AERAS  [to 8 Sep 2018]
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BMGF – Gates Foundation  [to 8 Sep 2018]
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Bill & Melinda Gates Medical Research Institute    [to 8 Sep 2018]
The Bill & Melinda Gates Medical Research Institute is a non-profit biotech organization. Our mission is to develop products to fight malaria, tuberculosis, and diarrheal diseases—three major causes of mortality, poverty, and inequality in developing countries. The world has unprecedented scientific tools at its disposal; now is the time to use them to save the lives of the world’s poorest people
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CARB-X   [to 8 Sep 2018]
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
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CEPI – Coalition for Epidemic Preparedness Innovations  [to 8 Sep 2018]
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EDCTP    [to 8 Sep 2018]
The European & Developing Countries Clinical Trials Partnership (EDCTP) aims to accelerate the development of new or improved drugs, vaccines, microbicides and diagnostics against HIV/AIDS, tuberculosis and malaria as well as other poverty-related and neglected infectious diseases in sub-Saharan Africa, with a focus on phase II and III clinical trials
3 September 2018
EDCTP launches €2.25 M emergency funding initiative in response to Ebola outbreak in the Democratic Republic of Congo
Today, the European & Developing Countries Clinical Trials Partnership (EDCTP) launched an emergency funding initiative ‘Mobilisation of research funds in case of Public Health Emergencies’ to support research activities in response to the  Ebola Virus Disease (EVD) outbreak in the Democratic Republic of Congo. Applications for research funding must be submitted by 10 September 2018.

Emory Vaccine Center    [to 8 Sep 2018]
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European Medicines Agency  [to 8 Sep 2018]
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3-6 September 2018
PRAC elects new vice-chair [Dr Martin Huber from Germany]
At its monthly meeting, the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) did not start or conclude a new referral.

European Vaccine Initiative  [to 8 Sep 2018]
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FDA [to 8 Sep 2018]
September 05, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities
… We’ve established a framework to help assure that drug products all meet the same high-quality standards, regardless of where they’re manufactured; and whether they’re brand name or generic products, or prescription or over-the-counter drugs. Today, we’re announcing several steps that improve on that effort.
Helping assure the quality and safety of globally produced products requires a variety of efforts at different times throughout the lifecycle of a drug’s manufacturing and finishing. Our inspections and surveillance of manufacturing facilities are an integral part of this oversight. We need to make sure that our inspections are prioritized based on potential risks to patients, and that we’re using our resources efficiently.
Today, to add greater transparency around our site selection model, we’re publishing our internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections. Our policy explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered…
Fondation Merieux  [to 8 Sep 2018]
Mérieux Foundation event
Global challenges in vaccine acceptance science and programs
September 24 – 26, 2018 – Les Pensieres Center for Global Health, Veyrier du Lac (France)
Gavi [to 8 Sep 2018]
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GHIT Fund   [to 8 Sep 2018]
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that devastate the world’s poorest people. Other funders include six Japanese pharmaceutical
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Global Fund [to 8 Sep 2018];&country=
India Supports Global Fund Efforts to Mobilize Funds
05 September 2018
India announced today it would host the Global Fund’s Preparatory Meeting of the Sixth Replenishment in New Delhi in February 2019, an important milestone to mobilize funds aimed at accelerating the end of AIDS, TB and malaria as epidemics.
Hilleman Laboratories   [to 8 Sep 2018]
Date: 09/01/2018
Hilleman Laboratories partners with innovative Future Vaccine Manufacturing Hub
Hilleman Laboratories, an equal joint-venture partnership between MSD and Wellcome Trust, is honored to be one of the key partners of the new Future Vaccine Manufacturing Hub led by Imperial College London. The hub has been established to increase immunisation coverage across the globe and improve the response to disease outbreaks through the rapid and cost-effective deployment of vaccines. £10 million of funding has been granted by the UK Department for Health, and will be managed by the Engineering and Physical Sciences Research Council (EPSRC).
The all-new Future Vaccine Manufacturing Hub aims to address two major challenges facing creation of future vaccine manufacturing systems:
:: How to design vaccine production systems that can produce tens of thousands of new doses within weeks of a new threat being identified
:: How to improve current manufacturing processes and change the way vaccines are manufactured, stabilized and stored so that existing and new diseases can be prevented effectively, at reduced costs…
Human Vaccines Project   [to 8 Sep 2018]
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IAVI  [to 8 Sep 2018]
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IVAC  [to 8 Sep 2018]
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IVI   [to 8 Sep 2018]
IVI’s 18th Vaccinology Course gathers 120 international participants from 19 countries in Seoul September 3-7
:: Annual Course to update on the recent development in vaccinology, including basics of immunology, epidemiology, vaccine design and development
:: Featured experts include: Stanley Plotkin (University of Pennsylvania), Dr. Barney Graham (US NIH), Dr. Randy Schoepp (USAMRID), Dr. Andy Pollard (University of Oxford), and Dr. Eric Mintz (US CDC)
:: Donor-supported fellowship invites 12 developing country participants to help increase country capacities in vaccines, immunization
:: Week-long course supported by GlaxoSmithKlein, EuBiologics, Sky 72 Golf Club, Seoul Metropolitan City, and Community Chest of Korea – Incheon
JEE Alliance  [to 8 Sep 2018]
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MSF/Médecins Sans Frontières  [to 8 Sep 2018]
Selected Press Releases/Statements
DRC 2018 Ebola outbreaks
North Kivu: MSF treats 65 Ebola patients in first month
Project Update 7 Sep 2018
Médecins Sans Frontières (MSF) has treated 65 patients confirmed to be diagnosed with Ebola in the first month of intervention in the latest Ebola outbreak, in North Kivu, Democratic Republic of Congo (DRC). This number is more than 80 percent  of the total number of confirmed patients hospitalised in Ebola Treatment Centres so far during this epidemic. Of the patients confirmed Ebola positive in Mangina Ebola Treatment Centre, 29 have recovered and returned to their families. Three patients remain under treatment…

