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| i3 InLine |
| January 21, 2010 |
With regulatory agencies comparing notes, companies need coordinated registration approach
An increased emphasis on global drug development and safety concerns has prompted regulatory agencies to develop more synergistic relationships that facilitate information sharing. As such, pharmaceutical and biologic companies planning to market their products in multiple countries need to develop registration strategies that account for this new level of regulatory cooperation.
"As 2010 begins, the industry is at a crossroads regarding registration," according to Anne Tomalin, president, i3 CanReg. "Whereas in the past companies might have wanted to keep one country's market approval application independent from their applications for that same product in another country, today they are less likely to succeed by taking a jurisdiction-by-jurisdiction approach because those countries are talking to each other about the applications," she said. Click here to continue reading this article online. Blank (1/12)
Learn more about i3's acquisition of CanReg
i3 announced in December that it acquired CanReg, a global regulatory consulting firm that assists pharmaceutical, biotechnology, medical-device and diagnostics clients at all stages of regulatory approval. Operating as i3 CanReg under the leadership of President Anne Tomalin, the division provides customized guidance, education and training to companies of all sizes.
"Anne and her team have a depth and a breadth of knowledge about global regulation and international harmonization that will serve i3's clients well," said Tracy Tsuetaki, president of i3 Research.
Expert outlines 2010's top trends in medical research
This top-10 list, assembled by FasterCures Executive Director Margaret Anderson, reveals some likely medical and scientific trends that will affect research in 2010, including FDA regulation, health care information technology, and new methods in clinical trials and research. The Huffington Post (1/7)
Researchers develop faster approach to making H1N1 flu vaccine
Austrian researchers said a vaccine-production method that uses insect cells allowed for the creation of recombinant influenza viruslike particles in 10 weeks, significantly less time than the months it takes to produce vaccines using the conventional egg-based technique. "Our work demonstrates that recombinant influenza viruslike particles are a very fast, safe and efficient alternative to conventional influenza vaccines and represent a significant new approach for newly emerging influenza strains like swine-origin H1N1 or H5N1," a researcher said. Bloomberg Businessweek/HealthDay News (1/6)
Expert: Stem cell rules will spur advances in genetic disorders
The government's decision to overturn restrictions on federal funding for studies involving human embryonic stem cells is more likely to spur advances in the treatment of genetic diseases first "before we will see advances in cell-replacement therapy," said Story Landis, chairman of a stem cell task force at the NIH. Landis said the rules cover more stem cell lines, allowing scientists to study lines with disease-causing mutations and develop better treatments for genetic disorders. Yahoo!/HealthDay News (1/5)
Lilly's R&D unit counts on outsourcing to develop drugs
Eli Lilly and Co. is optimistic that the strategy of using Chorus, its unit for research and development, to outsource trials of its products will cut costs and speed up the discovery of treatments. The company is expected to use data from a contract research organization in deciding whether to proceed with late-stage development of a rheumatoid arthritis molecule. Lilly joins other major drugmakers in relying on contractors to replenish their pipelines. The Wall Street Journal (1/5)
FDA will launch study on drugs' effects on pregnancy
The FDA announced a research collaboration that will focus on the safety of drugs given to pregnant women. The Medication Exposure in Pregnancy Risk Evaluation Program was prompted by concern about insufficient clinical trials on the issue at a time when two-thirds of women reportedly take at least one prescription drug during pregnancy. Reuters (12/30)
ARB blood pressure drugs might reduce risk of dementia
Researchers said angiotensin receptor blockers used for high blood pressure and heart disease might substantially lower the risk of Alzheimer's disease and dementia. The study also found patients with Alzheimer's or dementia who took the drugs along with angiotensin-converting enzyme inhibitors were less likely to die early or be admitted to a nursing home. Reuters (1/12)
Germany reduces H1N1 vaccine order with GSK to 34 million doses
The German Ministry of Health reduced its order of
GlaxoSmithKline's H1N1 flu vaccine by about 30% to 34 million doses. Other governments might also change their orders, the drugmaker said. Bloomberg Businessweek/The Associated Press (1/12)
