EDCTP    [to 7 October 2017]
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
2 October 2017
Call for participants: Workshop in Portuguese on EDCTP grant proposal writing
EDCTP is calling for applications from researchers interested in participating in a workshop on EDCTP Calls for Proposals and grant…

European Medicines Agency  [to 7 October 2017]
EMA Management Board: highlights of October 2017 meeting
Board hears update on preparations for Brexit and adopts Agency’s mid-year report …

EMA takes yet another step in public engagement with its first public hearing
Summary report now published …

European Vaccine Initiative  [to 7 October 2017]
04 October 2017
Report on Role and Impact of EU’s ‘Poverty-Related and Neglected Diseases’ projects
The European Commission Research and Innovation Directorate published a report it had commissioned to evaluate the role and impact of the European Union’s (EU) Research Framework Programme activities in the field of Poverty-Related and Neglected Diseases (PRNDs).
The study focuses on the impact of past EU funding (€1.445bn) in PRND research supported from EU Framework Programmes (FP5–7, 1998–2013), as well as the first European and Developing Countries Clinical Trials Partnership (EDCPT) (2003–2013) and relevant research under the Innovative Medicines Initiative (IMI) (2008–2013). EVI is positively mentioned on several occasions throughout the report and is listed as one of the top ten organisations receiving EDCTP funding during the evaluation period.
FDA [to 7 October 2017]
October 06, 2017 – FDA awards six grants for natural history studies in rare diseases

October 06, 2017 – FDA awards 15 grants for clinical trials to stimulate product development for rare diseases

October 05, 2017 – FDA approves first test for screening Zika virus in blood donations

October 02, 2017 – Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s Adverse Event Reporting System (FAERS) and new search tool

What’s New for Biologics
:: October 5, 2017 Approval Letter – cobasZika (PDF – 39KB)  Posted: 10/6/2017
:: Influenza Virus Vaccine for the 2017-2018 Season  Updated: 10/5/2017
Fondation Merieux  [to 7 October 2017]
October 6, 2017
The “Cent Gardes” Conference brings together the world’s foremost experts on HIV/AIDS at Les Pensières
On October 6-8, the Mérieux Foundation organizes the “Cent Gardes” Conference focusing on HIV/AIDS, in partnership with the Agence France Recherche Nord&Sud Sida-HIV Hépatites (ANRS) and the Institut national de la santé et de la recherche médicale (Inserm).
More than 50 experts from 10 countries will participate in this edition of the Cent Gardes Conference. The symposium focuses on the HIV vaccine, which remains a high priority to end the global HIV epidemic.
The experts will notably discuss the role of antibodies in HIV prevention and therapy. The mechanisms of HIV transmission and mucosal immunity will also be explored. Some presentations will highlight the functional cure for HIV, which aims to remove the negative effects of HIV infection without eliminating all virus from the body…
IAVI  [to 7 October 2017]
October 4, 2017
New HIV-Prevention Discoveries Harness the Power of Potent Antibodies
Scientists have known for some time that a fraction of people living with chronic HIV infection produce broadly neutralizing antibodies (bnAbs), which can overcome HIV’s high levels of diversity to block replication. At IAVI’s Neutralizing Antibody Center (NAC) in La Jolla, California, a team of researchers from IAVI and The Scripps Research Institute (TSRI) recently found themselves out to pasture, thanks to similarities between bnAbs and cow antibodies.
Now two more discoveries involving NAC researchers could have implications for development of both a vaccine and long-acting HIV prevention, according to studies published in PLOS Pathogens and Science

MSF/Médecins Sans Frontières  [to 7 October 2017]
Press release
Doctors Without Borders Brings Interactive Exhibition on Global Refugee Crisis to Seattle
October 04, 2017
The international medical humanitarian organization Doctors Without Borders/Médecins Sans Frontières (MSF) opens Forced From Home this week in Seattle. The interactive exhibit seeks to tell the individual stories of the more than 65 million displaced people worldwide, and to help visitors understand the humanitarian consequences of displacement. Forced From Home exhibitions has already toured Boulder and Salt Lake City in September, welcoming more than 6,000 visitors.
NIH  [to 7 October 2017]
October 6, 2017
DNA damage caused by cancer treatment reversed by ZATT protein
— Scientists discover a new way that cells fix an important and dangerous type of DNA damage.

NIH to fund Centers of Excellence on Minority Health and Health Disparities
October 5, 2017 — Twelve specialized research centers will conduct multidisciplinary research, research training, and community engagement activities.

