💉 AstraZeneca, Merck’s Lynparza gets FDA thumbs up; WHO’s drug dependence resource repository; Climate financing for gelato
Extreme heat sweeps across Asia; Learning from primate genomes; What’s hindering the HIV fight?
Hello and welcome to The Kable for the last time this week. 2022, it turns out, was the most violent year against health workers and facilities in conflicts in the past decade. More than half of the 1,989 attacks and threats documented were in only Ukraine and Myanmar.
The US FDA has given a greenlight to AstraZeneca and Merck’s Lynparza for limited use in the treatment of advanced prostate cancer. The treatment can now be used earlier, in combination with J&J’s Zytiga, to treat patients with metastatic castration-resistant prostate cancer with BRCA mutations.
The FDA has also cleared the incorporation of Masimo’s advanced monitoring tech – including brain function monitoring, regional oximetry and CO2 measurements – into Philips’ patient monitors, IntelliVue MX750 and MX850. This integration hopes to help clinicians make faster decisions without the need for additional monitoring equipment.
Also, ABK Biomedical has received FDA investigational device exemption (IDE) to begin a clinical study involving patients with unresectable hepatocellular carcinoma (uHCC), a kind of liver cancer, using its Y90 radioembolization technology.
Meanwhile, Pfizer is claiming that data from phase 3 trials show that its experimental combo of antibiotics Aztreonam-Avibactam (ATM-AVI) is effective and well-tolerated in treating deadly infections caused by gram-negative drug-resistant bacteria. Is this goodbye to AMR?
Speaking of AMR, the European Parliament is placing it among the top three priority health threats. Members of the European Parliament are calling on EU member countries to develop national action plans against AMR. They also announced a bunch of other recommendations to fight this global health threat.
AstraZeneca is throwing in the towel in its development of Brazikumab to treat inflammatory bowel diseases, including Crohn’s disease and ulcerative colitis. A delay in the development timeline and a changing competitive landscape was too much for them to take.
In Japan, however, Viatris is targeting ulcerative colitis; the company has signed a licensing agreement with Swedish InDex Pharmaceuticals for the commercialization of the TLR9 agonist, Cobitolimod.
Roche is looking to either sell or shutter its biologics manufacturing site in California by 2029; it claims it no longer needs large volumes of the products being produced at the site in question.
In India, a subsidiary of Dr Reddy’s Laboratories is investing $40 million into an R&D and pilot-scale facility to produce therapeutic proteins, antibodies and viral vectors in the city of Hyderabad.
Also, in India, the CDSCO has approved AstraZeneca’s Tremelimumab combination for unresectable hepatocellular carcinoma (uHCC) treatment.
A global plastics treaty is in the works, as you know from Kables earlier this week. Scientific American reports on how fossil fuel interests could weaken the accord that comes out of these deliberations.
Globally, fertility rates are starting to fall below replacement rates. By the end of the century, the number of people on the planet could shrink for the first time since the Black Death.
A report by the Norwegian Refugee Council lists the most neglected displacement crises of 2022. Burkina Faso is at the very top of that list. It turns out Ukraine has been hogging all the aid and attention, leaving other vulnerable groups neglected.
Senegal’s Institut Pasteur de Dakar and the Mastercard Foundation have announced a $45 million partnership to expand the workforce and work towards vaccine manufacturing autonomy on the continent.
In Tunisia, the Central Pharmacy is deep in debt. Given the financial crisis, the state has reduced imports, and citizens are struggling to find medicines for diabetes, cancer and heart disease.
In Rwanda, the FDA has imposed a ban on the import of a drug used to treat epilepsy and bipolar disorder over quality issues. The drug in question is manufactured by India’s 4Care Lifescience.
In South Africa, the government is preparing to implement the National Health Insurance Bill to achieve universal health coverage.
In the US, for the first time ever, the demand for better pay, benefits, and work conditions is leading early-career researchers from the National Institutes of Health to begin the process of unionising.
In Argentina, healthcare workers at public hospitals are launching a strike today in Mendoza Province. They are demanding – you know it – better pay and working conditions.
In Israel, like in pretty much every country everywhere, there is a critical shortage of doctors.
