Announcements

Announcements
 
 
BMGF – Gates Foundation  [to 21 October 2017]
http://www.gatesfoundation.org/Media-Center/Press-Releases
OCTOBER 16, 2017
Bill & Melinda Gates Foundation Releases Open-Source Software to Support Efforts that Expand Access to Financial Services in Developing Countries
New code reduces complexity and cost of building payment platforms that connect poor customers to merchants, banks, mobile money providers, governments

EDCTP    [to 21 October 2017]
http://www.edctp.org/
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
18 October 2017
EDCTP requests proposals for conference management services
EDCTP is soliciting proposals from conference management companies for the provision of services for the Ninth EDCTP Forum…

European Medicines Agency  [to 21 October 2017]
http://www.ema.europa.eu/ema/
20/10/2017
Unparalleled access to clinical data – one year on
Over 3,000 clinical documents published, 3,600 registered users and positive stakeholder feedback …

20/10/2017
New action plan to foster development of advanced therapies
Actions address specific challenges identified by stakeholders
… ATMPs are medicines for human use that are based on genes or cells. These therapies offer ground-breaking new opportunities for the treatment of disease and injury. They are particularly important for severe, untreatable or chronic diseases for which conventional approaches have proven to be inadequate.
ATMPs can be classified into four main groups: gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered medicinal products and combined ATMPs. EMA has received 18 marketing authorisation applications since the ATMP regulation came into force in 2009. Nine products have been approved.
The Agency’s Committee for Advanced Therapies (CAT) plays a central role in the scientific assessment of ATMPs, as it provides the expertise needed to evaluate these medicines. Other initiatives include European Commission research programmes, the innovation offices in the national competent authorities and EMA’s PRIME scheme…

17/10/2017
EMA’s procedural handling of safety review was complete and independent
EMA’s procedural handling of safety review was complete and independent
European Ombudsman concludes her inquiry into the HPV vaccines referral
The European Medicines Agency (EMA) has welcomed the decision from the European Ombudsman which concludes that there was no maladministration by the Agency in the handling of its safety review of human papillomavirus (HPV) vaccines.
The conclusions of this review were that the available evidence does not support that two specific syndromes, complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) in young women and girls are caused by HPV vaccines. These vaccines are given to prevent infections with the most common types of HPV which can cause cervical cancer, other HPV-related cancers and pre-cancerous conditions.
The procedure was conducted by EMA’s Pharmacovigilance Risk Assessment Committee’s (PRAC) in 2015.
The Ombudsman’s review followed a complaint which expressed concerns about aspects of the PRAC’s handling of the referral procedure.
Following her inquiry into the procedural aspects complained about, the Ombudsman concluded that her inquiry did not identify any procedural issues that could have negatively affected the work and conclusions of the PRAC referral procedure. The examination of scientific evidence was complete and it was independent.
The Ombudsman also considered that EMA’s conflicts of interest policy was fully complied with during the referral procedure on HPV vaccines and that no conflicts of interest were detected.
The Agency welcomes two suggestions made by the Ombudsman to further improve the information on its scientific assessments that it provides to the public and will now explore ways to address these.

European Vaccine Initiative  [to 21 October 2017]
http://www.euvaccine.eu/news-events
19 October 2017
EDUFLUVAC Final Meeting
After four years of collaborative research activities towards the development of a broadly reactive influenza vaccine, the European Commission-funded project EDUFLUVAC will be concluded by the end of October 2017. The EDUFLUVAC partners met for the final project meeting on 09-10 October in Brussels, Belgium to review the results generated and plan for future activities.
Promising pre-clinical results in different animal models have been obtained, but more research is needed to optimise the strategy undertaken by the consortium, which is based on the Epitope Dilution Phenomenon and the use of baculovirus-derived virus-like particles…

16 October 2017
TRANSVAC: European Vaccine Research and Development Infrastructure
Open Call for Vaccine Development Services
 
 
FDA [to 21 October 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
October 18, 2017 –
FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
The U.S. Food and Drug Administration today approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL).
“Today marks another milestone in the development of a whole new scientific paradigm for the treatment of serious diseases. In just several decades, gene therapy has gone from being a promising concept to a practical solution to deadly and largely untreatable forms of cancer,” said FDA Commissioner Scott Gottlieb, M.D. “This approval demonstrates the continued momentum of this promising new area of medicine and we’re committed to supporting and helping expedite the development of these products. We will soon release a comprehensive policy to address how we plan to support the development of cell-based regenerative medicine. That policy will also clarify how we will apply our expedited programs to breakthrough products that use CAR-T cells and other gene therapies. We remain committed to supporting the efficient development of safe and effective treatments that leverage these new scientific platforms…
 
 
Gavi [to 21 October 2017]
http://www.gavi.org/library/news/press-releases/
16 October 2017
Attack on health facilities puts all Syrian children at risk
Gavi CEO urges all parties in Syria to stop attacks against health facilities following destruction of vaccine stocks and equipment.
 
 
GHIT Fund   [to 21 October 2017]
https://www.ghitfund.org/
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 ·
2017.10.18      
Upcoming Event: GHIT R&D Forum on December 8th

… The 200-person R&D Forum on December 8th will create opportunities for GHIT’s development partners to share project overviews, R&D progress to date, and lessons learned over the past five years. The event offers unique opportunities to engage with scientists and experts across a multitude of organizations, as well as develop new partnerships to further build our community and accelerate global health R&D…
 
 
MSF/Médecins Sans Frontières  [to 21 October 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Doctors Without Borders Challenges Pfizer’s Unmerited Patent for Pneumonia Vaccine in Delhi High Court
NEW YORK/NEW DELHI, OCTOBER 13, 2017—The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières(MSF) filed a petition before the High Court of Delhi today to overturn a patent granted to Pfizer pharmaceutical corporation on the pneumococcal conjugate vaccine (PCV).
 
