💉Africa CDC donates equipment to SAHPRA; WHO to convene Traditional Medicine Global Summit; Novo Nordisk diversifies its obesity drugs
#404 | Bacteria to detect cancer; Gene therapies to reverse deafness; Climate change to worsen food poisoning
Hello there! Welcome back to The Kable. In 2021, the African Union Heads of State established the Partnerships for African Vaccine Manufacturing (PAVM) initiative to support the continent’s vaccine manufacturing industry. One of the initiative’s priorities is to strengthen National Regulatory Authorities, or NRAs, to ensure the production of safe and high-quality vaccines. In keeping with PAVM’s objectives, yesterday, the Africa CDC handed over equipment worth $750,000 to the South African Health Products Regulatory Authority (SAHPRA, for short). This equipment is meant to support SAHPRA’s regulatory functions related to vaccine manufacturing.
This next story also begins in 2021, when US Environmental Protection Agency (EPA) inspectors found that the biopharma manufacturer Genentech stored waste without a permit. The company also failed to meet several other requirements related to hazardous material disposal, including those related to monitoring hazardous waste air emissions, inspections of emissions control equipment, and overfill protection controls for a hazardous waste tank. These lapses put both human and environmental health at risk. Earlier this week, the EPA announced a settlement with Genentech. The company will pay over $158,000 in civil penalties for its violations at three locations at its now-closed South San Francisco facility.
Currently, Gavi donates HPV vaccines to Kenya and girls in the country can avail the two-dose vaccine for free. But by 2027, when donor support is expected to end, a single dose could cost as much as KES 14,000 (~$97). Research suggests that substantial government funding, possibly upwards of $10 million per year, could be needed to achieve 90% coverage and sustain the vaccination programme. Lower-cost alternatives with similar or greater health benefits are being considered.
And finally, the Bill & Melinda Gates Foundation recently announced nearly 50 grant recipients who are developing global health and development solutions for their communities using AI-enabled large language models (LLMs). In keeping with their focus on reducing global inequity, the grants target innovations in LMICs. Of all the selected projects, 29 are based in Africa. We’re particularly excited by the projects to support antibiotic prescribing in Ghana, NCD risk factor targeting in Kenyan youth, and predicting disease emergence in Uganda.
3 weeks to the 10th-anniversary edition of Pharmaconex the beating heart of African pharmaceutical manufacturing in Egypt. Africa and West Asia will lead the worldwide pharma story in the coming decade, so don't miss out on this opportunity to network with your peers across the African continent. And the icing on the cake? As a registered visitor, a free, year-long subscription to The Kable is all yours. Claim your free year.
The Week That Was
This has been a fairly light week in The Kable. The week began with news that Japanese researchers have developed a new continuous-flow manufacturing process for Cefazolin. The scientists hope their innovation will lead to a stable drug supply, enhance new drug development, and help us respond to rare diseases and disasters.
On Tuesday, the WHO issued a medical product alert concerning a batch of contaminated cold syrup. Again. The contaminants were unacceptably high levels of ethylene and diethylene glycol. Again. The syrup was manufactured by an Indian company. Again.
And spiking temperatures are affecting human health. Extreme heat is pushing more people indoors, potentially increasing the spread of infectious diseases in poorly ventilated indoor spaces. The heat also compromises our immune system’s ability to battle pathogens. To add to that, high temperatures are helping fungi adapt and become more dangerous, expanding the habitat of disease-bearing insects and animals and also leading to a spike in bacterial infections.
Speaking of extreme heat, the global average temperature for July 2023 was the highest ever recorded. It is also likely the highest recorded in at least 120,000 years.
And finally, to wrap up this light week, the WHO has classified the EG.5 Covid variant, currently circulating in the US, China, South Korea, Japan, Canada and other countries, as a “variant of interest”. It has an increased transmissibility, but that doesn’t mean it’s a more dangerous variant.
