Biosecurity Briefing: NIAID, BARDA awarded contracts to develop a next generation anthrax vaccine, as well as two contracts for development of a multivalent Ebola and Marburg vaccine.
Tue, 07 Oct 2008 15:55:10 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-10-06-niaidbardavaccontracts.html
Biosecurity Briefing: HHS announced that the dept. has called for 2 measures to prepare for an anthrax attack--issue kits containing antibiotics for postal workers and liability protections for private sector businesses engaged in some cntr. measures.
Mon, 06 Oct 2008 21:02:38 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-10-06-hhsprepanthrax.html
Biosecurity Briefing: On September 3, 2008, Emergent BioSolutions, Inc., announced that it had been awarded a $24.3 million contract to develop its anthrax monoclonal antibody AVP-21D9. The contract was awarded jointly by BARDA and NIAID.
Biosecurity Briefing: The Times of India reported that a company in India has imported 200 doses of Biothrax, the only anthrax vaccine approved by the FDA. Xinhua News Agency reported that neighboring Bangladesh is expanding its bird flu prep programs.
Fri, 13 Jun 2008 20:45:39 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-06-13-indiaanthrxvacbangladesh.html
Biosecurity Briefing: Drug Industry Daily news reports the FDA approved Levaquin (levofloxacin) for use in pediatric patients who have been exposed to Bacillus anthracis. This is the first and only pediatric indication for Levaquin.
Fri, 16 May 2008 19:23:46 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-05-16-fdaapprovantimicrobialpedathrax.html
Biosecurity Briefing: CQ Politics reported that the HHS released a request for proposals (RFP) for development of a new anthrax vaccine. The RFP requires 25 million doses of a vaccine that can be administered in only three doses.
Mon, 10 Mar 2008 14:57:04 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-03-07-hhsrfpanthraxvac.html
Biosecurity Briefing: The Human Genome Sciences, Inc., (HGSI) announced results from two animal studies of its treatment drug, ABthrax (raxibacumab) that "...demonstrate a survival benefit in two animal species..."
Fri, 21 Dec 2007 19:29:24 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/content/anthrax/2007-12-21-studyabthraxprotectsmonkeysrabbits.html
Biosecurity Briefing: The Dept of HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) posted a draft request for proposal for Anthrax recombinant Protective Antigen (rPA) vaccine for the Strategic National Stockpile.
Mon, 03 Dec 2007 17:28:48 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-11-30-hhsissuesdraftrfprpaanthraxvac.html
Biosecurity Briefing: The House Committee on Homeland Security expressed disappointment regarding the pace with which the agency has moved toward the development and procurement of a recombinant protective antigen anthrax vaccine.
Biosecurity Briefing: According to a study in Infection and Immunity, anthrax vaccine with a new adjuvant administered nasally provided guinea pigs greater protection against lethal doses of anthrax than the standard vaccine administered by injection.
Fri, 24 Aug 2007 21:03:00 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/content/2007/2007-08-24-studyshowsnewadjuvantprotectagainstanthrax.html
Biosecurity Briefing: SIGA Tech. received an award from NIAID to accelerate development of its smallpox antiviral drug ST-246. SRI Intl announced DoD�s DTRA awarded contract to facilitate preclinical research in developing broad spectrum antibiotics.
Biosecurity Briefing: SIGA Technologies, Inc., announced that NIAID and HHS BARDA awarded the pharmaceutical company a $55 million contract to fund the development of additional formulations and smallpox-related indications for its antiviral drug ST-246.
Biosecurity Briefing: Reuters reported that British vaccine developer Acambis won a $425 million, 10-year contract to supply the U.S. govt with 9 million doses of the ACAM2000 smallpox vac. each year for delivery to the Strategic National Stockpile.
Biosecurity Briefing: A study published in the October 9, 2008, issue of the New England Journal of Medicine evaluates the Novartis H5N1 influenza vaccine, which employs a prime-boost strategy to induce immunity.
Mon, 27 Oct 2008 20:55:28 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-10-27-novartish5n1vacwithh5n3vac.html
Biosecurity Briefing: GSK results of trials for its pre-pandemic H5N1 vaccine Prepandrix. Vaxin, Inc., announced NIH awarded grant for ongoing development of avian flu vac for poultry. XOMA, Ltd., announced establishment of a MOU with Texas A&M System.
Biosecurity Briefing: CDC survey assessed factors that affect the knowledge regarding H5N1 in Afghanistan. Novavax, Inc. announced positive results from the 2nd stage of human clinical trial of its pandemic flu virus-like particle vac candidate.
