Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 11 July 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Old age changes the way blood accesses the brain

July 7, 2020
A new study in mice shows that contrary to longstanding dogma, blood proteins easily cross into the brain, but transport machinery breaks down with age

Press Release
The Leukemia & Lymphoma Society, The Mark Foundation for Cancer Research and The Paul G. Allen Frontiers Group Partner to Award $6.75M in New Grants to Drive the Next Wave of Novel Cancer Therapies
July 1, 2020

 

BARDA – U.S. Department of HHS [to 11 July 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
July 9, 2020: BARDA and JPEO-CBRND establish partnership with Retractable Technologies, Inc. to expand the capacity to manufacture needles and syringes in the US

July 9, 2020: BARDA and JPEO-CBRND establish partnership with Becton Dickinson to expand domestic manufacturing capacity for needles and syringes

July 7, 2020: HHS, DOD Collaborate with Novavax to Produce Millions of COVID-19 Investigational Vaccine Doses in Commercial-Scale Manufacturing Demonstration Projects
The U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) today jointly announced a $1.6 billion agreement with Novavax, Inc. of Gaithersburg, Maryland, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine. By funding this manufacturing effort, the federal government will own the 100 million doses of investigational vaccine expected to result from the demonstration projects.
The doses would become available for use in clinical trials or, if the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or licenses (approves) the investigational vaccine, the federal government could distribute the doses as part of a COVID-19 vaccination campaign.
FDA can issue EUAs to facilitate the availability of an unapproved product only after several statutory requirements are met. For investigational vaccines being developed to prevent COVID-19, an assessment will be made on a case-by-case basis depending on the clinical trial data and the total scientific evidence available about the vaccine candidate. Additional analysis is required for FDA to license a vaccine…

July 7, 2020: HHS, DOD Collaborate with Regeneron on Large-Scale Manufacturing Demonstration Project of COVID-19 Investigational Therapeutic Treatment

 

BMGF – Gates Foundation [to 11 July 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 11 July 2020]
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 11 July 2020]
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.
07.07.2020  |
CARB-X is funding Spanish biotech Vaxdyn to develop a new vaccine to prevent infections that cause life-threatening pneumonia and other deadly infections
CARB-X is awarding Vaxdyn, based in Seville, Spain, up to US$892,000, plus an additional $6.36 million if certain project milestones are met, to develop a new vaccine to prevent life-threatening drug-resistant infections, including pneumonia.

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 11 July 2020]
http://cepi.net/
Latest News
Nominations open for experts to join COVAX group advising on COVID-19 vaccine candidates
COVAX, one of the four ACT Accelerator Pillars, is setting up an Independent Product Group to advise on COVID-19 vaccine candidates. Deadline for nominations to join Friday 17 July.
COVID-19 09 Jul 2020

CEPI expands partnership with Clover Biopharmaceuticals to rapidly advance development and manufacture of COVID-19 vaccine candidate
Funding will support clinical development in parallel with scale-up of manufacturing capacity to potentially produce hundreds of millions of doses per year.
COVID-19 07 Jul 2020

 

EDCTP [to 11 July 2020]
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
Latest news
09 July 2020
Today! – Online information session on Career Development Fellowships call

 

Emory Vaccine Center [to 11 July 2020]
http://www.vaccines.emory.edu/
No new digest content identified.

