| December 11, 2007 | News for the biotech, medical device, drug and food regulatory profession |
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- U.S., China collaborate to ensure product safety
The U.S. and China have signed two agreements that aim to ensure the safety of food, drugs and medical devices imported from China. The deals, which were signed at the China-U.S. Joint Commission on Commerce and Trade meeting, call for the creation of bilateral mechanisms to offer information on imported goods and improvements in the access of U.S. officials to production facilities in China. The Oregonian (Portland)/Associated Press
(12/11)  
- Downsizing good for Big Pharma, analysts say
A number of leading U.S. drug firms have resorted to cost-cutting measures this year, including announced job losses of more than 30,000. While austerity plans at companies such as Eli Lilly and Co. and Bristol-Myers Squibb Co. are troubling employees and the drugmakers themselves, analysts see the downturn as an opportunity for drug giants to reduce bloat and channel research to more productive ends. CNNMoney.com/Fortune
(12/10)
- Novo Nordisk settles insulin patent suit
Denmark-based Novo Nordisk announced it has settled its patent infringement case against Pfizer, in which it alleged Pfizer's Exubera was based on its own inhaled insulin treatment that has yet to be marketed. Pfizer recently settled a contract dispute with its Exubera partner, Nektar Therapeutics, for $135 million. The Boston Globe/Associated Press (free registration)
(12/10), Reuters
(12/10)
- OTC omeprazole obtains FDA approval
The FDA has granted Dexcel Pharma Technologies Ltd. approval to market omeprazole, a generic version of AstraZeneca PLC's heartburn drug Prilosec, for use without prescription. Perrigo Co., Dexcel's partner in marketing the drug, said the over-the-counter tablets may be launched in the U.S. in the first quarter of 2008. Forbes/Associated Press
(12/10)
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| Biotechnology |  |  |
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- GSK forms alliances with two biotech firms
GlaxoSmithKline PLC has signed deals with two biotech companies as part of its bid to find new drugs outside its own laboratories. One is a potential $1.4 billion deal with California-based OncoMed Pharmaceuticals that would allow GSK access to its novel antibodies that target cancer stem cells. The other is a drug development deal with Belgium-based Galapagos NV for new anti-infective medicines against up to six targets. San Diego Union-Tribune/Reuters
(12/10)
| Food & Dietary Ingredients | | |
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- California advisory board calls for caffeine review
The Science Advisory Board Developmental and Reproductive Toxicant Identification Committee of California on Monday called for a study to determine whether sodas and energy drinks containing caffeine pose health risks to pregnant women. The advisory panel also called for an urgent review of bisphenol A, which has been shown to have effects on hormone levels. Yahoo!/Associated Press
(12/10)
| Medical Devices | | |
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- Volcano to acquire CardioSpectra for $25M
Volcano Corp. will acquire San Antonio-based CardioSpectra for $25 million in a deal that will enable it to expand in the high-resolution imaging market. The deal, which is expected to close by the end of the year, will allow Volcano to access CardioSpectra's optical coherence tomography technology, which offers detailed images of blood vessels, blood clots and stents. American City Business Journals/Sacramento
(12/10)
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| The Buzz(CORPORATE ANNOUNCEMENTS)
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All New 2008 Edition!
NEW DRUG DEVELOPMENT: A REGULATORY OVERVIEW
This all-new 2008 edition addresses the most cutting-edge developments redefining how new drugs are developed and regulated today. Find out why New Drug Development is pharma/biotech's "go-to" resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes. Shipping January 2008.
Interested in learning more about advertising in FDLI SmartBrief? Contact Chris Pope at 202 737-5500 ext 295 or cpope@smartbrief.com.
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Introduction to Food Law and Regulation, Jan. 22 and 23
During this interactive two-day program, you will learn the essential elements of food law and regulation while acquiring an orientation to administrative agencies and furthering your understanding of how FDA and USDA promulgate and enforce regulations. Learn how the food industry is being impacted by the new legislation, the FDA Amendments Act of 2007 (FDAA Act). Speakers are confirmed! Pending state approval, Continuing Legal Education credits will be approved. Learn more about Introduction to Food and register online.
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A human resource recruitment tool
FDLI's Job Exchange offers members access to quality professionals in the food and drug industries. This service includes the opportunity to post job openings, view jobs posted, submit a resume, as well as view resumes posted. Job Exchange is updated regularly as new submissions are received. While posting resumes is complimentary, only FDLI Members can submit job postings for FREE.
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