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 | A summary of the top news impacting the pharma industry. |
| September 25, 2007 |
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| Spotlight |  | |
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- Pharma informatics: In the eye of a perfect storm
For decades, the health care industry, governments and their agencies have been amassing data about patients, how physicians treat them, and the safety, efficacy and cost effectiveness of the drugs they are prescribed. i3 CEO Glenn Bilawsky says pharma informatics are now becoming available and will be the next important resource in pharma's toolbox. "Pharma informatics will provide the intelligence to better inform patients, physicians, managed care organizations and governments about the appropriate use of products, and they can confirm safety and efficacy findings from clinical trials," Bilawsky says. Continue reading this article online. 
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AMWA Conference Oct. 11 to 13
i3 Statprobe will be participating as an exhibitor and sponsor at the upcoming American Medical Writers Association Annual Conference in Atlanta. AMWA brings together communicators and educators engaged in the medical and allied health professions. The 67th annual conference offers the latest developments in technology and software, current publication standards, regulations, and medical communication.
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| In Development | | |
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- NIH grants to fund "knock your socks off science"
The NIH is awarding $483 million in grants for creative and interdisciplinary medical research that one agency official called "knock-your-socks off science." One group of Boston scientists plans to use new information linking genes to human diseases to transform drug discovery. The Boston Globe (free registration)
(9/6)
- Researchers look for "green" drug coatings in U.K.
U.K. researchers are looking to replace harsh solvents typically used in the process of coating delicate biopharmaceutical drugs by developing "green" methods.
Researchers from the University of Nottingham are working on a new method of coating drugs that involves dissolving the polymer coatings in supercritical carbon dioxide, which then encapsulates the drugs. In-PharmaTechnologist.com
(9/18)
- Scientists close to developing insulin pills
Researchers at Robert Gordon University in the U.K. claim they are closer to developing oral insulin upon their discovery that the drug can be covered by a coating to prevent its degradation in the stomach. The study offers hope to diabetes patients who are afraid of injections and presents a more convenient form of the medication, researchers note. BBC
(9/11)
- New fast-acting antidepressants cut time to relief
A new class of selective serotonin reuptake inhibitors has greatly reduced the time needed to take effect in mice, according to researchers. Current medications can take up to six weeks to reach therapeutic levels, during which time the threat of suicide is high. "Anything you can do to get a faster response" is desirable, said one professor of neuropharmacology and neurotoxicology, adding that the new drugs may have side effects. Yahoo!/HealthDay News
(9/5)
| In Market | | |
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- Generic drug industry to flourish, analyst says
Generic drug makers will continue reaping bigger profits, as the annual sales growth rate of 14% for generic drugs is far above that of the single-digit annual growth rate of brand-name drugmakers, top industry analyst Doug Long predicts. However, Long warns that price competition and "innovation slowdown" will affect the growth of generic drug makers. The Boston Globe/Associated Press (free registration)
(9/6)
- FDA to evaluate clinical observations through Sermo
Sermo is granting the FDA Center for Devices and Radiological Health access to its interactive community to evaluate physicians' clinical observations. For two months, the FDA will observe the kinds of information shared on Sermo, and for the following four months, the agency will work to improve communication with practicing physicians. Healthcare IT News
(9/6)
- Analysts consider potential of Bristol-Myers' diabetes drugs
The diabetes treatments that Bristol-Myers Squibb Co. is partnering with other drugmakers to develop each could take in $1 billion a year in sales, analysts say. Pfizer and AstraZeneca will participate in making two of the new drugs, which are expected to introduce a different approach to diabetes treatment. The strategy also will help the drugmaker recover from the patent expiration of its blockbuster drug Plavix in 2011. Bloomberg
(9/13)
| Technology & Informatics | | |
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- Digital signature standard cuts costs of traditional paper trail
The SAFE-BioPharma Association's development of a global standard for digital identities has helped the industry transition to electronic information exchange. The standard, now in Version 2.1, lets member companies cut the costs and time spent creating, printing, signing, storing and maintaining paper originals. Bio-IT World
(8/28)
- Commentary: A holistic approach to e-clinical data management
Clinical trials have become massively more complex, and the need to track an ever-expanding number of data sources calls for a new way to manage this disparate electronic data, the founder and CEO of PharmaPros Corp. says. Electronic data lifecycle management aims to offer real-time access to the entire electronic data lifecycle, which allows for time-critical decisions and adaptive trial designs. Bio-IT World
(8/28)
- AstraZeneca, BioWisdom ink partnership deal
AstraZeneca has become the first partner for BioWisdom's new Safety Intelligence Program, which features a comprehensive, easy-to-use database of drug safety intelligence that can be used to guide informed decision-making. Bio-IT World
(9/18)
- HP licenses inkjet-based patch technology
HP has licensed a drug-delivery patch based on its inkjet printer technology to Ireland-based Cropson. The patch, which contains as many as 90,000 microneedles per square inch and microprocessors programmed to monitor the rate and level of drug delivery, could replace hypodermic needles or pills. CNET
(9/11)
| Regulatory Affairs | | |
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- Senate sends drug safety bill to the White House
The Senate yesterday unanimously approved a bill that expands the FDA's powers on drug safety. The bill, which gives the agency extensive authority to monitor drugs on the market and extends programs that solicit fees from drug and medical device makers to help fund FDA product reviews, has been submitted to the White House where President George W. Bush is expected to sign it into law. The Washington Post/Reuters
(9/20)
- Expert to lead FDA orphan drugs unit
The FDA has appointed Timothy Cote head of its Office of Orphan Products Development, the agency announced Wednesday. Cote, a previous director for the Centers for Disease Control in Rwanda, takes over for acting director Debra Lewis. Forbes/Associated Press
(9/19)
- Study: Adverse drug-reaction reports increasing
Reports to the FDA of adverse drug effects increased two and a half times from 1998 to 2005, according to a new study. The lead author says the current drug-safety evaluation system "is not working," and harmful drugs are getting into the marketplace. The FDA and drug industry experts say the reasons for the increases are not well understood but could be linked to increased reporting by patients and physicians and more awareness of drug safety issues. USA TODAY
(9/10)
- Imposing transparency on clinical trials
Some lawmakers, scientists and advocacy groups say that rules on clinical trial reporting should be reformed but disagree on how to enact any changes. At issue is how the trial results should be disclosed, possibly involving a results database. Los Angeles Times
(9/17)
| i3 News | | |
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DIA Clinical Forum Oct. 14 to 17
i3 is exhibiting at the DIA Clinical Forum in Madrid, Spain, which features 11 clinically focused conferences, workshops and training courses covering Clinical Data Management, eClinical, Clinical R&D, Project Management for Clinical Trials, Pharmacovigilance, Statistics, Knowledge Management, Medical Writing, Medical Information and Communications, Information Technology, and Innovative Medicines.
| SmartQuote | | |
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 | You have to know how to accept rejection and reject acceptance."
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| About i3 |
i3 is a global pharmaceutical services company that brings together the leading
minds in specialized areas of expertise. Together, we apply rigorous science to
deliver integrated strategies and solutions of the highest quality throughout
the product lifecycle. And we're backed by the unmatched health care
intelligence and resources of UnitedHealth Group, one of the largest health and
well-being companies in the world.
To gain sharper insights that lead to better patient care, look to i3. Learn
more at
i3global.com.
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