NIH to fund seven Research Centers in Minority Institutions
October 5, 2017 — Awards to support institutional research capacity and foster the career development of new and early career investigators.

Monoclonal antibodies against Zika show promise in monkey study
October 5, 2017 — Further development toward clinical evaluation is warranted.

NIH Director’s high-risk research awards announced for 2017
October 5, 2017 — NIH Common Fund funds 86 awards for highly innovative biomedical research.

Multiple research approaches are key to pandemic preparedness, NIAID officials say
October 5, 2017 — Preparedness in the face of major disease outbreaks can save thousands of lives.
[See Featured Journal Content above for more detail]

NIDCR announces 2017 Sustaining Outstanding Achievement in Research awards
October 4, 2017 — Grants support ambitious, long-term research of meritorious mid-career investigators.

NIH Grantee Wins 2017 Nobel Prize in Chemistry
October 4, 2017 — The 2017 Nobel Prize in Chemistry has been awarded to National Institutes of Health grantee Joachim Frank, Ph.D., of Columbia University, New York City.
PATH  [to 7 October 2017]
Announcement | October 02, 2017
PATH hires chief of staff for the Office of the President
Erica Sessle brings international, multi-sectoral leadership experience in health sciences and public health

UNAIDS [to 7 October 2017]
Press statement
UNAIDS welcomes appointment of Natalia Kanem as Executive Director of UNFPA
GENEVA, 5 October 2017—UNAIDS welcomes the appointment by the United Nations Secretary-General of Natalia Kanem as the Executive Director of the United Nations Population Fund (UNFPA).
“As part of the Joint United Nations Programme on HIV/AIDS, the United Nations Population Fund’s work is critical in meeting the reproductive health needs of women and adolescents,” said Michel Sidibé, Executive Director of UNAIDS. “I look forward to working closely with Ms Kanem. Her experience in public health, her strong leadership and her commitment to social justice will be invaluable in our efforts to end AIDS as a public health threat.”…

Press statement
UNAIDS congratulates Mariangela Simão on her appointment as Assistant Director-General at the World Health Organization
GENEVA, 3 October 2017—UNAIDS warmly congratulates Mariângela Batista Galvão Simão on her appointment as the Assistant Director-General for Drug Access, Vaccines and Pharmaceuticals at the World Health Organization (WHO)…

UNICEF  [to 7 October 2017]
6 October 2017
UNICEF’s preventive plan to mitigate the risk of Acute Water Diarrhoea (AWD) and Cholera among Rohingya Refugees
GENEVA/DHAKA, Bangladesh – This is a situation update from Maya Vandenant, Chief of Health, UNICEF Bangladesh, – to whom quoted text may be attributed – for today’s press briefing at the Palais des Nations in Geneva.
[See Milestones above for more detail]
Partners commit to reduce cholera deaths by 90 per cent by 2030
Geneva, 03 October 2017 – An ambitious new strategy to reduce deaths from cholera by 90 per cent by 2030 will be launched tomorrow by the Global Task Force on Cholera Control (GTFCC), a diverse network of more than 50 UN and international agencies, academic institutions, and NGOs that supports countries affected by the disease.
[See Milestones above for more detail]

