FDA

FDA to assess drugmakers’ websites

Thursday, April 28, 2011 12:18 PM

U.S. drug regulators will scrutinize consumer reactions to websites for prescription drugs in an attempt to research how to apply advertising rules to social media, according to a Bloomberg report. 

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FDA finds Vertex’s HVC drug effective

Wednesday, April 27, 2011 01:48 PM

The FDA has indicated that Vertex Pharmaceuticals’ experimental drug telaprevir cures more patients of hepatitis C than any current therapies, according to a Bloomberg report. 

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Eli Lilly 's new anti-psychotic offers no weight gain

Wednesday, April 27, 2011 12:49 PM

The schizophrenia drug Zyprexa was one of Eli Lilly's biggest success stories; however, the company has also paid big settlements regarding claims that it hid data about a burdensome weight-gain side effect. As a result, Lilly has begun late-stage trials for a next-generation schizophrenia drug that offers treatment without weight gain, according to FierceBiotech.

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Boehringer enrolls first patient in phase III trial for HVC

Wednesday, April 27, 2011 12:09 PM

Boehringer Ingelheim Pharmaceuticals has begun enrollment at North American sites in its phase III clinical trial program for BI 201335, the company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase III trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, the most challenging HCV genotype to treat.

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A.P. Pharma raises $4.5 million, names new CEO

Tuesday, April 26, 2011 11:58 AM

California-based A.P. Pharma has raised $4.5 million in convertible notes and named a new CEO, according to Silicon Valley/San Jose Business Journal.  The specialty pharmaceutical company's lead drug candidate is designed to prevent acute-onset and delayed-onset chemotherapy-induced nausea and vomiting.

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Perceptive’s survey shows increasing interest in adaptive trial designs

Monday, April 25, 2011 12:55 PM

Perceptive Informatics, an eClinical solutions provider and a subsidiary of the Boston-based company Parexel, has results of a global survey conducted during its recent webinar entitled "Implementing Bayesian Response Adaptive Trials." The webinar was attended by over 300 professionals from the biopharmaceutical industry across a broad range of clinical, statistical and regulatory functions. Perceptive polled these professionals about their plans for the implementation of adaptive clinical trial designs.

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China: a quick and cost-efficient direction for drug development

Monday, April 25, 2011 12:12 PM

U.S. companies seeking to conduct clinical trials of new drugs and medical devices, Dr. R. Stephen Porter of Tennessee says China provides a lower-cost setting in which jobs can be accomplished more quickly, according to The Tennessean.

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Streamlining IRB approval process yields dramatic results in turnaround time for University of Maryland

Monday, April 25, 2011 08:02 AM

Last March it took 35 days for a full Institutional Review Board (IRB) approval for a clinical trial from the University of Maryland’s School of Medicine, which reviews more than 1,000 applications annually. This March, IRB approval time dropped to 21 days, and just 13 days in February.

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New data show number of principal investigators dropping 11% globally, and 20% in U.S.

Monday, April 25, 2011 08:02 AM

The number of principal investigators (P.I.s) filing 1572s worldwide has declined sharply, according to new data from the Tufts Center for the Study of Drug Development (CSDD).

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Biotechs say FDA regulations impede job creation

Friday, April 22, 2011 12:13 PM

Drug and medical device companies are having a hard time creating jobs and delivering innovative new therapies to patients because of tight government regulations, limits in science and research funding and high taxes reported biotech industry leaders at a recent congressional hearing in San Diego, according to The San Diego Union-Tribune.

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