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NIH's National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) began the open-label, U.S. Phase III GRADE trial to compare the long-term benefits/risks of four diabetes drugs in combination with …
Published on 6/3/2013
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Onyx Pharmaceuticals Inc. (NASDAQ:ONXX) and Bayer AG (Xetra:BAYN) said they plan to submit an sNDA to FDA by mid-year for Nexavar sorafenib to treat radioactive iodine-refractory, differentiated thyroid cancer, with …
Published on 6/3/2013
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Pfizer Inc. (NYSE:PFE) said twice-daily oral Xalkori crizotinib led to a median progression-free survival (PFS) of 7.7 months, the primary endpoint, vs. 3 months for investigator's choice of Alimta pemetrexed from Eli …
Published on 6/3/2013
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Sanofi (Euronext:SAN; NYSE:SNY) said on Monday it discontinued development of two Phase III compounds: iniparib (BSI-201), which was in development to treat non-small cell lung cancer (NSCLC) and ovarian cancer; and …
Published on 6/3/2013
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Synta Pharmaceuticals Corp. (NASDAQ:SNTA) fell $2.51 (34%) to $4.87 on Monday after reporting median overall survival (OS) data from an interim analysis of the open-label Phase IIb portion of the international Phase IIb…
Published on 6/3/2013
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GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and partner Genmab A/S (CSE:GEN) said first-line treatment with IV Arzerra ofatumumab plus chlorambucil chemotherapy met the primary endpoint in the Phase III COMPLEMENT-1 trial …
Published on 5/29/2013
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Merck & Co. Inc. (NYSE:MRK) said it no longer plans to submit regulatory applications for preladenant to treat Parkinson's disease after an initial review of data from three double-blind Phase III trials "did not …
Published on 5/23/2013
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Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said once-daily 3 mg subcutaneous liraglutide met the three co-primary endpoints in the Phase IIIa SCALE Obesity and Pre-diabetes trial to treat obesity. Liraglutide reduced mean …
Published on 5/23/2013
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Salix Pharmaceuticals Inc. (NASDAQ:SLXP) said budesonide rectal foam given twice daily for two weeks and then once daily for four weeks met the primary endpoint in a pair of Phase III trials to treat ulcerative colitis…
Published on 5/22/2013
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Upsher-Smith Laboratories Inc. (Maple Grove, Minn.) said on Wednesday that once-daily USL255 as adjunctive therapy met the primary endpoint in the Phase III PREVAIL trial, and that FDA accepted for review an NDA for …
Published on 5/22/2013
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Novartis AG (NYSE:NVS; SIX:NOVN) said once-daily QVA149 met the primary endpoint of improving patient self-reported shortness of breath during daily activities as measured by Transition Dyspnea Index (TDI) scores from …
Published on 5/21/2013
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Aduro BioTech Inc. (Berkeley, Calif.) stopped early a Phase II trial evaluating CRS-207 plus GVAX Pancreas cancer vaccine and cyclophosphamide to treat pancreatic cancer after the combination met the primary endpoint of…
Published on 5/20/2013
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H. Lundbeck A/S (CSE:LUN) and partner Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) presented additional data on Monday showing that some doses of Brintellix vortioxetine significantly improved depression rating scores …
Published on 5/20/2013
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Pfizer Inc. (NYSE:PFE) said it discontinued the Phase III B1931008 trial evaluating inotuzumab ozogamicin to treat relapsed or refractory CD22-positive aggressive non-Hodgkin's lymphoma. The move came after an interim …
Published on 5/20/2013
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XenoPort Inc. (NASDAQ:XNPT) fell $1.03 (15%) to $5.72 on Monday after discontinuing development of arbaclofen placarbil based on top-line data showing that twice-daily doses of the product missed the co-primary …
Published on 5/20/2013
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Novo Nordisk A/S (CSE:NVO; NYSE:NVO) reported data on Friday from the 74-patient Phase III paradigm 2 trial evaluating N9-GP -- a glyco-pegylated derivative of recombinant human Factor IX -- to treat and prevent …
Published on 5/17/2013
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ThromboGenics N.V. (Euronext:THR) disclosed in a business update for the period ending April 30 that ocriplasmin missed the primary endpoint in the Phase IIa MIVI-5 trial to treat focal vitreomacular adhesion (VMA) …
Published on 5/17/2013
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Halozyme Therapeutics Inc. (NASDAQ:HALO) gained $1.24 (18%) to $7.98 on Thursday after reporting data from 24 evaluable patients in the open-label, dose-escalation Phase Ib portion of a Phase I/II trial to treat …
Published on 5/16/2013
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Helsinn Healthcare S.A. (Pazzallo-Lugano, Switzerland) said a single dose of its oral Netu-palo-FDC (NEPA) plus dexamethasone was superior to a single dose of oral palonosetron plus dexamethasone on the primary endpoint…
Published on 5/16/2013
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Oncothyreon Inc. (NASDAQ:ONTY) fell $0.64 (25%) to $1.97 on Thursday after reporting data from two Phase II trials of once-daily oral PX-866 to treat recurrent glioblastoma multiforme (GBM) and recurrent or metastatic …
Published on 5/16/2013
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Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) said once-daily 25 and 50 mg oral fasiglifam each met the primary endpoint of reducing HbA1c from baseline to week 24 vs. placebo in the Phase III CCT-003 trial to treat Type …
Published on 5/16/2013
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Bristol-Myers Squibb Co. (NYSE:BMY) reported interim data late Wednesday from 52 evaluable patients showing that concurrent dosing with the pharma's Yervoy ipilimumab plus nivolumab led to an objective response rate (…
Published on 5/15/2013
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The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said IV MPDL3280A once every three weeks led to an objective response rate (ORR) of 21% in 140 patients with locally advanced or metastatic solid tumors whose …
Published on 5/15/2013
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Bharat Biotech International Ltd. (Hyderabad, India) said oral Rotavac significantly reduced severe rotavirus diarrhea by 56% during the first year of life vs. placebo in an Indian Phase III trial to prevent rotavirus …
Published on 5/14/2013
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Eli Lilly and Co. (NYSE:LLY) discontinued development of enzastaurin (LY31765) after top-line data showed daily enzastaurin missed the primary endpoint of improving disease-free survival (DFS) vs. placebo in the Phase …
Published on 5/10/2013