Announcements

Announcements

 

Paul G. Allen Frontiers Group [to 17 Oct 2020]
https://alleninstitute.org/what-we-do/frontiers-group/news-press/
Press Release
No new digest content identified.

 

BARDA – U.S. Department of HHS [to 17 Oct 2020]
https://www.phe.gov/about/barda/Pages/default.aspx
BARDA News
October 13, 2020: Trump Administration Expands Manufacturing Capacity with Cytiva for Components of COVID-19 Vaccines
To meet the Trump Administration’s Operation Warp Speed goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD ) today announced an agreement with Cytiva, headquartered in Massachusetts, to expand the company’s manufacturing capacity for products that are essential in producing COVID-19 vaccines…

 

BMGF – Gates Foundation [to 17 Oct 2020]
http://www.gatesfoundation.org/Media-Center/Press-Releases
Press Releases and Statements
No new digest content identified.

 

Bill & Melinda Gates Medical Research Institute [to 17 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
Review ARTICLE
Front. Immunol., 14 October 2020 | https://doi.org/10.3389/fimmu.2020.517290
Challenges of Developing Novel Vaccines With Particular Global Health Importance
Penny M. Heaton, Bill & Melinda Gates Medical Research Institute, Cambridge, MA, United States
Six of the top ten leading causes of death in low resource settings could potentially be prevented by vaccination. Development of vaccines for individuals in these populations is difficult because of the biological complexity of the prevalent pathogens and the challenges inherent to development of any vaccine. This review discusses those challenges and promising advances to address them and highlights recent progress in development of vaccines against several pathogens of interest.

 

CARB-X [to 17 Oct 2020]
https://carb-x.org/
News
10.14.2020  |
CARB-X is funding Polyphor to develop a new antibiotic to treat multidrug-resistant Enterobacteriaceae Gram-negative bacterial infections
CARB-X is awarding up to US$2.62 million to Polyphor AG (SIX:POLN), headquartered in Allschwil, Switzerland, to develop a new antibiotic to treat serious Enterobacteriaceae Gram-negative bacterial infections, including those caused by life-threatening carbapenem-resistant Enterobacteriaceae (CRE).

 

CEPI – Coalition for Epidemic Preparedness Innovations [to 17 Oct 2020]
http://cepi.net/
Latest News
Private sector companies provide financial support for CEPI’s COVID-19 vaccine programmes
14 Oct 2020 By Jodie Rogers
As CEPI continues to advance its COVID-19 vaccine portfolio to respond to the global crisis, private sector companies have stepped up and pledged financial support to fund CEPI’s vital work.
This includes donations from Nestlé, Sumitomo Mitsui Financial Group, Inc. (SMFG), Founders Pledge, ADX Labs, Beiersdorf, and A Collected Man, among other supporting organisations.
Financial contributions from our private sector partners will be used to support CEPI’s vaccine development and manufacturing efforts. Based on the principles of speed, scale, and access, CEPI has provided up to US $895 million in funding to date to accelerate the development of nine COVID-19 vaccine programmes, with eight of our partners having already entered clinical trials. Through taking an active portfolio management approach, CEPI is seeking to invest in further COVID-19 vaccine candidates to increase the number of shots on goal in our search for a safe and effective COVID-19 vaccine.

 

EDCTP [to 17 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 17 Oct 2020]
http://www.vaccines.emory.edu/
Vaccine Center News
No new digest content identified.

 

European Medicines Agency [to 17 Oct 2020]
http://www.ema.europa.eu/ema/
News & Press Releases
News: First long-acting injectable antiretroviral therapy for HIV recommended for approval
CHMP, Last updated: 16/10/2020

 

 

News: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 2020
CHMP, Last updated: 16/10/2020

 

European Vaccine Initiative [to 17 Oct 2020]
http://www.euvaccine.eu/
Latest News
No new digest content identified.

 

FDA [to 17 Oct 2020]
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Press Announcements /Selected Details
October 15, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 15, 2020

October 14, 2020 – FDA Approves First Treatment for Ebola Virus

October 13, 2020 – Coronavirus (COVID-19) Update: Daily Roundup October 13, 2020

 

FDA – COVID-19 Vaccines [to 17 Oct 2020]
www.fda.gov/covid19vaccines
Upcoming Events
Vaccines and Related Biological Products Advisory Committee Meeting
10/22/2020 Virtual
Agenda
The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. On October 22, 2020, the Center for Biologics Evaluation and Research’s (CBER), Vaccines and Related Biological Products Advisory Committee (VRBPAC) 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.