 

European Medicines Agency [to 11 July 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
Press release: International regulators align positions on phase 3 COVID-19 vaccine trials
Last updated: 09/07/2020
Medicines regulatory authorities from around the world have published a report  today highlighting the outcomes of the second workshop on COVID-19 vaccine development that was convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA).
The report describes the regulatory positions agreed by the meeting participants on two key topics:
:: Data needed from laboratory, animal and human studies to allow initiation of phase 3 clinical trials for a COVID-19 vaccine; and
:: Considerations for study design for phase 3 clinical trials.
Phase 3 is the last phase of testing of a vaccine before it can be submitted to a regulatory authority for evaluation and possible approval. The main focus of phase 3 trials is to demonstrate efficacy and safety of the vaccine.
The meeting participants stressed the need for large phase 3 clinical trials that enroll many thousands of people, including those with underlying medical conditions, to generate relevant data for the key target populations.
There was also broad agreement that clinical studies should be designed with stringent success criteria that would allow a convincing demonstration of the efficacy of COVID-19 vaccines. However, whether a vaccine would be considered as acceptable for approval is assessed case-by-case on the basis of all available data on its safety and efficacy

 

 

Press release: International regulators provide guiding principles for COVID-19 clinical trials
Last updated: 01/07/2020
EMA has endorsed a joint statement on prioritisation of COVID-19 clinical trials published by the International Coalition of Medicines Regulatory Authorities (ICMRA). Medicines regulators from around the world have jointly developed this statement to step up global collaboration to facilitate and expedite the development and evaluation of therapeutics, diagnostics and vaccines against COVID-19.
“As the COVID-19 pandemic continues to evolve in many countries, we have seen unprecedented global collaboration and a surge in research and development of potential medicines and vaccines against coronavirus disease around the world,” said Guido Rasi, Chair of ICMRA and EMA’s Executive Director. “We, as regulators, support the trials that are providing robust and reliable results required for regulatory decision-making, and evidence that can be used across the globe for all patients affected by COVID-19.”…

 

European Vaccine Initiative [to 11 July 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 11 July 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements
July 10, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 10, 2020

July 10, 2020 – Coronavirus (COVID-19) Update: FDA prepares for resumption of domestic inspections with new risk assessment system

July 9, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 9, 2020

July 8, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 8, 2020

July 6, 2020 – Coronavirus (COVID-19) Update: Daily Roundup July 6, 2020

July 6, 2020 – Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test

 

Fondation Merieux [to 11 July 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.

 

Gavi [to 11 July 2020]
https://www.gavi.org/
News releases
No new digest content identified.

 

GHIT Fund [to 11 July 2020]
https://www.ghitfund.org/newsroom/press
GHIT was set up in 2012 with the aim of developing new tools to tackle infectious diseases that No new digest content identified.

 

Global Fund [to 11 July 2020]
https://www.theglobalfund.org/en/news/
No new digest content identified.

 

Hilleman Laboratories [to 11 July 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 11 July 2020]
http://www.humanvaccinesproject.org/media/press-releases/
HVP COVID Report
COVID-19 Vaccines: Proceed at Warp Speed or Festina Lente?
By John P. Moore, PhD.
Professor of Microbiology and Immunology
Weill Cornell Medicine. New York

 

IAVI [to 11 July 2020]
https://www.iavi.org/newsroom
July 9, 2020
IAVI and Scripps Research Join Efforts with NIH to Expedite Development of Globally Accessible and Affordable HIV Antibody Combination Products
Antibody injections could offer HIV protection that would be of special value to women and girls in low-income countries
NEW YORK – JULY 9, 2020 – Today during the global conference AIDS 2020: Virtual, IAVI, a scientific research organization dedicated to addressing urgent unmet health needs including HIV and tuberculosis, announced an innovative collaboration with Scripps Research and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH). These leading scientific organizations are pooling their HIV broadly neutralizing antibody (bnAb) assets and expertise to develop a combination product specifically designed to be produced at scale to provide prompt, affordable, and sustainable global access, should bnAbs be shown to be efficacious for HIV prevention and possibly for treatment.
Through this collaboration, scientists from the IAVI Neutralizing Antibody Center (NAC), Scripps Research, and NIH will work together to expedite the development of a combination product, including their most potent and broadly neutralizing antibodies, that is designed to protect against the wide genetic diversity of circulating HIV strains…

 

 

International Coalition of Medicines Regulatory Authorities [ICMRA]
http://www.icmra.info/drupal/en/news
Selected Statements, Press Releases, Research
No new digest content identified.