 
NIH  [to 21 October 2017]
http://www.nih.gov/news-events/news-releases
October 18, 2017
Norman Sharpless sworn in as director of the National Cancer Institute
— Succeeds Harold Varmus, M.D., who stepped down in March 2015.

Experts Outline Pathway to a Universal Influenza Vaccine
October 17, 2017 — NIH-Led meeting identifies knowledge gaps, development goals.
Scientists and clinicians from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the California Institute of Technology discuss key considerations for developing a universal influenza vaccine in a meeting report appearing in the October 17 issue of Immunity. The report summarizes discussions from a workshop NIAID held June 28-29, 2017, in Rockville, Maryland, entitled, “Pathway to a Universal Influenza Vaccine.” The workshop brought together U.S. and international experts from academia, industry and government to identify knowledge gaps in influenza research and to set goals to fill these knowledge gaps. NIAID will use the report to develop a strategic plan and research agenda aimed at the development of a universal influenza vaccine.
 
 
PATH  [to 21 October 2017]
http://www.path.org/news/index.php
Announcement | October 18, 2017
Join PATH at the 66th American Society of Tropical Medicine and Hygiene Annual Meeting
PATH experts to share latest research and innovations to tackle malaria and other Neglected Tropical Diseases, underscore critical role of US in global health

UNAIDS [to 21 October 2017]
http://www.unaids.org/en
Update
20 October 2017
Civil society and WFP increasing food security in Ukraine
 
19 October 2017
UNAIDS urges United Republic of Tanzania to implement HIV Prevention 2020 Road Map
 
19 October 2017
Republic of Moldova to fund HIV prevention services for key populations
 
18 October 2017
Parliamentarians call for firm action towards ending the AIDS epidemic
 
17 October 2017
ILO’S VCT@WORK has reached 6 million workers

UNICEF  [to 21 October 2017]
https://www.unicef.org/media/
20 October, 2017
Violence in Myanmar driving up to 12,000 Rohingya refugee children into Bangladesh every week – UNICEF
DHAKA, BANGLADESH/GENEVA, 20 October 2017 – Desperate living conditions and waterborne diseases are threatening more than 320,000 Rohingya refugee children who have fled to southern Bangladesh since late August, including some 10,000 who crossed from Myanmar over the past few days, UNICEF said today.

7,000 newborns die every day, despite steady decrease in under-five mortality, new report says
NEW YORK/GENEVA/WASHINGTON, 19 October 2017 – Every day in 2016, 15,000 children died before their fifth birthday, 46 per cent of them – or 7,000 babies – died in the first 28 days of life, according to a new UN report.
 
 
Wellcome Trust  [to 21 October 2017]
https://wellcome.ac.uk/news
News / Published: 19 October 2017
First international awards in new Engagement Fellowships
Wellcome’s Engagement Fellowships for 2017 have been awarded to Sara Kenney, Alok Jha, Anita Shervington and our first international fellows, Elizabeth Kimani and Nabeel Peterson. 
Over the next three years the fellows will explore the topics of comic creation, science journalism, child nutrition, inclusion and equity in science.

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Industry Watch  [to 21 October 2017]
:: FDA Approves GSK’s Shingles Vaccine with Agenus’ QS-21 Stimulon® Adjuvant
– SHINGRIX containing QS-21 Stimulon® demonstrates remarkable efficacy of greater than 90% in pooled studies against shingles
– Shingles is a major public health issue in the US, impacting as many as 1 in 3 adults over the age of 50 years

LEXINGTON, Mass., Oct. 20, 2017 /PRNewswire/ — Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced today that the US Food and Drug Administration (FDA) granted marketing authorization to GlaxoSmithKline’s (GSK) herpes zoster vaccine, SHINGRIX, containing Agenus’ proprietary immune adjuvant QS-21 Stimulon®. SHINGRIX is indicated for prevention of herpes zoster (also known as shingles) in adults aged 50 years and older. The addition of QS-21 Stimulon helps improve the vaccine’s effectiveness by boosting immune response in older adults who often experience age-related decline in immunity…

:: Lilly and CureVac Announce Global Collaboration to Develop mRNA Cancer Vaccines
– Immuno-oncology collaboration aims to develop up to five cancer vaccines that target neoantigens across multiple tumor types
– CureVac to receive an upfront payment of $50 million and an equity investment of €45 million

INDIANAPOLIS and TÜBINGEN, Germany, Oct. 18, 2017 /PRNewswire/ — Eli Lilly and Company and CureVac AG have announced a global immuno-oncology collaboration focused on the development and commercialization of up to five potential cancer vaccine products based on CureVac’s proprietary RNActive® technology. The companies will use messenger RNA (mRNA) technology that targets tumor neoantigens for a more robust anti-cancer immune response…
Under the terms of the agreement, CureVac will receive an upfront payment of $50 million and an equity investment of €45 million. CureVac is also eligible to receive more than $1.7 billion in development and commercialization milestones if all five vaccines are successfully developed, plus tiered royalties on product sales. Lilly is responsible for target identification, clinical development and commercialization. CureVac will be responsible for mRNA design, formulation and manufacturing of clinical supply and retains the option to co-promote the vaccine products in Germany.
CureVac’s proprietary RNActive technology will be used to deliver mRNA that ultimately directs the human immune system to target the encoded neoantigens. These tumor-specific neoantigens instruct the patient’s existing immune system to mount a selective and potent response to eradicate the cancer.