NEWS SCAN: FDA comment request, new drug for C difficile , anthrax vaccine order, Ebola vaccine partnership

May 27, 2011

FDA requests comments on food safety controls
The US Food and Drug Administration (FDA) said yesterday that it is seeking public comments on prevention control measures for food facilities, a request based on provision of the FDA Food Safety Modernization Act that was signed into law in January. In a press release, the FDA said the new law requires food and feed facilities to assess their food safety hazards and identify and implement preventive controls. The FDA is asking stakeholders to weigh in on what control measures are appropriate and workable. It said it will consider the feedback as it develops guidance. Comments are due electronically or in writing by Aug 22.
May 26 FDA request for comment press release
In another development yesterday, the FDA announced that it launched a Web portal to disclose more information on inspections and court actions. It said in a statement that the move is part of a transparency initiative launched in 2009 to make information on FDA actions easier to access, download, and search. The FDA said the Web portal contains more information on company practices that could be a threat to public health, recalls, and inspection findings.
May 26 FDA transparency press release
FDA compliance and enforcement Web portal

FDA approves new C diff drug
The FDA today approved a new treatment for Clostridium difficile–associated diarrhea (CDAD). The drug fidaxomicin (Dificid) is a macrolide antibiotic made by Optimer Pharmaceuticals, based in San Diego, that is taken two times a day for 10 days, with or without food. In a May 12 press release the company said fidaxomicin is the first new antibiotic for C diff infections in nearly 30 years. The FDA said in a statement that two safety and efficacy trials of the drug, which included 564 patients with CDAD, compared the new drug with vancomycin, commonly used to treat the condition. Response was similar in both studies, but a greater number of patients taking fidaxomicin had sustained improvement 3 weeks after treatment ended compared with the vancomycin group. Recurrent diarrhea is common in some CDAD patients. The FDA said to maintain the new drug's effectiveness and reduce the development of drug-resistant infections, fidaxomicin should be used to treat only confirmed or strongly suspected C diff infections.
May 27 FDA press release
May 12 Optimer press release

US government to buy 45 million more doses of anthrax vaccine
The US government has announced its intention to buy 44.75 million doses of BioThrax (Anthrax Vaccine Adsorbed) from its maker, Emergent BioSolutions, the company said in a press release yesterday. The vaccine doses will be added to the Strategic National Stockpile over 5 years. BioThrax is the only anthrax vaccine licensed by the US Food and Drug Administration. Emergent, of Rockville. Md., said it anticipates finalizing a contract with the federal government during the third quarter of 2011. On May 7 the company announced it had already sold 17.92 million doses to the government. In a press release that day, Emergent stated that 3.42 million doses of BioThrax are worth up to $101 million. Projecting from that, today's announced order could be worth up to $1.3 billion.
May 26 Emergent press release
May 7 Emergent press release

Medicago, USAMRIID to collaborate on VLP Ebola vaccine candidate
Biotechnology company
Medicago Inc. yesterday announced that it has begun a research collaboration with the US Army Medical Research Institute of Infectious Diseases (USAMRIID) to develop a plant-based virus-like-particle (VLP) vaccine for preventing Ebola fever. No vaccine currently exists for Ebola, which causes an often-fatal hemorrhagic fever. Louis Vezina, Medicago's chief scientific officer, said in a release, "Our expertise in the development of VLP vaccines using our transient expression system, coupled with USAMRIID's experience and knowledge, creates an ideal combination for the rapid development of a new generation of efficacious and competitive VLP vaccines."
May 26 Medicago press release

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