 

Fondation Merieux [to 17 Oct 2020]
http://www.fondation-merieux.org/
News, Events
October 20 – 21 2020
Mérieux Foundation co-organized event
7th Global Task Force on Cholera Control (GTFCC) Annual Meeting
Virtual

October 30 – November 3 2020
Mérieux Foundation co-organized event
6th World One Health Congress 2020 – Virtual Event
Virtual

 

Gavi [to 17 Oct 2020]
https://www.gavi.org/
News releases
16 October 2020
Gavi receives 2020 Princess of Asturias Award for International Cooperation
The Princess of Asturias Foundation recognises Gavi “…for their work in facilitating universal access to vaccines to reduce the impact of infectious diseases and for contributing to the protection of half of the global child population through vaccination routines.”
The presentation of the awards, presided over by TM the King and Queen and with the presence of TRH The Princess of Asturias and the Infanta Sofía, took place as a virtual event in Asturias, Spain on 16 October. Gavi CEO Dr Seth Berkley accepted the award on behalf of Gavi.

15 October 2020
Why handwashing with soap is the most effective way to stop viruses
We may not yet have vaccines or treatments against COVID-19, but there is one powerful combo that can help stop the spread of the virus, which many of us already have access to: soap and water.
There’s a reason why governments and public health experts worldwide have been telling us to wash our hands – it really works. Good hand hygiene could reduce cases of respiratory diseases by 20%, and diarrhoea by 30%. That means it has potential to have a huge impact on the spread of the coronavirus.

13 October 2020
Strong systems for strong vaccine coverage
With support from the Vaccine Alliance, countries provided more than 400 million campaign and routine vaccinations in 2019. At the same time, Gavi disbursed a record US$ 331 million in health system support. This is nearly double the level of US$ 172 million in 2015, at the end of the previous five-year strategic period, and a significant increase from US$ 284 million in 2018. In June 2018, the Gavi Board agreed to make available additional HSS funding to countries with unmet needs to strengthen coverage and equity; 30 countries were approved in 2019 for a total of US$ 238 million, with a strong focus on extending immunisation to reach under-served communities..

 

GHIT Fund [to 17 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 17 Oct 2020]
https://www.theglobalfund.org/en/news/
News/Updates
Results Report 2020 Executive Summary and Translations
15 October 2020
An executive summary and translations of the Global Fund Results Report 2020 are now available for download:
Full Report – download in English | Français

 

Global Research Collaboration for Infectious Disease Preparedness [GloPID-R] [to 17 Oct 2020]
https://www.glopid-r.org/news/
News
No new digest content identified.

 

Hilleman Laboratories [to 17 Oct 2020]
http://www.hillemanlabs.org/
No new digest content identified.

 

Human Vaccines Project [to 17 Oct 2020]
http://www.humanvaccinesproject.org/media/press-releases/
Press Releases
No new digest content identified.

 

IAVI [to 17 Oct 2020]
https://www.iavi.org/newsroom
No new digest content identified.

 

 

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
No new digest content identified.

 

IFRC [to 17 Oct 2020]
http://media.ifrc.org/ifrc/news/press-releases/
Selected Press Releases, Announcements
Sudan
Sudan floods: “The conditions are simply appalling” says IFRC Secretary General, as emergency appeal remains woefully underfunded
Geneva, 15 October – The Secretary General of the International Federation of Red Cross and Red Crescent (IFRC) has returned from Sudan, where unprecedented flooding has killed more than 100 people and left over 875,000 people in need of humanitarian a …
15 October 2020

Europe, France, Italy, Netherlands, Spain, United Kingdom
Red Cross raises the alarm across Europe: “Your best defence against this virus is you”
Budapest/Geneva, 14 October 2020 – The International Federation of Red Cross and Red Crescent Societies (IFRC) is urging European governments and its citizens to simultaneously exercise leadership and remain vigilant as COVID-19 ravages the region. Mor …
14 October 2020

Asia Pacific, Vietnam
One million swamped by deadly floods as Viet Nam faces another major storm
Hanoi, Viet Nam, October 14, 2020 – Close to a million people have been severely affected by prolonged flooding in central Viet Nam as the country faces another major tropical storm and further dangerous floods. Red Cross holds grave fears that deadly …
14 October 2020

