COVERS MOXIDECTIN APPROVAL
Mark Sullivan, the founder, Managing Director and Board Member of Medicines Development for Global Health, was interviewed by Dr. Norman Swan on today’s
, broadcast nationally in Australia. The interview covers MDGH’s business model, the FDA’s approval of Moxidectin, and the medicine’s potential to help the fight against river blindness, which is a leading global cause of preventable blindness. Click anywhere to listen to a recording on the ABC’s website.
U.S. FDA APPROVES MOXIDECTIN FOR THE TREATMENT OF RIVER BLINDNESS
NOT-FOR-PROFIT BIOPHARMACEUTICAL COMPANY RECEIVES FDA APPROVAL FOR A NEW RIVER BLINDNESS TREATMENT.
Medicines Development for Global Health (MDGH) and the World Health Organisation Special Programme for Research and Training in Tropical Diseases (TDR) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved moxidectin 8 mg oral for the treatment of river blindness (onchocerciasis) in patients aged 12 years and older. The FDA has also awarded MDGH a priority review voucher (PRV)....
Human Neonatal Rotavirus Vaccine Paper in NEJM
The Rotavirus Vaccine Program at the Murdoch Children’s Research Institute has published results from their study evaluating the efficacy of an oral human neonatal rotavirus vaccine (RV3-BB) in preventing rotavirus gastroenteritis. Amanda Handley, Director at Medicines Development, has been providing project management services on this program since January 2013. Congratulations to all the program team...
Moxidectin Phase III Study Lancet Publication
Medicines Development for Global Health is delighted to announce the publication of the moxidectin Phase III study in the Lancet. The paper’s authors, coordinated by the previous Sponsor of moxidectin, the UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases, concluded that “Moxidectin would therefore be expected to reduce parasite transmission between treatment...
Good Management Practice: Partners Address Project Management Challenges for Neglected Tropical Disease Study
The February 2018 edition of Clinical Researcher’s Q&A with Mark Sullivan and Craig Rayner on good management practice. Please click here to read the Q&A.
Medicines Development for Global Health Announces Submission of the Moxidectin NDA to the FDA and Priority Review Designation
Medicines Development for Global Health is pleased to announce the submission of a New Drug Application for moxidectin as an oral treatment for river blindness to the US Food and Drug Administration (FDA). The FDA have also confirmed that moxidectin has qualified for priority review. Please see attached press release for further details. The FDA...
MDGH Joins Neglected Tropical Disease NGO Network
Medicines Development is pleased to announce that it has been accepted as a member of the Neglected Tropical Disease NGO Network (NNN), a global forum for nongovernmental organizations working together on NTDs. The NNN was established in October 2009 to create a global forum for nongovernmental organizations working to control onchocerciasis, lymphatic filariasis, schistosomiasis, soil...
Improvements to the US FDA Priority Review Program for Neglected Diseases
There are two bills on FDA reauthorization in the US Congress aimed at improving the FDA Priority Review Program for Neglected Tropical Diseases. The neglected tropical diseases world is benefiting from this prescient legislation to address the market failure in neglected tropical diseases. However, in reviewing the proposed legislation, there are some unexpected and potentially...
Excellence in Innovation Award
The Cancer Therapeutics CRC has received the Australian CRC Association’s (CRCA) Award for Excellence in Innovation at the annual awards dinner in Canberra on May 2017. As Participant Partner of the Cancer Therapeutics CRC, Medicines Development is proud to be involved with the ground breaking research targeted to the treatment of various cancers....
MDGH is proud to be a foundation member of the Global Health Alliance Melbourne
MDGH has played a central role in the establishment of the Global Health Alliance Melbourne (GLHAM) which aims to capitalize on Victoria’s strengths and capabilities in global health expertise. The ten foundation organizations – Australian Red Cross, BioMelbourne Network, Burnet Institute, The Fred Hollows Foundation, Global Ideas, Medicines Development for Global Health, Monash University, Nossa...
Mark Sullivan presenting at American Society of Tropical Medicine and Hygiene
Neglected tropical diseases (NTDs) remain important sources of morbidity, mortality and disadvantage in low and middle-income countries, and yet the development and registration of new treatments for these diseases is rare. Funding to support the research and development of new medicines for these diseases is directly correlated with their low potential for return on investment,...
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