Patient diary firm invivodata announced its next annual patient-reported outcomes (PRO) conference. The meeting will be held on April 12-14, 2011 in Ft. Lauderdale. The meeting "is an opportunity for clinical researchers to advance their knowledge on the what, how, and when of successfully incorporating PROs into product development and commercialization,” said Jean Paty, the company's cofounder. Here's a recent interview.

Is the U.S. internet already straining under the load of online video? Sandvine, a Canadian web traffic analysis firm, did a bit of research and came up with a few statistics. One of them is that Netflix users account for a fifth of all downstream traffic in the U.S. from 8-10 p.m. In Latin America, the firm reports that people use the same amount of bandwidth whether connected to a mobile device or a desktop computer, thanks to high-quality content from YouTube and PPstream. Here's a press release.

Germany's Extedo can help manage electronic submission of regulatory documents to European authorities. The company has improved its free validation engine for eCTDs, NeeS, NTAs and other documents. The latest version of the software is the same one used by European officials, and upgrades the number of supported countries. It also includes a veterinary rule set, according to Tore Bergsteiner, CEO. Here's a release.

Sylogent has updated its software to assist with registering clinical trials in databases required by elite medical journal editors. In part, the company offers electronic document management, automatic posting of trials to the FDA-NIH clinicaltrials.gov project and ways to manage patients who inquire about specific studies. The firm is based in the U.S. but offers no additional information about its executives. Here's a release.

In a major win for the pharmaceutical industry, lobbyists appear to have blocked the regulatory pathway for generic biotechnology products in the U.S. Many so-called biosimilar products are already prescribed in Europe without the quality issues of which manufacturers have warned. European hurdles for biosimilars remain higher than for small molecule generics, with unnamed analysts predicting that full trials will be needed to establish similar safety profiles for branded and generic biotech products. The co-head of the FDA, Margaret Hamburg, is on record saying the regulations for biosimilars will "never" be finished. Here's a wire service story.

The Obama administration ordered a review of ethics in government-sponsored clinical trials in the wake of new revelations about misconduct in antibiotic research in Guatemala from 1946-1948. American scientists in the country deliberately gave mental patients syphilis, a replay of the infamous Tuskegee experiment from 1932-72 in which the same thing happened to African-American prison inmates in Alabama. Federal task forces are generally symbolic in nature, and that appears to be the case here. As best we can tell, no current or future NIH trials are on hold or delayed. Here's a news story and the web page of the effort.

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