💉 Another Bausch + Lomb purchase; VBI Vaccines and Brii Biosciences' hep B partnership; US FDA's updated risk-based inspection model
#379 | Eliminating cancer chromosomes; Enjoying idle time a sign of creativity; The health risks of air pollution
Hello, and welcome back to The Kable. As always, this Friday Kable is a stranger to paywalls, so you should share it with every life sciences person you know; let them also partake in our ridiculous humour and lame wordplay.
Now that you’ve shared the joy, on to the news.
Bausch + Lomb just a few days ago bought Novartis’ Xiidra and other ophthalmology products. Now, the company has signed a $106.5 million deal to acquire J&J Vision’s Blink line of OTC eye and contact lens drops.
US-based VBI Vaccines is expanding its hep B partnership with China-based Brii Biosciences. The latter now has global rights to VBI’s hep B immunotherapeutic candidate and an exclusive license for VBI’s approved hep B vaccine in the Asia Pacific region.
The US unit of India’s Cipla is initiating a recall of six batches of albuterol sulfate inhalation aerosolused to treat bronchospasm because of a container defect. No related adverse events have been reported.
The non-profit medical research organization LifeArc has announced its new Rare Disease Translational Challenge. By 2030, the Challenge will offer £100 million worth of funding and support to researchers involved in innovations to improve the lives of people with rare diseases. Initially, £40 million will be used to set up five Translational Rare Disease Centres across the UK.
The first half of 2023 has been good for Brazil’s Amazon rainforest, and it’s been good for President Lula. Deforestation in the Amazon has fallen 34%, touching its lowest level in four years. Never mind the fact that even this reduced forest area that was cleared is over thrice the size of New York City.
The US thinks China needs to do more to disrupt illicit supply chains which fuel the former’s opioid addiction crisis. The US wants other countries to engage China on the topic as well.
In recent years, Kenya has made strides in managing TB, especially the multi-drug-resistant kind. Digital chest X-ray machines. The TB Innovative Technologies Tools Project for TB screening, diagnosis and prevention. Improved oral treatments. The Kenya Medical Research Institute is working on two vaccines for adults and children and also prospecting for natural product sources for treatments. Gavi reports on how Kenya is leading the way for other high TB-burden countries to take on the disease.
In Sweden, after broiler flocks, people are increasingly contracting Campylobacter infection from the intestinal bacteria. The number of reported cases is only expected to rise. As if we didn’t do it enough during Covid, authorities are encouraging more hand washing. Also, being more careful when working with raw chicken.
In Chile, animal deaths from bird flu are showing no signs of abating. So far this year, over 13,000 sea lions, over 2,000 Humboldt penguins, 30 chungungos, 21 spiny porpoises, 15 Chilean dolphins and one huillÃn have been found dead. Shared feeding habitats between marine animals and potentially virus-carrying birds has contributed to these high numbers. At this rate, it's surprising that there still are any sea lions left to perish.
In Brazil, authorities are waiting around for a Brazilian-developed dengue vaccine, while a Japanese vaccine, Qdenga, has already been approved. 2022 saw over 1.4 million probable dengue cases in the country, so naturally, people aren’t happy about this.
The CEO of Moroccan pharma manufacturer Sothema talks to Bloomberg about how Africa can develop a robust homegrown pharma industry.
And finally, after the death of a four-year-old, Nigeria confirms an outbreak of diphtheria in its capital city, Abuja.
The Week That Was
This first week of July began with news of Europe planning for future vaccine apartheid. The European Commission entered agreements with Pfizer and many European drugmakers to reserve capacity for the production of up to 325 million vaccines per year in case of a future pandemic. The deals even call for stockpiling when needed. Naturally, vaccine equity activists aren’t too pleased about that.
In the latest update in the Gambia’s cough syrup tragedy, the relatives of 20 children whose deaths were linked to India-made cough syrups sued the manufacturer, Maiden Pharmaceuticals. They also sued Gambia’s Health Ministry, its Medicines Control Agency, and the local distributor of the drugs, Atlantic Pharmaceuticals.
There is a growing recognition of the connections between contagious diseases like AIDS and TB, and NCDs. The Global Fund to Fight AIDS, Tuberculosis and Malaria is expanding its focus to integrate NCD treatment into its funding efforts.
