Announcements

Announcements
 
AERAS  [to 21 Jul 2018]
http://www.aeras.org/pressreleases
No new digest content identified.
 

BMGF – Gates Foundation  [to 21 Jul 2018]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

Bill & Melinda Gates Medical Research Institute    [to 21 Jul 2018]
https://www.gatesmri.org/
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
No new digest content identified.

CARB-X   [to 21 Jul 2018]
https://carb-x.org/
CARB-X is a non-profit public-private partnership dedicated to accelerating antibacterial research to tackle the global rising threat of drug-resistant bacteria.
No new digest content identified.

CEPI – Coalition for Epidemic Preparedness Innovations  [to 21 Jul 2018]
http://cepi.net/
No new digest content identified.

EDCTP    [to 21 Jul 2018]
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
No new digest content identified.

Emory Vaccine Center    [to 21 Jul 2018]
http://www.vaccines.emory.edu/
No new digest content identified.

European Medicines Agency  [to 21 Jul 2018]
http://www.ema.europa.eu/ema/
16/07/2018
EMA’s proactive publication of clinical data a success
First report on unprecedented transparency policy shows high user satisfaction
The European Medicines Agency (EMA) has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070). Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorisation applications for new medicines as of 1 January 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines.
The report covers one year from the launch of EMA’s clinical data website on 20 October 2016 and lists the 50 medicines for which clinical data were published, including orphan, paediatric, biosimilar and generic medicines, as well as the corresponding 54 regulatory dossiers. These data have attracted a total of 3,641 users, resulting in 22,164 document ‘views’ and 80,537 ‘downloads’ for non-commercial research purposes…
 

European Vaccine Initiative  [to 21 Jul 2018]
http://www.euvaccine.eu/news-events
19 July 2018
First pre-clinical results of the PRIMALVAC project published in npj Vaccines
New article published on 17 July 2018 in npj  Vaccines: “Down-selection of the VAR2CSA DBL1-2 expressed in E. coli as a lead…

FDA [to 21 Jul 2018]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
July 19, 2018 –
 Statement by FDA Commissioner Scott Gottlieb, M.D., on the formation of a new work group to develop focused drug importation policy options to address access challenges related to certain sole-source medicines with limited patient availability, but no blocking patents or exclusivities
 
July 18, 2018 –
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for delivery at the Brookings Institution on the release of the FDA’s Biosimilars Action Plan
 
July 18, 2018 –
FDA approves first cancer drug through new oncology review pilot that enables greater development efficiency
 
July 17, 2018 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on new efforts to empower consumers by advancing access to nonprescription drugs

 
Fondation Merieux  [to 21 Jul 2018]
http://www.fondation-merieux.org/
No new digest content identified.

 
Gavi [to 21 Jul 2018]
http://www.gavi.org/library/news/press-releases/
No new digest content identified.
 
 

GHIT Fund   [to 21 Jul 2018]
https://www.ghitfund.org/newsroom/press
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
No new digest content identified.

Global Fund [to 21 Jul 2018]
http://www.theglobalfund.org/en/news/?topic=&type=NEWS;&country=
News
Breaking Barriers. Building Bridges.
20 July 2018
Peter Sands, Executive Director of the Global Fund, speaks in our video series from the 22nd International AIDS Conference.

News
New Agreements with HIV Drug Suppliers to Save $324 Million
16 July 2018
GENEVA – The Global Fund to Fight AIDS, Tuberculosis and Malaria has signed multi-year framework agreements with suppliers of HIV medication that will save US$324 million by the end of 2021 and secure the supply of lifesaving drugs for over 4 million people.
The framework agreements, engaging 14 pharmaceutical companies, build an enlarged base of suppliers and deliver cost competitiveness and supply security, essential elements in expanding HIV treatment in the most reliable and cost-effective way. Projected contracts for antiretroviral drugs total US$1.2 billion over the coming four years.
“These agreements are a strategically smart and highly effective way to secure greater volumes of medication that save lives,” said Peter Sands, Executive Director of the Global Fund. “In a complex, high-volume business, it’s a performance-based approach that reduces risk and gets essential HIV drugs at the most competitive prices, with consistency and reliability.”…
 

Hilleman Laboratories   [to 21 Jul 2018]
http://www.hillemanlabs.org/
No new digest content identified.
 

Human Vaccines Project   [to 21 Jul 2018]
http://www.humanvaccinesproject.org/media/press-releases/
No new digest content identified.
 

IAVI  [to 21 Jul 2018]
https://www.iavi.org/
No new digest content identified.

 

IFFIm
http://www.iffim.org/library/news/press-releases/
No new digest content identified.

 

IVAC  [to 21 Jul 2018]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
No new digest content identified.
 

IVI   [to 21 Jul 2018]
http://www.ivi.int/
No new digest content identified.

 
JEE Alliance  [to 21 Jul 2018]
https://www.jeealliance.org/
No new digest content identified.
 

