update

    Ipsen Group(Euronext:IPN; Pink:IPSEY), Boulogne-Billancourt, France Astellas Pharma Inc.(Tokyo:4503), Tokyo, Japan Menarini Group, Florence, Italy Takeda Pharmaceutical Co. Ltd.(Tokyo:4502), Osaka, Japan Teijin Pharma …

    Published on 3/9/2015
  • Asfotase alfa regulatory update

    Alexion Pharmaceuticals Inc.(NASDAQ:ALXN), Cheshire, Conn. Product: Asfotase alfa (ENB-0040) Business: Endocrine/Metabolic Alexion said FDA accepted and granted Priority Review to a BLA for asfotase alfa to treat …

    Published on 3/9/2015
  • Boniva ibandronate regulatory update

    Chugai Pharmaceutical Co. Ltd.(Tokyo:4519), Tokyo, Japan Taisho Pharmaceutical Holdings Co. Ltd.(Tokyo:4581), Tokyo, Japan GlaxoSmithKline plc(LSE:GSK; NYSE:GSK), London, U.K. Roche(SIX:ROG; OTCQX:RHHBY), Basel, …

    Published on 3/9/2015
  • Exparel regulatory update

    Pacira Pharmaceuticals Inc.(NASDAQ:PCRX), Parsippany, N.J. Product: Exparel (formerly DepoBupivacaine) Business: Neurology FDA issued a complete response letter to Pacira for an sNDA for Exparel bupivacaine as a nerve …

    Published on 3/9/2015
  • Eylea aflibercept ophthalmic solution regulatory update

    Regeneron Pharmaceuticals Inc.(NASDAQ:REGN), Tarrytown, N.Y. Bayer AG(Xetra:BAYN), Leverkusen, Germany Product: Eylea aflibercept ophthalmic solution (VEGF Trap-Eye) Business: Ophthalmic Regeneron said the European …

    Published on 3/9/2015
  • Harvoni ledipasvir regulatory update

    Gilead Sciences Inc.(NASDAQ:GILD), Foster City, Calif. Product: Harvoni ledipasvir (GS-5885)/sofosbuvir (GS-7977) Business: Infectious The U.K.s NICE issued a preliminary appraisal recommending Harvoni ledipasvir/…

    Published on 3/9/2015

< Previous   1  2  3  4  5  6  Next >
Subscribe Now
Free Trial

About BioCentury

Decision-shaping business intelligence for the global biotech and pharma industry since 1993