Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 PDP FUNDERS GROUP Items in blue or purple should be hyperlinked to the full text version; if I have made mistakes many apologies. If you have any issues that you would like to include in the Update please send them to Jane Rowley ([email protected]). FUNDER ANNOUNCEMENTS (SINCE NOVEMBER 1, 2012) Australia - AUSAID 2 November 2012: Australian leadership to fight malaria and save lives Foreign Minister Bob Carr today announced Australia will spend more than $100 million over the next four years to help reduce deaths and illness from malaria in the Asia-Pacific region. Senator Carr announced the funding at Malaria2012: Saving Lives in the Asia Pacific conference in Sydney. … Australia's funding for malaria includes support for several country and regional programs, including $14.5 million to address drug resistant malaria control and elimination activities in the Mekong and over $20 million for malaria programs in Solomon Islands, Vanuatu and Papua New Guinea. Australia will also provide $10 million for malaria research as the first investment under the aid program's new Medical Research Strategy. Senator Carr recently announced the appointment of Mr James Gilling as Australia's Ambassador for HIV/AIDS, Tuberculosis and Malaria. This appointment reflects Australia's focus on the major health challenges facing the region. The World Health Organisation's Defeating Malaria in the Americas, Europe, the Middle East, Asia and the Pacific Report was also launched at the conference. US - NIH 28 November 2012: HIV treatment reduces risk of malaria recurrence in children A combination of anti-HIV drugs has been found to also reduce the risk of recurrent malaria by nearly half among HIV-positive children, according to researchers supported by the National Institutes of Health. The combination of protease inhibitors lopinavir and ritonavir contributed to an overall reduction of 40 percent in the rate of malaria among a group of HIV-positive infants and children up to 6 years old in Uganda who were also being treated with anti-malarial drugs. This reduction was in comparison to malaria incidence among children receiving a drug treatment of one of a class of drugs called nonnucleoside reverse transcriptase inhibitors (NNRTIs). Protease inhibitors interfere with the reproduction of HIV by blocking the protease enzyme of HIV. The protease inhibitor combination used in the study did not appear to inhibit an initial bout of malaria — but reduce the chances of a recurrence of the disease following a successful treatment. The researchers found that blood levels of anti-malarial drugs were higher in children who had received the protease inhibitors, which may help explain their effectiveness at preventing malaria's return. … Wellcome Trust 12 November 2012: Candidate vaccine reduces malaria by approximately one-third in African infants Results from a large-scale clinical trial, published in the ‘New England Journal of Medicine’, have shown that a new candidate vaccine being developed by GlaxoSmithKline (GSK) can help protect African infants against malaria. Infants aged 6-12 weeks who received the candidate vaccine RTS,S had one-third fewer episodes of clinical malaria - including one-third fewer severe episodes - than infants who received a control vaccine. In terms of side-effects, reactions to the two vaccines were similar. The trial was conducted at 11 research centres in seven African countries, including at the KEMRIWellcome Trust Research Programme, one of the Wellcome Trust's Major Overseas Programmes. The UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 trial was carried out together with GSK and the PATH Malaria Vaccine Initiative (MVI), with funding from the Bill & Melinda Gates Foundation to MVI. … 15 November 2012: Common enzyme deficiency may hinder plans to eradicate malaria A Wellcome Trust-funded study estimates that around 350 million people living in malaria-endemic countries are deficient in an enzyme that means they can suffer severe complications from taking primaquine, a key drug for treating relapsing malaria. This finding is important because primaquine is recommended in the global action plan to eliminate malaria and is the only drug to prevent malaria relapse. The study, funded by the Wellcome Trust, suggests that the benefits of implementing a treatment programme with this drug need to be weighed against the potential harm to a substantial proportion of the population. People who have a deficiency in the enzyme glucose-6-phosphate dehydrogenase (G6PD) experience severe complications in response to treatment with primaquine, caused by the breakdown of their