Announcements
Paul G. Allen Frontiers Group [to 24 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
News
Mouse study uncovers links between unsung brain cells and Huntington’s disease — and possible path for human therapies
October 21, 2020
Astrocytes, once thought of as inert ‘brain glue,’ may turn out to be key players in Huntington’s and other neurodegenerative diseases.
News
New cell line lets researchers use CRISPR to reversibly switch off genes
October 20, 2020
‘CRISPR interference’ technique enables study of basic cell biology and disease in human stem cells
BARDA – U.S. Department of HHS [to 24 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
No new digest content identified.
BMGF – Gates Foundation [to 24 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
OCTOBER 19, 2020
At 2020 Grand Challenges Annual Meeting, Bill & Melinda Gates Foundation and Grand Challenges Partners Announce New Initiatives to Advance Global Health Innovation
Researchers and scientists from around the world convene to accelerate R&D to address COVID-19 and other global health challenges
Bill & Melinda Gates Medical Research Institute [to 24 Oct 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 24 Oct 2020]
https://carb-x.org/
News
10.21.2020 |
CARB-X is funding Cellics Therapeutics to develop a novel macrophage nanosponge to prevent and treat sepsis
CARB-X is awarding up to US$3.94 million to Cellics Therapeutics, based in San Diego, CA, USA, to develop a new treatment for sepsis caused by drug-resistant Gram-positive and Gram-negative bacteria.
10.20.2020 |
CARB-X 2019-20 Annual Report: Record high awards and funding during its fiscal year in the race against drug-resistant bacteria
CARB-X closed out its 2019-20 fiscal year with a record number of awards and a list of solid achievements, ramping up its efforts to accelerate innovation to combat the spread of antibiotic resistant bacteria. During the fiscal year which ended July 31, 2020, CARB-X granted $127.5 million to product developers and issued 23 new awards to support the early development of novel antibacterial products – the highest number of new awards in any single year since CARB-X was launched in 2016. The achievement is just one of the highlights in CARB-X’s 2019-2020 Annual Report published today.
CEPI – Coalition for Epidemic Preparedness Innovations [to 24 Oct 2020]
http://cepi.net/
Latest News
USA joins CEPI to support the development of epidemic vaccines
A total of US$20 million will be provided to CEPI through USAID to support programmes advancing vaccines against emerging infectious diseases
Blog 23 Oct 2020
CEPI expands global manufacturing network, reserving manufacturing capacity for more than 1 billion doses of COVID-19 vaccines
CEPI has signed agreements with Biofabri (Spain) and GC Pharma (Republic of Korea) to reserve vaccine manufacturing capacity for more than 1 billion doses of COVID-19 vaccines designated by CEPI.
COVAX 21 Oct 2020
Two more laboratories join CEPI’s centralised network to standardise assessment of COVID-19 vaccines
The NIBSC and Q2 Solutions will work alongside five other laboratories, using the same testing reagents and following common protocols, for uniform evaluation and direct comparisons of COVID-19…
Blog 20 Oct 2020
EDCTP [to 24 Oct 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
No new digest content identified.
Emory Vaccine Center [to 24 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.
European Medicines Agency [to 24 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: Strengthening global collaboration on COVID-19 real-world evidence and observational studies
Last updated: 23/10/2020
Medicines regulators from around the world discussed their experiences with supporting and assessing real-world evidence to facilitate regulatory decision-making on COVID-19 treatments and vaccines during a workshop convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The workshop was co-chaired by Health Canada and the European Medicines Agency (EMA) and took place on 13 October 2020. Participants discussed the progress made in building international patient cohorts, pregnancy research, and vaccines surveillance and vigilance during the pandemic. The outcomes of the discussions are highlighted in the summary report, which has been published today.
Observational research can complement the knowledge gained through clinical trials to support the evaluation of potential therapeutics and vaccines against COVID-19. Real-world evidence generated by observational studies is fundamental to understanding the benefits and risks of medicines when used in clinical practice for the prevention and treatment of COVID-19.
Workshop participants shared their lessons learnt from ongoing COVID-19 observational studies based on real-world data in various countries and regions around the world. Studies derived from such data can provide information that is critical to understanding the benefits and risks of medicines in real-life use by patients and healthcare professionals. Closer collaboration between international regulators and information sharing in this area will benefit patients globally…
European Vaccine Initiative [to 24 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.
FDA [to 24 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
October 23, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
:: On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization.
:: The FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 and for other critically needed products to treat symptoms of COVID-19 or to provide supportive care to those with COVID-19.
:: The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary which provides a quick look at facts, figures and highlights of the agency’s response efforts.
