💉 Gilead bets on liver disease; EFTA bats for extended IP; Is long Covid really real?
#504 | The US FDA love affair with Indian manufacturing continues
Hello, and welcome back to The Kable for your weekly round-up of what has been an unusually light week in the life sciences.
The week began with a leaked draft of a potential agreement between India and the European Free Trade Association (EFTA) raising concerns among civil society and patient advocacy groups. They fear that the deal, expected to be finalised by April, could hinder access to affordable generic medicines in India by introducing a six-year period of data exclusivity for brand-name drugmakers. This exclusivity would protect the results of preclinical and clinical trials from being shared with generic manufacturers, effectively extending the monopoly of brand-name drugs and blocking India's National Drug Regulatory Authority from approving generic alternatives, with far-reaching implications for global medicine accessibility. MSF has written to government authorities in India, asking them to reject the deal, stating that the IP provisions will hinder access to affordable drugs from India. Yesterday, India confirmed that it has firmly rejected the EFTA bloc's demand for a data exclusivity clause, affirming its commitment to protecting the domestic generic drugs industry. Something tells us this story hasn't been put to bed yet.
Elsewhere, in no surprise, the WTO could not reach an agreement to waive intellectual property rights for Covid tests and treatments for poorer countries, despite years of discussion and the significant need demonstrated by the disparity in vaccine access between high-income and low-income countries.
The more things change, the more they remain the same. And sometimes, they don't change at all. Anyway, apropos of nothing, the US FDA recently intensified its regulatory actions and among those targeted, Indian ophthalmology firm Madhu Instruments received scrutiny for unsanitary manufacturing conditions at its New Delhi facility, leading to products being deemed adulterated and potentially harmful. Despite the company's response to a Form 483 issued after an October 2022 inspection, the FDA found the measures inadequate, citing issues such as peeling paint, obstructed airflow due to improperly placed plastic bags over filters, and visibly dirty manufacturing equipment, casting doubt on the plant's suitability for drug and device production. Hmmm!
Speaking of change, not much has changed on the bird flu front, either. In Cambodia, one more human, the third this year, has contracted bird flu. In Antarctica, scientists hope baby penguinsdon't succumb to it. And the US says it is approximately 18 months away from identifying an effective vaccine for the current strain of avian flu, amidst ongoing efforts to devise a distribution strategy. The outbreak has impacted 22 commercial and backyard flocks this year alone, contributing to over 81 million poultry and aquatic birds being culled across 47 states in the past 24 months.
Last year, there was much tom-tomming at COP28 on how a loss and damage fund has been set up to help countries at risk from climate change. Turns out higher-income countries have not even nominated their representatives for the board of the newly established fund, leading to potential delays in the fund's efforts to aid communities affected by climate change. Despite developing countries nominating 13 of their 14 representatives, the lack of nominations from developed countries as of February 2024 threatens to postpone the operational and funding disbursement milestones of the board. This delay highlights the challenges in international climate negotiations and could impact the fund's ability to meet its deadlines and strategic decisions for addressing loss and damage associated with climate impacts.
And finally, a concentrated cannabis extract, known as PHEC-66, has demonstrated significant potential in killing melanoma cells in laboratory settings by inducing programmed cell death or apoptosis. This discovery, backed by studies from RMIT University and Charles Darwin University, opens a promising new avenue for treating melanoma, a particularly challenging form of skin cancer. Yes, further research is necessary to validate these findings, but hey 🤟🏾.
Stories Of The Week
The billion-dollar ghost hunt. The amount of rampant medical gaslighting around the world when it comes to long Covid could almost have one believe long Covid doesn't exist. Except, what are all these organisations putting in so much money into then? Like the US National Institutes of Health (NIH), which is significantly expanding its investment in long Covid research, adding $515 million to the Recover program, raising the total funding to $1.65 billion since its inception three years ago. This new funding aims to deepen the understanding of long Covid's biology, develop potential treatments, and distinguish between those who recover and those who suffer long-term effects from Covid infections.
(Recover)
The great disappearing act. For nearly two years now, cholera has been running rampant around the world. Several regions and nations would've been fighting losing battles against cholera, if not for the limitless vaccine stockpiles. But wait, what stockpiles? There are no stockpiles. The global emergency stockpile of cholera vaccines, managed by the WHO and other UN agencies, is currently depleted, with all available doses for this month already distributed amidst a surge in worldwide outbreaks. This acute shortage, exacerbated since October 2022 when the WHO recommended halving the vaccine dosage to conserve supplies, has led to a projected deficit of at least 50 million doses for the year, against a backdrop of escalating cases and fatalities. In January alone, 17 countries reported over 40,900 cases and 775 deaths. The scarcity is compounded by the fact that there is only one WHO-approved vaccine producer, Eubiologics, with the other approved producer having discontinued production in 2022.