red blood cells. The deficiency is caused by a mutation in the gene for the enzyme. … 22 November 2012: Three-year study searches for new biological markers to measure parasite clearance in Chagas' disease The Drugs for Neglected Diseases initiative (DNDi) has received a £1.9 million Strategic Translation Award from the Wellcome Trust to identify new biological markers for the evaluation of treatment efficacy in Chagas’ disease, a potentially fatal neglected tropical disease. … The funding from the Wellcome Trust will be used to conduct the first large-scale study involving treatment of non-human primates (macaques) who were naturally infected with the parasite that causes Chagas' disease while living in an outdoor environment. The animals will be treated with three different drug regimens compared with placebo and tested for clearance of the parasite over a period of 12 months after treatment using a range of blood tests. The primary goal of the study is to see whether these tests can accurately measure parasitological cure. … PDP PRESS RELEASES (SINCE NOVEMBER 1, 2012) DNDi 8 November 2012: International Medical Conference to Assess Progress and Shortcomings of Global Health Revolution for Neglected Patients Meeting the lifesaving needs of people left behind by the global health revolution will be the focus of a major medical conference in December in New York, held by Doctors Without Borders/Médecins Sans Frontières (MSF), the Drugs for Neglected Diseases initiative (DNDi), and Mount Sinai School of Medicine’s Global Health Program. The symposium, Lives in the Balance: Delivering Medical Innovations for Neglected Patients and Populations, will bring together some of the top minds in the field of global health. The goal will be to examine the progress and shortcomings of a decade’s worth of international initiatives aimed at addressing urgent health needs of the poorest populations in the world. Dr. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases at the US National Institutes of Health, will deliver the keynote address at the symposium, which will take place December 13-14, 2012, at Mount Sinai Hospital in New York City. …. 12 November 2012: USD 3 Million Awarded to Find Biomarkers for Potential Test of Cure for Chagas Disease Today at the 61st Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), the Drugs for Neglected Diseases initiative (DNDi) announces a new USD 3 million Strategic Translation Award from the Wellcome Trust to identify new biological markers for the evaluation of treatment efficacy in Chagas disease, a potentially fatal neglected tropical disease. …. The USD 3 million Wellcome Trust Award will fund the first-ever large-scale study involving treatment UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 of non-human primates (macaques) naturally infected in their outdoor living environment with the parasite that causes Chagas disease,Trypanosoma cruzi. The animals will be treated with three drug regimens versus placebo: benznidazole at optimal dose, benznidazole at suboptimal dose, and another azole compound with anti-parasite activity. Over a period of 12 months after treatment, the animals will be examined for clearance of the Chagas parasite through polymerase chain reaction (PCR) and other blood tests. The primary goal of the study is to see if these blood tests can accurately measure parasitological cure. … 13 November 2012: Open Access Initiative Reveals Drug Hits for Deadly Neglected Tropical Diseases The Drugs for Neglected Diseases initiative (DNDi) and Medicines for Malaria Venture (MMV) announce today the identification of three chemical series targeting the treatment of deadly neglected tropical diseases (NTDs), through DNDi’s screening of MMV’s open access Malaria Box. The resulting DNDi screening data are among the first data generated on the Malaria Box to be released into the public domain, exemplifying the potential of openly sharing drug development data for neglected patients. The open access Malaria Box (mmv.org/malariabox) is an MMV initiative launched in December 2011 to catalyse drug discovery for malaria and neglected diseases. It contains 400 molecules, selected by experienced medicinal chemists to offer the broadest chemical diversity possible and is available free of charge. In return, MMV requests that any data gleaned from research on the Malaria Box are shared in the public domain within two years. To date, more than 100 Malaria Boxes have been delivered to over 20 countries for research on diseases including malaria, neglected diseases, HIV and cancer. DNDi, in partnership with the Laboratory for Microbiology, Parasitology and Hygiene (LMPH), University of