Central African Republic
“The tip of the iceberg”: Stream of patients offer glimpse into scale of sexual violence
Project Update 7 Sep 2018

Evacuation of refugees and migrants out of Libya is urgently needed
Press Release 7 Sep 2018

Abductions and violence, the price to pay to cross Mexico
Project Update 3 Sep 2018

NIH  [to 8 Sep 2018]
September 5, 2018
Clinical trial testing topical cream plus influenza vaccine in progress
— Cream regimen could boost immunity.
A Phase 1 clinical trial examining whether a topical cream can enhance the immune response conferred by a “pre-pandemic” influenza vaccine is underway at Baylor College of Medicine in Houston. Investigators are evaluating whether imiquimod cream, which is commonly used to treat genital warts and certain skin cancers, can boost the body’s immune response to an H5N1 influenza vaccine. The trial is enrolling 50 healthy adults ages 18-50 years. Baylor is one of the Vaccine and Treatment Evaluation Units (VTEUs) — a network of clinical research sites that can rapidly enroll large volunteer cohorts to evaluate experimental vaccines against infectious diseases. The VTEUs are funded and managed by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health…

PATH  [to 8 Sep 2018]
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Sabin Vaccine Institute  [to 8 Sep 2018]
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UNAIDS [to 8 Sep 2018]
5 September 2018
First ladies from Africa and China working towards a future free from AIDS

UNICEF  [to 8 Sep 2018]
Selected Press Releases/Reports/Statements
Statement by UNICEF Executive Director Henrietta Fore on the eve of Yemen peace talks
“The children of Yemen need to heal. They need justice. They need lasting peace, now.”