FDA panel to evaluate safety of 3 anemia drugs
The FDA plans to assemble an advisory committee to review the safety of using anemia drugs Epogen, Aranesp and Procrit in patients with chronic kidney disease. Officials said the meeting was prompted by trial results that linked one of the medicines to a higher risk of stroke. NYTimes.com (1/6) The Wall Street Journal/Dow Jones Newswires (1/6)
GAO notes significant price increases for small but vital drugs
Prices for small-selling but vital medicines, including Sumycin for infection and Inderal for chest pain, increased 100% or more at least once between 2000 and 2008, according to a report from the Government Accountability Office. Congressional investigators noted that drugmakers were not always responsible for the increases, attributing more than half of the cases to middlemen's decisions. NYTimes.com (1/10)
Chip helps pinpoint gene mutations linked to drug efficacy
U.S. scientists used a chip called DMET, or drug-metabolizing enzymes, to identify genetic variations associated with the efficacy and toxicity of drugs. "This type of turn-key testing, if validated, could eventually replace highly specialized, time-consuming and labor-intensive testing -- thus allowing more institutes the opportunity to pursue genotyping and pharmocogenetic research," one of the researchers said. United Press International (12/31)
British scientists create synthetic artery using nanotechnology
U.K. researchers developed a polymer bypass graft capable of transferring nutrients to tissue by copying human blood vessels. The artificial artery, which was made using nanotechnology, might lower the risk of amputations and heart attacks in coronary-artery and lower-limb arterial surgery. BBC (1/3)
Silicon nanowires could help introduce molecules into cells
U.S. scientists were able to deliver molecules into cells using beds of vertical silicon nanowires, which pierce the cells to provide direct access. The technique could help scientists to rapidly maneuver cells in reprogramming stem cells and screening new treatments, among other uses. MIT Technology Review (1/2010)
U.K. scientists create working model of human stomach
U.K. scientists created a machine that is the first model of the human stomach, which will be used to study the complexities of digestion. The Dynamic Gastric Model will be used in food science and pharmaceutical research. Google/The Press Association (U.K.) (12/31)
Report: FDA approved the most drugs in 4 years in 2009
The FDA approved 26 new treatments in 2009, the most in four years but only one more than in 2008, according to a Washington Analysis report. Blood thinner Effient, by Eli Lilly and Co. and Daiichi Sankyo, and Sanofi-Aventis' heart drug Multaq were among the approvals, while Novo Nordisk's liraglutide for diabetes and Amgen's osteoporosis drug denosumab failed to secure approval. The Wall Street Journal/Dow Jones Newswires (1/5)
Analysis: Firms seek minor changes as health bill nears finalization
Generic-drug firms, medical-device makers and health insurers are working to introduce minor changes to the health reform bill as top Democrats in both chambers of Congress work on the final version, according to this Reuters analysis. Generics companies want the measure to provide more incentives for the adoption of generic treatments, while device firms want the bill to delay until at least 2013 a proposed $20 billion tax during the next decade. Meanwhile, pharmaceutical and biotech firms do not plan to vie for last-minute changes to the measure. Reuters (1/11)
Lawmakers want ban on deals to delay generic drugs
The chairman of the Federal Trade Commission and a group of House lawmakers are pressing for a law to prohibit pharmaceutical companies from paying competitors to delay bringing cheaper, generic alternatives to the market. The ban already is written into the House health care bill, but the provision was not included the Senate's version of the measure. NYTimes.com (1/12)
Commentary: Allowing imported drugs would hurt industry
Aside from safety and security risks, allowing the importation of prescription drugs would pave the way for price controls that stunt growth and stifle innovation in the industry, writes Dr. Gilbert Ross, medical director of the American Council on Science and Health. Lawmakers are portraying imported drugs as an effective means to cutting health care costs without explaining the negative effects on the drug industry, Ross says. The Wall Street Journal (1/7)
Upcoming i3 events
BioPartnering North America
Jan. 24 to 26 in Vancouver, British Columbia
i3 CanReg presentation Jan. 25
ExL Pharma conference -- Site Selection, Activation and Communication
Feb. 1 and 2 in Washington, D.C.
i3 presenter: Bill Gwinn, Vice President, Clinical Informatics, i3 Pharma Informatics
Feb. 1: "How to Accelerate Site Selection, Study Activation, and Patient Recruitment for Faster Clinical Trials Workshop"
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