💉 Fruity flavours to prevent MDR-TB; UKDRI funding for neurodegeneration research; US FDA approval for BMS' cancer therapy
💉 Fruity flavours to prevent MDR-TB; UKDRI funding for neurodegeneration research; US FDA approval for BMS' cancer therapy
#474 | Measles cases rise; BMGF funds Micron's measles shot manufacturing; A new killer of pain discovered
Hello, and welcome back to The Kable for our last edition this week. To kick things off, we have a story from SciDev.Net on the potential for AI to transform healthcare in Africa. Ahead of the 3rd International Conference on Public Health in Africa (CPHIA), a panel discussion touched on how AI can contract drug development timelines and costs, make the continent more pharmaceutically self-reliant, and the steps African countries need to take to facilitate wider AI adoption, including creating an enabling regulatory environment.
And speaking of Africa’s efforts towards localising pharma production, Nigeria’s Fidson Healthcare and China’s Jiangsu Aidea Pharmaceutical Co. have inked a deal to drive local pharmaceutical manufacturing in Nigeria. Particularly, the partners will focus on producing drugs to treat HIV in the West African country.
Still in Nigeria, the Federal Government has declared a state of emergency in the health sector. The shortage of qualified personnel, medical equipment, and drugs has contributed to the situation.
Coming to the Caribbean region, Cuba is working on developing a rapid test for the detection of dengue fever. This project is a joint effort of the Center for Immunoassay and the Ministry of Public Health. Their alternative hopes to make testing for dengue a lot faster and more convenient than current diagnostics like the Umelisa IgM Dengue IgM.
In India, Astra Zeneca Pharma India wants to sell its plant in the city of Bengaluru. Its parent company is mulling the sale as part of a strategic review of its global manufacturing and supply network. They’re hoping to find a buyer who will also act as a contract manufacturer for its products which are currently manufactured or packaged at the site.
Meanwhile, Malaysia’s Sime Darby (SDHB) is selling its healthcare business to Columbia Asia Healthcare for RM5.7 billion.
To train future public health leaders and advance vaccine R&D, especially for pathogens with pandemic potential, the International Vaccine Institute (IVI) has inked an MoU with the University of Cambridge, the University of Hong Kong (HKU), and the Hong Kong Jockey Club (HKJC). The partners will establish the Hong Kong Jockey Club Global Health Institute (HKJCGHI), with two labs at HKU. Scheduled to open in the second quarter of next year, the founding partners want the GHI to specialise in vaccine process and platform development, epidemiology, immunology, health economics, and capacity-building.
Coming to Big Pharma, Bristol Myers Squibb’s $4 billion acquisition of Turning Point Therapeutics has paid off. The US FDA has approved BMS’s Augtyro to treat patients with non-small cell lung cancer driven by the rare ROS1 mutation. Pfizer and Roche already have drugs targeting this mutation, but BMS is confident its drug will outperform its competitors’.
Yesterday, 3M announced a name for its healthcare business spinoff: Solventum, which is solving + momentum. The spinoff is expected to be completed in the first half of 2024.
Astellas is acquiring the oncology-focused biopharma company Propella Therapeutics and PRL-02, its phase 1 prostate cancer therapy, for $175 million.
The UK Dementia Research Institute has announced the first projects to be funded through its £30 million partnership with LifeArc, the medical research charity. A total of £14.5 million has been allocated to 7 projects focused on developing new tests, treatments, and medical devices for people with neurodegenerative conditions like Alzheimer’s, Parkinson’s, motor neuron disease, and frontotemporal dementia. All the projects are listed here.
A report by Act4Biosimilars has revealed new insight into country-wise differences in biosimilar adoption across Europe, highlighting disparities between Central, Eastern, and Western Europe. Biosimilar adoption levels vary because of differences in treatment guidelines, biosimilar reimbursement, relevant policies, procurement mechanisms, affordability, and other factors. The report suggests steps to remedy the situation, using the Act4Biosimilars Action Plan as a guide to increase equitable access to biologics.
As the number of sexually transmitted diseases rises steadily in the US, the US FDA has cleared its first at-home, mail-in test for chlamydia and gonorrhoea. The FDA has described this de novo clearance as a public health milestone. The test is sold by the aptly named LetsGetChecked.
And finally, Labiotech is introducing us to the ‘biotech mafia’ – specialised biotech VC firms, which are once again dominating investments in the sector as the wave of generalist investors recedes post-pandemic.
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The Week That Was
The week began in full swing with news that the WHO has commissioned 16 "Vaccine Value Profiles" (VVPs) to guide global vaccine development for endemic pathogens. The VVPs are part of a broader initiative to focus on diseases predominantly affecting LMICs, which are often overlooked by vaccine developers due to uncertainties about market viability. They will facilitate evidence-based prioritisation and strategic decision-making, influencing initiatives like Gavi's Vaccine Investment Strategy and the Immunization Agenda 2030. The first volume of the Supplement will include VVPs for pathogens like respiratory syncytial virus (RSV), Group B Streptococcus, and Leishmaniasis, along with commentary on neglected tropical diseases.