In Iran, an imported case of malaria caused by Plasmodium falciparum has been reported. The last positive case of Plasmodium falciparum was observed in the country 30 years ago.
In Nigeria, there have been a total of 162 deaths from among 944 cases of Lassa fever over a period of 20 weeks.
And finally, in Bangladesh, there was a sevenfold rise in dengue cases from April to May.
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The week that was
This week started with updates from the 76th World Health Assembly. As part of the NCDs Global Action Plan 2023-2030, the WHO released an update to its 2017 list of ‘best buys’ to tackle the global burden of NCDs. The list of NCD best buys includes taxes and bans on tobacco and alcohol advertising, comprehensive nutrition labelling policies, interventions for asthma treatment and more.
In India, opposition to the online sale of pharmaceutical drugs is in full swing. Late last week, the All India Organization of Chemists and Druggists sent a letter to the cabinet secretary with an appeal to ban online pharmacies on the grounds that they are violating norms and putting lives at risk. Draft rules to regulate online pharmacies have not been finalised after an August 2018 draft notification; the Delhi High Court has granted the central government 6 weeks to inform it about the outcome of deliberations on these draft rules.
Meanwhile, an updated version of a WHO pandemic agreement, known as "Zero+", has seen the removal of language that linked the use of public R&D funds to private sector commitments on transparency of pricing and transfer of technology. The revised text has been criticised as weaker in regard to regulating the pharma industry, moving away from stricter regulation and relying more on voluntary measures.
Also, a United Nations committee met this week in Paris. The agenda? Coming up with a treaty to end global plastic pollution. The Intergovernmental Negotiating Committee for Plastics hopes to come up with a legally-binding treaty by the end of 2024. Right now, it’s a coalition of countries wanting to restrict plastic production versus a coalition intent on scaling up recycling instead.
Further, according to a report published by the Food and Agriculture Organisation (FAO) and the World Food Programme (WFP), hunger is only set to get worse in 18 hotspots around the world. Not only are more people in an increasing number of locations around the world experiencing hunger, but the severity of their hunger is also worsening.
On the Covid front, Science reported on how vaccine developers working on updated coronavirus shots need existing vaccines – such as the approved Pfizer and Moderna shots – as a benchmark to compare their new candidates against. But the pharma companies’ policies, as well as their contracts with the US government, prohibit the use of their shots for research purposes.
As for bird flu, scientists have discovered how the current bird flu virus gained new genes and greater virulence. They have identified the direct ancestor to the current H5N1 viral strains, which gained a different version of the protein Neuraminidase before spreading from Europe to the Americas. After reaching North America, the virus rapidly changed again to become more virulent, mixing with flu viruses in North American wild birds and swapping a number of genes. These modifications not only allowed the virus to become more adapted to different types of bird populations (even atypical hosts like eagles and buzzards), but it also became the severe disease-causing villain that it now is. Avian influenza is no longer just a poultry problem; it is also a wild bird problem, a mammalian problem, and with more mutations, it could become a human problem.
A new report by Bloomberg Intelligence projected that sales of branded obesity drugs – a market worth roughly $2.5 billion last year – will touch $44 billion in 2030. Close to 70% of that amount will be accounted for by the US; in Europe, analysts expect things to ramp up relatively slowly.
And finally, a recent study by the Earth Commission warned that Earth had crossed seven out of eight key environmental safety limits, pushing the planet and its inhabitants into a "danger zone".
Compounding problems. Yesterday, we highlighted the huge market for branded obesity drugs in the years to come. Branded drugs like Novo Nordisk’s Wegovy and Ozempic are set to dominate that market, but currently, demand is far outstripping supply. Consumers are reaching for versions of the weight loss drugs compounded in pharmacies instead. But the versions of semaglutide – the active ingredient in the branded drugs – used in these compounded drugs are not FDA-approved; they usually contain a version of the API used in lab research and not approved for use in people. After reports of adverse events in patients who used compounded semaglutide, the US FDA has warned about the safety risks associated with them.
Potential legal action in cough syrup case. An investigation backed by the Gambian government had found that the deaths of over 70 children in the country last year were extremely likely to have been caused by cough syrups made by India’s Maiden Pharmaceuticals. Indian authorities had denied these allegations after conducting their own tests. In an update to the situation, the Gambia has hired a US law firm with the intention of exploring legal action. Against which parties? That hasn’t been revealed. But this would be the first international litigation in the case.
