#512 | Heat alert for East Asia; AI for Africa; Vaccine for UTIs
Hello, and welcome back. You’re just in time for the longest Kable of the year so far.
Last week, we told you that India might be facing a shortage of polio vaccines soon. Well, Sanofi is promising not to let this happen. Sanofi, however, isn’t making any promises about their R&D team, with a proposed pipeline shakeup leading to a worldwide restructuring, which means lots of research people will need to update resumés. Sanofi is in good company when it comes to axing R&D jobs. Novartis is looking to lay off about 700 people.
Two Indian companies have received red flags from the US FDA. A warning letter for Natco Pharma which the company says won’t affect operations. Kilitch Healthcare was scolded over unsanitary manufacturing conditions.
Elsewhere, a report from law firm Baker McKenzie says 2024 will see a rise in investment and innovation in healthcare & life sciences in the APAC region. Where is a dictionary with the definition of compounding when one really needs it?
In other news about APAC, there’s quite a rise in infectious Pertussis cases in the Philippines with 54 casualties already.
Over in Sierra Leone, human bones have led to an emergency declaration. People are increasingly getting addicted to Kush and digging up buried humans for their bones because said bones are used to make Kush.
In less gory news, Neuralink may not yet have set the world on fire, but it already has competition, with Synchron saying it is ready to trial its implants in human brains.
Last week, we had lots to say about bird flu. This week, a little less. In the US, officials have issued a health alert for bird flu infections, cautioning HCPs to be on the lookout for cases in humans. The US CDC says the risk to humans is low but has nevertheless asked states to have a rapid testing plan in place. How did cows in the US get bird flu, though? Some speculate it might have been chicken waste fed to cattle that caused it. Dairy farms in the US are banning visitors and chopping trees to prevent more cows from falling ill. Oh, but bird flu is not limited to the US. There has been a new outbreak on a poultry farm in the Philippines as well.
And finally, who doesn’t love records? We certainly love them. And it gives us great joy to announce March was yet another record month on the global heat index, making it the 10th consecutive month to set a record.
In 10 days, doors will open to the inaugural edition of Pharmaconex West Africa. The newest edition to the Pharmaconex Family, Pharmaconex West Africa, brings its decade of knowledge and expertise to Nigeria. It will be held from 22-24th of April in Lagos, Nigeria, and you really should REGISTER TO ATTEND. The Kable is Editorial Partner to Pharmaconex, and your registration gives you free access to limitless knowledge and connections!
Stories Of The Week
Mosquito menace ramps up in Latin America. Not too long ago, we wrote about how dengue is overpowering health systems in Brazil. Add neighbours Argentina and Peru to the mix as well. In Argentina, rising temperatures have triggered the country’s worst dengue fever outbreak, with mosquitoes hatching earlier and expanding into cooler southern regions, exacerbating the risk of annual epidemics. The current season has seen a record 232,996 cases, significantly surpassing previous records, leading to strain on medical facilities and shortages of insect repellent. Scientists attribute this increase to climate change, which is extending the mosquito season and facilitating the spread of dengue to areas previously unaffected. In Peru, dengue deaths have more than tripled this year, prompting the government to enact an emergency decree to intensify efforts against an epidemic exacerbated by climate change, particularly affecting poorer regions. The current outbreak has seen deaths increase from 33 last year to 117, with suspected cases also tripling to approximately 135,000. This surge in dengue, attributed partly to the Aedes Aegypti mosquito’s adaptation to changing climates, poses a significant health threat, especially to vulnerable groups like infants and pregnant women.
(Reuters, Reuters)
Moderna pauses African sojourn. Like many people around the world, we, too, cheered when Moderna announced it was building a factory in Kenya. Unfortunately, that dream has now soured with Moderna halting work on its only plant in Africa, ostensibly due to lack of demand for its Covid vaccine from the continent. This $500 million plant was supposed to produce up to 500 million doses annually. After pausing the project, Moderna says it is now reconsidering how best to meet the continent’s evolving healthcare needs and ensure equitable access to its vaccines.