Antwerp, screened all the compounds in the Malaria Box against the parasites responsible for the three NTDs on which DNDi mainly focuses: sleeping sickness (human African trypanosomiasis), leishmaniasis (including visceral leishmaniasis, or kala azar, also known as black fever), and Chagas disease. This initial screen identified two potential drug series for the treatment of sleeping sickness and one for leishmaniasis. The DNDi screens have yielded valuable information that will strengthen DNDi’s research pipeline. All the biological data from DNDi’s screen, together with the existing preliminary data from MMV, are now publicly available on the open-source ChEMBL database (www.ebi.ac.uk/chembl/malaria). 30 November 2012: DNDi Applauds Call for Scale-Up of Pediatric HIV Treatment in US PEPFAR Blueprint for an AIDS-Free Generation The Drugs for Neglected Diseases initiative (DNDi) welcomed the US President’s Emergency Plan for AIDS Relief (PEPFAR)’s new ‘PEPFAR Blueprint: Creating an AIDS-Free Generation,’ released by US Secretary of State Hillary Clinton in advance of World AIDS Day, and its focus on ensuring ambitious scale-up of treatment and diagnosis for people with HIV/AIDS, including children living with HIV/AIDS. …. EVI 21 November 2012: EVI Press Release on the interim results of the recent RTS, S phase III efficacy trial The European Vaccine Initiative urges continued and sustainable malaria vaccine development efforts and funding. …. While these results are comforting, a need still exists for further improvement of the malaria vaccine. Therefore EVI urges continued and sustainable support for second generation Malaria vaccines. Dr Odile Leroy, Executive Director of European Vaccine Initiative (EVI) “We have come a long way in Malaria vaccine development, and the recent results of the RTS,S efficacy trial are a major step in the development of malaria vaccines. It is unambiguously clear that a highly effective malaria vaccine is not yet within reach, and can only be attained by sustainable funding and development efforts for the next decade.” … UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 IAVI 29 November 2012: World AIDS Day Statement 2012 … Vaccine research, in particular, has advanced in leaps and bounds since a trial in Thailand established for the first time, three years ago, that HIV transmission can be prevented through vaccination. Researchers have now explored the underlying biology of the modest protection observed in that trial, laying the groundwork for improvements on the vaccine regimen it assessed. Indeed, two major trials currently being planned aim to do just that. Meanwhile, vaccine designers have isolated scores of new broadly neutralizing antibodies against HIV and extensively explored the mechanisms by which the most potent of them block the virus’s entry into its target cells. They have also begun to unravel how these relatively rare antibodies arise and are refined within the body. Armed with this information, researchers are now in the early stages of designing vaccine candidates and immunization strategies that might elicit just such antibodies in people. Further, major advances in the development of novel vehicles for the delivery of vaccine antigens and for stimulating immune responses to those antigens have generated considerable optimism in the field. Indeed, leading researchers now believe that, if appropriately deployed, the combination of existing and emerging HIV prevention tools with new HIV vaccines could not only reverse the tide of the pandemic but bring it to an end. Even a partially effective vaccine could by itself have a huge impact on HIV epidemics around the world. Modeling by IAVI and the Futures Institute suggests that a preventive HIV vaccine of 70 percent efficacy that is distributed to just 40 percent of the population in low- and middle-income countries could avert almost nine million new infections—about a third—in the first decade after introduction, assuming current trends in HIV prevention coverage are maintained. The realization of all this promise depends on sustained funding for HIV prevention research. Political will, too, must be sustained to secure the progress already made in the campaign against HIV. We must remember that any call to bring about the “end of AIDS” will only be fulfilled if HIV prevention remains high on the list of global health priorities. Scaling up access to proven prevention interventions, and continuing investment in the development of new tools, including microbicides and vaccines, must therefore feature prominently in the dialogue about achieving and moving beyond the Millennium Development Goals. … MVI 9 November 2012: