Clinical Intelligence

VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

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Echo Therapeutics launches diabetes study

Thursday, October 13, 2011 12:31 PM

Echo Therapeutics has initiated a clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. The company expects to complete and announce the results of the study in the fourth quarter, and plans to subsequently begin a separate study in critical care patients.

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FDA approves Fluoxetine 60mg tablets

Tuesday, October 11, 2011 12:55 PM

Edgemont Pharmaceuticals has reported that the FDA has approved its New Drug Application (NDA) for Fluoxetine tablets 60 mg.

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Biotron’s phase IIa Hepatitis C study shows positive results

Tuesday, October 11, 2011 12:29 PM

Australian drug development company Biotron has released results from its phase IIa trial of its lead drug candidate, BIT225 in Hepatitis C virus (HCV) infected patients.

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FDA approves Combivent Respimat for COPD

Tuesday, October 11, 2011 12:11 PM

Boehringer Ingelheim Pharmaceuticals has reported that the FDA has approved COMBIVENT RESPIMAT, a new, propellant-free inhaler product that uses a slow-moving mist to deliver the same active ingredients of COMBIVENT Inhalation Aerosol in a metered dose inhaler (COMBIVENT MDI). COMBIVENT RESPIMAT will be available for patients in mid-2012.

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FDA approves Cialis for treatment of BPH

Friday, October 7, 2011 12:01 PM

The FDA has approved Cialis (tadalafil) to treat the signs and symptoms of benign prostatic hyperplasia (BPH), a condition in which the prostate gland becomes enlarged, and for the treatment of BPH and erectile dysfunction, when the conditions occur simultaneously. Cialis was approved in 2003 for the treatment of ED.

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Halozyme launches phase II pancreatic cancer trial

Thursday, October 6, 2011 10:47 AM

Halozyme Therapeutics has reported the commencement of patient dosing in a phase II clinical trial with pegylated rHuPH20 (PEGPH20) in patients with stage IV previously untreated pancreatic cancer. This multi-center, international, randomized, placebo-controlled trial will study the safety, tolerability and efficacy of gemcitabine plus PEGPH20 compared to gemcitabine plus placebo.

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Boston Scientific begins patient enrollment for OMEGA trial

Thursday, October 6, 2011 10:32 AM

Boston Scientific has started patient enrollment in the OMEGA clinical trial, designed to evaluate the safety and effectiveness of the company's OMEGA platinum chromium bare-metal coronary stent system in treating patients with a single coronary artery lesion.  This prospective, single-arm trial will enroll 328 patients at 40 sites in the U.S. and Europe.  The first patient was enrolled this week by Andrejs Erglis, M.D., OMEGA principal investigator, at Paul Stradins Clinical University Hospital in Riga, Latvia.  The trial's coordinating principal investigators are John Wang, M.D., of Union Memorial Hospital in Baltimore, Maryland, and Christian Hamm, M.D., of the Kerckhoff Heart and Thorax Center in Bad Nauheim, Germany.

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The CenterWatch Monthly, October 2011

Tuesday, October 4, 2011 11:01 AM

Sponsors take action to reduce protocol amendments

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GeoVax completes enrollment for HVTN 205 trial

Monday, October 3, 2011 11:05 AM

GeoVax Labs has completed enrollment for a phase IIa clinical trial testing its HIV/AIDS vaccine. The vaccine is being developed for use in uninfected people to prevent infection should they be exposed to the virus. The trial, designated HVTN 205, is being conducted by the HIV Vaccines Trials Network (HVTN), which is funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. A total of 299 participants are enrolled in HVTN 205.

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