World TB Day 2018
A recap of Aeras World TB Day activities.
Bill & Melinda Gates Medical Research Institute [to 7 April 2018]
The Bill & Melinda Gates Medical Research Institute is a non-profit research organization dedicated to combating diseases that impact the world’s poorest. We strive to combat inequities in health by accelerating progress in translational science to ensure life-saving products are available and accessible to everyone. We consider ourselves pioneers dedicated to uncovering radical solutions that will close the gap between cutting-edge scientific innovation and its application to challenges in global health.
Published on April 3, 2018
Building the Gates MRI Culture to Achieve our Mission
As the CEO of a new medical research institute, I get asked a lot of questions. What types of diseases will the Gates MRI focus on? How is your approach unique, and how do you intend to accelerate progress in translational medicine? These are important questions, but there’s one question in particular that I’ve found myself thinking about since the conception of the Gates MRI: what kind of culture is necessary to achieve our mission and save lives?…
FDA [to 7 April 2018]
What’s New for Biologics
April 4, 2018 Approval Letter – Flublok Quadrivalent (PDF – 32KB)
Fast Track Designation Request Performance
The Food and Drug Administration Modernization Act of 1997 (FDAMA) includes Section 112, “Expediting study and approval of fast track drugs.” This section mandates the Agency to facilitate the development and expedite review of drugs and biologics intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track adds to existing programs, such as accelerated approval, the possibility of a “rolling review” for an application. An important feature of fast track is that it emphasizes the critical nature of close early communication between the FDA and sponsor to improve the efficiency of product development.
To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use. FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met. This report illustrates CBER’s performance in reviewing and deciding on these requests.
Details on the FDA fast track program, including Section 112 of FDAMA and the proposed and final rules in the Federal Register can be found in the Guidance for Industry: Expedited Programs for Serious Conditions––Drugs and Biologics – 5/2014; Appendix 2; Appendix 3 – (CDER MAPP 6020.3); CBER SOPP 8405; Appendix 4.
Gavi [to 7 April 2018]
03 April 2018
New typhoid vaccine to receive Gavi support
Gavi has earmarked US$ 85 million to fund the introduction of the vaccine in the world’s poorest countries.
Geneva, 3 April 2018 – Governments across Africa and Asia can apply for funding to protect children against typhoid fever. Gavi, the Vaccine Alliance will support eligible countries to introduce the new typhoid conjugate vaccine into their routine immunisation schedules.
“The typhoid conjugate vaccine will not only save lives, but also bolster the fight against anti-microbial drug-resistance,” said Dr Seth Berkley CEO of Gavi, the Vaccine Alliance. “Expanding vaccine coverage will play an important role in reducing illnesses and deaths from typhoid. Gavi is looking forward to working with countries to support the introduction of this safe and effective vaccine.”…
IAVI [to 7 April 2018]
April 5, 2018
IAVI Welcomes Distinguished New Members to its Board of Directors
Linda-Gail Bekker, Mark Dybul, and Christina Hull Paxson join IAVI Board in 1Q 2018
The International AIDS Vaccine Initiative (IAVI) is pleased to announce that Linda-Gail Bekker, MBChB, DTMH, DCH, FCP(SA), PhD; The Hon. Mark Dybul, MD; and Christina Hull Paxson, PhD, have been appointed to IAVI’s Board of Directors.
“IAVI welcomes these exceptionally accomplished and visionary leaders to our Board and is honored to have them as partners in our efforts to accelerate the development of an effective HIV vaccine and other urgently needed prevention measures,” said Mark Feinberg, MD, PhD, CEO of IAVI. “Together they bring a deep understanding of the communities most affected by HIV/AIDS and a remarkable track record for innovation and collaboration in global health programs and policies.”…
IVAC [to 7 April 2018]
IVAC’s Executive Director Kate O’Brien, MD, MPH has been selected as one of the prestigious Canada 150 Research Chairs.
The announcement follows another important honor for Dr. O’Brien, an appointment to the Gavi Board and the Policy and Performance Committee.
NIH [to 7 April 2018]
April 6, 2018
Research offers clues for improved influenza vaccine design
— These efforts contribute to NIAID’s larger plan to develop a universal influenza vaccine.
Article: Y Chen et al. Influenza infection in humans induces broadly cross-reactive and protective neuraminidase-reactive antibodies. Cell DOI: 10.1016/j.cell.2018.03.030 (2018).
NIH completes in-depth genomic analysis of 33 cancer types
April 5, 2018 — Data set includes molecular and clinical information from over 10,000 tumors.
UNAIDS [to 7 April 2018]
Bordeaux signs Paris Declaration to end the AIDS epidemic in cities
05 April 2018
On 4 April, Bordeaux became the latest city to sign up to the Paris Declaration to end the AIDS epidemic in cities. The Mayor of Bordeaux and former French Prime Minister Alain Juppé signed the declaration alongside UNAIDS Executive Director Michel Sidibé at the opening of AFRAVIH, the international francophone HIV and hepatitis conference being held in Bordeaux, France, from 4 to 7 April.
The Wistar Institute [to 7 April 2018]
Press Release Apr. 4, 2018
Wistar Professor Chi Van Dang Named AACR Academy Fellow
Wistar Institute professor Chi Van Dang was elected as a Fellow of the American Association for Cancer Research (AACR) Academy Class of 2018.
DCVMN – Developing Country Vaccine Manufacturers Network [to 7 April 2018]
7 April 2018
Regional workshop: Optimization of vaccines’ manufacturing, containers and testing for global supply
7 May 2018 to 10 May 2018
Hyderabad / India