RTS,S malaria candidate vaccine reduces malaria by approximately one-third in African infants Results from a pivotal, large-scale Phase III trial, published online today in the New England Journal of Medicine (NEJM), show that the RTS,S malaria vaccine candidate can help protect African infants against malaria. When compared to immunization with a control vaccine, infants (aged 6-12 weeks at first vaccination) vaccinated with RTS,S had one-third fewer episodes of both clinical and severe malaria and had similar reactions to the injection. In this trial, RTS,S demonstrated an acceptable safety and tolerability profile. … MMV 13 November 2012: Open access initiative reveals drug hits for deadly neglected tropical diseases See press release under DNDi PATH 12 November 2012: PATH’s Drug Development program announces positive phase 1 results for its antidiarrheal medication PATH’s Drug Development program announced today the completion of two phase 1 clinical studies for iOWH032—its investigational new drug to treat acute secretory diarrhea caused by diseases such as cholera. The studies evaluated the drug’s safety and tolerability and measured the extent and rate of its absorption, distribution, metabolism, and excretion, reporting no serious adverse events. Based UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 on these outcomes, iOWH032 will proceed into the next phase of clinical trials in Bangladesh in early 2013. The development of iOWH032 is funded by the Bill & Melinda Gates Foundation. Unlike most currently available medications, iOWH032 is designed to treat the diarrheal processes directly by reducing fluid secretion, thus shortening both the duration and severity of the symptoms. If approved, the drug would be used in conjunction with oral rehydration therapy and encourage wider adoption of and compliance with treatment. … 14 November 2012: Revolutionary meningitis vaccine breaks another barrier; first to gain approval to travel outside cold chain Signaling a potential breakthrough for immunization programs in resource-poor countries, researchers today announced at the American Society of Tropical Medicine and Hygiene (ASTMH) conference that regulatory authorities—after conducting a rigorous review of stability data—will for the first time allow a vaccine in Africa to be transported and stored for as long as four days without refrigeration or even an icepack. The meningitis A vaccine known as MenAfriVac®, created to meet the needs of Africa’s meningitis belt, can now be kept in a controlled temperature chain (CTC) at temperatures of up to 40°C for up to four days, a decision that could help increase campaign efficiency and coverage and save funds normally spent maintaining the challenging cold chain during the “last mile” of vaccine delivery. The outcome of the review and decisions of the Drugs Controller General of India (DCGI), supported by a Health Canada analysis and confirmed by the World Health Organization (WHO) Vaccines Prequalification Programme, was revealed during a presentation this afternoon at the ASTMH conference in Atlanta by Godwin Enwere, MD, medical director for the Meningitis Vaccine Project. The regulatory approval has the effect of permitting the re-labeling of MenAfriVac®, while ensuring that the vaccine remains effective and safe throughout its life cycle. … 28 November 2012: New technology for producing thermostable vaccines. Bend Research Inc., PATH, and Fraunhofer USA Center for Molecular Biotechnology (FhCMB) announce the development of a new technology for the production of thermostable vaccines. Utilizing novel formulation and spray-drying processing methods, the technology has enabled scientists at Bend Research, PATH, and FhCMB to develop a spray-dried influenza vaccine product that is stable at 50°C for over 2 months. The technology can also be applied to emerging influenza and other vaccines. …. 28 November 2012: PATH names Amie Batson as chief strategy officer PATH today announced the appointment of Amie Batson to the newly created position of chief strategy officer. Ms. Batson is currently senior deputy assistant administrator for global health with the US Agency for International Development (USAID) in Washington, DC. Her 20-year career in global health includes positions with the World Bank, the World Health Organization, and UNICEF. Ms. Batson will have responsibility for helping guide PATH’s strategy, strengthening its partnerships and business relationships in the global health community, and contributing to PATH’s advocacy and policy priorities. She will join PATH in mid-April 2013 and report to Steve Davis, PATH’s president and CEO. … 28 November: PATH announces new