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09/03/2010 04:00 AM
Optimer Pharmaceuticals Announces Presentations Of Additional Fidaxomicin Phase 3 Data At Upcoming ICAAC Annual Meeting
Results from studies related to Optimer Pharmaceuticals, Inc.'s (Nasdaq: OPTR) lead developmental product candidate, fidaxomicin, will be presented at the 50th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) to be held at the Boston Convention and Exhibition Center in Boston on September 12-15, 2010...
09/03/2010 02:00 AM
Transdel Pharmaceuticals Presents Phase 3 Study Data On Ketotransdel® At World Pain Congress In Montreal, Canada
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, announced the final data set from its Phase 3 study of Ketotransdel® (TDLP-110) at the 13th World Congress on Pain in Montreal, Canada...
09/03/2010 02:00 AM
Soligenix Announces Publication Of Article Identifying Domains Within The Ricin Toxin A Subunit As Targets Of Protective Antibodies
Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced the publication of an article online in Vaccine. The article describes the systematic identification of neutralizing and non-neutralizing B-cell epitopes on ricin toxin's enzymatic A subunit (RTA)...
09/03/2010 02:00 AM
Inhibitex Successfully Completes Phase 1a Trial Of INX-189
Inhibitex, Inc. (Nasdaq: INHX), announced that it has successfully completed a Phase1a, first-in-man, single ascending dose trial of INX-189, its nucleotide polymerase inhibitor in development for the treatment of chronic hepatitis C (HCV) infections. In this trial, 42 healthy volunteers received either a single oral dose of INX-189, ranging from 3 mg to 100 mg, or placebo...
09/03/2010 02:00 AM
Halozyme Begins Phase 2 Clinical Trials With Insulin Analogs Lispro And Aspart With RHuPH20 In Type 1 And Type 2 Diabetes
Halozyme Therapeutics, Inc. (Nasdaq: HALO) announced the initiation of two Phase 2 Ultrafast Insulin treatment studies that utilize its rHuPH20 hyaluronidase enzyme (PH20) in combination with the two leading commercially available mealtime analogs: insulin aspart, the active ingredient in NovoLog®, and insulin lispro, the active ingredient in Humalog®...
09/02/2010 04:00 AM
Eisai Announces The Start Of The First Clinical Study Of Ban2401, A Novel Monoclonal Antibody Targeting Neurotoxic Protofibrils
Eisai Co., Ltd. (Headquarters: Tokyo, Japan, President & CEO: Haruo Naito, "Eisai") announced today the start of the first patient enrolled clinical study with BAN2401, a novel monoclonal antibody that is being developed as a potential next-generation therapeutic treatment for Alzheimer's disease...
09/02/2010 04:00 AM
Trial To Test Experimental Drug For Advanced Pancreatic Cancer
Cancer Research UK's Drug Development Office has launched a clinical trial* to test an experimental drug in patients with advanced (Stage IV) pancreatic cancer - one of the most difficult cancers to treat. Around 60 patients with advanced pancreatic cancer will be recruited for the first Phase I/IIclinical trial of a drug called MK-0752** in this disease...

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09/01/2010 07:00 AM
Tygacil (tigecycline): Label Change - Increased Mortality Risk
Healthcare professionals should consider alternatives to Tygacil in patients with severe infections.
08/26/2010 12:40 PM
Huber Needles: Recall - Risk of Coring
Risk of infection, damage or death of tissue, swelling, or other serious adverse health consequences occurring as a result of the core travelling through blood vessels into the patient’s lungs.
08/26/2010 11:30 AM
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens
Increase in reports of bloodborne infection transmission resulting from the shared use of fingerstick and point-of-care blood testing devices.
08/25/2010 12:25 PM
TimeOut Capsules: Undeclared Drug Ingredient
Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil, a chemical similar to sildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
08/25/2010 09:38 AM
MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient
UPDATED 08/25/2010. Product marketed as dietary supplement contains undeclared Aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
08/25/2010 08:00 AM
Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events
Customers asked to immediately quarantine the use of affected lots due to the potential for serious thromboembolic events.
08/24/2010 08:15 AM
Mr. Magic Male Enhancer: Undeclared Drug Ingredient
Product marketed as dietary supplement contains undeclared hydroxythiohomosildenafil and sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
08/23/2010 05:50 PM
INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow
Potential for failure of a pressure switch, which may have an impact on the administration of INOMAX for inhalation to patients.
08/19/2010 09:00 PM
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk
FDA evaluating clinical trial data that suggest patients taking drug may be at an increased risk for cardiovascular events compared to those taking carbidopa/levodopa
08/16/2010 12:45 PM
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
Companies failed to provide evidence of clinical benefit of midodrine hydrochloride because required post-approval studies that verify the clinical benefit of the drug have not been done.
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