October 22, 2020 – FDA Approves First Treatment for COVID-19
Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval…
October 20, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020
October 19, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 19, 2020
FDA – COVID-19 Vaccines [to 24 Oct 2020]
www.fda.gov/covid19vaccines
Upcoming Events
10/22/2020
Vaccines and Related Biological Products Advisory Committee
The Committee will meet in open session, to discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. View webcast
10/20/2020
Advisory Committee on COVID-19 Vaccines
Dr. Peter Marks provides an update on COVID-19 vaccines and discusses the upcoming Vaccines and Related Biological Products Advisory Committee meeting.
Fondation Merieux [to 24 Oct 2020]
http://www.fondation-merieux.org/
News, Events
No new digest content identified.
Gavi [to 24 Oct 2020]
https://www.gavi.org/
News releases
No new digest content identified.
GHIT Fund [to 24 Oct 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 24 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
No new digest content identified.
Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 24 Oct 2020]
https://www.glopid-r.org/news/
News
UKCDR seeks supplier for online, mixed-media platform to support COVID-19 researchers in low resource settings
21/10/2020
The UK Collaborative on Development Research (UKCDR) is seeking to commission a supplier to develop an online, mixed-media platform which will support coordination of researchers funded by the COVID-19 Research Coordination and Learning Initiative (COVID CIRCLE) partners, undertaking COVID-19 research relevant to low resource settings.
The platform will enable researchers to connect, identify synergies and opportunities for collaboration, facilitate information sharing and host an online resource hub.
This platform will support COVID CIRCLE’s broader ambitions to improve coordination and efficiency of research funding and practice, to increase the impact of research response to COVID-19 with a focus on low and middle-income countries. GloPID-R is partnering UKCDR for COVID CIRCLE.
The deadline for electronic copies of proposals is 23:30 GMT on November 1, 2020.
Hilleman Laboratories [to 24 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.
Human Vaccines Project [to 24 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.
IAVI [to 24 Oct 2020]
https://www.iavi.org/newsroom
October 22, 2020
IAVI, Merck KGaA, Darmstadt, Germany, and Serum Institute of India Join Forces to Develop Monoclonal Antibodies for COVID-19 and Ensure Prompt and Equitable Global Access
:: Promising COVID-19 treatment being developed with equitable global access as a central goal.
:: Approach that is complementary to future COVID-19 vaccines.
:: Leverages each partner’s significant expertise, geographic footprint, and infrastructure.
:: Unique among ongoing partnerships for COVID-19 monoclonal antibodies, aims to ensure access to a class of innovative therapies that have, to date, been out of reach in low- and middle-income countries (LMICs).
PUNE, INDIA, and NEW YORK — OCTOBER 22, 2020 — Today, IAVI, a nonprofit scientific research organization dedicated to addressing urgent, unmet global health challenges, and Serum Institute of India Pvt. Ltd., a leading manufacturer of vaccines and biologics, announced an agreement with Merck KGaA, Darmstadt, Germany, a leading science and technology company, to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic.
The agreement builds on the advanced antibody discovery and optimization expertise of IAVI and Scripps Research, gained from years of experience in HIV broadly neutralizing antibody research and development, and on Merck KGaA, Darmstadt, Germany’s and Serum Institute’s significant capabilities in design and scale up of accelerated manufacturing processes for mAb production. The global development plan is being led by the three organizations in partnership.
The two companies have broad networks across complementary geographic areas that will be crucial to reach given the worldwide spread of COVID-19. If the highly potent and broadly cross-reactive SARS-CoV-2 neutralizing antibody candidates being advanced through this partnership are shown to be efficacious in clinical trials, either as a single antibody or a potential combination of both candidates, Merck KGaA, Darmstadt, Germany will lead commercialization in developed countries. Serum Institute has a proven track record of more than 50 years in developing affordable medicines and is the world’s largest producer of vaccines. Serum Institute will lead global manufacturing as well as commercialization in low- and middle-low-income countries, including India…
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
Global Roadmap for Tailored Clinical Biosimilar Development: Instrumental for Sustainable Access to Biologics (24 September 2020)
Following its first peer-reviewed scientific paper on biosimilar medicines development: the Path Towards Tailored Clinical Biosimilar Development (Biodrugs), the International Generic and Biosimilar medicines Association (IGBA), which represents global manufacturers of generic and biosimilar medicines, today released a new policy…
IFFIm
http://www.iffim.org/
Announcements
No new digest content identified.
IFRC [to 24 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Europe
Red Cross warns: Vigilance needed as Europe’s intensive care beds fill up
IFRC has warned people not to take their foot off the brake as hospital intensive care units in many cities across Europe near capacity.
