Announcements

Announcements
 
FDA [to 2 September 2017]
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/default.htm
Selected Press Announcements
August 31, 2017 –
Statement from Center for Drug Evaluation and Research Director Janet Woodcock regarding safety concerns related to investigational use of Keytruda in multiple myeloma

August 30, 2017 –
FDA approval brings first gene therapy to the United States

August 29, 2017 –
FDA approves new antibacterial drug

FDA approves first U.S. treatment for Chagas disease

August 28, 2017 –
Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s new policy steps and enforcement efforts to ensure proper oversight of stem cell therapies and regenerative medicine
 
IAVI  [to 2 September 2017]
https://www.iavi.org/
August 15, 2017
IAVI Partnership with MSD Aims to Improve HIV Prevention for People Who Need it Most
IAVI ramped up its efforts to engage communities to better understand the future of HIV prevention this month with the addition of three Richard T. Clark (RTC) Fellows as part of the 2017 MSD Fellowship for Global Health.
The program seeks to build non-governmental organizations’ (NGO) capacity and to make sustainable and systematic improvements in health-service delivery for people in greatest need. IAVI was one of 10 NGOs selected to participate in the program this year, and the Fellows will support IAVI’s mission to develop HIV vaccines and other prevention modalities for people who bear the greatest burden of HIV globally – particularly women, youth, men who have sex with men, sex workers, and mobile communities in sub-Saharan Africa….

August 14, 2017
The Right APPROACH: IAVI Clinical Network Helps Janssen Assess Promising Mosaic HIV Vaccine
Scientists at the International AIDS Society conference in Paris recently announced that in an early-stage clinical trial, a new HIV vaccine regimen generated antibody responses in 100 percent of volunteers in most arms of the study. The global pharmaceutical company Janssen led the trial, known as APPROACH, which amongst others is supported by the International AIDS Vaccine Initiative (IAVI) and its clinical research center (CRC) partners in Africa. Volunteers recruited by PSF in Kigali, Rwanda, and UVRI-IAVI in Entebbe, Uganda – both part of the IAVI-Africa Clinical Research Network – were among those who participated.
Paul Stoffels, Chief Scientific Officer at Janssen’s parent company Johnson & Johnson, said in a press release: “In recent years, a new optimism has emerged that we will find an effective HIV vaccine in our lifetime. The results from today’s study add to that belief and we look forward to advancing to the next stage of clinical development as quickly as possible.”…
 
MSF/Médecins Sans Frontières  [to 2 September 2017]
http://www.doctorswithoutborders.org/news-stories/press/press-releases
Press release
Drug to Treat Chagas Disease to Become Available in the U.S.
August 31, 2017
Pharmaceutical company Chemo Group announced today that it will make a drug to treat the neglected tropical disease Chagas available to people in the United States. The U.S. Food and Drug Administration’s (FDA) approval of the drug, benznidazole, means that Chagas pediatric patients in the U.S. could receive access to a therapy that Doctors Without Borders/Médecins Sans Frontières (MSF) has been using for decades to treat people living with Chagas across Latin America. Though Chagas affects an estimated 300,000 people in the U.S., the treatment was previously only available through the Centers for Disease Control and Prevention and was not FDA approved.
 
NIH  [to 2 September 2017]
http://www.nih.gov/news-events/news-releases
August 30, 2017
Sequencing all 24 human chromosomes uncovers rare disorders
— Study from NIH and other institutions may help improve prenatal genetic screening

August 30, 2017
NIAID scientists illuminate mechanism of increased cardiovascular risks with HIV
— Tick saliva molecule blocks process in human cells, nonhuman primates.

UNAIDS [to 2 September 2017]
http://www.unaids.org/en
Statement
WHO, UNAIDS STATEMENT ON HIV TESTING SERVICES: NEW OPPORTUNITIES AND
ONGOING CHALLENGES
29 August 2017 :: 8 pages
PDF: http://www.unaids.org/sites/default/files/media_asset/2017_WHO-UNAIDS_statement_HIV-testing-services_en.pdf
…WHO and UNAIDS do not support mandatory or compulsory testing of individuals on public health grounds. HIV testing, no matter how it is delivered, must always respect personal choice and adhere to ethical and human rights principles…
 
UNICEF  [to 2 September 2017]
https://www.unicef.org/media/
Selected News Releases
UNICEF scaling up its emergency response in Bangladesh
DHAKA, 31 August 2017 – UNICEF with partners are scaling up the emergency response in the flood-affected northern and central parts of Bangladesh. UNICEF is also providing urgent support in Cox’s Bazar district with the recent influx of Rohingya children and their families. Children are the hardest hit and require the support to survive and outlive the physical and mental trauma of flood and displacement.

More than 180 million people lack basic drinking water in countries ravaged by conflict or unrest – UNICEF
NEW YORK/STOCKHOLM, 29 August 2017 – More than 180 million people do not have access to basic drinking water in countries affected by conflict, violence and instability* around the world, UNICEF warned today, as World Water Week gets under way.

Spread of acute watery diarrhoea and suspected cholera slows in Yemen amid unprecedented response efforts from unsung local heroes
AMMAN/SANA’A, 28 August, 2017 – The Yemeni people continue to be hit by an unprecedented and mostly man-made humanitarian crisis. Amid the suffering, ordinary Yemenis are leading a heroic daily fight against acute watery diarrhoea and cholera which is now paying off.
 
Wellcome Trust  [to 2 September 2017]
https://wellcome.ac.uk/news
News / Published: 29 August 2017
UK science centres get £13 million for public engagement
Wellcome is giving £13 million in funding to five science centres around the UK to encourage new and different ideas that will help to make science more accessible. 
The funding has been awarded through the Inspiring Science Fund.
 
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DCVMN – Developing Country Vaccine Manufacturers Network  [to 2 September 2017]
http://www.dcvmn.org/
25 September 2017 to 28 September 2017
DCVMN Annual General Meeting
Seoul / Korea
 
PhRMA    [to 2 September 2017]
http://www.phrma.org/press-room
August 30, 2017
PhRMA Announces Dr. Richard Moscicki as New Chief Medical Officer and Executive Vice President
PhRMA today announced Richard A. Moscicki, M.D. will join the organization as chief medical officer and executive vice president.