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Seattle Genetics Inc. (NASDAQ:SGEN), Bothell, Wash. Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Adcetris brentuximab vedotin (SGN-35) Business: Cancer FDA accepted for review an sBLA to expand the…
Published on 5/20/2013
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Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Product: Betmiga mirabegron (Myrbetriq, Betanis) (YM178) Business: Genitourinary The U.K.'s NICE issued final appraisal determination (FAD) recommending Betmiga mirabegron…
Published on 5/20/2013
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Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Cobas EGFR Mutation Test Business: Diagnostic FDA approved the cobas EGFR Mutation Test from Roche as a companion diagnostic for cancer drug Tarceva erlotinib. …
Published on 5/20/2013
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Elixir Medical Corp., Sunnyvale, Calif. Product: DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System Business: Cardiovascular Elixir received CE Mark approval for its DESolve Novolimus Eluting Bioresorbable…
Published on 5/20/2013
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Biogen Idec Inc. (NASDAQ:BIIB), Weston, Mass. Swedish Orphan Biovitrum AB (SSE:SOBI), Stockholm, Sweden Product: Eloctate rFVIIIFc (Long-lasting rFACTOR VIII) Business: Hematology FDA accepted for review a BLA from …
Published on 5/20/2013
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Curis Inc. (NASDAQ:CRIS), Lexington, Mass. Genentech Inc., South San Francisco, Calif. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Erivedge …
Published on 5/20/2013
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Cipla Ltd., Mumbai, India Product: Etacept etanercept Business: Autoimmune India's Association of Biotechnology Led Enterprises sent a letter to the Drug Controller General of India (DCGI) asking whether the approval of…
Published on 5/20/2013
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Eisai Co. Ltd. (Tokyo:4523; Osaka:4523), Tokyo, Japan Product: Halaven eribulin mesylate (E7389) Business: Cancer Eisai said it submitted a Type II variation application to EMA to expand the indication of Halaven …
Published on 5/20/2013
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Dainippon Sumitomo Pharma Co. Ltd. (Tokyo:4506; Osaka:4506), Osaka, Japan Takeda Pharmaceutical Co. Ltd. (Tokyo:4502), Osaka, Japan Product: Latuda lurasidone (SM-13496) Business: Neurology Dainippon disclosed in its …
Published on 5/20/2013
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Paladin Labs Inc. (TSX:PLB), Montreal, Quebec QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY), North Sydney, Australia Product: MoxDuo IR morphine/oxycodone (Q8003 IR) Business: Neurology FDA's Anesthetic and Analgesic Drug …
Published on 5/20/2013
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TaiGen Biotechnology Co. Ltd., Taipei, Taiwan Warner Chilcott plc (NASDAQ:WCRX), Dublin, Ireland Product: Nemonoxacin (TG-873870) Business: Infectious TaiGen submitted a pair of NDAs in Taiwan and China for oral …
Published on 5/20/2013
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Actavis Inc. (NYSE:ACT), Parsippany, N.J. Product: Norethindrone Transdermal Delivery System Business: Endocrine/Metabolic Actavis said that FDA accepted for review an NDA for Norethindrone Transdermal Delivery System …
Published on 5/20/2013
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Arbor Pharmaceuticals Inc., Atlanta, Ga. Product: Nymalize nimodipine Business: Neurology Arbor said FDA approved an NDA for Nymalize nimodipine oral solution to improve neurological outcomes in adult patients with …
Published on 5/20/2013
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BioDelivery Sciences International Inc. (NASDAQ:BDSI), Raleigh, N.C. KunWha Pharmaceutical Co. Ltd., Seoul, South Korea TTY Biopharm Co. Ltd., Taipei, Taiwan Meda AB (SSE:MEDAA), Solna, Sweden Product: Onsolis (Breakyl…
Published on 5/20/2013
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Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC), Seattle, Wash. Product: Pixuvri pixantrone Business: Cancer Germany's Federal Joint Committee (G-BA) issued a final benefit assessment saying cancer drug Pixuvri …
Published on 5/20/2013
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Bristol-Myers Squibb Co. (NYSE:BMY), New York, N.Y. Product: Recothrom (formerly rThrombin) Business: Hematology FDA approved an sBLA from Bristol-Myers Squibb for Recothrom as an aid for achieving hemostasis during …
Published on 5/20/2013
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Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Riociguat (BAY 63-2521) Business: Cardiovascular Bayer submitted a regulatory application in Japan for riociguat to treat chronic thromboembolic pulmonary hypertension…
Published on 5/20/2013
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Medivir AB (SSE:MVIR B), Huddinge, Sweden Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Simeprevir (TMC435) (formerly TMC435350) Business: Infectious FDA accepted and granted Priority Review to an NDA from …
Published on 5/20/2013
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Johnson & Johnson (NYSE:JNJ), New Brunswick, N.J. Product: Simponi golimumab Business: Autoimmune FDA approved an sBLA from Johnson & Johnson for subcutaneous Simponi golimumab to treat moderately to severely active …
Published on 5/20/2013
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Genentech Inc., South San Francisco, Calif. Astellas Pharma Inc. (Tokyo:4503), Tokyo, Japan Chugai Pharmaceutical Co. Ltd. (Tokyo:4519), Tokyo, Japan Roche (SIX:ROG; OTCQX:RHHBY), Basel, Switzerland Product: Tarceva …
Published on 5/20/2013
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Boehringer Ingelheim GmbH, Ingelheim, Germany Eli Lilly and Co. (NYSE:LLY), Indianapolis, Ind. Product: Trajenta (Tradjenta) linagliptin Business: Endocrine/Metabolic Germany's Federal Joint Committee (G-BA) issued a …
Published on 5/20/2013
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Illumina Inc. (NASDAQ:ILMN), San Diego, Calif. Product: verifi prenatal test (prenatal diagnostic) Business: Diagnostic Illumina's Verinata Health Inc. subsidiary and partner PerkinElmer Inc. (NYSE:PKI, Waltham, Mass.) …
Published on 5/20/2013
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Algeta ASA (OSE:ALGETA), Oslo, Norway Bayer AG (Xetra:BAYN), Leverkusen, Germany Product: Xofigo radium-223 (BAY88-8223) (formerly Alpharadin) Business: Cancer FDA approved an NDA from Bayer for Xofigo radium-223 …
Published on 5/20/2013
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Alexza Pharmaceuticals Inc. (NASDAQ:ALXA), Mountain View, Calif. Product: Adasuve staccato loxapine, (formerly AZ-004) Business: Neurology The European Commission approved an MAA for Adasuve Staccato loxapine from …
Published on 2/25/2013
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Theravance Inc. (NASDAQ:THRX), South San Francisco, Calif. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), London, U.K. Product: Anoro Ellipta, Anorno umeclidinium bromide/vilanterol (GSK573719/vilanterol) Business: Pulmonary …
Published on 2/25/2013