 

IRC International Rescue Committee [to 17 Oct 2020]
http://www.rescue.org/press-release-index
Media highlights [Selected]
Statement
Humanitarian leaders call on global donors to fund nutrition crisis on World Food Day
October 16, 2020

Press Release
El Comité Internacional de Rescate y los compañeros de tecnología lanzaron un iniciativo digital para combatir la desinformación entregada a los refugiados venezolanos y las poblaciones desplazadas en Colombia
[The International Rescue Committee and technology partners launched a digital initiative to combat misinformation delivered to Venezuelan refugees and displaced populations in Colombia]
October 16, 2020

Press Release
New Report Finds 73% of Refugee and Displaced Women Reported an Increase in Domestic Violence Due to COVID-19
October 15, 2020

Press Release
As US and UK struggle to contain COVID-19, conflict-affected states show encouraging signs in slowing virus transmission – IRC
October 14, 2020

 

IVAC [to 17 Oct 2020]
https://www.jhsph.edu/research/centers-and-institutes/ivac/index.html
Updates; Events
IVAC Support for SAGE October 2020 Meeting
October 2020
WHO’s Strategic Advisory Group of Experts (SAGE) on Immunizations met October 5-7, 2020 to discuss topics including the use of pneumococcal vaccines in older adults, expanded recommendations on rotavirus vaccines, the impact of the pandemic on immunization, and the Immunization Agenda 2030. IVAC regularly participates in semiannual SAGE meetings, providing research summaries and other assistance to […]

 

IVI [to 17 Oct 2020]
http://www.ivi.int/
Selected IVI News, Announcements, Events
IVI and global health partners encourage vaccine diplomacy
October 13, 2020, SEOUL, Korea — The International Vaccine Institute (IVI) hosted a virtual State Forum today to advocate for multilateral cooperation through vaccine diplomacy. During a coronavirus pandemic with the continuous threat of more neglected infectious diseases spreading around the world, the forum convened a panel of country ambassadors and vaccine experts to promote partnership and equity in global health.

“Our coming together today is visible evidence of the kind of solidarity that will end this pandemic, prevent the next one, and control and eradicate more neglected diseases that disproportionately affect low- and middle-income countries,” said George Bickerstaff, Chair of IVI’s Board of Trustees, in his welcome.

The forum was livestreamed online from IVI headquarters in Seoul, Korea and featured remarks from First Lady Kim Jung-sook of the Republic of Korea and Queen Sylvia of Sweden, as well as ambassadors from the Republic of Korea, Sweden, India, Finland, Mexico, and Pakistan. A panel of leaders in global health urged support for stronger partnership, including Dr. Soumya Swaminathan, Chief Scientist of the World Health Organization; Dr. Seth Berkley, CEO of Gavi, the Vaccine Alliance; Dr. Richard J. Hatchett, CEO of CEPI; Ms. Etleva Kadilli, Director of the Supply Division at UNICEF; and Dr. Peter Hotez, Dean of the National School of Tropical Medicine at Baylor College of Medicine.

IVI’s 2020 annual State Forum commemorated the international organization’s founding in October of 1997 under the theme of “Building Vaccine Diplomacy and Advocacy.” Dr. Jerome Kim, Director General of IVI, presented on IVI’s approach to sustainable vaccine development, highlighting South-South and Triangular Cooperation as catalysts for diplomacy and making available life-saving vaccines.

“Ending the COVID-19 pandemic and ridding the world of other dangerous though ‘neglected’ infectious diseases will require countries to commit to vaccine diplomacy with the support and partnership of the scientific community, international organizations, and industry,” said Dr. Jerome Kim.

The IVI State Forum 2020 was livestreamed on October 13, 2020 at 5:00 PM Korea Standard Time, and a recording of the event may be accessed here.

 

JEE Alliance [to 17 Oct 2020]
https://www.jeealliance.org/
Selected News and Events
No new digest content identified.

 

MSF/Médecins Sans Frontières [to 17 Oct 2020]
http://www.msf.org/
Latest [Selected Announcements]
Venezuela
MSF teams improve conditions for Venezuelan returnees in quarantine centres…
Project Update 13 Oct 2020

 

National Vaccine Program Office – U.S. HHS [to 17 Oct 2020]
https://www.hhs.gov/vaccines/about/index.html
No new digest content identified.

