FDA

START expands with phase I center in Shanghai

Thursday, September 22, 2011 10:45 AM

South Texas Accelerated Research Therapeutics (START), a US-based group that claims to run the world’s largest co-ordinated network of phase I clinical trials in oncology, has opened a phase I research facility in China at Fudan University Shanghai Cancer Centre, the city’s largest cancer hospital, according to PharmaTimes.

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Obama plans to reduce market exclusivity to 7 years

Tuesday, September 20, 2011 02:03 PM

President Obama is not giving up when it comes to trying to introduce competition to expensive drugs made by biotechnology, according to a report by the New York Times.

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Novartis' canakinumab to potentially treat childhood arthritis

Monday, September 19, 2011 12:48 PM

Novartis has presented late-stage data showing that canakinumab, recently rejected by US regulators for gout, shows potential as a treatment for patients with the most serious form of childhood arthritis, according to PharmaTimes.

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EMA joins FDA in growing movement toward risk-based monitoring of clinical trials

Monday, September 19, 2011 08:02 AM

Along with the FDA and the Clinical Trials Transformation Initiative (CTTI), the European Medicines Agency (EMA) is advocating for risk-based monitoring of trials, while at the same time saying current GCP rules render quality management in trials too costly and need to be reworked.

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VIVUS to re-submit QNEXA NDA

Thursday, September 15, 2011 12:21 PM

VIVUS has reached agreement with officials of the Endocrine and Metabolic Division of the FDA on a plan that allows for an early resubmission of the QNEXA New Drug Application for the treatment of obesity. The resubmission plan allows VIVUS to seek approval for an initial indication that includes obese men and women of non-child bearing potential.  Based on this agreement, VIVUS intends to resubmit the QNEXA NDA by the end of October 2011, prior to completion of the FORTRESS study.

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Marshall Edwards initiates phase I ME-143 trial

Friday, September 9, 2011 12:48 PM

Marshall Edwards, an oncology company focused on the clinical development of novel therapeutics targeting cancer metabolism, has initiated a phase I clinical trial of its lead drug candidate ME-143 in patients with refractory solid tumors. The trial is being conducted in collaboration with the Sarah Cannon Research Institute in Nashville, Tennessee, following the approval of an Investigational New Drug (IND) application by the FDA last month.

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FDA’s new guidance on monitoring clinical trials strongly encourages taking a risk-based approach

Monday, September 5, 2011 08:02 AM

Arisk-based approach to monitoring clinical trials: It’s the way to go now.

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FDA approves Lupin’s UltramR ER

Wednesday, August 31, 2011 01:04 PM

Lupin Pharmaceuticals has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Tramadol Hydrochloride Extended-Release Tablets, 100, 200 and 300 mg strengths. Lupin will begin shipping its Tramadol ERshortly.

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Aterena Zentaris’ AGHD study shows favorable results

Tuesday, August 30, 2011 12:03 PM

Aeterna Zentaris has reported favorable top-line results of its completed phase III study with AEZS-130 as the first oral diagnostic test for Adult Growth Hormone Deficiency (AGHD). The results show that AEZS-130 reached its primary endpoint demonstrating >90% area-under-the-curve (AUC) of the Receiver Operating Characteristic curve, which determines the level of specificity and sensitivity of the product. The company is currently proceeding with further detailed analyses of the data and preparing for a pre-New Drug Application (NDA) meeting with the FDA in the upcoming months, which would be followed by the filing of a NDA for the registration of AEZS-130 in the United States.

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AiCuris’ Letermovir receives Fast Track designation

Monday, August 29, 2011 12:58 PM

AiCuris announced today that the FDA has granted Fast Track designation for one of its lead drugs, AIC246, an inhibitor of the human cytomegalovirus (HCMV).

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