💊 Sanofi partners up with Middle East's PureHealth; US FDA issues guidance on nitrosamine impurities; Doctors Without Borders end longest-running Malawi project
#400 | Killing cancer cells; Maintaining a fungal balance; Breathing in cancer
Hello! Welcome back to The Kable for a fresh dose of Monday
blues news. Well, they are blues for some people, especially in Bangladesh, where a deadly, record outbreak of dengue fever is overwhelming hospitals. So far this year, there have been nearly 61,500 infections and at least 293 deaths. This makes it the deadliest outbreak since the first epidemic was recorded in 2000. And the peak season that runs through August and September is barely even here yet.
Meanwhile, Singapore is moving over CRISPR-Cas9; CRISPR-Cas13 is here. Scientists from A*STAR’s Genome Institute of Singapore and the NUS School of Medicine have used a CRISPR-Cas13 editor, delivered by adeno-associated virus (AAV), to overcome the limitations of the CRISPR-Cas9 technology. In their research, they were able to clear the EV-A71 virus, which causes hand, foot, and mouth disease in a mouse model. Further development could lead to this tech being used clinically to treat a range of human RNA viruses.
Nitrosamine drug substance-related impurities, or NDSRIs, usually form in drug products through the nitrosation of APIs, which have secondary or tertiary amines when they are exposed to nitrosating agents like residual nitrites in excipients. These NDSRIs are unique to each API, and often lack carcinogenicity and mutagenicity data. NDSRIs have been identified in a number of drug products and could also be present in APIs. So the US FDA has issued guidance on the recommended acceptable intake limits for NDSRIs. Being implemented immediately, the guidance provides drug manufacturers with a framework to predict the impurities’ mutagenic and carcinogenic potential.
In 1994, Doctors Without Borders began HIV/AIDS prevention and control activities in Malawi. DWB’s work in Malawi, particularly their project in the Chiradzulu district, set a precedent. The project was wildly successful: it showed that it was possible to tackle HIV in low-income rural settings. It proved wrong the conception that patients would not comply with the strict HIV treatment routine. And it paved the way for the advocacy for cheaper drug prices and access to antiretroviral therapy in low-income countries. Now, after 20+ years of collaboration with DWB, Chiradzulu health authorities have taken over HIV treatment and care, paving the way for Doctors Without Borders to close one of its longest-standing projects in the country.
Meanwhile, Sanofi has entered a collaborative agreement with the Abu Dhabi Health Services Company, a subsidiary of PureHealth, the Middle East’s largest healthcare platform. The partners intend to focus on diagnostic performance and accuracy in rare diseases, particularly for lysosomal storage disorders like Gaucher disease and Fabry disease.