MSF/Médecins Sans Frontières  [to 21 Jul 2018]
http://www.msf.org/
Selected Press Releases/Statements
Tuberculosis
Last-minute pressure to drop language on protecting access to affordable medicines from TB Summit declaration negotiations
20 Jul 2018

Central African Republic
Protecting as many children as possible in an emergency context
20 Jul 2018
HIV/AIDS
MSF at AIDS 2018
16 Jul 2018
 

NIH  [to 21 Jul 2018]
http://www.nih.gov/news-events/news-releases
July 17, 2018
Broadly acting antibodies found in plasma of Ebola survivors
— NIAID-supported discovery could lead to therapy for deadly illness.

 

PATH  [to 21 Jul 2018]
https://www.path.org/media-center/
July 17, 2018 by PAT

PATH, reimagined
Leading global public health organization celebrates 40th anniversary with dynamic new brand experience

 

Sabin Vaccine Institute  [to 21 Jul 2018]
http://www.sabin.org/updates/pressreleases
No new digest content identified.
 
 

UNAIDS [to 21 Jul 2018]
http://www.unaids.org/en
No new digest content identified.

 

UNICEF  [to 21 Jul 2018]
https://www.unicef.org/media/press-releases
Selected Press Releases/Reports/Statements
Statement
Access to children in need in Syria continues to be severely restricted
Statement by Geert Cappelaere, UNICEF Regional Director for the Middle East and North Africa

Press release
16/07/2018
Statement by UNICEF Executive Director Henrietta Fore at High Level Political Forum side event on ending newborn deaths

News note
16/07/2018
Record number of infants vaccinated in 2017
As over 19 million children miss out on vaccinations, UNICEF and WHO call for concerted efforts to reach all children
[See Milestones/Perspectives above for more detail]
 
 

Vaccine Confidence Project  [to 21 Jul 2018]
http://www.vaccineconfidence.org/
No new digest content identified.
 

Vaccine Education Center – Children’s Hospital of Philadelphia  [to 21 Jul 2018]
http://www.chop.edu/centers-programs/vaccine-education-center
Published on Jul 16, 2018
Dr. Offit Addresses Reintroduction of Intranasal Flu Vaccine and Recommendations for Use
After a three-year hiatus, the intranasal flu vaccine is once again recommended for use during the 2018-2019 influenza season. In these videos, Dr. Offit explains the changes to the intranasal flu vaccine and the recommendations regarding its use by the CDC and AAP.
 

Wellcome Trust  [to 21 Jul 2018]
https://wellcome.ac.uk/news
Published: 18 July 2018
How lived experiences of dementias have informed science and the arts
Since October 2016, a team of scientists and artists and people experiencing dementias have been exploring, challenging and shaping perceptions of dementias. As their two-year residency in The Hub at Wellcome Collection draws to a close, here are some highlights
 

The Wistar Institute   [to 21 Jul 2018]
https://www.wistar.org/news/press-releases
No new digest content identified.

World Organisation for Animal Health (OIE)   [to 21 Jul 2018]
http://www.oie.int/en/for-the-media/press releases/2018/
18/07/18
Countries step up to tackle antimicrobial resistance
Paris/Geneva/Rome, 18 July 2018 – Countries are making significant steps in tackling antimicrobial resistance (AMR), but  serious gaps remain and require  urgent action, according to a report released today by the Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and the World Health Organization (WHO).
The report charts progress in 154 countries and reveals wide discrepancies. Some, including many European countries, have been working on AMR policies in human and animal sectors for more than 4 decades. Others have only recently started to take action to contain this growing threat. Progress in developing and implementing plans is greater in high-income than low-income countries but all countries have scope for improvement. No country  reports sustained capacity at scale in all areas.
The report looks at surveillance, education, monitoring and regulating consumption and use of antimicrobials in human health, animal health and production, as well as plants and the environment – as recommended in the Global Action Plan published in 2016…

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BIO    [to 21 Jul 2018]
https://www.bio.org/insights/press-release
No new digest content identified.

DCVMN – Developing Country Vaccine Manufacturers Network  [to 21 Jul 2018]
http://www.dcvmn.org/
No new digest content identified

IFPMA   [to 21 Jul 2018]
http://www.ifpma.org/resources/news-releases/
No new digest content identified

PhRMA    [to 21 Jul 2018]
http://www.phrma.org/press-room
No new digest content identified.

Industry Watch  [to 21 Jul 2018]
:: Moderna Opens New Manufacturing Site in Norwood, MA
200,000 Square Foot State-of-the-Art Plant Built to Support Development of mRNA Medicines
July 17, 2018
NORWOOD, Mass.–(BUSINESS WIRE)–Moderna Therapeutics, a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the opening of its state-of-the-art manufacturing facility in Norwood, Massachusetts.
“Thanks to companies like Moderna, Massachusetts continues to be a global leader in the industry and we welcome their growth and investment in Norwood to support the manufacturing market here in the Commonwealth.”
The digitally-enabled and environmentally sustainable 200,000 square foot clinical development manufacturing plant was built to advance Moderna’s pipeline of mRNA-based medicines. Designed to Current Good Manufacturing Practices (cGMP) specifications, the site gives the company the capacity to develop materials for preclinical toxicology studies as well as Phase 1 and 2 clinical development programs, and to manufacture, test and run fill/finish operations for its portfolio of mRNA development candidates.
Today, Moderna has 21 programs in its mRNA pipeline, including potential treatments for different forms of cancer, rare diseases, infectious diseases and heart failure…