| December 13, 2007 | News for the biotech, medical device, drug and food regulatory profession |
 |  |
- FDA imposes stronger warnings on epilepsy drug
Studies showing potentially life-threatening skin reactions to carbamazepine have prompted the FDA to issue stronger warnings on the epilepsy drug, in addition to the black-box warning for anemia it already carries. The agency also recommended that people with Asian ancestry undergo a genetic test before taking the drug, as they are 10 times more likely to develop skin reactions such as toxic epidermal necrolysis and Stevens-Johnson syndrome. Sold under the brand names Carbatrol, Tegretol and Equetro, cabamazepine is also used to treat bipolar disorder and nerve pain. The Wall Street Journal (tiered subscription model)
(12/13)  
- Merck pulls 1.2M doses of childhood vaccine
Merck & Co. is withdrawing from the market about 1.2 million doses of the Hib vaccine, used to protect children against meningitis, pneumonia and other critical diseases, after the firm detected a sterilization problem in a production facility. The recall -- of 11 batches of Pedvaxhib and two shipments of Comvax, a combination vaccine for both Hib and hepatitis B -- is precautionary, as there was no proof that the vaccine itself was contaminated, FDA officials said. The Wall Street Journal (free content)
(12/13)
- FDA clears Teva's generic Trileptal
Teva Pharmaceutical Industries Ltd. has obtained final FDA approval for its 150-, 300- and 600-milligram oxcarbazepine tablets. The drug is a generic version of Novartis AG's epilepsy drug Trileptal, which reportedly racked up $594 million in sales for the first nine months of 2007. The approval comes amid an unresolved patent dispute between Teva and Novartis over the drug. Forbes/Associated Press
(12/12)
- Mylan's generic bipolar drug gets tentative FDA OK
The FDA has granted tentative approval to Mylan Laboratories for lamotrigine tablets in 25-, 100-, 150- and 200-milligram doses. Lamotrigine is Mylan's generic version of Lamictal, GlaxoSmithKline PLC's drug for bipolar disorder. Reuters
(12/12)
 |
|  |
| | The #1 Event for Clinical & Outsourcing Professionals
Partnerships with CROs has set the standard in outsourcing and clinical development conferences. We are proud to bring you the event that provides the information to engage you and your partners as you continue to foster relationships that bring critical therapies to patients who need them the most safely and efficiently. | |
 |
|  |
| Biotechnology |  |  |
|
- Stem cells useful in predicting drug toxicity, study says
U.S. researchers were able to determine the toxicity of valproate, an anti-epileptic drug that has been associated with autism and spina bifida, by observing the response of embryonic stem cells to various dosages. Scientists found that exposing the cells to the drug caused alterations in concentrations of glutamate and kynurenin, key molecules that play an important role in early brain development. M.I.T. Technology Review
(12/13)
- Novozymes-Millipore cultures promise to speed biologics development
Millipore and Novozymes have forged an agreement to develop and market CellPrime, nonanimal cell cultures designed to hasten the development of biologics from mammalian cells. A Novozymes official said that the cultures meet increased regulatory demand for consistent, quality products that are not animal-derived and could help speed the approval of biotech drugs. In-PharmaTechnologist.com
(12/13)
| Food & Dietary Ingredients | | |
|
- USDA halts Canadian potato shipments over pests
The USDA has banned additional seed-potato shipments from Alberta, Canada, into several U.S. states, including Idaho, Washington and California, after receiving reports that the shipments may contain golden nematodes that attack potato plants. "We'd like to be able to trace any potential seed shipments from Alberta all the way to the field where they might have been planted," USDA spokesman Larry Hawkins said. FLEXNEWS/Dow Jones Newswires
(12/12)
 |
|  |
| The Buzz(CORPORATE ANNOUNCEMENTS)
Life Cycle Management for pharmaceutical and biotechnology products requires a thorough understanding of the interaction between FDA regulation and intellectual property. Pharmaceutical Law Group provides expert advice to both companies and investors in analyzing market exclusivities, Orange Book listing requirements, and other legal and regulatory provisions at the Intersection of FDA Regulation and Intellectual Property. For more information, please contact Gregory Glover by clicking here.
"Meta-Analysis" Is Changing Drug Safety Standards. To help you understand the potentially far-reaching implications, "The Pink Sheet" has just released: Understanding The New Drug Safety Standards: The Emerging Science of Meta-Analysis, A special report and Avandia case study. Find out more or call 800-332-2181.
How to Succeed in Asia: Subscribe to PharmAsia News, from the publisher of "The Pink Sheet." Starting in January 2008 PharmAsia News will become a paid subscription publication with expanded original and exclusive coverage of drugs, biologics and devices in key Asian markets including China, India and Japan. Sign up now while it's still free.
Interested in learning more about advertising in FDLI SmartBrief? Contact Chris Pope at 202 737-5500 ext 295 or cpope@smartbrief.com.
 | |
 |
|  |
| Medical Devices | | |
|
- Medtronic's defibrillator wire lead replacement raises concerns
Thousands of cardiac patients are considering whether to have surgery to replace their Medtronic Sprint Fidelis defibrillator wire leads, which have been linked to five deaths and have a potential for fractures, despite a recommendation to leave the leads in place unless they are fractured. NYTimes.com
(12/13)
-
Medtronic gets FDA OK for cardiac monitors: The FDA has granted Medtronic approval to market its Reveal DX and Reveal XT insertable devices designed to help doctors monitor the heart's electrical activity in patients with syncope or abnormal heart rhythms. The company said it plans to market Reveal DX in the U.S. next week, followed by Reveal XT. American City Business Journals/Minneapolis/St. Paul
(12/12)
- Jury rules in favor of C.R. Bard in patent suit
A federal jury in Arizona has ordered W.L. Gore & Associates to pay $185 million to C.R. Bard in connection with a patent-infringement case involving certain W.L. Gore ePTFE vascular grafts and stent grafts. Meanwhile, the court is still evaluating W.L. Gore's challenge to the validity of C.R. Bard's patent. CNNMoney.com/Thomson Financial
(12/12)
| FDLI Items | | |
|
-
A Program on Food Safety: Problems & Solutions -- experts discuss what needs to be done and predict what will happen, Jan. 24
This conference will explore the most significant food safety issues facing the industry from the perspective of the industry, government, consumer groups and others. The program also will explore the various legislative initiatives that have been proposed and will evaluate the impact the proposed legislation would have on the industry, and which proposals, if any, are more likely to accomplish their objectives. Get more information about the Food Safety Conference here or register now.
-
Update magazine -- Jan/Feb issue feature topic is food regulation
Update brings you the latest news from FDLI and the industry, featuring viewpoints on industry-specific trends, articles on varied topics of regulatory concern, changes at FDA, news about FDLI activities and more. Published bi-monthly, Update magazine is free to all individuals within FDLI member organizations, and available by subscription for nonmembers. Interested in becoming an author? Get more information here.
| SmartQuote | | |
|
 | Trust yourself. You know more than you think you do."
|
| |
| |
|
Read more at SmartBrief.com |
|
A powerful website for SmartBrief readers including:
|
|
|
|
| |
| |
| | Recent FDLI SmartBrief Issues:
- Wednesday, December 12, 2007
- Tuesday, December 11, 2007
- Monday, December 10, 2007
- Friday, December 07, 2007
- Thursday, December 06, 2007
| | | Lead Editor: Maureen Backman
Mailing Address:
SmartBrief, Inc.®, 1100 H ST NW, Suite 1000, Washington, DC 20005 | |
| |
|
| © 1999-2011 SmartBrief, Inc.® Legal Information |
|