Wellcome Trust  [to 7 October 2017]
Published: 4 October 2017
Introducing our new science strategy
After almost a year as Director of Science, Jim Smith gives an update on our new approach to science funding: Improving health through the best research.
I have been Director of Science at Wellcome for 10 months now. During this time I’ve been learning how Wellcome works and spending as much time as possible meeting the people we support, both in the UK and abroad. With my first anniversary coming up, it’s a good time to set out our stall and discuss Wellcome’s approach to funding science.
I set out this approach today in our new science strategy: Improving health through the best research [PDF 1MB]. The strategy outlines what we plan to do over the next five years and how we plan to do it. It has four broad aims:
:: creating knowledge
:: strengthening research capacity
:: using knowledge effectively
:: promoting an environment in which research can flourish.
BIO    [to 7 October 2017]
Oct 3 2017
Sixth Annual BIO Patient and Health Advocacy Summit Concludes Today
The 2017 Patient and Health Advocacy Summit wrapped up today, having offered the nearly 240 patient groups, companies and organizations new ways to connect, strategize, learn and partner.  For the past six years, the BIO Patient and Health Advocacy Summit has brought together a diverse group of organizations including patient advocacy, health care providers, academia, government, think tanks, professional societies and the biotechnology industry to focus on bringing the patients’ voice to the drug development process.
IFPMA   [to 7 October 2017]
Published on: 03 October 2017
WIPO and the Research-Based Pharmaceutical Industry Team up to Facilitate Access to Key Medicine Patent Information
GENEVA, 13h00 CET – 3 October 2017 – The World Intellectual Property Organization (WIPO) and the research-based pharmaceutical industry today launched a new partnership to promote the accessibility of patent information for health agencies tasked with procurement of medicines.
WIPO Director General Francis Gurry and Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), signed an agreement establishing the Patent Information Initiative for Medicines, or “Pat-INFORMED,” on the sidelines of the Assemblies of the Member States of WIPO.
WIPO and IFPMA, the global trade association representing the research-based pharmaceutical industry, are co-sponsors of the initiative, which originated in the industry’s efforts to add clarity to the patent information around medicines. It couples the industry’s work in this area with WIPO’s well-established expertise in organizing patent data from across the globe.
Pat-INFORMED will clearly link public patent information to registered medicines in a new online global gateway, helping health professionals to navigate the medicine-procurement process for the benefit of their citizens.
“Pat-INFORMED will make it easier for procurement experts to assess the patent status of medicines, underlining how a well-designed and implemented patent system incentivizes innovation while making available and accessible key information about patented inventions,” said Mr. Gurry. “I welcome the engagement of IFPMA and its membership in this initiative, which responds to real needs in the public health community.”…
Industry Watch
:: Bavarian Nordic Secures Contract Award for Supply of Freeze-dried IMVAMUNE Smallpox Vaccine to the U.S. Government
:: Initial base award secures additional IMVAMUNE bulk contract of USD 100 million
:: Contract includes initial options valued at USD 439 million
:: Potential for contract value to increase if options to purchase additional IMVAMUNE bulk or freeze dried doses are exercised.
COPENHAGEN, Denmark, September 27, 2017 – Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) today announced the award of a sole source contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), for the procurement of freeze-dried IMVAMUNE® smallpox vaccine. The potential value of the initial base and optional awards is in excess of USD 539 million.

The initial award in the contract calls for the manufacturing and storage of USD 100 million of IMVAMUNE bulk. This is the third such award to manufacture vaccine bulk; with the two prior orders totaling USD 233 million. The initial options in the contract are divided between two distinct areas, the first of which is the filling and freeze-drying of IMVAMUNE from the three bulk awards, with total potential value of USD 299 million. The second part of the contract contains provisions for clinical development, regulatory commitments, and parts of the establishment and validation of fill/finish activities, with potential value of up to USD 140 million. The award also contains options to acquire additional vaccine bulk and/or freeze-dried doses of IMVAMUNE in the future.

To ensure the production capacity to secure the future IMVAMUNE stockpile at the U.S. Strategic National Stockpile, Bavarian Nordic will invest approximately USD 75 million over the coming years in the construction of a fill/finish manufacturing line at its facility in Denmark. As part of Bavarian Nordic’s long-standing partnership with BARDA, a potential optional award of up to USD 33 million (part of the USD 140 million mentioned above) is dedicated to process transfer, and validation of the new manufacturing line. This strategic investment will allow Bavarian Nordic to recognize the full value chain of the manufacturing process, to maintain control of the product cycle throughout, and the potential to provide these services to third parties in the future.

“We are proud to be part of a long-standing and successful partnership with BARDA and this latest contract starts a new chapter, as we supply an improved formulation of our vaccine as part of the U.S. government commitment to protect the nation from a smallpox outbreak “ said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic. “Our latest strategic investment that will expand our manufacturing capacities will add value, not only to our partnerships, but also to our proprietary pipeline.”…

:: PnuVax awarded $29.4 million USD grant to advance innovative vaccine into clinical trials
   :: Pneumonia, one of the diseases caused by pneumococcal bacteria, is currently the leading single killer of young children worldwide, despite advances in prevention and treatment
   :: $29.4 million USD grant from the Bill & Melinda Gates Foundation will advance vaccine’s clinical development and biomanufacturing scale-up
   :: Novel low-cost approach that may lead to increased access to vaccine, with potential to save millions of lives
Kingston, Canada – 2 October 2017 – PnuVax Incorporated, an organization dedicated to the production of high quality vaccines and biopharmaceuticals for the promotion of public health worldwide, today announced that it is the recipient of a $29.4 million USD ($36 million CDN) grant. The grant will be used to further develop and clinically evaluate PnuVax’s innovative pneumococcal conjugate vaccine. Milestone payments will be received over the next three years as the vaccine progresses from process development through to biomanufacturing scale-up and proof-of-concept clinical trials…