 

NIH [to 17 Oct 2020]
http://www.nih.gov/news-events/news-releases
Selected News Releases
NIH begins large clinical trial to test immune modulators for treatment of COVID-19
October 16, 2020 — The trial expects to enroll approximately 2,100 hospitalized adults with moderate to severe COVID-19 at medical facilities in the United States and Latin America.

NIH study aims to identify promising COVID-19 treatments for larger clinical trials
October 13, 2020 — The ACTIV-5 Big Effects Trial will enroll adult volunteers hospitalized with COVID-19.

 

 

NHGRI researchers work with patients, families and the scientific community to improve the informed consent process
October 13, 2020 — As genome-editing trials become more common, informed consent is changing.

 

PATH [to 17 Oct 2020]
https://www.path.org/media-center/
Press Releases
No new digest content identified.

 

Sabin Vaccine Institute [to 17 Oct 2020]
http://www.sabin.org/updates/pressreleases
Statements and Press Releases
No new digest content identified.

 

UNAIDS [to 17 Oct 2020]
http://www.unaids.org/en
Selected Press Releases/Reports/Statements
16 October 2020
COVID-19’s impact on HIV treatment less severe than feared

15 October 2020
Chatbot answers young people’s questions about HIV, health and relationships

14 October 2020
UNAIDS saddened by the death of Guillermo Soberon

13 October 2020
Chinese young people take centre stage on HIV prevention

13 October 2020
COVID-19 impacting HIV testing in most countries

12 October 2020
New HIV infections: men outnumber women

 

UNICEF [to 17 Oct 2020]
https://www.unicef.org/media/press-releases
Selected Press releases, Statements
Statement
10/15/2020
Remarks by UNICEF Executive Director Henrietta Fore at the High-Level Special Event on Strengthening Global Governance of Food Security and Nutrition
As prepared for delivery

Statement
10/15/2020
Remarks by Henrietta H. Fore, UNICEF Executive Director, at the Global Handwashing Day: Accelerating Toward Hand Hygiene for All Event
As prepared for delivery

Press release
10/14/2020
FACT SHEET: Lack of handwashing with soap puts millions at increased risk to COVID-19 and other infectious diseases

 

Unitaid [to 17 Oct 2020]
https://unitaid.org/
Featured News
13 October 2020
Unitaid supports call for intellectual property waivers and action for access to COVID-19 products
Geneva – Unitaid calls on countries to take the necessary measures to facilitate and promote access to vaccines, therapeutics and diagnostics that will help fight the COVID-19 pandemic. This should include ensuring that they have the legal and health systems in place that enable fast production, importation, registration and deployment of effective products, once these become available.

In this context, Unitaid welcomes the proposal submitted by India and South Africa to the TRIPS Council for a temporary waiver on copyrights, industrial designs, patents, lay-out designs of integrated circuits and trade secrets/undisclosed information for products to prevent, contain or treat COVID-19.

Every solution that helps remove potential access barriers is welcome according to Marisol Touraine, Chair of the Unitaid Executive Board and former French Minister of Health, and will help countries to face the pandemic with new tools.

Marisol Touraine stressed that, “the waiver will not solve all challenges, but it is an important step. While countries and companies also need to do their part, this sends a clear message that we are facing an urgent and exceptional situation, that requires exceptional measures.”

Unitaid believes that a range of solutions will be needed in order to ensure that people across the globe have access to the products needed to combat COVID-19. “Just as we will need a range of products – such as protective equipment, tests, medicines and vaccines – to tackle COVID-19, we will need multiple approaches to ensuring access”, said  Dr Philippe Duneton, Unitaid Executive Director a.i., “Information sharing, voluntary licensing, technology transfer, flexibilities and waivers can all contribute to expanding access.”

 

Vaccination Acceptance Research Network (VARN) [to 17 Oct 2020]
https://vaccineacceptance.org/news.html#header1-2r
Announcements
No new digest content identified.

 

Vaccine Confidence Project [to 17 Oct 2020]
http://www.vaccineconfidence.org/
Research and Reports
She Hunts Viral Rumors About Real Viruses
17 Oct 2020, New York Times
For Heidi Larson, the founder of the Vaccine Confidence Project, dispelling vaccine hesitancy means building trust — and avoiding the term “anti-vaxxer.”

 

Vaccine Education Center – Children’s Hospital of Philadelphia [to 17 Oct 2020]
http://www.chop.edu/centers-programs/vaccine-education-center
No new digest content identified.

