FDA

Report: U.S. medical innovation at risk without funding

Thursday, October 6, 2011 12:03 PM

U.S. venture capitalists are decreasing their investments in biopharmaceutical and medical device companies, reducing their concentration in prevalent disease areas and shifting investment away from the United States towards Europe and Asia, according to a report by the National Venture Capital Association'sMedIC Coalition.

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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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PointCross awarded IDIQ contract by FDA

Monday, October 3, 2011 11:26 AM

PointCross Life Sciences has been awarded an Indefinite Delivery Indefinite Quantity (IDIQ) contract by the FDA to provide an integrated off-the-shelf software environment comprising of a hosting repository, visualization and analysis functions, and search and discovery capabilities.  This environment will enable FDA pharmacologists / toxicologist reviewers and statisticians to access, manipulate, and analyze nonclinical regulatory submissions in electronic formats including the CDISC Standard for the Exchange of Nonclinical Data (SEND).  The software will also facilitate search and discovery across multiple studies for signal identification and validation of toxicity findings in order to better support science-based regulatory decision making.

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Survey: Mid-tier CROs shut out of post-marketing

Monday, October 3, 2011 08:02 AM

Large CROs garner 57% of the post-marketing studies currently being outsourced, while another 25% of that work is awarded to the few firms that specialize in safety. The remaining 19%? That’s scattered among numerous mid-sized CROs.

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FDA approves REMICADER for pediatric UC

Tuesday, September 27, 2011 12:02 PM

FDA has approved Janssen Biotech’s REMICADER (infliximab) for the treatment of moderately to severely active ulcerative colitis (UC) in pediatric patients who have had an inadequate response to conventional therapy.  This marks the 16th approval of REMICADER in the U.S. and the seventh for the anti-tumor necrosis factor (TNF)-alpha in the treatment of inflammatory bowel disease (IBD) spanning adult and pediatric Crohn's disease and adult and pediatric UC.  It is estimated that 1.4 million Americans have IBD with the number evenly split between UC and Crohn's disease.  An estimated 150,000 children under age 17 are living with symptoms of IBD.

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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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