What’s hampering the fight against HIV? Transgender and gender-diverse people are 13 times more likely to contract HIV than the rest of the adult population, but certain barriers have kept members of the community from getting tested and accessing treatment in sub-Saharan Africa. For starters, quantitative data is lacking, which means that some countries don’t even have the information they need to build useful, targeted programmes. Studies have also found gaps in HIV services which make it harder to maintain treatment regimens. Some experts believe that trans-led HIV interventions are critical to giving the trans community equitable access to diagnostic and treatment services.
The stigma against the LGBTQ community also plays its part in this health crisis. In Uganda, a law signed by the President last week now provides the death penalty for some acts of homosexuality, including those that might spread HIV. In Ghana and Kenya, too, similar bills are gaining support. This points to the fact that eliminating HIV is more than just a problem of data or health service delivery. Devex reports on the issues which are hampering Africa’s progress towards ending HIV as a public health threat by 2030.
Say no to drugs. Yesterday, the WHO’s Expert Committee on Drug Dependence (ECDD) launched a new repository of all drug dependence technical reports and resources, covering over 450 substances. This is an important resource for health professionals and policymakers, especially since many of the substances reviewed by the committee otherwise have limited information about their public health risks. This repository is the only online and freely accessible collection of information on new psychoactive substances and medicines for medical and scientific use. By improving information sharing, the committee hopes to increase awareness of the abuse, harm and dependence caused by psychoactive substances so that effective public health responses can be designed and implemented. Additionally, this resource could also be useful to source information about the therapeutic use of psychoactive drugs.
Nuclear action. The nucleus of a cell has long been considered metabolically inert. Like a monarch, it imports its needs through supply chains in the cytoplasm, not lifting a finger to provide for or protect itself. But a new study suggests that maybe nuclei can actually do a little something to take care of themselves. In a state of crisis – for instance, when there is DNA damage – the nucleus calls on antioxidant enzymes to protect itself, with the cellular respiratory enzymes relocating from the mitochondria to the nucleus. These findings of metabolic activity within the nucleus could potentially lead to improved research in cancer and drug resistance in the future.
(Molecular Systems Biology)
What’s good for Parkinson’s... is also good for ALS, it turns out. ALS, or amyotrophic lateral sclerosis, is currently incurable. But a clinical trial has now demonstrated that Ropinirole, which is used in patients with Parkinson’s disease, is also safe to use in patients with ALS. In ALS patients, the drug delayed disease progression by 27.9 weeks on average. While some patients were found to be more responsive to the treatment, the researchers were able to predict this clinical responsiveness in vitro by using motor neurons taken from patient stem cells. However, further studies are needed to verify the efficacy of the drug. We can expect phase 3 trials soon.
(Cell Stem Cell)
Scarred hearts and kidneys. Progressive fibrosis is witnessed in organs like kidneys and the heart either due to ageing or chronic tissue injury. Chronic kidney disease (CKD) is characterized by damaged kidneys which cannot filter blood well enough; progressive fibrosis – or scarring of the kidneys – is also a common feature of this condition. Thus far, the underlying mechanism has been a bit opaque to researchers. But some kind mice offered to give themselves up for the sake of science, and now researchers have discovered a protein which causes kidney and heart damage. This might mean new treatments for CKD. Yay.
(Science Translational Medicine)
Take a shot. In the off chance that you still need convincing to take a Covid vaccine, Swiss researchers have found that about 17% of unvaccinated people reported long Covid symptoms up to two years after their initial infection. That’s all; this story is only here to tell you not to be an anti-vaxxer.
Deep sequencing. Vascular anomalies encompass myriad conditions which affect arteries, veins and the lymphatic system. These can be vascular malformations, benign vascular tumours, or malignant ones. Vascular anomalies may resolve over time, but in the cases that they don’t, they can cause visible deformities, impair breathing or swallowing, cause intense pain, or even threaten patients’ lives. But now researchers have found generic variants not previously known in patients with life-threating vascular anomalies. Instead of conventional sequencing methods, the researchers used deep sequencing of the genome in the tissue samples and cell-free DNA of patients. They found that 6 out of 10 patients placed on targeted therapies linked to these newly-discovered genetic variants saw improvements in their health.