 

Wellcome Trust [to 17 Oct 2020]
https://wellcome.ac.uk/news
Opinion | 13 October 2020
Once we have effective Covid-19 treatments, it shouldn’t only be the rich who benefit
Jeremy Farrar, Director, Wellcome
We need a range of treatments to make Covid-19 preventable and treatable. Jeremy Farrar describes recent progress made by research and why more investment is needed.

Opinion | 12 October 2020
More people should have access to monoclonal antibodies. Covid-19 can make that happen
Lindsay Keir, Partner, Innovations team Wellcome
Monoclonal antibodies, one of the most promising treatments for Covid-19, are usually expensive and not available worldwide. Lindsay Keir highlights what needs to be done to change that.

 

The Wistar Institute [to 17 Oct 2020]
https://www.wistar.org/news/press-releases
Press Releases
Oct. 13, 2020
Advancement of Anticancer Compounds for B Cell Cancer Therapy Targeting a Cellular Stress Response Mechanism
IRE-1 inhibitors block a main pathway in the endoplasmic reticulum stress response that supports cell survival under stressful conditions and is important for B cell cancer development.

 

WFPHA: World Federation of Public Health Associations [to 17 Oct 2020]
https://www.wfpha.org/
Latest News
2019-2020 Annual report is now available!
Oct 13, 2020 | News
Here you’ll learn about our major initiatives from the past 12 months, explore our achievements in advancing public health globally and have an insight of our plan for the next year.

 

World Organisation for Animal Health (OIE) [to 17 Oct 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 17 Oct 2020]
https://alliancerm.org/press-releases/
Press Releases
ARM and NAMCP Publish Recommendations to Increase Patient Access in Joint Study, “Roadmap for Navigating the Provider Side of Cell and Gene Therapy (CGT) Patient Access in US Managed Care.”
October 12, 2020
Washington, DC

 

BIO [to 17 Oct 2020]
https://www.bio.org/press-releases
Press Releases
No new digest content identified.

 

DCVMN – Developing Country Vaccine Manufacturers Network [to 17 Oct 2020]
http://www.dcvmn.org/
News; Upcoming events
DCVMN establishes an international consortium of laboratories to study the in-house validation of novel in vitro assay for childhood vaccines
Nyon, 29th September 2020 – The Developing Countries Vaccine Manufacturers’ Network (DCVMN), with the support of a grant awarded by the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), has established an international consortium of laboratories, to advance the in-house validation of a serological potency test for whole-cell pertussis-containing childhood vaccines.

Pertussis, commonly known as whooping cough, is a severe disease caused by the Bordetella pertussis bacterium. A cornerstone of routine childhood immunization programs around the world, pertussis-containing vaccines save hundreds of thousands of lives annually.

The project, budgeted at 750 thousand USD, aims to support the in-house validation of a serological assay (Pertussis Serological Potency Test – PSPT) to replace the Kendrick Test currently used for Pertussis potency testing. The PSPT benefits from increased reliability and reproducibility, ultimately reducing the cost of a single vaccine dose while sparing countless laboratory animals from the distress implied in the current test…

 

ICBA – International Council of Biotechnology Associations [to 17 Oct 2020]
https://internationalbiotech.org/
News
No new digest content identified.

 

IFPMA [to 17 Oct 2020]
http://www.ifpma.org/resources/news-releases/
Selected Press Releases, Statements, Publications
IFPMA statement on “Intellectual Property and COVID-19”
16 October 2020
The COVID-19 pandemic has had profound health, social and economic impact around the world. The biopharmaceutical industry has made addressing the pandemic its top priority, devoting its resources, expertise, know-how, and intellectual assets to developing potential treatments, diagnostics and vaccines at unprecedented pace, while committing to and engaging in unprecedented levels of international collaboration and coordination through initiatives such as ACT-AACTIV and CEPI to ensure equitable access to products being developed.

The intellectual property (IP) system has enabled collaboration between biopharmaceutical innovators and governments, universities and other research partners to speed up progress on our most pressing unmet medical needs, including hundreds of potential COVID-19 treatments, diagnostics and vaccines for patients around the world.  It has also been the driving force behind the many innovations that will help us overcome the pandemic, giving rise to nearly all of the molecules, platforms, and other technologies that have enabled industry to target COVID-19 at an advanced stage, and helping to ensure the resources and conditions needed to see the development of promising treatments through to approval.   IP will also continue to play a crucial role long after this pandemic is over, to ensure that the world is prepared with innovative solutions for future global health crisis, in addition to other pressing healthcare needs.

