💉 Moderna breaks ground in the Philippines; Valneva's Lyme disease vaccine gets pushed back; Sandoz bulks up with more generics
#334 | Shootings overtake Covid in the US; Sharjah gets a new medical district; Roche bets big on organoids
Hello, and welcome back to The Friday Kable, where for the first time in what feels like ages, we have a fairly light Kable for you.
Moderna is setting up an Enterprise Solutions Hub in the Philippines, providing business services across the Asia Pacific region and expanding commercial operations.
Valneva's poor luck with vaccines is extending to it's Lyme disease candidate with Pfizer. In the latest setback, the companies have pushed back submission timelines for the vaccine to 2026.
Two more manufacturing reprimands from the US FDA by way of Form 483s for Eli Lilly's plant in Indianapolis, US and Rentschler's facility in Baden-Wurttemberg, Germany.
Novartis' Sandoz has acquired exclusive rights to sell six generic small-molecule candidates in the US from Malta-based Adalvo. The products, which address oncology, antifungal/antibiotic, and pulmonary disease markets worth around $3 billion, are part of Sandoz's ongoing efforts to become the world's largest and most valued generics company.
In the US, Covid has dropped down to the fourth spot in leading causes of death for last year. At number 3? Drug overdoses, automobile fatalities and shootings.
Also in the US, a school in Detroit shut down after one student died and 17 others fell ill to a mystery illness, later identified as hand-foot-and-mouth disease.
And finally, the Emirate of Sharjah has a new medical district, Jawaher Boston Medical District, featuring hospitals, laboratories, and R&D centres. The project is a collaboration between Beeah Group, Mass General Brigham Hospitals Network, and Dana-Farber Cancer Institute, and aims to boost Sharjah's healthcare sector with global expertise and integrated services. The district will focus on various specialisations, including lifestyle and preventive medicine, oncology, women's health, paediatrics, cardiovascular diseases, neurosciences, behavioural health, and rehabilitation medicine.
The week that was
CAMO-Net, or the Centres for Antimicrobial Optimisation Network, is a new research consortium being set up by research teams from the UK, South Africa, Uganda, and Brazil. As the name of the network suggests, its objective is to optimise antimicrobial use in humans by means of a transnational ecosystem which works across low-, middle- and high-resource settings.
Japan’s Astellas Pharma is gearing up for the loss of patent protection for its main money makers, especially its prostate cancer drug Xtandi with its largest acquisition - at $5.9 billion - of USA’s Iveric Bio, and its range of ophthalmology treatments.
In India, a multi-institutional study led by the Indian Institute of Science has found that the dengue-causing virus has also evolved dramatically in the subcontinent over the last few decades. It turns out that the Indian variants are extremely different from the strains which were originally used to develop the vaccines.
South Korea's International Vaccine Institute (IVI) has commenced clinical development of DuoChol, a low-cost oral cholera vaccine in capsule form. A phase 1 trial is planned in Sweden, with funding from the Wellcome Trust and the Swedish government. DuoChol has a similar composition to Dukoral, the first WHO-qualified oral cholera vaccine. But given its dry formulation, it is an improvement over existing vaccines’ thermostability and can also be transported at lower weights and volumes.
As the European Commission is proposing an overhaul to the legislation governing its pharmaceutical industry, a group of 19 EU member states also want to reduce their dependence on imported pharma ingredients, especially from China. Belgium, Spain, France, Germany and other countries want to ensure the EU’s drug ingredient supply security with a Critical Medicines Act as the region is currently largely dependent on imports from a few locations.
We seem to be finally bouncing back from the consequences of the pandemic, with a new WHO report saying that health systems have started showing the first major signs of recovery as the delivery of routine health services sees fewer disruptions.
GSK has been ahead of the competition in the race to get an RSV vaccine to market. And it has finally got its first approval for Arexvy from the US FDA. Covering adults aged 60 years and over, the approval means that the shot may be launched in time for the 2023/24 RSV season.
The Bill and Melinda Gates Foundation is trying to figure out how to make vaccines available to Gavi countries in a similar timeline as their rollout will take in high-income countries. The Foundation has announced a $200 million commitment to be awarded over the coming 18 months for the development and delivery of affordable childhood vaccines.
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Roche sees organoids as the future of drug discovery. German bigwig Roche has established the Institute of Human Biology (IHB) to collaborate with external partners in developing improved models for drug development. At present, drug developers mainly rely on animal models, which can poorly predict human responses. Roche sees human model systems, such as organoids, as a more accurate way of predicting patient responses to new treatments.
