Most Clicked FDLI SmartBrief Stories
1. Amphastar-Momenta rivalry regarding generic heparin intensifies
FDLI SmartBrief | Nov 02, 2009
Sens. Max Baucus, D-Mont., and Chuck Grassley, R-Iowa, launched an investigation into Amphastar Pharmaceuticals' hiring of security company Kroll, as the drugmaker competes with Momenta Pharmaceuticals to gain FDA approval for a generic version of low-molecular-weight heparin. Amphastar's general counsel said the company asked Kroll to look into a possible conflict of interest between Janet Woodcock, head of the FDA's drug unit, and a co-founder of Momenta. Wall Street Journal, The (11/02)
2. IVAX, Omnicare settle kickback allegations regarding Risperdal
FDLI SmartBrief | Nov 04, 2009
IVAX Pharmaceuticals and Omnicare agreed to resolve allegations that they solicited kickbacks in exchange for encouraging doctors to prescribe Johnson & Johnson's antipsychotic Risperdal to patients at nursing homes, the Justice Department said. Omnicare, which will pay $98 million, denied wrongdoing despite the settlement. Reuters (11/03)
3. FDA program to curb medication errors
FDLI SmartBrief | Nov 05, 2009
The FDA plans to better prevent errors in dosing and dispensing of pharmaceuticals through the Safe Use program. As part of the program, the agency released guidance on dosage for makers of over-the-counter drugs that come with droppers or other dosing devices. CNN (11/04) Washington Post, The (11/04)
4. FDA decides against Lipitor-Zetia combo
FDLI SmartBrief | Nov 03, 2009
The FDA rejected an application to market cholesterol drugs Lipitor and Zetia as a combination treatment because of a lack of manufacturing and stability data. Merck & Co., which developed Zetia with Schering-Plough, said it is reviewing the complete-response letter "to determine a new timetable for filing." Wall Street Journal, The (11/02)
5. FDA approves osteoarthritis drug from Nuvo Research
FDLI SmartBrief | Nov 06, 2009
Canadian biotech firm Nuvo Research gained FDA approval for Pennsaid, a topical pain treatment for osteoarthritis of the knee. Nuvo and partner Covidien plan to introduce the product in the U.S. in the first half of 2010. Reuters (11/05)
6. Amgen accused of giving kickbacks to boost Aranesp sales
FDLI SmartBrief | Nov 02, 2009
Fifteen states sued Amgen for allegedly bribing health care providers to bill insurers for anemia drug Aranesp, leading to overpayment from Medicaid and private insurance companies. The claims are without merit, Amgen said, and it is prepared "to examine these matters with the states before the court." Los Angeles Times (10/31)
7. Senate sunshine provisions would shed light on doctor-industry ties
FDLI SmartBrief | Nov 04, 2009
The Senate Finance Committee has included in its health reform proposal so-called sunshine provisions that would promote transparency among drug and medical device makers that pay doctors for consultations and speeches. AdvaMed backed the sunshine initiative, and the Pharmaceutical Research and Manufacturers of America said any laws on payment disclosures should not imply that doctor-industry ties are inappropriate. New York Times, The (11/03)
8. Tainted beef might be tied to 2 deaths
FDLI SmartBrief | Nov 03, 2009
Officials with the U.S. Centers for Disease Control and Prevention say E. coli bacteria in fresh ground beef products may have caused two deaths and 28 people in Northeastern states to fall ill. Ashville, N.Y.-based Fairbank Farms has recalled the beef. Wall Street Journal, The (11/02) Reuters (11/02)
9. Reducing salt intake might protect bone health
FDLI SmartBrief | Nov 04, 2009
By reducing sodium consumption, people can reduce the amount of calcium they secrete and may be able to boost bone health. According to a study, moderate reduction also can have a positive affect in reducing blood pressure. FoodNavigator (11/02)
10. 3 restraining orders placed on ZymoGenetics regarding Recothrom
FDLI SmartBrief | Nov 05, 2009
A federal court in Tennessee granted three temporary restraining orders against ZymoGenetics, preventing it from marketing Recothrom, a drug used to control hemorrhage. The orders came after King Pharmaceuticals and three other firms filed a lawsuit accusing ZymoGenetics of unfair competition and false advertising, among other claims. In a regulatory filing, the biotech firm denied wrongdoing and said it plans to "vigorously defend" itself against the allegations. American City Business Journals (11/04)
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