Despite the critical role that IP has successfully played in enabling innovation and collaboration, some stakeholders have proposed to weaken national and international IP frameworks during the COVID-19 pandemic. While we share the objective of equitable access to medicines, we disagree with the premise that IP rights are potential barriers to R&D, public-private collaborations or access to COVID-19 products. Our experience shows the opposite. Indeed, because IP is so critical to each of the goals of innovation, collaboration and access, such proposals would undermine all of them, and therefore would fail to achieve what is so urgently needed.

One-size-fits all proposals advocating for diluting or suspending IP rights during this pandemic disregard the specific circumstances of each situation, each product and each country – all facing very different challenges regarding the manufacture and distribution of COVID-19 treatments and vaccines. The international IP system already has rules and practices to permit customized solutions to real-world problems that may arise…

Biopharmaceutical industry support EU regulators exceptional transparency measures and call other regulatory authorities to follow
Geneva, 13 October 2020: IFPMA & EFPIA support European Medicines Agency’s (EMA) initiative to implement exceptional transparency measures that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19.[1] The biopharmaceutical industry represented by IFPMA and EFPIA encourage other national regulatory authorities to follow EMA’s example.

The European Medicines Agency (EMA) announced several exceptional transparency measures[2] that are targeting regulatory activities for the assessment and approval of medicines and vaccines for COVID-19.[3] These transparency measures are focused on accelerating the publication of key documents at this exceptional time, such as news announcements for rolling reviews and compassionate use opinions, as well as implementing shorter timeframes for publishing public assessment reports. The measures also include publication after marketing authorization of the complete version of the risk management plan and the clinical trial data used in support of the regulatory approval for the medicine and vaccine. Along with the implementation of the measures comes the added responsibility of providing the appropriate context around the availability of this additional data and information. It is paramount to ensure that safeguards are in place to preserve privacy of patients who volunteer in the biomedical research.

Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) says: “As an industry, we recognize that there are important public health benefits associated with making clinical trial results more widely available and hope that such measures will help to broaden confidence in the science and the decision-making that is guiding the development of medicines and vaccines for COVID-19.”

Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) are of the same view: “We believe that this initiative will better inform patients, health care professionals, researchers, media, policymakers, and the general public about ongoing regulatory processes and procedures. The EMA initiative of exceptional transparency measures will help to enhance trust and confidence in the evaluation and approval process that is critical during COVID-19.”

IFPMA applauds APEC for trailblazing efforts to demonstrate return on ethics for SMEs through Vision 2025
GENEVA, 13 October 2020: Today, IFPMA joined hundreds of diverse stakeholders from more than 30 economies spanning the Asia-Pacific and beyond in a shared commitment to solidify and grow the world’s largest public-private, multi-sectoral partnership in the advancement of business ethics in the medical device and biopharmaceutical sectors, through Vision 2025.  This roadmap builds on a decade of work in the APEC region, resulting in the adoption of codes of ethics for industry bodies representing nearly 20,000 enterprises of every size across the APEC region, including in 10 economies where they previously did not exist.

Vision 2025 acknowledges that more needs to be done in the next five years to achieve regional alignment and implementation in ethical business practices while advancing the best interest and health of patients. These efforts are also crucial to COVID-19 response and recovery.

IFPMA members are firmly behind this roadmap, launched at the 2020 APEC Business Ethics for SMEs Virtual Forum.

 

“APEC is at the forefront of driving the most essential value in our healthcare systems today, and that’s integrity,” said David Ricks, President of the IFPMA and Chairman and CEO of Eli Lilly and Company. “We make medicines that improve people’s health or sustain their life. Trust is the bedrock of the modern pharmaceutical industry. Integrity and trust in our enterprise come first in everything that we do”, he added.

 

“Integrity is the cornerstone principle for any organization that values trust. And trust is the lifeblood of healthcare and innovation. In this context we realize our essential integrity is to pioneering new treatments that save countless lives. Integrity is our ultimate tool to win the battle against COVID-19,” said Jean-Christophe Tellier, Chief Executive Officer and Chairman of the Executive Committee at UCB, incoming President of IFPMA…

 

PhRMA [to 17 Oct 2020]
http://www.phrma.org/
Selected Press Releases, Statements
No new digest content identified.