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Idenix Pharmaceuticals Inc. (NASDAQ:IDIX) said FDA lifted a partial clinical hold on HCV product IDX184 after reviewing interim data from 31 patients in a Phase IIb trial. The biotech now plans to enroll an additional …
Published on 2/3/2012
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The U.K.'s NICE issued draft guidance recommending against the use of three breast cancer diagnostics to guide decisions about chemotherapy use in women with estrogen receptor-positive, lymph node-negative, HER2-…
Published on 2/3/2012
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FDA's Oncologic Drugs Advisory Committee will meet on March 21 to discuss an NDA from Talon Therapeutics Inc. (OTCBB:TLON) for Marqibo vincristine to treat Philadelphia chromosome-negative acute lymphoblastic leukemia (…
Published on 2/3/2012
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Threshold Pharmaceuticals Inc. (NASDAQ:THLD) gained $1.70 (132%) to $2.99 on Friday after partnering with Merck KGaA (Xetra:MRK) to co-develop and commercialize Threshold's cancer product TH-302. The product, a hypoxia-…
Published on 2/3/2012
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AstraZeneca plc (LSE:AZN; NYSE:AZN) reported 4Q11 and FY11 financial results Thursday and announced a new restructuring initiative that includes 7,300 in employee cuts. About 2,200 R&D positions and 3,750 SG&A positions…
Published on 2/2/2012
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Dynavax Technologies Corp. (NASDAQ:DVAX) gained $0.40 (11%) to 4.06 on Thursday after agreeing with FDA to expand the age range of the proposed indication for the company's Heplisav HBV vaccine. Dynavax now plans to …
Published on 2/2/2012
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Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said FDA accepted for review NDAs for a pair of its insulin products to treat Type I and II diabetes: insulin Degludec and DegludecPlus. The PDUFA date is July 29. Insulin Degludec …
Published on 2/2/2012
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Merck & Co. Inc. (NYSE:MRK) reported financial results on Thursday and provided a regulatory update, including announcing FDA approval of an extended-release, once-daily formulation of Janumet sitagliptin/metformin to …
Published on 2/2/2012
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FDA's Oncologic Drugs Advisory Committee will meet on March 20 to discuss applications for two sarcoma drugs -- Votrient pazopanib from GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Taltorvic ridaforolimus from Merck & Co…
Published on 2/2/2012
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ThromboGenics N.V. (Euronext:THR) withdrew a BLA for ocriplasmin to treat symptomatic vitreomacular adhesion (VMA) after receiving notice that FDA intended to grant the application a six-month Priority Review. …
Published on 2/2/2012
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Arena Pharmaceuticals Inc. (NASDAQ:ARNA) received notice that FDA's Endocrinologic and Metabolic Drugs Advisory Committee will meet in 2Q12 to discuss the resubmitted NDA for lorcaserin to treat obesity. A specific …
Published on 2/1/2012
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The German Institute for Quality and Efficiency in Health Care (IQWiG) said breast cancer drug Halaven eribulin mesylate from Eisai Co. Ltd. (Tokyo: 4523; Osaka:4523) provides "no additional benefit" over chemotherapy. …
Published on 2/1/2012
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The German institute for Quality and Efficiency in health Care (IQWiG) said Dupuytren's contracture drug Xiapex collagenase clostridium histolyticum from Pfizer Inc. (NYSE:PFE) demonstrated "no additional benefit" over …
Published on 2/1/2012
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The U.K.'s NICE issued draft guidance recommending against Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ) in combination with prednisone or prednisolone in patients with metastatic, castration-resistant prostate …
Published on 2/1/2012
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Sangamo BioSciences Inc. (NASDAQ:SGMO) gained $0.74 (21%) to $4.19 on Wednesday after granting Shire plc (LSE:SHP; NASDAQ:SHPGY) exclusive, worldwide rights to zinc finger DNA-binding protein (ZFP) therapeutics …
Published on 2/1/2012
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UCB Group (Euronext:UCB) partnered with Astellas Pharma Inc. (Tokyo:4503) to co-develop and co-commercialize UCB's anti-TNF therapy Cimzia certolizumab pegol in Japan. The new deal follows last month's announcement that…
Published on 2/1/2012
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Boehringer Ingelheim GmbH (Ingelheim, Germany) and partner Eli Lilly and Co. (NYSE:LLY) said FDA approved Jentadueto linagliptin/metformin to treat Type II diabetes. The partners plan to launch the product early this …
Published on 1/31/2012
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FDA accepted for review an NDA from NPS Pharmaceuticals Inc. (NASDAQ:NPSP) for Gattex teduglutide to treat short bowel syndrome (SBS). NPS, which requested Priority Review, said it expects FDA to assign a PDUFA date …
Published on 1/31/2012
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Roche (SIX:ROG; OTCQX:RHHBY) plans to nominate up to 11 directors for election to the board of Illumina Inc. (NASDAQ:ILMN) at the sequencing company's annual meeting this year as part of an unsolicited acquisition bid …
Published on 1/31/2012
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SkyePharma plc (LSE:SKP) said Axel Mueller resigned as CEO to pursue other interests. CFO Peter Grant replaces him. SkyePharma was up 2.38p to 34.38p on Tuesday.
Published on 1/31/2012
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Hanmi Pharmaceutical Co. Ltd. (KOSDAQ:128940) and Spectrum Pharmaceuticals Inc. (NASDAQ:SPPI) partnered to co-develop Hanmi's neutropenia product SPI-2012 (formerly LAPS-GCSF). Spectrum has an option to license …
Published on 1/31/2012
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Transparency Life Sciences LLC launched a prototype of its web platform through which patients, physicians, researchers and other stakeholders can provide input on clinical trial designs. The company believes that …
Published on 1/31/2012
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Cell Therapeutics Inc. (NASDAQ:CTIC; Milan:CTIC) withdrew an NDA for Pixuvri pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) in patients who failed two or more lines of prior therapy. …
Published on 1/30/2012
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Amsterdam Molecular Therapeutics Holding N.V. (Euronext:AMT) said the European Commission asked for more information from EMA's CHMP before it can make a final decision on an MAA for Glybera to treat lipoprotein lipase…
Published on 1/30/2012
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Thirteen biopharma companies partnered with several governments and international health organizations to eliminate or control 10 neglected tropical diseases by 2020. The partners agreed to sustain or expand existing …
Published on 1/30/2012