Drugs & Biologics

• FDA review: Long-acting asthma drugs pose serious risks
  The FDA should revoke clearance for asthma drugs known as long-acting beta agonists for children in light of clinical evidence linking them to a higher risk of asthma attacks and death, according to a review from the agency's drug-safety personnel. The FDA plans to gather a panel of outside experts this week to evaluate the safety of AstraZeneca's Symbicort, Novartis AG's Foradil and GlaxoSmithKline's Advair and Serevent. NYTimes.com (12/5), Reuters (12/5)

• FDA analysis raises concerns about Synvisc-One trial
  FDA staff expressed concerns about Genzyme's study of Synvisc-One, a single-dose version of its injectable treatment for osteoarthritis of the knee, saying it was conducted in a small population and did not undergo adequate agency evaluation because it took place in Europe. The review, however, said the medicine seems as safe as the older formulation. An advisory committee will meet Tuesday to consider Synvisc-One for approval. Reuters (12/5)

• Bayer faces lawsuit over anti-bleeding drug Trasylol
  Canadian attorneys filed a lawsuit against Bayer and related firms on behalf of the family of a 67-year-old woman whose fatal heart attack after surgery in 2003 was allegedly caused by Trasylol, an anti-bleeding medication. The class-action suit claims that Bayer did not sufficiently warn doctors and patients about the drug's risks. Bayer officials said they "have not been notified of any legal action in Canada." CTV.ca (Canada) (12/7)

• Court drops 1 of 3 Boniva patent claims against Dr. Reddy's
  A district court in New Jersey concluded that Dr. Reddy's Laboratories did not infringe on one of Hoffmann-La Roche's patents for Boniva, a once-monthly treatment for osteoporosis. A Dr. Reddy's spokesman said the firm is still "in litigation for two other listed patents." Despite the court ruling, it remained unclear whether Dr. Reddy's can launch its version earlier than planned. The Economic Times (India) (12/8)

Biotechnology

• Groups urge Chinese community in Canada to donate stem cells
  SUCCESS, a Chinese immigrant organization in Canada, teamed up with the Canadian Blood Services as well as the OneMatch Stem Cell and Marrow Network for an information session held Sunday that was aimed at encouraging the Chinese community in the country to contribute stem cells. Only 17% of registered stem cell donors in Canada come from ethnic backgrounds, and fewer than 5% have Asian ancestry. CBC.ca (Canada) (12/7)

• Government agency chooses Kansas to house biodefense lab
  The Department of Homeland Security has selected Kansas State University to be the site of its $450 million National Bio and Agro-Defense Facility. The research center, which will focus on livestock ailments and biological dangers, is expected to give the state's economy a significant boost. Texas and Mississippi, however, are thinking about challenging the agency's decision. The Guardian (London)/The Associated Press (12/8)

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Food & Dietary Ingredients

• FDA official: Texas incident involving biotech cotton not a safety risk
  An experimental cotton seed from Monsanto that was bioengineered to generate a pesticide-producing protein was mistakenly combined with commercial cotton in Texas in October, but authorities said the incident is not linked to safety risks. An FDA senior adviser said animal feed produced from the harvested crop containing the biotech cotton was used at cattle-feed lots. Amarillo Globe-News (Texas)/The Associated Press (12/7)

• U.S. and China agree on free trade, U.S. agriculture secretary says
  U.S. Agriculture Secretary Ed Schafer, urging action on a world trade agreement, said the U.S. and China agree on the need to resist protectionist farm tariffs. "We pledged as two of the world's largest agricultural producers to encourage the rest of the world to back away from protectionism," he said. The News & Observer (Raleigh, N.C.)/The Associated Press (12/6)

• Melamine standards may need tightening
  Standards on melamine in food may need to be tightened in the U.S. and Europe after a panel recommended more stringent controls on the contaminant, which has been linked to sickness and death in China. The guideline set at a World Health Organization meeting is 0.2 milligrams per kilogram of body weight. It is currently 0.63 mg in the U.S., 0.5 mg in Europe and 0.35 mg in Canada. Bloomberg (12/6)

Medical Devices

• Official: FDA uses risk-based approach for device-trial inspections
  The FDA is using a quantitative risk-based strategy as an early intervention in evaluating clinical trials of medical devices, said an official with the Center for Devices and Radiological Health. This method involves small and medium-sized institutional review boards as well as those "that have never been inspected or not in a very long time," the official said. FDAnews (12/5)

Hot Topics

Top five news stories selected by FDLI SmartBrief readers in the past week.

• KV Pharmaceutical faces lawsuit from shareholders (American City Business Journals)

• Concerns arise about studies conducted overseas (The Wall Street Journal (tiered subscription model))

• Final report: Artificial chemical contaminated Chinese heparin (U.S. News & World Report)

• FDA staff: Solvay's enzyme pill has pig-virus risks (AlertNet)

• Lawmaker calls for "complete change" in FDA leadership (The Wall Street Journal (tiered subscription model))

• Results based on number of times each story was clicked by readers.

FDLI Items

• Acheson, Levitt and other food experts to discuss what the food industry can expect from FDA during the new administration. Register for the audioconference, New Administration Forecast, Dec. 15, 1 p.m. to 2:30 p.m. EST
  An elite panel of speakers, including David Acheson, Alison Kretser, Stuart Pape and Bruce Silverglade, with moderator Joseph Levitt, will make their forecasts on what to expect in the areas of food safety legislation, new funding for FDA, consumer protections and activities in the nutrition area. Read the article on FDA's food safety campaign featured in the Dec. 1 SmartBrief. Learn more about the audioconference. Register online. Register by fax.

• Call for sessions: FDLI's 52nd Annual Conference, April 22 to 23, 2009
  You are invited to submit a proposal for a 90-minute, concurrent session scheduled during FDLI's Annual Conference in Washington, D.C. The theme for this Annual Conference is "Opportunities and Challenges Facing FDA and New Administration." Your submission is to include a title, two- to three-sentence description and proposed participants. Submit your proposal to smg@fdli.org no later than Dec. 19, using the subject line: Call for Sessions. Proposal submission does not guarantee selection. FDLI will review submissions and consider how proposed sessions complement the Annual Conference. You will be notified if your session has been selected.

Associate General Counsel - Regulatory Cardinal Health San Diego, CA Corporate Counsel Genentech South San Francisco Director, Compliance Salix Pharmaceuticals Raleigh, NC

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