 

 

International Generic and Biosimilar Medicines Association [IGBA]
https://www.igbamedicines.org/
News
No new digest content identified.

 

 

IFFIm
http://www.iffim.org/
Announcements
IFFIm issues NOK 2 billion in Vaccine Bonds for COVID-19 vaccine development
07 Jul 2020
IFFIm has issued NOK 2 billion in Vaccine Bonds to accelerate the availability of financing for urgent COVID-19 vaccine research and development by the Coalition for Epidemic Preparedness Innovations

 

IFRC [to 11 July 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
No new digest content identified.

 

IVAC [to 11 July 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates
New VIEW-Hub Look
July 2020
VIEW-hub is IVAC’s publicly accessible interactive platform to visualize real-time information on vaccine use, product type, coverage levels, impact assessments, and disease burden estimates. It has a new look now.

 

IVI [to 11 July 2020]
http://www.ivi.int/
Selected IVI News & Announcements
IVI welcomes the First Lady of South Korea to a solidarity event for global health and vaccine equity
July 8, 2020

 

JEE Alliance [to 11 July 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 11 July 2020]
http://www.msf.org/
Latest [Selected Announcements]
Coronavirus COVID-19 pandemic
As COVID-19 spreads, fear drives people away from hospitals in Yemen
Press Release 9 Jul 2020

Malawi
Tackling a silent woman-killer in Malawi
Voices from the Field 9 Jul 2020

El Salvador
People are dying at home amid collapsing health system in El Salvador
Project Update 9 Jul 2020

Cambodia
Innovation needed to respond to COVID-19 in Cambodia
Project Update 7 Jul 2020

Access to medicines
Governments must scale up better TB treatment as J&J drops crucial drug pr…
Press Release 6 Jul 2020

Iraq
2019 MSF Iraq annual report
Report 6 Jul 2020

 

National Vaccine Program Office – U.S. HHS [to 11 July 2020]
https://www.hhs.gov/vaccines/about/index.html
NVAC 2020 Meetings
September 23-24, 2020 Meeting (Virtual)

 

NIH [to 11 July 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH launches clinical trials network to test COVID-19 vaccines and other prevention tools
July 8, 2020 — Network website features secure method for volunteering for studies.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19.
The COVID-19 Prevention Trials Network (COVPN) was established by merging four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network (HVTN), based in Seattle; the HIV Prevention Trials Network (HPTN), based in Durham, N.C.; the Infectious Diseases Clinical Research Consortium (IDCRC), based in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles. Those individual networks will continue to perform clinical trials for HIV vaccine and prevention and other infectious diseases in addition to their new COVID roles…

 

PATH [to 11 July 2020]
https://www.path.org/media-center/
Selected Announcements
PATH recognized at AIDS 2020 for research on promoting community-led HIV services in Vietnam
July 8, 2020 by PATH
Yesterday, at the 23rd International AIDS Conference (AIDS 2020), PATH’s Bao Ngoc Vu, MD, received one of the International AIDS Society/Merck Sharpe & Dohme Prizes for Operational and Implementation Research in Differentiated Service Delivery in recognition of outstanding research in differentiated service delivery…

PATH receives new five-year contract from USAID for malaria vaccine research and development
Seattle, WA, July 7, 2020 – PATH is proud to announce a new five-year, $27 million partnership with the United States Agency for International Development (USAID) to develop a next-generation malaria vaccine. The project will focus on identifying and advancing vaccines with greatest potential to benefit those at highest risk of disease and death from malaria. Despite impressive declines in malaria deaths and cases over the past two decades, progress has stalled, and malaria continues to kill over 400,000 people each year; young African children remain most vulnerable. New tools are urgently needed to reduce disease and death attributable to malaria, and to accelerate elimination and eventual eradication…