(Moderna)
Make in Africa. Stories like the one above emphasise just how important it is for Africa to be fully self-sufficient when it comes to its healthcare needs. Devex has an important piece on its website on how this pharma transformation can happen. Work is being actively put into expanding its pharmaceutical manufacturing capabilities to enhance health security across the continent. But the road ain’t easy. Significant hurdles include limited access to pharmaceutical patents held abroad, a lack of skilled labour, insufficient infrastructure, inadequate local R&D, weak regulatory systems, and perceived financial risks to investors. Despite these issues, efforts are progressing, with stakeholders gathering for a major conference in Addis Ababa, launched by the newly formed African Pharmaceutical Technology Foundation, to discuss innovation, intellectual property, and technology transfer in Africa’s pharmaceutical sector. The discussions underscored the necessity for Africa to develop a tailored intellectual property strategy and explored mechanisms like voluntary licenses and the Medicines Patent Pool to enhance access. However, the success of these initiatives depends on various factors, including international cooperation and the development of local expertise and infrastructure. One line that stood out for us in this article… “The subsidiary of a foreign company is not necessarily what I would call African manufacturing.“
(Devex)
Cough, cough. Last year and the year before that, everybody around the world had gotten familiar with cough syrups and child deaths, thanks to cases primarily from The Gambia and Indonesia. Thanks to Nigeria, cough syrups might just be returning to the limelight. The country’s health regulator, NAFDAC, is recalling a batch of J&J’s children’s cough syrup, Benylin Paediatric, due to a dangerously high level of diethylene glycol found during laboratory testing. This toxic substance was the cause of the fatal poisonings mentioned above. The affected batch, produced in South Africa in May 2021 and expiring in April 2024, is used to treat symptoms like cough, congestion, hay fever, and allergies in children aged two to 12. The manufacturer, now Kenvue after a corporate spin-off, has yet to respond to comments on the recall.
(NAFDAC)
Access for all. The UK Biobank has launched the Global Researcher Access Fund to aid researchers from low- and middle-income countries access its extensive biomedical database at a significantly reduced cost. The fund will cover the £500 fee for three years, a stark contrast to the £9,000 fee charged to researchers from high-income countries. Researchers from less affluent nations have so far been underrepresented, with fewer than 50 projects to date, due to financial constraints. This initiative aims to democratise access to vital data, fostering a more inclusive global research environment. The fund, targeting a $100,000 goal and currently supported by major pharmaceutical donations, seeks to empower researchers worldwide, regardless of economic barriers.
(Devex)
Hepatitis keeps pace with TB. The 2024 Global Hepatitis Report by the WHO reveals a concerning increase in deaths from viral hepatitis, now matching TB as the second leading infectious cause of death globally, claiming 1.3 million lives annually. Despite advancements in diagnostic and treatment technologies and decreased product costs, the coverage rates for testing and treatment have not improved significantly. The report emphasises the potential to achieve WHO’s 2030 elimination goal with urgent actions and highlights the recent increase in hepatitis deaths from 1.1 million in 2019 to 1.3 million in 2022, primarily due to hepatitis B and C. It also calls for expanded access to testing, diagnostics, and treatment, alongside improved data use, community engagement, and innovative financing to overcome the substantial funding gaps hindering the fight against viral hepatitis.
(WHO)
The future comes calling. With the significant advances in vaccine technology we’ve seen in the past couple of decades, we’re seeing innovative approaches to targeting complex diseases like cancer using recombinant DNA, viral vectors, and mRNA technologies. Pharma Manufacturing looks at what the big vaccines of the future will be. Notably, BioNTech and Genentech are advancing an mRNA-based vaccine for pancreatic cancer into phase 2 trials, showing promise in improving patient outcomes by targeting specific mutations. Similarly, other companies like Transgene and OSE Immunotherapeutics are developing vaccines for ovarian, head and neck cancers, and non-small cell lung cancer (NSCLC), respectively, with the latter showing potential as a second-line treatment post-immune checkpoint inhibitor failure. Additionally, collaborative efforts by Merck and Moderna are focusing on a personalised mRNA cancer vaccine, indicating a broader industry shift towards highly tailored treatments. Beyond cancer, companies are also progressing vaccines against infectious diseases like influenza, CMV, Zika, and Lyme disease, leveraging modern mRNA platforms to enhance efficacy and adaptability. This surge in vaccine innovation is also extending to public health challenges like HIV and addiction, with ongoing research into preventative vaccines for HIV and substance abuse.
(Pharma Manufacturing)
Breakthroughs
Oral spray vaccine for UTIs. A new vaccine, MV140, is showing promising results in preventing urinary tract infections (UTIs), particularly benefits older adults who are highly susceptible to this ailment. In a long-term clinical study at the UK’s Royal Berkshire Hospital involving 89 patients, approximately 54% remained UTI-free for nine years post-treatment with two sprays of a pineapple-flavored suspension under the tongue. This vaccine, which exhibited no significant side effects, significantly extended the UTI-free period, averaging about 54.7 months across participants. Despite its efficacy, experts emphasise the need for broader trials, especially to benefit those with complex UTIs and older individuals in care homes who face high risks of antibiotic-resistant infections. This study represents a crucial step in combating the global issue of antibiotic resistance, particularly as effective treatments for UTIs have not seen innovation since the advent of antibiotics nearly a century ago.