Mini sensor. Some day in the future, biopsies will be a lot less cumbersome and much more fun. Scientists are working on a new sensor made of two magnets – one fixed and one free to twist and shout. Creating a magnetic field can move the second one around, freeing it up to explore the insides of your body and gather temperature and pressure readings to detect issues there. This sand grain-sized device could help measure blood pressure, monitor medication metabolism, and possibly even guide a needle through your insides as your doctor and you take a peak on a video screen. Fun, no?
Studying primate genomics to understand human genomics. What can we learn from monkeys and apes? Half a decade ago, researchers had sequenced genomes from less than 10% of primate species. But now, scientists have sequenced genomes from nearly half of all primate species; they’ve investigated more than 800 genomes from 233 species from around the world. This accounts for all 16 primate families. So we’re learning about human genomics from primates like apes, lemurs, monkeys and whatnot, with data which can inform research about human health, conservation biology, and even social structures.
Naturally, this is a huge body of work. Researchers from 24 countries have contributed to it, with samples coming in from countries like Brazil and India which are hotspots for primate diversity but have so far been under-represented in genetic studies. The work has been published in a series of 10 papers in Science and Science Advances, but researchers claim this is hardly the end of the project.
Sleep to remember. Sleep is super important in strengthening memory because that’s when your brain gets the time and space to consolidate all that information you’re trying to store in there. Scientists from UCLA Health and Tel Aviv University have provided the first physiological evidence of what happens in the human brain to help with memory. They’ve proven the dominant theory of the dialogue between our memory hub, the hippocampus, and the cerebral cortex, which is linked to reasoning and planning. They’ve also discovered that targeted deep-brain stimulation during a specific time in the sleep cycle appears to enhance memory consolidation. For this, they used a closed-loop system which delivered electrical pulses in a brain region in synchronization with brain activity in another region. This mechanism could, one day, present a cure for patients with Alzheimer’s disease.
Climate change comes for Asia. Extreme heat has once again swept across Asia, breaking seasonal temperature records and raising questions about the region's ability to adapt to swiftly changing climate conditions. After severe heatwaves in April, temperatures rose sharply again in late May, typically the onset of the cooler monsoon period. Record highs were observed in China, Southeast Asia and other areas, with climate experts warning of more to come.
Researchers emphasised that these events would likely worsen with climate change progression. In Vietnam, the ongoing heatwave has necessitated power rationing due to high air conditioning use, with the highest-ever temperature of 44.1 Celsius recorded on May 6. Meanwhile, China's Shanghai experienced its hottest May day in over a century, with the heatwave expected to persist for several more days.
Earlier in April, India, Pakistan, and Southeast Asia suffered severe heat waves leading to significant infrastructure damage and a surge in heat stroke cases. Temperature records were also broken in May, with Singapore witnessing its hottest month in 40 years.
Scientists have cautioned that regions unfamiliar with such heat extremes, including eastern Russia, Beijing, and surrounding districts, could be most vulnerable. However, even countries like India, where high humidity is already causing unsafe "wet bulb" temperatures, may find preparation insufficient. Apart from the various health conditions caused by extreme heat alone, we guess it is also time to prepare for the next set of climate-induced illnesses.
How are a film, a hotel and chocolate shops fighting global warming? We’re not sure. Climate financing, at least when done right, should be financing loans, grants, equity investments and more to aid developing countries in climate mitigation and adaptation efforts. But the countries that supported these projects are all counting their investments as “climate financing”.
Developed countries have pledged to channel $100 billion a year towards such financing, but with no real guidelines on what exactly counts as climate finance, Japan’s airport expansion in Egypt and Italy’s gelato stores in Asia could be whatever the financing countries choose to call them. Some sustainable features here, and a mention of deforestation there, are all it took for them to feel nice and green about their investments. The lack of transparency in the whole process has made it hard to know how much of wealthy countries’ climate funding is actually achieving any good. Reuters has tried anyway, uncovering all the strange places climate money is really going.