
13 février, 2006 20:04
Xanthus' Symadex(TM) shows Remyelination in Multiple Sclerosis ...
PR Newswire (press release) - New York,NY,USA
13 /PRNewswire/ -- Xanthus Life Sciences, Inc., today announced that data from a study conducted with a Multiple Sclerosis (MS) animal model demonstrated that ...
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/02-13-2006/0004280425&EDATE=
Medivir Acquires All Rights in the Cathepsin S Project from US ...
Business Wire (press release) - San Francisco,CA,USA
... several series of highly potent and selective compounds that have demonstrated efficacy in pre-clinical models of rheumatoid arthritis and multiple sclerosis. ...
Medivir Acquires All Rights in the Cathepsin S Project from US ...
Finanzen.net - Germany
... several series of highly potent andselective compounds that have demonstrated efficacy in pre-clinicalmodels of rheumatoid arthritis and multiple sclerosis. ...
http://finanzen.net/news/news_detail.asp?NewsNr=372307
Also, women with breast implants typically can't be scanned with a mammogram. Breast CT scans could improve screening for both types of patients, Tornai said. .
Bristol-Meyers Settlement Gets Approval
Click the link below to read the full story:
http://www.forbes.com/feeds/ap/2006/02/09/ap2513193.html?partner=alerts
FDA News Digest
February 13, 2006
________________________________________________________
IN THIS WEEK'S ISSUE
" News
-- Report Shows Meeting Early with FDA Helps Drug Review Process
-- FDA, Industry Group Meet to Discuss Postmarket Safety of Devices
-- Latest 'Patient Safety News' Video Available Online
" Recalls/Safety Alerts
" Upcoming Public Meetings
" Question of the Week
________________________________________________________
http://www.fda.gov/cvm/disaster.htm
Report Shows Meeting Early with FDA Helps Drug Review Process
FDA has released a report showing that meetings between FDA and a drug or biologic sponsor early in the product approval process can improve the efficiency of the review process by boosting the quality of early applications. In fiscal year 2005, FDA received more than 2,400 requests for these meetings.
http://www.fda.gov/bbs/topics/news/2006/NEW01312.html
FDA, Industry Group Meet to Discuss Postmarket Safety of Devices
FDA and the Advanced Medical Technology Association met in early February to discuss improving the regulatory oversight of medical devices once they reach the market. The two groups plan future collaborations to help advance this goal.
http://www.fda.gov/bbs/topics/news/2006/NEW01314.html
Latest 'Patient Safety News' Video Available Online
FDA has posted the February edition of "Patient Safety News," a Web-based video news program aimed primarily at health professionals. The program features information on new drugs, biologics, and medical devices, as well as FDA safety notifications and product recalls.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/index.cfm
To view an archive of past FDA news releases, go to
http://www.fda.gov/opacom/hpnews.html.
To access the RSS feed of FDA news releases, go to
http://www.fda.gov/bbs/topics/news/rssPress.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
________________________________________________________
RECALLS/SAFETY ALERTS
Food Recalls:
Swad Dry Dates; 7- and 14-oz. sizes
Reason for recall: undeclared sulfites
http://www.fda.gov/oc/po/firmrecalls/raja02_06.html
Ingles Markets' 9" Old Fashion Apple Pie
Reason for recall: undeclared walnuts
http://www.fda.gov/oc/po/firmrecalls/ingles02_06.html
Animal Feed Recall:
One lot of Purina Layena Sunfresh Recipe Pellets poultry feed; 50-lb. bags
Reason for recall: contains excessive salt and doesn't meet company's quality standard
http://www.fda.gov/oc/po/firmrecalls/purina02_06.html
Safety Alerts:
FDA is alerting doctors who perform heart bypass surgery and their patients that Trasylol (aprotinin injection), used to prevent blood loss during surgery, has been linked to serious side effects such as heart attacks, strokes, and kidney problems in heart bypass patients. FDA advises several actions including toxicity monitoring and limiting use of the drug to when benefit outweighs risk.