(BioPharma Reporter)
Supercharging cancer-fighting cells. Recent research has advanced the potential of CAR T cells, a type of bioengineered immune cell used in cancer treatment, by enhancing their longevity and effectiveness with high levels of a protein that makes them more stem-cell-like. Two independent studies published in Nature found that increasing the FOXO1 protein in CAR T cells rejuvenates them, giving them stem cell properties and a renewed capacity to combat cancer. This discovery has opened new possibilities for treating both solid tumours and blood cancers more effectively. The modified CAR T cells, showing heightened gene activity and improved metabolism, demonstrated significantly better outcomes in reducing cancer in experimental models. These findings suggest a promising future for using genetically engineered CAR T cells to improve cancer treatments, with clinical trials expected to start within two years.
(Nature, Nature)
Corporate
Big Pharma’s busy week. It has been a very busy week in Big Pharma land. In the year’s biggest deal so far, J&J is acquiring Shockwave Medical for $13.1 billion. Elsewhere, Vertex Pharma is boosting its immunology pipeline with a $4.9 billion bet on Alpine Immune Sciences. Continuing its bull run in ADCs, Merck has signed a deal worth up to $208 million to acquire a University of Buffalo startup called Abceutics. Talking of ADCs, the other Merck, Merck KGaA, is partnering with Caris Life Sciences, a company specialising in AI and precision medicine, to accelerate the development of ADCs for cancer treatment. The deal could see Caris receive up to $1.4 billion, apart from tiered royalties. Novartis is paying $150 million upfront to Arvinas for global rights to a protein-degrading drug that targets the androgen receptor to treat prostate cancer. The deal also includes a preclinical molecule addressing an androgen receptor variant. And finally, since it seems no mention of deals can be made lately without mentioning Gingko Bio, here it is. Ginkgo has broadened its collaboration with Novo Nordisk to enhance the manufacturing processes of Novo Nordisk’s medications. The new arrangement also includes collaboration on early pipeline projects and technology advancements for scalable manufacturing solutions.
(JnJ, Alpine, UBuffalo, Caris, Arvinas, Gingko)
Bottom line
Hotting up. In a prophetic call to action, UNICEF has sounded the alarm for over 243 million children in East Asia and the Pacific, who stand on the brink of unprecedented peril as the spectre of record-breaking heat looms over the coming summer months. This dire forecast not only sketches a future where the air’s embrace turns from nurturing to threatening but also underscores the heightened vulnerability of children to the wrath of climate change. With their bodies less equipped to ward off the insidious advances of heat-induced maladies, children are at a disproportionate risk for chronic respiratory issues, asthma, and cardiovascular diseases. As the region stares down the barrel of intensified heat waves, coupled with the stifling foe of high humidity, the need for vigilance has never been more pressing.
(UNICEF)
Melting down. Last year in March, a meteorological milestone was reached at the Concordia research station in East Antarctica, recording a jaw-dropping 38.5°C jump in temperature above the seasonal average – the largest such increase documented at a weather station. This event underscores a growing concern among scientists about the unforeseen acceleration of climate impacts in a region once deemed too cold to notice the early effects of global warming. Over recent years, there’s been an alarming trend of more frequent and severe weather anomalies in Antarctica, causing glaciers to recede and sea ice levels to plummet after remaining stable for a century. Researchers grappling with the scale and implications of these changes warn that this could signify a dramatic and rapid shift in the continent’s climate system. Such shifts not only pose a risk to local biodiversity and ecosystems but could also have profound effects on global sea levels and climate patterns.
(The Guardian)
Long reads
AI for Africa. Pharmacogenomics reveals that a person’s genetic makeup plays a crucial role in how they react to medications. Yet, despite Africa being the most genetically diverse continent and projected to house nearly a quarter of the global population by 2050, it’s starkly underrepresented in pharmacogenomics research. This gap in data not only hampers the effectiveness of treatments for its diverse populations but also poses significant health risks, as seen with medications like the HIV/AIDS drug efavirenz in Zimbabwe, which had severe side effects not observed in Western populations due to genetic differences. This Nature piece outlines how AI can make the difference for Africa, provided it is Africans who’re driving that change.
(Nature)
Oh, and Gopal Nair doesn’t want you to see this.