In keeping with its vision for a New Public Health Order, the Africa CDC inked an MoU with the United States Pharmacopoeia Convention (USP) to widen access to quality-assured medical products in Africa. The plan is to enhance regional manufacturing, create a robust regulatory and market environment, and boost clinical and public health lab networks.
The Global Environment Facility (GEF) unveiled a $1.4 billion fund to address worldwide environmental crises such as biodiversity loss and climate change. The fund, which is expected to directly benefit 14 million people, half of whom are women disproportionately affected by these crises, will be distributed across 88 countries, focusing on Least Developed Countries and Small Island Developing States.
In disappointing news for everyone who buys Happy Meals primarily for the toys, the WHO released new guidelines on policies to protect children from the harmful effects of food marketing.
A new study in The Lancet discovered a link between access to clean water and sanitation and lower Antibiotic Resistance Genes (ARG) abundance, suggesting that improving these conditions could help combat antibiotic resistance.
Sanofi signed an MoU with pharma manufacturers Arabio and Lifera to boost production and supply of vaccines in Saudi Arabia, driving the region’s self-sufficiency in pharma manufacturing.
For a change, vaccine supply is actually prioritising the region with the greatest need – Africa. Gavi announced that 12 countries - Ghana, Kenya, Malawi, Benin, Burkina Faso, Burundi, Cameroon, Democratic Republic of the Congo, Liberia, Niger, Sierra Leone and Uganda - are set to receive 18 million doses of malaria vaccines over the next couple of years.
And finally, El Niño is officially here. The world saw the hottest day ever on Monday and then again on Tuesday, and this record is likely to be shattered again and again. Good luck to us all.
Newsworthy
WASH for all. For the first time, a new UNICEF and WHO report provides an in-depth analysis of the gender inequalities involved in WASH in households. The report, titled Progress on household drinking water, sanitation and hygiene 2000-2022: Special focus on gender notes that 1.8 billion people live in households without on-premises water supplies. In 7 out of 10 such households, women and girls are responsible for fetching water. Over half a billion people also still share sanitation facilities; women and girls are more likely to feel and face safety risks using a toilet not in their house. Factors like these increase their health risks and compromise their privacy and dignity. Overall, they bear a disproportionate impact of the lack of WASH facilities, including additional burdens of work and exposure to disease, while limiting their opportunities for education and employment. We’re far from achieving our WASH-linked SDGs, and these stark gender disparities are doing nothing to help.
(WHO)
Reassessing risk. With the number of quality issues emerging for pharma products, the US FDA has recently updated its risk-based model to decide which pharma manufacturing facilities its Centre for Drug Evaluation and Research needs to inspect. With the Food and Drug Omnibus Reform Act, the FDA has added a risk factor concerning the compliance history of establishments in the country or region in which a particular facility is located. This adds to risk factors currently under consideration, like compliance history of the establishment itself, time since it was last inspected, inherent risk of the drug or device being made, or prior recalls from the facility. One of the main challenges of this new risk factor is that even if a particular site has an acceptable compliance history, it may be subject to more frequent inspections because of the region they’re located in. We’ve already placed our bets on which country seems likely to have the most FDA inspections in the years to come. Have you?
(US FDA)
R&D
Tug of war. A recent study conducted by scientists at St. Jude Children's Research Hospital has uncovered a competition for glutamine between immune cells and tumour cells. The researchers have identified a molecular pathway that could potentially be targeted with drugs to exploit this competition. The study reveals that dendritic cells, particularly type-1 conventional dendritic cells (cDC1s), play a crucial role in mediating T cell priming and therapeutic efficacy against tumours. Glutamine serves as an intercellular metabolic checkpoint that regulates communication between tumour cells and cDC1s, influencing anti-tumour immune function. By resupplying glutamine to the tumour microenvironment, the researchers observed reduced tumour growth and improved activation of anti-cancer T cells by dendritic cells. This discovery highlights the importance of nutrients in immune function and offers new possibilities for enhancing therapeutic interventions and understanding cell-cell communication in immunometabolism.