cervical cancer test for low-resource countries. China’s State Food and Drug Administration (SFDA) recently approved QIAGEN’s careHPV™ test for sale. Developed jointly with PATH, an international, nongovernmental organization, careHPV, which is produced in China, will be sold in that country by January 2013. The test is likely to become available in India later in the year, with other countries to follow. The long awaited announcement means that low-resource countries, which largely have not been able to mount successful, national cervical cancer screening and treatment programs, soon will have a new option. CareHPV provides results more rapidly than other DNA tests and is designed especially for use in clinics that lack reliable clean water or electricity. CareHPV detects the DNA of 14 different types of the human papillomavirus (HPV) that cause cervical UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 cancer. …. CareHPV works well with samples taken from the cervix by doctors and nurses during pelvic examinations. It shows nearly the same sensitivity with vaginal samples taken without a pelvic exam. The PATH studies found that vaginal sampling is an attractive option for many women mainly because pelvic exams are uncomfortable and may be embarrassing. Some health care professionals initially were skeptical of vaginal sampling, but they quickly began to see its potential for dramatically increasing the ability of a clinic to collect and process many samples in a cost-effective, and rapid, manner. If the new test were used broadly, millions of women could be screened and those with precancer promptly treated, preventing deadly cervical cancer later in life . Sabin 5 November 2012: Clinical Trials for First-Ever Human Hookworm Vaccine Advance The Sabin Vaccine Institute (Sabin) today announced the start of Part II of its Phase I clinical trial of the Na-GST-1 vaccine candidate, marking another major milestone in the progress toward developing a human hookworm vaccine. Part II of the trial commenced in Americaninhas, Brazil, following successful vaccinations in Part I of the study, which began in Belo Horizonte, Brazil in late 2011. An independent Safety Monitoring Committee (SMC) recently reviewed results from Part I of the study and determined that no safety issues had been observed after vaccinating healthy adults who had never been exposed to hookworm. They concluded that these promising results were sufficient to allow researchers to proceed to the next stage of the trial, in which hookworm-exposed adults will receive the vaccine candidate. Part II of the study is taking place in Americaninhas, a hookworm-endemic region of Brazil. The trial will enroll 66 healthy, hookworm-exposed adults between the ages of 18 and 45. Each volunteer will receive three injections over four months. Researchers will then follow each volunteer for 12 additional months, monitoring the vaccine’s safety and analyzing the recipients’ immune responses. 29 November 2012: Engaging a Rising China through Tropical Disease Elimination Today, the open-access journal PLoS Neglected Tropical Diseases published an editorial encouraging new global health partnerships between the United States and China. The article’s author, Dr. Peter Hotez, argues that relations between the United States and China can be strengthened by a coordinated effort to support neglected tropical disease (NTD) control programs in countries where these diseases are still a major public health concern. …. “A joint Sino-U.S. enterprise around NTD control and elimination could be a powerful and winning combination,” said Dr. Hotez. “While a long term approach is needed to reduce NTDs in Africa and elsewhere to levels similar to the United States Sand China, there is an opportunity for our nations to share programmatic expertise and funds for NTD programs. This is a chance to not only work on a major global health disparity, but is a way for the United States and China to build their diplomatic relationships with each other and with endemic countries.” … RECENTLY RELEASED PDP REPORTS/ BRIEFING PAPERS/ ARTICLES Articles in Peer Reviewed Journals • • • • • A Phase 3 Trial of RTS,S/AS01 Malaria Vaccine in African Infants. The RTS,S Clinical Trials Partnership. The New England Journal of Medicine. November 9, 2012DOI: 10.1056/NEJMoa1208394 Engaging a Rising China through Neglected Tropical Diseases. Hotez PJ. Editorial. PLoS Negl Trop Dis 6(11): e1599. doi:10.1371/journal.pntd.0001599. November 2012. Identification of Compounds with Anti-Proliferative Activity against Trypanosoma brucei brucei Strain 427 by a Whole Cell Viability Based HTS Campaign. Sykes ML et al. PLoS NTDs, November 