El Niño up to ño good. Countries across the Asia Pacific region are reeling from the effects of multiple disasters, and we have El Niño to blame. In the past few months, the International Federation of Red Cross Red Crescent Societies, or IFRC, released 8 Disaster Relief Emergency Fund allocations. Three went to Bangladesh, Nepal and Sri Lanka for the dengue crises they are facing; three allocations for flood-hit areas went to Mongolia, Pakistan and Afghanistan; Bangladesh received another for a tropical cyclone, while Mongolia was at the receiving end of the last one for a cold wave event.
This isn’t even the worst of it though. The full impact of El Niño on the region is expected to show itself between September this year and March next year. The IFRC outlines its work in the region and urges authorities and humanitarian organisations to invest in preparedness efforts for the multiple disasters that will come together and with more intensity.
Health for all. Next week, the WHO convenes the first-ever high-level global summit on traditional medicine. To be held on 17 and 18 August in the city of Gandhinagar in India, the Traditional Medicine Global Summit will be co-hosted by the Government of India. It will explore the role of traditional, complementary, and integrative medicine in addressing health challenges and advancing global health and sustainable development. The WHO Director-General, WHO Regional Directors, G20 health ministers, and high-level invitees from around the world will participate in the summit, as will scientists, traditional medicine practitioners, health workers and civil society organization members.
Whether you like it or not, traditional medicine is here to stay. The Summit is keen on bringing it into mainstream healthcare in an effective, appropriate and safe manner. The agenda of the Summit is to explore how scientific advances and evidence-based knowledge in support of traditional medicine can be scaled up. There will also be technical discussions on research, evidence, and learning; policy, data and regulation; innovation and digital health; and traditional medicine’s connections to biodiversity, equity and indigenous knowledge. The Summit will look into methodologies which can be used to outline a global research agenda, priorities, challenges and opportunities in the field. The hope is that a stronger evidence base will help countries to develop appropriate mechanisms to monitor and regulate practices, practitioners and products in traditional medicine. The WHO is also set to release complete results from a global survey on the topic later this year – results which will inform its traditional medicine strategy for 2025-2034.
Will Novo Nordisk win where Sanofi didn’t? Novo Nordisk isn’t about to put all its weight loss eggs in the GLP-1 basket. It is acquiring Montreal-based private biotech Inversago Pharma in a deal that could potentially cross the $1 billion mark. Inversago’s lead drug candidate INV-202 is a next-gen CB1 receptor blocker therapy. CB1, or cannabinoid receptor type 1, is found throughout the central nervous system; it regulates physiological processes and could be drugged to treat mood and anxiety disorders and suppress appetite.
In the past, Sanofi-Aventis have had some success in targeting the CB1 receptor. The European Medicines Agency approved their drug Acomplia in 2006 to treat obesity alongside diet and exercise. But after concerns about the psychiatric safety of the drug, Sanofi withdrew the product in 2008; the drug never even reached the US market.
Novo Nordisk hopes to do better. INV-202 only targets peripheral CB1 receptors like those in the kidneys, liver, pancreas, and gastrointestinal tract. By focusing on these peripheral tissues, Nordisk’s newly acquired once-daily pill will avoid the side effects that come with hitting CB1 receptors in the brain. Phase 1b results have already shown clinically-significant weight loss after 28 days of using the drug; the study also showed positive trends in lipid and glucose measures in the blood. Side effects were mostly gastrointestinal, with no serious adverse effects. The drug is currently in a phase 2 trial for diabetic kidney disease.
Biosensors ftw! In the past, bacteria have been engineered to carry out diagnostic and therapeutic functions, but they didn’t have the ability to identify specific DNA sequences and mutations outside of cells. Enter CATCH, or the Cellular Assay for Targeted CRISPR-discriminated Horizontal gene transfer. Quite the mouthful. A research team led by the University of California in San Diego has engineered bacteria to detect the presence of tumour DNA in a live organism. In a mouse model, these bacteria were able to detect colon cancer. The researchers believe there is an opportunity to use their CATCH strategy to detect gastrointestinal cancers and precancerous lesions. Further development and refinement are required, but in future, this innovation could lead to biosensors being developed to also identify infections, other cancers and a variety of diseases.