22 October 2020
Vietnam
Five million swamped by catastrophic floods in Vietnam
Kuala Lumpur/Hanoi/Geneva, October 20, 2020 – Red Cross is ramping up relief as catastrophic floods have affected five million people in central Vietnam. At least 178,000 homes have been submerged in floodwaters that h …
20 October 2020
IRC International Rescue Committee [to 24 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Press Release
As COVID-19 increases global food insecurity, less children are receiving nutrition support across conflict-affected states
October 22, 2020
Press Release
Civilian deaths in Sahel states increase 1,870 percent as military response fails to stop violence and humanitarian needs spike, warns IRC
October 20, 2020
IVAC [to 24 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
World Pneumonia Day Panel Discussion
October 2020
On November 13th from 10am to 11:30am EST, join us for a panel discussion on “Maintaining Progress on Childhood Pneumonia in the COVID-19 Era.” Pneumonia claims the lives of more young children than any other disease – over 800,000 children under 5 each year worldwide are lost to this largely preventable infectious disease. The COVID-19 […]
IVI [to 24 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
No new digest content identified.
JEE Alliance [to 24 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.
MSF/Médecins Sans Frontières [to 24 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Mediterranean migration
Lives on the line as legal appeal lodged to free the Sea-Watch 4
Press Release 23 Oct 2020
South Sudan
Worsening flooding increases health risks
Project Update 22 Oct 2020
Iraq
Humanitarians behind the scenes in Iraq
Voices from the Field 20 Oct 2020
National Vaccine Program Office – U.S. HHS [to 24 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.
NIH [to 24 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
No new digest content identified.
PATH [to 24 Oct 2020]
https://www.path.org/media-center/
Press Releases
PATH at the 51st Union World Conference on Lung Health
October 20, 2020 by PATH
Tuberculosis (TB) continues to be the leading cause of death from an infectious agent, more than 25 years after the World Health Organization declared it a global emergency. COVID-19 has rightly drawn the world’s attention, but the pandemic will likely increase the number of deaths from TB due to interruptions in services, particularly detection and treatment.
Join PATH at this year’s virtual Union Conference as we discuss our work in TB control and our vision for reimagining TB care to be more patient-centered and resilient, even amidst a pandemic.
Sabin Vaccine Institute [to 24 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.
UNAIDS [to 24 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
21 October 2020
Community-led campaign encourages people living with HIV to start treatment
A new community-led public information campaign, It is in Your Power to, aimed at encouraging people living with HIV to start antiretroviral therapy has been launched in the four largest areas of the Russian Federation.
20 October 2020
51st Union World Conference on Lung Health opens today as gains in reducing TB deaths risk being set back by COVID-19
The 51st Union World Conference on Lung Health opened today under the theme “Advancing Prevention”. In light of the COVID-19 pandemic, the conference is taking place virtually for the first time in its 100-year history
UNICEF [to 24 Oct 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Press release
10/22/2020
Over 1.5 million children at risk due to floods in central Viet Nam – UNICEF
The children’s agency is allocating an immediate $100,000 for emergency relief
Statement
10/22/2020
UNICEF Executive Director Henrietta Fore’s remarks at the Conference on Sustaining Support for the Rohingya Refugee Response
Checked against delivery
Statement
10/20/2020
‘Toxic brew’ of instability, armed violence, extreme poverty, hunger and COVID-19 putting the future of an entire generation of children and young people in the Central Sahel at risk
UNICEF Executive Director Henrietta Fore’s remarks at the Ministerial Roundtable Meeting on the humanitarian situation in the Central Sahel Region
Press release
10/19/2020
1 in 6 children lives in extreme poverty, World Bank-UNICEF analysis shows
The pre-COVID-19 analysis reveals that 356 million children struggle to survive on less than $1.90 a day, two-thirds of them in sub-Saharan Africa
Press release
10/19/2020
UNICEF to stockpile over half a billion syringes by year end, as part of efforts to prepare for eventual COVID-19 vaccinations
Initial preparatory work – in partnership with Gavi and WHO – will include purchasing boxes for the safe disposal of syringes and mapping out cold chain equipment to ensure delivery of effective vaccines
NEW YORK, 19 October 2020 – As the world awaits a COVID-19 vaccine, UNICEF has begun laying the groundwork for the rapid, safe and efficient delivery of the eventual vaccine by purchasing and pre-positioning syringes and other necessary equipment.
As soon as COVID-19 vaccines successfully emerge from trials and are licensed and recommended for use, the world will need as many syringes as doses of vaccine. To begin preparations, this year, UNICEF will stockpile 520 million syringes in its warehouses, part of a larger plan of 1 billion syringes by 2021, to guarantee initial supply and help ensure that syringes arrive in countries before the COVID-19 vaccines.