 

Sabin Vaccine Institute [to 11 July 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 11 July 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
10 July 2020
Ensuring access to quality, safe, and non-discriminatory services for HIV key populations and migrants in the context of the COVID-19 pandemic

10 July 2020
Survey shows that the COVID-19 pandemic increases vulnerability of LGBTI people

10 July 2020
UNAIDS and the wider United Nations system supporting the COVID-19 response in Nigeria

9 July 2020
Next global AIDS strategy: be part of making history

8 July 2020
Setting the next generation of goals for the global AIDS response

8 July 2020
Support for Uzbek mothers living with HIV

 

UNICEF [to 11 July 2020]
https://www.unicef.org/media/press-releases
Selected Press releases/Announcements
Press release
08/07/2020
Marley family to ‘reimagine’ Bob Marley’s One Love in support of UNICEF
Re-recording of iconic anthem will support UNICEF’s Reimagine campaign, a global fundraising appeal to respond, recover and reimagine a post-COVID-19 world fit for children

Press release
08/07/2020
UN agencies welcome latest relocations of unaccompanied children from Greece, call for further action and solidarity

 

Unitaid [to 11 July 2020]
https://unitaid.org/
Featured News
09 July 2020 | Press releases
FIND and Unitaid launch call for expression of interest to accelerate availability and manufacturing scale-up of rapid diagnostic tests for COVID-19
:: Call aims to fill major diagnostic gaps in the detection of active SARS-CoV-2 infection for patient management and contact tracing purposes in decentralized settings, most critically needed in low- and middle-income countries (LMICs)
:: Innovators, developers and manufacturers of rapid diagnostic tests and in vitro diagnostics, and LMIC-based diagnostic stakeholders, are invited to submit proposals
:: Launch of this EOI is the latest milestone for the Access to COVID-19 Tools (ACT) Accelerator Diagnostics Pillar, co-convened by FIND and The Global Fund to Fight AIDS, Tuberculosis and Malaria

 

Vaccination Acceptance Research Network (VARN) [to 11 July 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 11 July 2020]
http://www.vaccineconfidence.org/
Latest News & Archive
Report
The Public’s Role in COVID-19 Vaccination: Planning Recommendations Informed by Design Thinking and the Social, Behavioral, and Communication Sciences
Working Group on Readying Populations for COVID-19 Vaccine
Johns Hopkins Center for Health Security
July 2020
This report considers human factors in relation to future vaccines against the novel coronavirus (SARS-CoV-2), drawing on insights from design thinking and the social, behavioral, and communication sciences. It provides recommendations—directed to both US policymakers and practitioners, as well as nontraditional partners new to public health’s mission of vaccination—on how to advance public understanding of, access to, and acceptance of vaccines that protect against COVID-19.

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 11 July 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 11 July 2020]
https://wellcome.ac.uk/news
No new digest content identified.

 

The Wistar Institute [to 11 July 2020]
https://www.wistar.org/news/press-releases
Press Released
The Wistar Institute Appoints Chengyu Liang, M.D., Ph.D., as Professor in Its Cancer Center 
PHILADELPHIA — (July 6, 2020) — The Wistar Institute, an international biomedical research leader in cancer, immunology and infectious diseases, announces the appointment of Chengyu Liang, M.D., Ph.D., as professor in the Molecular & Cellular Oncogenesis Program of The Wistar Institute Cancer Center.
The Liang laboratory is focused on understanding the mechanisms that regulate fundamental cellular processes such as autophagy, cell death, DNA damage repair, and membrane trafficking in the context of cancer and infectious disease.

 

WFPHA: World Federation of Public Health Associations [to 11 July 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.

 

World Organisation for Animal Health (OIE) [to 11 July 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.