Biosecurity Briefing: On August 15, 2008, the World Health Organization (WHO) issued a report indicating that clinical samples from the 2008 influenza season provide evidence of a high degree of resistance to the antiviral drug oseltamivir (Tamiflu).
Mon, 25 Aug 2008 16:32:51 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-08-25-whooseltamivirresistsohemisphere.html
Biosecurity Briefing: Biomedical Advanced Research and Development Authority (BARDA) announced a RFP for an egg-based inactivated monovalent H5N1 vaccine at commercial scale for inclusion in the Strategic National Stockpile.
Biosecurity Briefing: Australia approves H5N1 vaccine Panvax, developed by CSL Limited; Sanofi to donate to WHO stockpile to help poor countries; HHS contracts to develop low-cost rapid diagnostic tests for influenza.
Fri, 20 Jun 2008 20:38:02 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-06-20-h5n1newsaustraliasanofihhs.html
Biosecurity Briefing: NEJM published results from a randomized clinical trial of whole virus H5N1 avian flu vac that was produced in cell-culture. Two doses of unadjuvanted vac produced evidence of a positive immune response for 3 clades of H5N1 virus.
Fri, 20 Jun 2008 20:19:16 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-06-20-positiveresultsh5n1vac.html
Biosecurity Briefing: A Reuters article describes Indonesia's new avian influenza reporting policy, which will now require human cases of avian influenza to be reported once every six months rather than immediately upon recognition.
Fri, 13 Jun 2008 21:00:17 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-06-13-indonesiareducesh5n1reportng.html
Biosecurity Briefing: On May 16, 2008, the World Health Organization (WHO) released a document that discusses options for human use of H5N1 influenza vaccine as well as options for use of the WHO H5N1 vaccine stockpile.
Fri, 23 May 2008 19:55:13 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-05-23-whoguideh5n1vacstock.html
Biosecurity Briefing: The Associated Press reported that GlaxoSmithKline has been granted a marketing license by the European Commission to begin distributing the first "pre-pandemic" influenza vaccine to hit the European market.
Fri, 23 May 2008 19:40:34 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-05-23-eulicenseprepanfluvac.html
Biosecurity Briefing: CIDRAP reported that the HHS purchased $192.5 million worth of clade 2.2 H5N1 vaccine from sanofi pasteur. The purchase will provide 6.4 to 38.5 million doses of the vaccine to the Strategic National Stockpile (SNS).
Mon, 05 May 2008 16:20:01 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/2008-05-02-hhsspends192mh5n1vaccine.html
Biosecurity Briefing: Reuters reported that Iomai, a small Gaithersburg, MD, biotechnology company, received "U.S. [Department of Health and Human Services] approval..." to begin phase II clinical trials testing "a bird flu skin patch on more people."
Biosecurity Briefing: The European Medicines Agency, equivalent of U.S. FDA, announced that it recommends "the authorization of...[Europe's] first 'pre-pandemic vaccine' for humans against influenza caused by the H5N1 virus."
Mon, 10 Mar 2008 16:20:39 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-03-07-1stprepanfluvaceulicense.html
Biosecurity Briefing: CDC reports seasonal flu more severe than last 2 years and a mismatch between this year's vac and two of predominant strains of flu. Europe reports unexpected emergence of H1N1 virus with a decreased sensitivity to oseltamivir.
Tue, 19 Feb 2008 15:31:18 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-02-15-fluvacmismatchresisteurope.html
Biosecurity Briefing: On January 29, 2008, the International Vaccine Institute (IVI) reported the results of a study that examines a new way of delivering influenza vaccines: sublingually, or under the tongue.
Fri, 01 Feb 2008 20:40:49 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-02-01-newundertonguefluvacstudy.html
Biosecurity Briefing: The European Centre for Disease Prevention and Control reported that "some of the A (H1N1) viruses in circulation this winter are resistant to the antiviral drug oseltamivir (also know by the brand name Tamiflu)."
Fri, 01 Feb 2008 20:39:52 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/international_biosecurity/2008-02-01-tamifluresistancefound.html
Biosecurity Briefing: PATH, an international, non-profit organization, announced a $39 million award from the Bill & Melinda Gates foundation to launch the rapid development of flu vaccines and "innovative vaccine technologies" for developing nations.