Press release
In eastern DRC, nearly 2.5 million people reached in effort to contain Ebola outbreak – UNICEF
[See Week in Review above for more detail]

Vaccine Confidence Project  [to 8 Sep 2018]
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Vaccine Education Center – Children’s Hospital of Philadelphia  [to 8 Sep 2018]
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Wellcome Trust  [to 8 Sep 2018]
Explainer / Published: 4 September 2018
Wellcome Flagships will focus on five health innovation challenges
Flagships are a new way of working for Wellcome. Director of Innovation Stephen Caddick explains what flagships are, how they’ll work and what we want to achieve.
One of the main ideas in our strategy, Innovation for Impact [PDF 200KB], is to identify a small number of health innovation challenges where we think a concerted effort could result in major, tangible improvements to people’s health.
Of course, this is easy to say and pretty hard to do. The key approach we’re using is based on building a series of linked activities, which we call Flagships.
We intend to commit up to £300m of our budget to five Flagships over the next six years. And we hope to work with partners who will share our commitment and help us to realise the ambition of each Flagship…
The Wistar Institute   [to 8 Sep 2018]
Press Release
Sep. 6, 2018
Synthetic DNA Vaccine Effective Against Influenza A Virus Subtype That Is Responsible for More Severe Influenza Seasons
Compared with conventional vaccines, synthetic DNA vaccines can be manufactured faster and may avoid the need for annual vaccine reformulations.

Press Release
Sep. 5, 2018
Enhancing the Efficacy of Immune Checkpoint Inhibitor Therapy Using a Novel Treatment Combination
PHILADELPHIA — (Sept. 5, 2018) — A combination of a novel inhibitor of the protein CK2 (Casein kinase 2) and an immune checkpoint inhibitor has dramatically greater antitumor activity than either inhibitor alone, according to research from The Wistar Institute that was published online in Cancer Research.
Press Release
Sep. 4, 2018
Synthetic DNA Technology Provides a Novel Strategy for Effective Delivery of a Complex Anti-HIV Agent
PHILADELPHIA — (Sept. 4, 2018) — Scientists at The Wistar Institute have applied their synthetic DNA technology to engineer a novel eCD4-Ig anti-HIV agent and to enhance its potency in vivo, providing a new simple strategy for constructing complex therapeutics for infectious agents as well as for diverse implications in therapeutic delivery. This critical development was published online in the journal EBio Medicine.

World Organisation for Animal Health (OIE)   [to 8 Sep 2018]
7 September 2018
Countries reaffirm political will to globally eradicate Peste des petits ruminants
The aim is to stamp out a virus, which kills millions of sheep and goats each year, and thus protect the livelihoods of hundreds of millions of poor rural families.
[See Milestones above for detail]

BIO    [to 8 Sep 2018]
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 8 Sep 2018]
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IFPMA   [to 8 Sep 2018]
Policy Positions – Publications
:: IFPMA AMR Policy Position: Reimbursement and Health Technology Assessment Reform
:: IFPMA AMR Policy Position: Supporting sustainable investments in antimicrobial R&D
:: IFPMA AMR Policy Position: The need for AMR R&D pull incentives

PhRMA    [to 8 Sep 2018]
September 5, 2018
Nearly 1 in 5 Hospitals Marks Up Medicine Prices at Least 700 Percent
Nearly one in five hospitals marks up medicine prices 700 percent or more, according to a new analysis from the Moran Company that was commissioned by PhRMA.

Industry Watch [to 8 Sep 2018]
:: NIH Selects CEL-SCI’s LEAPS Rheumatoid Arthritis Vaccine for Commercialization Accelerator Program
September 05, 2018   VIENNA, Va.– CEL-SCI Corporation (NYSE American: CVM) announced today that the National Institutes of Health (NIH) selected CEL-SCI and its LEAPS* rheumatoid arthritis vaccine candidate as a Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Commercialization Accelerator Program Phase II awardee for 2018-2019. LEAPS has been specifically selected by the NIH for the Commercialization Transition Track, which provides technical assistance to awardee companies to move NIH-funded technologies towards commercialization and market readiness…