Janssen gets FDA nod for type 2 diabetes drug | Novartis' plea for Glivec patent denied by Indian high court | India calls for notification before ending production of drugs
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April 1, 2013
FDLI SmartBrief
News for the food and drug law community

Drugs & Biologics
Janssen gets FDA nod for type 2 diabetes drug
The FDA has granted Janssen Pharmaceuticals approval for its type 2 diabetes drug Invokana. The drug, a sodium-glucose co-transporter 2 inhibitor, was the first of its class to gain federal approval. HealthDay News (3/29)
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Novartis' plea for Glivec patent denied by Indian high court
Western drugmakers suffered a major blow after the Indian Supreme Court rejected Novartis' petition for patent protection for its cancer treatment Glivec. The landmark ruling sets a reference point for other intellectual-property disputes in the country and is likely to affect many other drugmakers and their brand-name treatments, analysts say. Reuters (4/1)
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India calls for notification before ending production of drugs
Drugmakers will be required to notify regulators six months before ending the manufacture of essential treatments under India's Drug Price Control Order of 2013. The order also will include the maintenance of sales records for active pharmaceutical ingredients and bulk drugs. The Economic Times (India)/Press Trust of India (3/31)
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India considers price ceilings from the start
The Indian government is weighing limits on drugs prices as they reach market. A government official said drugmakers could be required to get a pricing OK before sales begin. "The idea is to ensure companies do not gold-plate drugs to exorbitantly increase prices while introducing those in the market," the official said. Business Standard (India) (4/1)
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Food & Dietary Supplements
Judge casts doubt on setting new FSMA deadlines
A federal judge in California questioned whether setting new deadlines for the Food Safety Modernization Act of 2010 would be less arbitrary and difficult to meet than those set by Congress. The Center for Food Safety and the Center for Environmental Health filed a lawsuit last year over the hundreds of deadlines that they say the FDA has not met as it works to implement the law, including setting up seven key food-safety regulations. FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said the agency has made progress, pointing to proposed rules for preventive controls in food facilities and for production and harvesting of vegetables and fruits. Food Product Design (3/29)
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CDC finds 24 cases of infection from E. coli outbreak
CDC officials announced Friday that 24 people became ill in an E. coli outbreak, with the STEC O121 strain detected in 15 states. Frozen-food products from Farm Rich could be the source of the outbreak, based on tests from the home of a New York patient, the CDC said. Reuters (3/29)
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Report urges FSIS to boost E. coli testing in boxed beef products
The USDA's Office of the Inspector General has released a report urging the Food Safety and Inspection Service to boost E. coli testing efforts for boxed beef products that are processed into tenderized steaks and ground beef. The OIG also detected data migration issues that occurred when FSIS changed over to its Public Health Information System that caused FSIS not to efficiently sample or evaluate ground beef and ground beef components. FoodSafetyNews.com (4/1)
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Study finds evidence of livestock-human MRSA transmission
Whole genome sequencing supports the conclusion that a type of methicillin-resistant Staphylococcus aureus can be transmitted from sheep to humans, according to a study in the journal EMBO Molecular Medicine. The study could lead to increased calls to limit the use of antibiotics in farm animals. FoodSafetyNews.com (3/29)
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Medical Devices
Federal court awards $176.5M to Covidien in patent suit
Ethicon Endo-Surgery, a unit of Johnson & Johnson, has been ordered to pay Covidien $176.5 million after a federal court ruled that Ethicon's Harmonic ultrasonic surgical devices infringed on certain claims of patents held by Covidien. Ethicon was reviewing the court's ruling and its options for appeal, a company spokeswoman said. Reuters (3/30)
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FDA labels Vascular's hemostasis valve recall as Class I
A recall initiated by Vascular Solutions involving its Guardian II and Guardian II NC hemostasis valves, which are used to stop blood loss during catheterization procedures, has been labeled as Class I by the FDA. The Minneapolis company recalled the products last month over concerns that air might enter the devices, which could cause an air embolism. MassDevice.com (Boston) (3/28)
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2013 conference calendar -- speak, register and save the dates!
There are plenty of speaking opportunities available for this year's FDLI conferences. Please e-mail our development team if you are interested in participating or have any session/program ideas. FDLI members routinely receive at least a 20% discount on FDLI conferences, webinars and publications. Upcoming programsinclude:
  • Introduction to Drug Law and Regulation | April 3-4 | Washington, D.C.
  • Introduction to Medical Device Law and Regulation | April 3-4 | Washington, D.C.
  • FDLI Annual Conference | April 23-24 | Washington, D.C.
  • China-U.S. Updates in Food and Drug Law | June 6-7 | Beijing, China
  • Advertising & Promotion Conference | Sept. 16-17 | Washington, D.C.
  • Food Advertising: Claims, Litigations and Strategies | Oct. 8 | New York City
  • FDA Regulation of Tobacco Products | Oct. 17 | Washington, D.C.
  • Enforcement, Litigation and Compliance | Dec. 10-11 | Washington, D.C.
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Who's Hiring?
Position TitleCompany NameLocation
CounselVerto Solutions, LLCWashington DC, DC
Director, Drug Safety & InnovationThe Pew Charitable TrustsWashington, DC
Associate General Counsel - RegulatoryUCB, Inc.Atlanta, GA
FDA/Healthcare AssociateArnold & Porter LLPWashington, DC, DC
Click here to view more job listings.
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-- Napoleon Bonaparte,
French military and political leader
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