Tue, 22 Jan 2008 13:35:13 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-01-18-gatesawardsmillionsfluvac.html
Biosecurity Briefing: BBAcambis has reported positive results from phase I clinical trials of its new flu vaccine. The FDA announced that "a test that simultaneously detects and identifies 12 specific respiratory viruses" has been cleared for marketing.
Fri, 11 Jan 2008 19:57:39 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/2008/2008-01-11-fluvactrials.html
Biosecurity Briefing: CIDRAP at the Univ. of Minnesota reported that the FDA's Pediatric Advisory Committee voted to recommend stronger language on warning labels of two antiviral flu medications, oseltamivir (brand name Tamiflu) and zanamivir.
Mon, 03 Dec 2007 17:51:12 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/avian_pandemic_flu/content/2007/2007-11-30-fdavotesstrongerwarnfludrugs.html
Biosecurity Briefing: HHS Secretary Mike Leavitt announced that the agency has established a public health advisory board to provide guidance on chemical, biological, radiological and nuclear (CBRN) threats. He also announced contracts for flu vaccine.
Fri, 22 Jun 2007 20:36:01 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-06-22-hhscbrnadvisorybrdvaxcontracts.html
Biosecurity Briefing: NIAID, BARDA awarded contracts to develop a next generation anthrax vaccine, as well as two contracts for development of a multivalent Ebola and Marburg vaccine.
Tue, 07 Oct 2008 15:55:10 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-10-06-niaidbardavaccontracts.html
Biosecurity Briefing: SIGA Tech. received an award from NIAID to accelerate development of its smallpox antiviral drug ST-246. SRI Intl announced DoD�s DTRA awarded contract to facilitate preclinical research in developing broad spectrum antibiotics.
Biosecurity Briefing: Advanced Life Sciences announced the award of a contract from the U.S. Dept of Defense Defense Threat Reduction Agency for advanced development of the antibiotic cethromycin as a potential broad-spectrum medical countermeasure.
Mon, 18 Aug 2008 14:38:59 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-08-18-dtracontractcethromycin.html
Biosecurity Briefing: Emergent BioSolutions, Inc., announced it has been awarded two grants from NIAID for the development of botulism and next-generation anthrax vaccine candidates. AP reported that sanofi-aventis will acquire vaccine-maker Acambis PLC.
Mon, 04 Aug 2008 16:15:47 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/other/2008-08-04-emergentniaidsanofiacambis.html
Biosecurity Briefing: The FDA issued a news release announcing a change in the format of letters that are sent to pharmaceutical companies to inform them of the FDA's decision regarding licensure of pharmaceutical products.
Biosecurity Briefing: HHS announced that the Annual Report to Congress on Project BioShield had been released. This Congressionally mandated report covers progress for the period from August 2006 through July 2007.
Biosecurity Briefing: CNW reported that Canadian pharmaceutical company Cangene made a large delivery of botulism antitoxin (BAT) to the U.S. government, intended for integration into the U.S. Strategic National Stockpile (SNS).
Fri, 13 Jun 2008 21:05:46 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/countrmeasr_dev/2008/2008-06-13-cangenebotulismantitox.html
Biosecurity Briefing: On April 14, 2008, the U.S. Department of Health and Human Services (HHS) issued a press release naming Robin Robinson, Ph.D. as the first director of the Biomedical Advanced Research Development Authority (BARDA).
Biosecurity Briefing: The Proceedings of the National Academy of Sciences (PNAS) published a study describing the generation of a new research strain of Ebola virus which would be "safe" to handle "outside of a biosafety level-4 facility."
Mon, 28 Jan 2008 14:56:30 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/agents_diseases/vhf/2008-01-25-ebolasafelaboratories.html
Biosecurity Briefing: HHS Secretary Michael Leavitt officially announced the 13 voting members of the National Biodefense Science Board (NBSB). It met for the first time from December 17-18 in Washington, DC.
Fri, 21 Dec 2007 19:16:48 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-12-21-natlbiodefensescienceboard.html
Biosecurity Briefing: A recent report issued by the FDA Science Board's Subcommittee on Science and Technology has concluded that FDA can no longer fulfill its mission without substantial and sustained additional appropriations.
Fri, 07 Dec 2007 14:01:00 GMThttp://www.upmc-biosecurity.org/website/biosecurity_briefing/archive/govt_response/content/2007-12-07-comrprtsfdainsufficientresources.html
Biosecurity Briefing: A paper published PLoS Medicine suggests that infection rates during a flu pandemic could be reduced if more people were vaccinated with lower doses of vaccine rather than if a lesser number of people are vaccinated with full doses.