FDA

Bayer’s phase III prostate cancer trial meets primary endpoint

Tuesday, September 27, 2011 11:39 AM

Bayer HealthCare Pharmaceuticals has reported that the investigational drug radium-223 chloride showed positive data in the phase III ALSYMPCA (ALpharadin in SYMptomatic prostate cancer) trial. The study met its primary endpoint by significantly improving overall survival by 44% in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases. All of the main secondary efficacy endpoints analyzed to date were met, including delay in skeletal-related events (SREs).

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EGEN, Nanotechnology Characterization Lab collaborate in brain cancer research

Tuesday, September 27, 2011 11:09 AM

EGEN is collaborating with the National Cancer Institute'sNanotechnology Characterization Laboratory in Frederick, Md., to accelerate human clinical testing of a nanotechnology-based gene therapy for brain cancer.

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Survey debunks consumer belief that all new FDA-approved drugs are better than the old

Monday, September 26, 2011 08:00 AM

Many consumers believe drugs do not receive FDA approval unless they are extremely effective and don’t have major side effects. At the same time, it’s a commonly held belief that new drugs are always safer than drugs that have been on the market for many years.

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FDA puts Immunomedics’ pancreatic cancer trial on hold

Friday, September 23, 2011 02:19 PM

Immunomedics, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, been notified by the FDA that a partial clinical hold has been placed on the company’s phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer, due to the administration of an incorrect dose to a patient enrolled at one of its trial sites.

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FDA approves Soliris

Friday, September 23, 2011 11:36 AM

The FDA has approved Soliris to treat patients with atypical Hemolytic Uremic Syndrome, a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

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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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