Like most of the world, the pandemic exposed significant gaps in the Western Pacific region's readiness to handle global health threats, particularly in surveillance, testing, and vaccine development. Devex offered a look at how equipped the region is to handle another pandemic and the steps countries in the region are taking towards pandemic preparedness. Among other things, the region is developing a network for regional genomic surveillance to understand virus evolution and inform vaccine development.
A new UNICEF report revealed that one-third of the world's children - approximately 739 million -Â currently live in areas with high or very high water scarcity, a situation exacerbated by climate change. The report -Â The Climate Changed Child, released ahead of the COP28 climate summit, claimed that in 2022, 436 million children lived in areas of extreme water vulnerability, facing both water scarcity and inadequate drinking water services. This vulnerability is a significant driver of preventable deaths among children under five. Most affected children are in LMICs in regions such as sub-Saharan Africa, Central and Southern Asia, and Eastern and South-Eastern Asia.Â
As nations gathered for talks on a treaty to address plastic pollution, a crucial debate festered between limiting plastic production and managing waste. Environmentalists and countries like the EU, Japan, Canada, and Kenya advocate for binding measures to reduce the production of virgin plastic, particularly those derived from fossil fuels, whereas the plastic and petrochemical industries, backed by countries like Saudi Arabia, are pushing for a focus on recycling and waste management. The talks are also mired in procedural disagreements, with countries like Saudi Arabia insisting on consensus-based decisions, potentially impeding progress.
Writing in SciDev.Net, Jean Kaseya, director-general of the Africa CDC, and Akhona Tshangela, programme coordinator for Partnerships for African Vaccine Manufacturing (PAVM), talked about how it is essential for African countries to work together to redefine vaccine accessibility and advance self-sufficiency to safeguard public health. They discussed Africa's efforts to improve vaccine procurement and self-sufficiency in response to the challenges revealed by the pandemic, such as delayed rollouts, unequal distribution, and vaccine hesitancy.
Despite the increase in clinical treatments for hepatitis B, from 26 in 2016 to 40 in 2023, the pipeline for future treatments is not robust, with a decrease in preclinical candidates. This lacklustre progress is attributed to economic and marketplace factors. Recent advancements in treatment, such as GSK's Bepirovirsen and Barinthus Therapeutics' VTP-300, show promise, but challenges remain in fully addressing the disease's complexity. Fierce Biotech offered a look at biotechs focused on hepatitis B and their determination to overcome clinical challenges and past failures in the field.
The WHOÂ launched the third edition of its Roadmap towards ending TB in children and adolescents. This five-year plan sets out 10 key actions aimed at improving the prevention, treatment, and care of TB in this demographic. It focuses on closing policy-practice gaps, integrating strategies within primary health care, and enhancing data and research.
For 8 years now, The Lancet has been compiling research on the link between climate change and human health. Its latest report is now out. And it does not make for pretty reading. The report says heat-related illnesses and deaths are escalating due to global warming. The study forecasts a 370% increase in annual heat deaths by mid-century if temperatures rise by 2°C above preindustrial levels.
Last month, the US FDA cautioned consumers against buying or using store-brand eyedrops from Walmart, CVS, Target, and a bunch of other companies due to the risk of contracting eye infections. The Indian company Kilitch Healthcare has been identified as the manufacturer of the drops in question, with Bloomberg reporting that Kilitch made the eyedrops in an unsanitary facility in India. Kilitch has now recalled 27 variants of eye drops being sold in the US after an FDA directive on October 25.
And finally, loneliness is a global problem affecting all age groups. Beyond the fact that loneliness isn’t the most pleasant feeling, people without enough strong social connections are at a higher risk of cardiovascular disease, anxiety, dementia, depression, suicide, and early death. Launching the new Commission on Social Connection, the WHO aims to address loneliness as a pressing health threat.
Newsworthy
Fruity flavours to fight MDR-TB. Multidrug-resistant tuberculosis (MDR-TB) is quite challenging to treat, for reasons that its name reveals. The medications that do work can produce many side effects. What’s more, there are no preventative treatments around yet. In a very promising development, researchers have found that a widely available oral antibiotic used to treat bacterial infections like pneumonia can do wonders in reducing the risk of developing MDR-TB.
In TB-CHAMP, a phase 3 trial conducted in South Africa, only five of 453 children exposed to adults with MDR-TB developed MDR-TB themselves when they were given the antibiotic Levofloxacin once daily over a period of 6 months. In the placebo group, 12 of 460 children got MDR-TB. 90% of the children in the study were under five years of age – an age group which is at higher risk of getting TB. Funded by Unitaid and led by Stellenbosch University, the study was the first of its kind to investigate the prevention of the most severe forms of TB in children. The researchers have already developed a fruit-flavoured, dispersible form of the treatment to ensure that children actually take the drug. This is the first time in the history of TB that an intervention for children is developed concurrently with treatments for adults. Now for a recommendation from the WHO.
