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A summary of the top news impacting the pharma industry.
January 21, 2009
  • i3 InLine polls readers on important issues for the biopharma industry in 2009
    In the previous issue of i3 InLine, i3 CEO Glenn Bilawsky sat down for a question-and-answer session to discuss the road ahead for the biopharma industry, including research and development and partnerships with contract research organizations.

    We would like to give our readers an idea of the biopharma industry's focus in 2009. Please take a moment to participate in the poll below. Look for the results in the next issue of i3 InLine.

    To read the full Q&A with Glenn Bilawsky, click here. Email this Story
Reader Poll: What is key to clinical research success in 2009?
Outsourcing options
New strategies for R&D business models


  In Development 
  • Pioneering research on stem cells under way in Texas
    Scott & White health system and the Texas A&M Health Science Center College of Medicine formed a team of researchers to develop a method for treating diseases using stem cells derived from the bone marrow of adults. The researchers are scheduled in September to begin clinical trials on diabetes patients. They also plan to conduct tests involving patients with Parkinson's and Alzheimer's diseases, stroke, and other ailments. Waco Tribune-Herald (Texas) (1/12) Email this Story
  • Scientists create artificial "good" cholesterol
    U.S. scientists devised an artificial form of high-density lipoprotein, or "good" cholesterol, made from a gold nanoparticle wrapped in fat molecules called lipids and a layer of protein. The synthetic compound is designed to increase HDL while trapping low-density lipoprotein, or "bad" cholesterol, which can cause strokes and other heart conditions. Yahoo!/Reuters (1/12) Email this Story
  • 2 studies provide clues to obesity
    Two research teams that worked on mice published findings that raise hopes for approaches to treating obesity. One study found that two FDA-approved medications -- 4-phenyl butyric acid for cystic fibrosis and tauroursodeoxycholic acid for liver disease -- can help the brain process leptin, a hormone that helps regulate appetite. Scientists in the other study reported that a genetic variant may be responsible for weight gain in fat people and leanness in thin individuals. The Washington Post/HealthDay News (1/6) Email this Story
  • Tests able to pinpoint healthy stem cells
    Canadian scientists developed a set of tests capable of differentiating normal stem cells from cancer-causing ones. The tests could help reduce the guesswork in developing treatments to eliminate cancer stem cells without harming healthy stem cells, one of the researchers said. Google/The Canadian Press (1/4) Email this Story
  In Market 
  • Protection from hepatitis A vaccine lasts decade or more
    Protection from the hepatitis A vaccine can last more than a decade, with antibodies still present 27 years after vaccination, according to a study from the CDC and the Alaska Native Tribal Health Consortium. The CDC said the data indicate that hepatitis A booster doses are not warranted or recommended. Reuters (1/6) Email this Story
  • Study: Early use of antibiotics in ICU reduces deaths
    Dutch researchers said the benefits of giving patients in an intensive care unit a precautionary dose of antibiotics, even before an infection sets in, trumps the risk that they will develop resistance to the drugs. The study found that immediate use of oral antibiotics reduced the risk of death in volunteer ICU patients by 11%. Reuters (1/1) Email this Story
  • Study validates combination vaccine for infants
    A U.S. study found that a combination vaccine against diphtheria, tetanus, pertussis, polio and flu is effective and well tolerated in children. The DTaP5-IPV-Hib vaccine has been routinely used in Canada for a decade. Reuters (1/8) Email this Story
  • FDA official: Bone drugs may raise risk of esophageal cancer
    FDA official Diane Wysowski said researchers should look into the potential risk of esophageal cancer tied to Merck & Co.'s Fosamax and other bisphosphonate drugs, which are designed to treat osteoporosis. In a letter published in a journal, she said Fosamax has been linked to 23 reports of esophageal tumors in the U.S. since its launch in 1995. Wysowski also advised physicians against using bisphosphonates for patients with Barrett's esophagus, a condition known to raise cancer risk. Reuters (12/31) Email this Story
  Technology & Informatics 
  • Experts devise map of molecular interactions in diseases
    U.S. and European researchers reported that by using a supercomputer and data from published articles, they were able to develop a comprehensive map that shows how molecules in various diseases interact with one another. The molecular manual could enhance treatment and shed light on heart disease, breast cancer and other conditions, the scientists said. Yahoo!/HealthDay News (12/29) Email this Story
  • Device uses nanoparticles to control drug delivery
    U.S. scientists created a device that uses two gold nanoparticles of dissimilar shapes that have different melting points, allowing for the controlled release of drugs when exposed to varying levels of infrared light. The technology could improve the treatment of diseases such as cancer and AIDS, which usually require many medicines that need to be taken at specific times. BBC (1/4) Email this Story
  Regulatory Affairs 
  • FDA finalizes rules on promoting off-label use
    The FDA completed guidelines that regulate when drugmakers may use published studies to promote products for applications that do not have regulatory approval. The rules will help ensure that health care professionals get "timely and accurate medical information" before medicines receive FDA clearance for expanded use, a spokesman for the Pharmaceutical Research and Manufacturers of America said. Reuters (1/12) Email this Story
  • FDA rolls out next-generation review system
    The FDA is rolling out its 21st Century Review Process, which is expected to improve work-flow timelines for product reviews and lead to more first-cycle product approvals. Two parts of the FDA Amendments Act -- the Risk Evaluation and Mitigation Strategies and a requirement for an advisory committee for most novel products -- could make it difficult for the agency to meet its deadline goals, according to this RPM Report analysis. The RPM Report (free registration) (12/2008) Email this Story
  • Drugs for rare diseases help increase approvals in 2008
    Specialty treatments from Amgen, Regeneron Pharmaceuticals and ViroPharma helped increase the number of novel medicines that the FDA approved last year. The agency's Web site noted 17 "new molecular entities" as of November, while an analyst in Washington reported that four others were cleared in December. Bloomberg (1/5) Email this Story
  i3 News 
It is every man's obligation to put back into the world at least the equivalent of what he takes out of it."
--Albert Einstein,
Nobel Prize-winning physicist

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