http://www.fda.gov/bbs/topics/news/2006/NEW01311.html
Consumers should stop using liquid-filled children's teething rings made by RC2 Brands (The First Years), FDA warns, because the liquid in the product is contaminated with bacteria that could cause serious illness if it is swallowed, enters the lungs, or absorbed through a cut. Illness risk is especially high in infants whose immune systems are compromised.
http://www.fda.gov/bbs/topics/news/2006/NEW01313.html
For a list of recalls, market withdrawals, and safety alerts involving FDA-regulated
products from the past 60 days, go to http://www.fda.gov/opacom/7alerts.html.
To access the RSS feed of FDA recalls information, go to
http://www.fda.gov/oc/po/firmrecalls/rssRecalls.xml.
[What is an RSS feed? See http://www.fda.gov/bbs/topics/news/newsfeeds.html.]
_________________________________________________________
UPCOMING PUBLIC MEETINGS
Feb. 17 -- Vaccines and Related Biological Products Advisory Committee
Under discussion: selection of strains to be included in the flu virus vaccine for 2006-2007
Location: Bethesda, Md.
http://www.fda.gov/oc/advisory/accalendar/2006/cber12391d021706.html
April 18-20 -- 2006 FDA Science Forum; includes sessions on topics that include drug safety, obesity, avian flu, and non-invasive medical devices.
Location: Washington, D.C.
http://www.fda.gov/scienceforum
For a list of FDA meetings, seminars, and other public events, go to
http://www.fda.gov/opacom/hpmeetings.html.
__________________________________________________________
QUESTION OF THE WEEK
What is a generic drug?
A generic drug is a copy of a brand-name drug that is the same in dosage, safety, strength, how it is taken, quality, performance and intended use.
As with brand-name drugs, FDA requires that generic drugs be safe and effective. Generic drugs must have the same quality, strength, purity and stability as brand-name drugs. Because generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.
For more on generic drugs, see http://www.fda.gov/cder/ogd/.
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA issued a Public Health Advisory to notify healthcare professionals and patients about adverse events, including methemoglobinemia, associated with the use of benzocaine sprays used in the mouth and throat. Benzocaine sprays are used in medical practice for locally numbing mucous membranes of the mouth and throat for minor surgical procedures or when a tube must be inserted into the stomach or airways. On February 8, 2006, the Veterans Health Administration (VA) announced the decision to stop using benzocaine sprays for these purposes. The FDA is aware of the reported adverse events and is reviewing all available safety data, but at this time is not planning action to remove the drugs from the market. The FDA is highlighting safety information previously addressed by the Agency (see link below), has provided other information for the consideration of clinicians in the PHA and will make further announcements or take action as warranted by the ongoing review. Read the complete MedWatch 2006 Safety summary, including links to the Public Health Advisory and supporting FDA documents, at:
http://www.fda.gov/medwatch/safety/2006/safety06.htm#benzocaine
http://www.law.com/jsp/article.jsp?id=1139565913200
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Texas Appeals Court Sides With Newspaper in $1 Billion Suit Over HIV Disclosure |
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http://www.law.com/jsp/article.jsp?id=1139565912910
The Bhopal Legacy: A Chemical Company Grows Up-and that pathetic amount of $200.00 to $300.00 is exactly what, Dow has in mind to compensate us; and deny they were at fault in anyway for there toxic breast implants!
http://dowethics.com/r/about/corp/bhopal.htm
Dow Executive Speech: Process Automation at Dow: Critical for Success. Enabler of Long-term profitability.-This Dow statement makes me want to vomit! How is, Dow avoiding government regulations? By making toxic chemicals and warfare to kill, human's in other countries for our government? YES! That is exactly why the, Breast Implant an Asbestos cover up has been ignored and more, Tort Reform was passed against us so they aren't held liable for their egregious actions that harmed millions of humans And children.
http://dowethics.com/r/dow_news/speeches/20021028a.htm