EnVivo Initiates Phase IIb Alzheimer’s Disease Trial For EVP-6124
May 13, 2010 by biotechcheck.com · Leave a Comment
EnVivo Initiates Phase IIb Alzheimer’s Disease Trial For EVP-6124
EnVivo Pharmaceuticals announced the initiation and dosing of patients in a Phase IIb study of its EVP-6124 compound, a selective alpha-7 nicotinic agonist in patients with mild to moderate Alzheimer’s disease. The multi-center, dose ranging, placebo controlled, six-month study taking place in the U.S. and Europe is designed to determine the safety and efficacy of EVP-6124 in producing …
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GOP, Democrats Increasingly Use Health Reform Lessons To Shape Other Policies
May 5, 2010 by biotechcheck.com · Leave a Comment
GOP, Democrats Increasingly Use Health Reform Lessons To Shape Other Policies
The Associated Press: Politics within the Republican Party are having a profound affect on sweeping policy issues “such as immigration, health care and deficit spending.” The reason behind this development is that many incumbent Republicans are moving to the right to protect themselves against primary election challenges. “On health care, the fiercely debated new law almost surely would have …
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Trade Negotiations Between EU, India Could Affect Access To Low-Cost Generic Drugs
April 28, 2010 by biotechcheck.com · Leave a Comment
Trade Negotiations Between EU, India Could Affect Access To Low-Cost Generic Drugs
The Associated Press examines the ongoing free-trade negotiations between the EU and India – a country that according to PricewaterhouseCoopers currently “makes one-fifth of the world’s generics.” The negotiations “could make it harder for millions … across the developing world to get lifesaving drugs. The deal is taking shape as India tries to transform itself from a generics powerhouse into …
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D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …
April 20, 2010 by biotechcheck.com · Leave a Comment
D-Pharm Receives Agreement Letter On Special Protocol Assessment For DP-b99 Study – A Pivotal Phase III Trial In Acute …
D-Pharm Ltd (DPRM: TASE) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA agreement letter indicates that “the design and planned analysis of the study adequately address the objectives …
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QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule Study For MoxDuo(R)IR In Patients With Post-Surgical …
April 19, 2010 by biotechcheck.com · Leave a Comment
QRxPharma Successfully Completes Pivotal Phase 3 Combination Rule Study For MoxDuo(R)IR In Patients With Post-Surgical …
QRxPharma (ASX: QRX and OTCQX: QRXPY) announced the successful completion of the first of two pivotal Phase 3 studies for MoxDuo®IR, an immediate-release Dual-Opioid™ pain therapy. Required for FDA New Drug Application (NDA) submission, this combination rule study — comparing the efficacy and safety profiles of MoxDuo®IR against component doses of morphine and oxycodone alone — demonstrated …
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