Sanofi's Menactra gets FDA nod as booster for meningococcal disease | Novo Nordisk drug wins FDA panel support for obesity | Ex-pharmacist in compounding case appears in court
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September 12, 2014
FDLI SmartBrief
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Drugs & Biologics
Sanofi's Menactra gets FDA nod as booster for meningococcal disease
Sanofi Pasteur has received the FDA's approval to use its Menactra vaccine as a booster against meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135, in patients 15 to 55. The FDA based its decision on data from an open-label study that backed the safety and immunogenicity of the Menactra booster dose in people who were given the shot four to six years prior. Medscape (free registration) (9/11) Share: Email
Novo Nordisk drug wins FDA panel support for obesity
An FDA advisory panel has recommended the approval of Novo Nordisk's injectable drug liraglutide for the treatment of obesity, saying the drug's benefits surpass its risks. The panel said the drug should be cleared for use in people with a body mass index of 30 or more, or those with a BMI of 27 or higher with at least one weight-related health problem. The drug, already cleared for diabetes treatment as Victoza, will be marketed as Saxenda if approved for obesity. Philly.com (Philadelphia)/The Associated Press (9/11), Reuters (9/11) Share: Email
Ex-pharmacist in compounding case appears in court
A former pharmacist at the New England Compounding Center faces criminal charges tied to a deadly meningitis outbreak in 2012. Prosecutors say the man knew the 17,000 vials of compounded back pain medication had not been properly sterilized or tested but shipped them anyway. Reuters (9/11) Share: Email
Lawmaker eyes tighter rules to curb Rx drug addiction in Mass.
Massachusetts state Sen. Anthony Petruccelli said recently passed legislation meant to curb prescription drug abuse allows the commissioner of the Department of Public Health to require prescribers to conduct risk assessments, check the Prescription Monitoring Program and assess the prescription history of patients. "We looked to assemble a package that would increase opportunities for both short- and long-term substance abuse recovery, and support a continuum of care," Petruccelli said. East Boston Times-Free Press (Mass.) (9/11) Share: Email
Global Focus
Advanced intraocular lens from AcuFocus gets CE mark
Regulators in Europe have given AcuFocus the CE mark for its IC-8 intraocular lens, designed to treat presbyopia in patients with cataracts. The company is preparing for a limited launch of the next-generation device in Europe. MassDevice.com (Boston) (9/11) Share: Email
Food & Dietary Supplements
Food producers slapped with FDA warning letters
The FDA issued warning letters this month to four food manufacturers for suspected safety violations. The letters went to M&B Sea Products of Massachusetts, Modern Macaroni of Hawaii and Japanese Specialty Food Distributors in Connecticut for allegedly violating the Hazard Analysis and Critical Control Points regulation for seafood. Ipsi Specialty Foods in Nebraska received a warning for failing to register as a commercial acidified foods processor with the FDA. Food Poisoning Bulletin (9/11) Share: Email
Recall of Vinh Fat Food frozen pork products updated in Canada
Possible contamination with E. coli O157:H7 prompted the Canadian Food Inspection Agency to update its recall of Pork Wontons, Pork Buns and Pork Spring Rolls from Vinh Fat Food Products. Those pork products with selling dates between July 10 and Sept. 8 are included in the recall. The products were sold in Alberta. Food Poisoning Bulletin (9/11) Share: Email
Medical Devices
FDA clears balloon catheter from Medtronic
The FDA has given Medtronic 510(k) clearance to market the NC Euphora balloon catheter. The device is used to help ensure proper positioning of drug-eluting coronary stents post-implantation. MassDevice.com (Boston) (9/11) Share: Email
Device used during MRI-based brain surgery wins FDA nod
IMRIS has secured 510(k) clearance from the FDA to market its HFD rocker arm, which is used in conjunction with the firm's VISIUS surgical theater. The device is designed to enable doctors to stabilize the patient's head when performing intraoperative MRI-based neurological surgery. FDAnews (9/11) Share: Email
Tobacco
S. Korea makes multiple moves to curb smoking
A plan to raise tobacco prices in South Korea to around $4.30 per pack starting next year was announced Thursday by the government. Minister of Health and Welfare Moon Hyung-pyo unveiled comprehensive nonsmoking measures, including linking tobacco taxes to inflation so prices consistently rise. Nonpricing policies will also be enforced by the government, including a ban on tobacco advertising at retailer stores and graphic health warnings on cigarette packs. Maeil Business Newspaper (South Korea) (9/11) Share: Email
FDLI Items
Rep. Henry Waxman just confirmed -- 30th Anniversary Hatch-Waxman Conference, Sept. 18
FDLI is pleased to announce that Rep. Henry Waxman, D-Calif., will be the keynote speaker at our upcoming meeting, celebrating the 30th anniversary of the Hatch-Waxman amendments. You'll want to hear how Rep. Waxman views the implementation of the historic law he authored three decades ago. You'll also want to be there, along with dozens of your colleagues, to find out what William B. Schultz, general counsel of the U.S. Department of Health and Human Services, thinks about this landmark legislation. Attend this conference and learn why the Act was passed, current FDA and industry developments, and ongoing brand-generic issues. Reserve your seat at this historic event. Share: Email
Receive a free digital copy of our Tobacco Primer with registration!
On Oct. 20, at the Hotel Monaco in Washington, D.C., FDLI will be offering its first-ever Introduction to Tobacco course. Our faculty will provide unbiased and practical information on the Tobacco Control Act, the FDA's approach to regulating tobacco products, substantial equivalence, harm reduction efforts, and the regulation of e-cigarettes, cigars and smokeless tobacco. BONUS: All attendees will receive a free digital copy of FDLI's Tobacco Primer with registration! Share: Email
Who's Hiring?
Position TitleCompany NameLocation
Senior or Principal ConsultantPAREXEL InternationalNationwide, United States
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Assistant General Counsel, RegulatoryCardinal HealthWaukegan, IL
Senior Counsel, Regulatory (FDA)CareFusionSan Diego , CA
Sr Manager, Business ConductGilead SciencesFoster City, CA
Counsel II, Legal (Anti-corruption) Gilead SciencesFoster City, CA
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SmartQuote
You learn so much from taking chances, whether they work out or not. Either way, you can grow from the experience and become stronger and smarter."
-- John Legend,
American singer and songwriter Share: Email
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