2012, 6(11): e1920. doi:10.1371/journal.pntd.0001920. In-Hospital Safety in Field Conditions of Nifurtimox Eflornithine Combination Therapy (NECT) for T. b. gambiense Sleeping Sickness. Schmid C et al. PLoS NTDs, November 2012, 6(11): e1920.doi:10.1371/journal.pntd.0001920. Fexinidazole: A Potential New Drug Candidate for Chagas Disease. Bahia MT et al. PLoS NTDs, UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 • • • • November 2012, doi:10.1016/S0140-6736(12)61732-2. Cell Biological Characterization of the Malaria Vaccine Candidate Trophozoite Exported Protein 1. Kulangara C et al. PLOS one, vol 7, issue 10, e46112 “Proof-Of-Concept” Evaluation of an Automated Sputum Smear Microscopy System for Tuberculosis Diagnosis. Lewis JJ et al. PLoS ONE 7(11): e50173. doi:10.1371/journal.pone.0050173 Feasibility of distributing rapid diagnostic tests for Malaria in the retail sector: Evidence from an implementation study in Uganda. Cohen J et al. PLoS ONE 7(11): e48296. doi:10.1371/journal.pone.0048296 Private sector drug shops in integrated community case management of malaria, pneumonia, and diarrhea in children in Uganda. Awor P et al. Am J Trop Med Hyg 2012vol. 87 no. 5 Suppl 9296 Other PDP Publications/ Briefing papers • • • • OneWorld Health Annual Report 2010-2011. November 2012 TB Alliance Annual Report. November 2012. Identifying and moving levers of acceptance and uptake of recommended quality-assured paediatric ACTs for non-complicated malaria. MMV commissioned study. November 2012. Manual for quantification of malaria commodities. Multi-agency report, led by MSH. November 2012. RECENTLY RELEASED PDP RELATED REPORTS/ BRIEFING PAPERS/ ARTICLES Reports/ briefing papers/ books Innovative Financing for Global Health R&D. Financial Innovations Lab Report. Milken Institute. November 2012. Multi-stakeholder Technical Meeting on Implementation Options Recommended by the WHO Consultative Expert Working Group on Research & Development (CEWG): Financing and Coordination. Report of a meeting held in October 2012. Primer on collaborative approaches to health R&D. Center for Global Health R&D Policy Assessment. Result for Development Institute. Online Tool. November 2012. Access to Medicine Index. 2012. Access to Medicine Foundation. November 2012. UNAIDS World AIDS Day report 2012. UNAIDS. November 2012. 2012 Report on Tuberculosis Research Funding Trends, 2005–2011. TAG and Stop TB Partnership. November 2012. Achieving the End: One Year and Counting. AVAC 2012 Report. AVAC. November 2012. Action Agenda to End AIDS : 1st Quarterly Progress Report. amfAR and AVAC. November 2012. Rethink HIIV. Edited by Bjorn Lomborg. Cambridge University Press. October 2012. New Technology Needs for Noncommunicable Diseases: A landscaping study. Nundy S & Han E. Center for Global Health R&D Policy Assessment. Result for Development Institute. November 2012. Total Market Initiatives for Reproductive Health. PATH, Abt Associates, Reproductive Health Supplies Coalition. November 2012 Boosting the Immunization Workforce: Lessons from the Merck Vaccine Network – Africa. FSG. November 2012. PDP RELATED NEWS/ ARTICLES (SINCE NOVEMBER 1, 2012) HIV/AIDS 3 November: Condoms treated with silver nanoparticles could 'completely inactivate' HIV, other STDs 5 November: Time magazine ranks OraQuick in-home HIV test among best inventions of 2012 7 November: Canadian-developed HIV vaccine shows promising results, no adverse effects UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 Malaria • Vaccines • • • • • 8 November: In Africa, we must do the most good with each pound spent on AidsHIV 14 November: Particle Sciences joins MOTIF project on HIV prevention 19 November: US panel advises HIV tests for everyone ages 15 to 64 19 November: Texas Biomed files for novel HIV vaccine 20 November: UNAIDS reports a more than 50% drop in new HIV infections across 25 countries as countries approach the 1000 day deadline to achieve global AIDS targets 29 November: Finally, SA announces single pill for HIV 29 November: Clinton reveals 'blueprint' for reaching an 'AIDS-free generation' 30 November: FT Health: Combating AIDS 2012 Beating the placebo in HIV prevention efficacy trials: The role of the minimal efficacy bound. Dimitrov D et al. Journal of Acquired Immune Deficiency Syndromes. 15 October 2012 Cervicovaginal HIV-1-neutralizing immunoglobulin A detected among HIV-1-exposed seronegative female partners in HIV-1-discordant couples. Choi R et al. AIDS. 13 November 2012; 26(17):2155-2163. SAMHD1 restricts HIV-1 infection in resting CD4+ T cells. Baldauf H et al. Nature Medicine. 