During 2021, assuming there are enough doses of COVID-19 vaccines, UNICEF anticipates delivering over 1 billion syringes to support COVID-19 vaccination efforts on top of the 620 million syringes that UNICEF will purchase for other vaccination programmes against other diseases such as measles, typhoid and more.
“Vaccinating the world against COVID-19 will be one of the largest mass undertakings in human history, and we will need to move as quickly as the vaccines can be produced,” said Henrietta Fore, UNICEF Executive Director. “In order to move fast later, we must move fast now. By the end of the year, we will already have over half a billion syringes pre-positioned where they can be deployed quickly and cost effectively. That’s enough syringes to wrap around the world one and a half times.”
In line with the longstanding collaboration between the two partners, Gavi will reimburse UNICEF for the procurement of the syringes and safety boxes, which shall then be used for the COVID-19 Vaccine Global Access Facility (COVAX Facility) and for other Gavi-funded immunization programmes if necessary…
Unitaid [to 24 Oct 2020]
https://unitaid.org/
Featured News
No new digest content identified.
Vaccination Acceptance Research Network (VARN) [to 24 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.
Vaccine Confidence Project [to 24 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
No new digest content identified.
Vaccine Education Center – Children’s Hospital of Philadelphia [to 24 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
Vaccine Update for Providers
October 2020
:: December 2020 event Registration is now open for the Dec. 9, 2020, Current Issues in Vaccines webinar. Dr. Offit’s presentation will be an Update on SARS-CoV-2 vaccines
The event will start at noon ET, and free continuing education credits will be offered for the live and archived event (CME, CEU, and CPE).
Wellcome Trust [to 24 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 20 October 2020
Wellcome’s bold ambitions to improve health through our new strategy
Jeremy Farrar, Director, Wellcome
Today, I’m delighted to introduce a new vision and strategy for Wellcome that I hope will have significant positive impacts on the course of human health over the next two decades.
The Wistar Institute [to 24 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
No new digest content identified.
WFPHA: World Federation of Public Health Associations [to 24 Oct 2020]
https://www.wfpha.org/
Latest News
No new digest content identified.
World Organisation for Animal Health (OIE) [to 24 Oct 2020]
https://www.oie.int/en/for-the-media/press-releases/2020/
Press Releases
No new digest content identified.
::::::
ARM [Alliance for Regenerative Medicine] [to 24 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
The Alliance for Regenerative Medicine Announces Election of 2021 Officers, Executive Committee, and Board of Directors
October 21, 2020
BIO [to 24 Oct 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.
DCVMN – Developing Country Vaccine Manufacturers Network [to 24 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
No new digest content identified.
ICBA – International Council of Biotechnology Associations [to 24 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.
IFPMA [to 24 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA launches Note for Guidance to help those acting on behalf of biopharmaceutical companies live
GENEVA, 22 October 2020: The International Association of Pharmaceutical Manufacturers and Associations (IFPMA) published today a Note for Guidance on how to foster ethical relationships with third party intermediaries in the biopharmaceutical sector. IFPMA’s mission rests on the establishment and promotion of ethical principles for the industry as a whole and anyone acting on its behalf, in line with societal expectations.
Third party intermediaries play an important role in supporting the activity of biopharmaceutical companies and in improving ongoing access for patients and healthcare professionals to innovative, reliable and effective medicines and vaccines. They can operate as clinical research organizations, distributors, wholesalers, distribution or sales agents, consultants, brokers, commission agents, and/or independent sales representatives. They serve an integral role in the biopharmaceutical sector and health systems and therefore hold a critical mission to act with fairness and foster patient trust.
The Note for Guidance aims to complement the 2019 IFPMA Code of Practice and provides best practices for companies when working with third party intermediaries, such as adopting a dedicated risk management program as part of their overall compliance program and code of ethics. This would include, among others, identifying whether there is a particular risk profile for corruption, based on a review of the intermediary’s internal policies and controls for bribery or all types of corruption. This should cover common business activities such as travel/accommodation, gifts, hospitality, sponsorship or grants, sales and marketing, procurement processes, and many more…
Position Paper – Best Practices for In-Country Testing and Sample Management
22 October 2020
PhRMA [to 24 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
Press Release
Pharmaceutical Supply and Payment Chain Coalition Announces Guiding Principles for Safe, Efficacious Access to COVID-19 Vaccine
October 22, 2020
[See COVID-19 Vaccines above for detail]
vaccines and global health :: ethics and policy 