(Nature)Â
Kill that (extra) chromosome. A study conducted by researchers at Yale University has revealed that cancer cells with extra chromosomes rely on those chromosomes for tumour growth, and eliminating them prevents tumour formation. The findings suggest that selectively targeting extra chromosomes could offer a new approach to treating cancer. Using the gene-editing tool CRISPR, the researchers developed a technique called Restoring Disomy in Aneuploid cells using CRISPR Targeting (ReDACT) to remove the aberrant third copy of the long portion of chromosome 1, which is commonly found in several types of cancer. They observed that when aneuploidy was eliminated from cancer cells, their malignant potential was compromised, and they lost their ability to form tumours. The researchers proposed the concept of "aneuploidy addiction," akin to the idea of "oncogene addiction," suggesting that cancer cells heavily rely on aneuploidy for their growth and survival. Moreover, the study revealed a vulnerability in cancer cells with extra chromosomes, as they were found to be more sensitive to certain drugs, providing a potential therapeutic target. The researchers aim to further investigate this approach in animal models and collaborate with pharma companies to advance towards clinical trials.
(Science)Â
In-utero schizophrenia? A recently published study has identified a correlation between schizophrenia and somatic copy-number variants (CNVs), which are genetic mutations that occur after genetic material is inherited. The research, conducted by scientists at the Howard Hughes Medical Institute and Boston Children's Hospital, analysed data from over 20,000 blood samples and identified two genes, NRXN1 and ABCB11, that were associated with schizophrenia when disrupted in utero. This study is one of the first to establish a link between somatic mutations and the risk of schizophrenia, expanding the understanding of genetic mechanisms beyond inherited mutations. The findings open up new avenues of research into the role of somatic variants in psychiatric disorders and raise questions about the impact of these mutations on other conditions.
(Cell Genomics)Â
The genetic connection in Down syndrome. A recent study has shed light on the role of interferon receptor genes in driving the developmental changes associated with Down syndrome. Using a mouse model of Down syndrome, the researchers used CRISPR-Cas9 technology to delete four interferon receptor genes and observed improvements in various developmental abnormalities, including heart conditions, brain development, and cognitive difficulties. The study suggests that blocking interferon signalling may offer a potential therapeutic approach to alleviate some of the co-occurring conditions in Down syndrome. The findings also have implications for understanding the effects of interferon signalling on foetal development in other conditions. Further research and clinical trials are needed to explore the cause-effect relationship and the potential benefits in humans.
(Nature Genetics)Â
The Kibble
Ever wonder what creative people do in their downtime? According to a new study from the University of Arizona, they have a party in their brains! That's right, while you're scrolling aimlessly through social media during your idle time, these folks are letting their thoughts do the cha-cha-cha, sliding from one idea to the next like they're on a mental dancefloor. This study found that when these idea-enthusiasts were left alone in a room with nothing but their thoughts, they threw a cerebral fiesta, feeling less bored and more engaged. The researchers even took their party game to the next level during the pandemic, when idle time went on steroids. They found that creative people were the master DJs of their mental playlists, reporting less boredom. The study's takeaway? Let's all channel our inner creative, learn the mental macarena, and turn idle time into an endless brainstorm boogie!
(Creativity Research Journal)Â
Bottom line
How dangerous is air pollution really? Air pollution is linked to 8 million annual deaths worldwide, equal to those attributed to tobacco, with impacts extending beyond lung cancer to other cancers, such as neck cancer and mesothelioma, as well as diseases like cardiovascular disease, strokes, heart attacks, type 2 diabetes, and neurodegenerative disease. Studies indicate that air pollution doesn't mutate DNA as traditionally believed but triggers an inflammatory response in macrophages, a type of white cell, which can turn cells in the lungs into cancer stem cells when combined with specific cancer-causing mutations. This ongoing inflammation, due to undigested pollutants, is hypothesised to be a central cause of the various diseases associated with pollution. Efforts are underway to curb air pollution, such as expanding low emissions zones and promoting electric cars, but challenges remain due to pollutants from non-exhaust sources. Therefore, the need for public health measures, increased awareness, and alternative solutions remains urgent, as over 90% of the global population lives in areas exceeding WHO's recommended levels of PM 2.5 air pollutants.
(Wired)
Oh, and Gopal Nair doesn't want you to see this.