 

 

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ARM [Alliance for Regenerative Medicine] [to 11 July 2020]
https://alliancerm.org/press-releases/
Press Releases
Alliance for Regenerative Medicine Responds to EU Pharmaceutical Roadmap
WASHINGTON, DC and BRUSSELS, BELGIUM – July 7, 2020
Leading international advocacy group calls for effective regulation, clinical trial support, and value-based reimbursement that benefits patient access to ATMPs

 

BIO [to 11 July 2020]
https://www.bio.org/press-releases
Press Releases
Biopharmaceutical Leaders Announce New Effort to Tackle Superbugs, Spur Development of New Antibiotics
July 9, 2020
Today more than 20 leading biopharmaceutical companies announced the creation of an estimated $1 billion fund to help support the pipeline for new antibiotic treatments. The AMR Action Fund was launched as the threat of antimicrobial resistance, or…

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 11 July 2020]
http://www.dcvmn.org/
News; Upcoming events
WEBINAR: Vaccine Innovation Priority Strategy (VIPS): Update
16 July 2020

WEBINAR: Defining the concept on fair pricing for medicines
21 July 2020

 

IFPMA [to 11 July 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
New AMR Action Fund steps in to save collapsing antibiotic pipeline with pharmaceutical industry investment
09 July 2020
:: New AMR Action Fund steps in to save collapsing antibiotic pipeline with pharmaceutical industry investment of US$1 billion
:: Partnership aims to bring 2 to 4 new antibiotics to patients by the end of the decade and facilitate needed long-term policy solutions
9 July 2020, Geneva — Today, more than 20 leading biopharmaceutical companies announced the launch of the AMR Action Fund [www.AMRactionfund.com], a ground-breaking partnership that aims to bring 2-4 new antibiotics to patients by 2030. These treatments are urgently needed to address the rapid rise of antibiotic-resistant infections – also called antimicrobial resistance, or AMR.  The companies have raised so far nearly US$1 billion new funding to support clinical research of innovative new antibiotics that are addressing the most resistant bacteria and life-threatening infections. Through the AMR Action Fund, pharmaceutical companies will join forces with philanthropies, development banks, and multilateral organizations to strengthen and accelerate antibiotic development. The Fund will focus on urgent public health needs.  It will provide much needed financial resources, as well as important technical support to help biotech companies bring novel antibiotics to patients.
The AMR Action Fund, an initiative of the international body representing the R&D pharmaceutical industry (International Federation of Pharmaceutical Manufacturers & Associations, IFPMA), was announced at simultaneous virtual launch events in Berlin, Germany, and Washington, D.C., USA, with a third event in Tokyo, Japan taking place on July 10.
AMR is a looming global crisis that has the potential to dwarf COVID-19 in terms of deaths and economic costs. While tragically the death toll of COVID-19 continues to rise, each year 700,000 people are dying from AMR. In some of the most alarming scenarios, it is estimated that by 2050 AMR could claim as many as 10 million lives per year.
“Unlike COVID-19, AMR is a predictable and preventable crisis. We must act together to rebuild the pipeline and ensure that the most promising and innovative antibiotics make it from the lab to patients,” said Thomas Cueni, Director General of the IFPMA, one of the organizers of the new fund. He adds: “The AMR Action Fund is one of the largest and most ambitious collaborative initiatives ever undertaken by the pharmaceutical industry to respond to a global public health threat”…

Joint Guidance on Virtual International Medical Congresses Impacted by COVID-19
02 July 2020

IFPMA Global Code Comparison Report 2020
02 July 2020

 

ICBA – International Council of Biotechnology Associations [to 11 July 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

PhRMA [to 11 July 2020]
http://www.phrma.org/
Selected Press Releases, Statements
New initiative to bridge the gap on antimicrobial innovation
Stephen J. Ubl   |     July 9, 2020
oday, more than 20 leading biopharmaceutical companies are launching the AMR Action Fund, a ground-breaking partnership to invest nearly $1 billion to ensure a robust and diverse pipeline of new medicines to treat drug-resistant infections…