7 November 2012; 18:1682-1689. Intravaginal practices and microbicide acceptability in Papua New Guinea: Implications for HIV prevention in a moderate-prevalence setting. Vallely A et al. BioMed Central. 1 November 2012 An assessment of the likely acceptability of vaginal microbicides for HIV prevention among women in rural Ghana. Abdulai M et al. BMC Women's Health. 1 November 2012 Broad and potent neutralization of HIV-1 by a gp41-specific human antibody. Huang J et al. Nature. 15 November 2012; 491:406-412. State of the science of adherence in pre-exposure prophylaxis and microbicide trials. Muchomba F et al. Journal of Acquired Immune Deficiency Syndromes. 15 November 2012; 61(4):490-498 Safety and efficacy of tenofovir/IQP-0528 combination gels - A dual compartment microbicide for HIV-1 prevention. Dezzutti C et al. Antiviral Research. 26 November 2012; 96(2):221-225. Special Supplement on the UNAIDS Report 2012 and modelling HIV/ AIDS estimates. Sexually Transmitted Infections. December 2012, Volume 88, Supplement 2. November 26. In vitro profiling of the vaginal permeation potential of anti-HIV microbicides and the influence of formulation excipients. Grammen C et al. Antiviral Research. 1 November 2012; 96(2):226-233. Poly (4-styrenesulfonic acid-co-maleic acid) is an entry inhibitor against both HIV-1 and HSV infections - Potential as a dual functional microbicide. Qiu M et al. Antiviral Research. 1 November 2012; 96(2):138-147. Artemisinin-resistant Plasmodium falciparum in Pursat province, western Cambodia: a parasite clearance rate study. Amaratunga C et al. The Lancet Infectious Diseases, Volume 12, Issue 11, Pages 851 - 858, November 2012 9 November: New studies shed light on what it cost to vaccinate girls against HPV in low income countries 27 November: Experimental product could offer faster method of developing new vaccines Dengue vaccine development: a 75% solution? Halstead SB. The Lancet, Volume 380, Issue 9853, Pages 1535 - 1536, 3 November 2012 Protective efficacy of the recombinant, live-attenuated, CYD tetravalent dengue vaccine in Thai schoolchildren: a randomised, controlled phase 2b trial. Sabchareon A et al. The Lancet, Volume 380, Issue 9853, Pages 1559 - 1567, 3 November 2012 UPDATE 46: NOVEMBER 1 TO NOVEMBER 30, 2012 • • Industry • • • Gov’ts – US • • • • WHO • Other • • • • • Effect of vaccines on bacterial meningitis worldwide. McIntyre PB et al. The Lancet, Volume 380, Issue 9854, Pages 1703 - 1711, 10 November 2012 Effectiveness of an oral cholera vaccine in Zanzibar: findings from a mass vaccination campaign and observational cohort study. Khatib AM et al. The Lancet Infectious Diseases, Volume 12, Issue 11, Pages 837 - 844, November 2012 6 November: Pharmaceutical conference focuses on global health and innovation 27 November: Now Released: The 2012 Access to Medicine Index 28 November: Gates-backed index offers Big Pharmas mixed grades on access and R&D practices 12 November: NIH vaccine chief Gary Nabel trades dream job for big pharma 13 November: Campaign Spending: What Else Can $2 Billion Buy? 16 November: USAID steps up its science efforts 27 November: WHO members develop plan to fight poor-quality medicines worldwide 29 November: WHO Members Agree On “Strategic Work Plan” On Health R&D – But No Convention 15 November: Global Fund names Mark Dybul executive director 15 November: Ins and outs of the Global Fund's management 27 November: Putting neglected tropical diseases under spotlight Global engagement for health could achieve better results now and after 2015. Carlsson G & Nordstrom. The Lancet, Volume 380, Issue 9853, Pages 1533 - 1534, 3 November 2012. UK investments in global infectious disease research 1997—2010: a case study. Head MG et al. The Lancet Infectious Diseases, Early Online Publication, 8 November 2012 ONGOING CONSULTATIONS FDA posts draft microbicide guidance for public comment The U.S. Food and Drug Administration (FDA) is seeking public comment on its newly-posted draft guidance for industry, entitled "Vaginal Microbicides: Development for the Prevention of HIV Infection." The purpose of the guidance is to assist sponsors in all phases of microbicide development. It outlines the types of nonclinical studies and clinical trials recommended throughout the drug development process to support approval of vaginal microbicides for prevention of human immunodeficiency virus (HIV). The FDA welcomes comments on this guidance until February 21, 2013. The guidance document is available at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm328834.htm UPCOMING MEETINGS December 6 2012: EVI 2012 Rendez-Vous. Heidelberg. Germany. December 13-14 2012: Lives in the Balance: Delivering Medical Innovations for Neglected Patients and Populations. New York. USA