Lending an ear. No mouse will ever be caught unawares for missing the sound of a cat meowing nearby again. Published in PNAS, research from The Institute of Psychiatry, Psychology & Neuroscience at King’s College London has succeeded at reversing deafness in mice. The research team used a genetic approach to address hearing loss driven by a defective Spns2 gene and restored low- and middle-frequency range hearing. This proof-of-concept study could encourage research into gene therapies or drugs for some types of degenerative hearing loss. But we doubt it’ll do much to help all the damage we do to our ears by blasting music on our headphones.
The common cold’s links to blood clots. Thrombocytopenia, or blood clots accompanied by a drop in platelet levels, is sometimes caused by exposure to heparin or spontaneously as an autoimmune condition without heparin exposure. In the past few years, it also emerged as a rare side effect of Covid vaccines made with inactivated adenoviral vector pieces.
Now new research shows that infection with adenovirus could cause a life-threatening blood clotting disorder. Adenovirus is one of the most common respiratory viruses, causing mild cold- and flu-like symptoms in children and adults alike. Published in the New England Journal of Medicine, the research sheds light on the virus’ role in causing anti-platelet factor 4 (anti-PF4) disorder. It opens up new avenues for research which could eventually lead to earlier diagnosis and optimized treatment for patients with anti-PF4 disorder.
(New England Journal of Medicine)
Down with AMR. Albicidin has emerged as a promising antibiotic in recent years, but some bacteria have succeeded in developing resistance to it. New research has uncovered the mechanism underlying this resistance. Researchers from Freie Universität Berlin in Germany used tools like RNA sequencing, protein analysis, X-ray crystallography and molecular modelling. They uncovered that bacteria like Salmonella typhimurium and E. coli developed albicidin resistance when exposed to increasingly higher concentrations of the substance. They implicated a gene amplification mechanism in the bacterial cells – as the cells multiplied, resistance amplified with an increase in the number of copies of the STM3175 (YgiV) gene.
Hold onto your houseplants! The world's greenery seems to have collectively said, "Nah, we're good," in the fight against CO2. We've been banking on increased photosynthesis (that's plants breathing in carbon dioxide and breathing out oxygen, for those who snoozed in biology class) to help soak up that nasty greenhouse gas. But a new study suggests that since 2000, plants have been on a bit of a breathing strike, absorbing less CO2 due to global warming drying the air. Our leafy friends are closing their pores to save water. And here we thought planting more trees would solve everything. Guess we can't just leaf this problem behind!
Climate change comes to your table. As the world heats up, so does the chance of getting a bad tummy bug, warns a German study. In a nutshell, the warmer the summer BBQ, the more likely you are to regret that undercooked chicken! Climate change isn't just melting ice caps; it's brewing a recipe for disaster in our gut. Whether it's naughty germs like Salmonella enjoying the extended summer holidays, or marine toxins gate-crashing the food chain thanks to those pesky algae blooms, the forecast is clear: more food-borne fiestas on the horizon! So, next time you're contemplating that medium-rare chicken skewer, remember: climate change already has a beef with us; let's not make it poultry too!
From the table to the air. Guess what? The very air we breathe is cooking up a new "villain" in the form of PM2.5, a microscopic pollutant with aspirations of world domination. Not content with just being "pollution," it's now gearing up to boost antibiotic resistance. A snazzy study in The Lancet Planetary Health has some alarming tea to spill: every 10% hike in this pesky air pollution means a 1.1% increase in antibiotic resistance! While we've been side-eyeing antibiotics and dodgy sanitation for years, it seems the air's been silently plotting its takeover. Your next mission, should you choose to accept it? Cleaning up the air and slapping down those drug-resistant bacteria.
(The Lancet Planetary Health)
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