The IHB, formerly the Institute for Translational Bioengineering, aims to harness human model systems for drug discovery and development. The Basel-based institute aspires to revolutionise medicine discovery and development over the next decade by combining biology, bioengineering, and data science. Roche aims to expand the IHB to around 250 scientists and bioengineers over the next four years, who will work with academics from Swiss Federal Institutes of Technology ETH Zurich and EPFL on a mix of exploratory research, bioengineering, and translational projects.
Take a nap, prevent Alzheimer's. New research suggests that deep sleep, also known as non-REM slow-wave sleep, could help protect against memory loss in older adults at risk of Alzheimer's disease. It may act as a "cognitive reserve factor" that increases resilience against the brain protein beta-amyloid, which is linked to dementia-related memory loss. Disrupted sleep has previously been associated with faster accumulation of beta-amyloid in the brain. However, the new study reveals that higher amounts of deep sleep can protect against memory decline in those with high levels of Alzheimer's pathology. This finding could help alleviate some of dementia's most devastating outcomes.
Despite the small sample size and healthy participants, the study opens the door for potential longer-term experiments examining sleep-enhancement treatments with far-reaching implications. To improve sleep quality, it is recommended to maintain a regular sleep schedule, stay mentally and physically active during the day, create a cool and dark sleep environment, and minimise caffeine intake and screen time before bed.
Early interventions. Significant changes in gut microbiota can occur in the earliest stages of Parkinson's disease, potentially before symptoms arise. Researchers from China and Germany analysed gut bacteria in people with early Parkinson's disease, those with REM sleep behaviour disorder (RBD), their close relatives, and healthy individuals. They observed similar bacterial changes in people with RBD and Parkinson's disease, with beneficial bacteria being depleted and harmful bacteria becoming more abundant. The study identified 12 potential biomarkers that could help distinguish people with RBD from healthy individuals. The findings may lead to earlier diagnosis and targeted treatments for Parkinson's disease.
What time is it? Tooth hurty. In a prehistoric twist on microbial research, scientists decided to hunt for unknown bacteria by going back in time, rather than exploring tropical islands or hydrothermal vents. By rummaging through the ancient tooth plaque of 34 humans and 12 Neanderthals, including a 102,000-year-old specimen, they pieced together high-quality genomes of two unknown green sulphur bacteria species.
The researchers managed to create "paleofurans" by inserting ancient Chlorobium genes into living bacteria. While these molecules may not be useful in themselves, this process shows how ancient microbial diversity could potentially help us discover new antibiotics or other molecules. So, brush your teeth and remember, the next great scientific discovery might be lurking in your dental plaque!
Pressure tactics. Ever wondered why people choke under pressure? Turns out, even monkeys can't handle the pressure of an impending jackpot reward! Researchers trained rhesus monkeys to perform a reaching task for different amounts of sugary water, and guess what? The monkeys performed worse when the stakes were high.
The scientists found that individual cells in the monkeys' motor cortex responded differently to the size of the expected reward. When the jackpot was on the line, the neural signatures for each planned reach movement got blurry and harder to distinguish, like a monkey brain trying to juggle too many bananas at once.
So, next time you find yourself choking under pressure, remember that you're not alone. Your ancestors beat you to it.
Munching on microgreens. Need a lifeline during a catastrophe? Look no further than zinc-infused microgreens! Researchers at Penn State found that soaking seeds of plants like peas and sunflowers in zinc makes the resulting microgreens a potential saviour in the face of global malnutrition or even disasters like nuclear wars, asteroid strikes, or supervolcano eruptions.
These trendy, nutrient-packed mini-plants might have started as gourmet garnishes, but they could be our ticket to surviving a world gone wild. Just picture it: a post-apocalyptic dinner party with zinc-enriched microgreens as the main course. Who knew such a small plant could hold the key to human survival?
(Frontiers in Plant Science)
Not a boa vista. Climate shocks could force millions of Brazilians into extreme poverty by 2030, according to a World Bank report. The poorest would be impacted by natural disasters, such as floods and droughts, as well as rising food prices and reduced labour productivity. Despite Brazil's strong position in renewable energy, with almost half of its energy supply coming from renewables, the World Bank urges further investments in low-carbon sources.
Every Friday, we relax our paywall so you can see for yourself the value of paying ₹500/month (or ₹4500/year) for a concise download of the day’s top news and events at the intersection of human and animal health, climate change and environmental science. Please consider becoming a paid subscriber.