This is in addition to the good news we wrote about yesterday – also funded by Unitaid, the endTB clinical trial has found three new all-oral, shortened regimens for drug-resistant TB that were safe and effective for everyone – for children, pregnant women, and people with certain comorbidities as well.
(Unitaid)
Get your shots, kids! In front of that TB silver lining, however, is the dark cloud of measles. The WHO and the US CDC have released a new report revealing a staggering annual rise in measles cases and deaths in 2022. Cases spiked by 18% to an estimated 9 million, with deaths jumping 43% to touch 136,000 – most of which were among children. Compared to 22 in 2021, 37 countries had large or disruptive outbreaks in 2022, with the majority in Africa. The Eastern Mediterranean was a distant second. But given the declining vaccination rates witnessed globally over the past few years, especially due to Covid, this jump in cases isn’t a surprise.
(US CDC)
Sticking it to measles. Not all news on the measles front is gloomy, though. Yes, cases are rising, but innovations are looking to keep pace too. Look no further than Micron Biomedical's advancement in vaccine technology, particularly their development of a needle-free vaccine for measles and rubella. Micron has just received a $23.6 million grant from the Bill & Melinda Gates Foundation aimed at establishing a commercial manufacturing facility for this unique, dissolvable, microarray-based drug and vaccine delivery technology. This technology, once approved, is set to target small children, focusing initially on the measles and rubella vaccine. The grant's primary purpose is to facilitate the mass production of this needle-free technology, which will be sold exclusively in low- and middle-income countries (LMICs), as it currently lacks the mumps component necessary for broader commercialisation.
Micron's needle-free vaccine technology represents a significant step forward in addressing the high rates of measles-related deaths in LMICs. This innovative approach eliminates the need for refrigeration during transport and reduces the reliance on trained clinicians for administration, two major obstacles in traditional vaccine delivery. The technology works by dividing a typical injection into 150 doses, freeze-dried and shaped into sharp projectiles on a small button, allowing healthcare workers to easily administer the vaccine by pressing it into the skin. This not only simplifies the vaccination process but also makes it pain-free, potentially increasing vaccine acceptance and coverage. Micron's efforts align with the WHO’s recommendation for measles vaccination in children, and a recent Phase 1/2 trial in Gambia has shown positive results, indicating the safety and effectiveness of the technology with a leading commercial measles and rubella vaccine.
(Micron Biomedical)
It’s raining recalls, hallelujah. The 'pharmacy of the world' has been having a tough time of it lately. Facing increasing scrutiny over its pharmaceutical and regulatory practices, this year especially hasn’t been the best of years for India on the world pharma stage. Despite its pre-eminent global position in generic drug production, there's been a concerning trend of poor manufacturing practices leading to serious consequences. Yesterday, we spoke about Kilitch Healthcare, which was asked to recall its eye drops from the US market due to unsanitary production conditions. Previously, Global Pharma had to recall its eye drops after they were linked to infections and severe adverse effects, including vision loss and even deaths. This issue isn't isolated to eye drops; there have been reports of deaths in The Gambia and Uzbekistan linked to Indian-made cough syrups. The Indian government had taken some action against some companies but also walked back some action. So crickets, basically. And this problem isn’t new or isolated. A cursory glance at Kables throughout this year will reveal how many recalls have been issued of Indian-made drugs in the US and elsewhere, highlighting ongoing issues in the Indian pharmaceutical industry.
Despite these challenges, India remains a significant global supplier of generic drugs. To address these concerns, India's Health Minister announced new regulations, including mandatory testing for cough syrups before export. However, as inspections increase, more issues may surface, with India having the lowest percentage of acceptable drug manufacturing facility inspections compared to other major countries, raising concerns about the future of its role as a quality pharmacy provider. But we have hope. And a prayer.
(The Economic Times)
R&D
Wonderdrug for pain relief. In a groundbreaking study, a team of researchers from NYU College of Dentistry's Pain Research Center discovered a promising new pain relief compound. After screening 27 million compounds, they found one, CBD3063, that effectively reversed various types of chronic pain in animals without the side effects commonly associated with pain medications like Gabapentin. This small molecule works by targeting the inside of a calcium channel, a novel approach in pain treatment. The research, involving collaborations across several universities, demonstrated CBD3063's effectiveness in reducing different types of pain in animal models, including neuropathic and inflammatory pain. The team is now focusing on refining CBD3063 and preparing for clinical trials, hoping to offer a safer, more effective alternative for chronic pain management.
(PNAS)
Old bones, new tricks. A study recently published in eLife zooms in on senescent osteoclasts in the spine. Normally, osteoclasts help maintain our bones, but when they get old and senescent, they stop working right. The researchers found that these underperforming cells are linked to lower back pain, which is a huge deal since most of us will experience it at some point. They tried out a drug named Navitoclax on mice and saw that it not only got rid of these worn-out osteoclasts but also reduced spinal pain significantly. This is promising because it means this approach could potentially be a new way to treat lower back pain in humans. But, of course, they need to test it more in clinical trials before it becomes a go-to treatment.
(eLife)
Oh, and Gopal Nair doesn't want you to see this.
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.