(Reuters)
Agency Observer
Boosting biomanufacturing in LMICs. The pandemic has starkly highlighted the fragility of global supply chains, particularly affecting the access of low- and middle-income countries (LMICs) to essential medical products due to the concentration of manufacturing capacities in a few nations. Recognising the need for equitable access to biological products like vaccines and monoclonal antibodies, the WHO is launching the Biomanufacturing Workforce Training Initiative. This initiative, organised by WHO's Local Production and Assistance Unit in collaboration with other WHO divisions, aims to bolster biomanufacturing capabilities in LMICs through comprehensive training programs designed to enhance local production quality and sustainability. The initiative will leverage existing WHO activities, the Global Training Hub for Biomanufacturing established in South Korea, and future regional training centres, underscoring a commitment to improving the global health sector's resilience and self-sufficiency.
(WHO)
Breakthroughs
Researchers at Harvard University have developed a groundbreaking synthetic antibiotic named cresomycin, showcasing exceptional effectiveness against both Gram-positive and Gram-negative bacteria, including formidable multidrug-resistant strains. Cresomycin, detailed in a Science paper, leverages a novel component-based synthesis approach, allowing it to outmanoeuvre the antimicrobial resistance mechanisms that render many existing antibiotics ineffective. This innovative strategy, inspired by the lincosamides class of antibiotics but distinct in its fully synthetic and novel chemical structure, enables cresomycin to bind more tightly to bacterial ribosomes, circumventing the common resistance tactic of ribosomal RNA methyltransferase production by bacteria. Funded by a $1.2 million grant from CARB-X, this promising compound and others developed by the team are moving towards preclinical studies, aiming to tackle the global challenge of antibiotic resistance that claims over a million lives annually.
(Science)
Corporate
Gilead swipes right on CymaBay; Astellas and Kelonia set up a blind date. In keeping with trends through this week, corporate moving and shaking too has been relatively underwhelming, especially considering all the action we've witnessed in the year so far. There still were two noteworthy deals to include here though. First, Gilead punted $4.3 billion on acquiring CymaBay, securing a promising drug candidate, Seladelpar, aimed at treating primary biliary cholangitis (PBC), a rare liver disease. Elsewhere, Astellas, through subsidiary Xyphos, has entered into a research and licensing deal exceeding $800 million with Kelonia to develop up to two immuno-oncology programs. This collaboration combines Kelonia's lentiviral delivery technology with Xyphos' convertible CAR platform, aiming to create adaptable cancer therapies capable of targeting multiple tumour types.
(CymaBay, Astellas)
Outbreaks
Canine cough capers. Remember the raft of mystery respiratory ailments in dogs across the US last year? That tail-wagging drama may not have finished unfolding yet. Despite efforts by the United States Department of Agriculture to pinpoint a cause, the expert conclusion was more mundane than expected: no new pathogen, just the usual suspects behaving unpredictably. Experts, observing a gradual increase in such illnesses, speculate factors like disrupted vaccinations, the rise of certain dog breeds, and increased social interactions at pet care facilities could be to blame. A twist in the tail, however, is a study from the University of New Hampshire that suggested a potentially new pathogen in 14% of cases, even if one not as viral as Covid.
(USA Today)
Bottom line
Nature's A-listers in crisis. In the latest episode of "Humans vs. Planet Earth," the UN has dropped a bombshell report, showcasing how almost half of the globe's migratory VIPs (Very Important Species) are on the decline, with a guest appearance by the grim reaper for more than one-fifth of them, threatening extinction. These creatures, in their tireless pursuit of survival, play key roles, from pollinators to carbon storage units, yet here we are, humans, playing the ultimate villain in this drama. Over-exploitation and habitat remodelling (because 'destruction' is so passé) lead the charge in this saga, with climate change and pollution as the supporting cast. Amidst this dire backdrop, a glimmer of hope shines as some species, like the blue whale and humpback whale, show what resilience looks like, defying the odds by improving their conservation status.
(UN State of the World’s Migratory Species)
Long reads
Diplomacy meets disaster movie. When the Director General of the WHO ventures out of his diplomatic comfort zone to lambast the ongoing negotiations for a new multilateral pandemic agreement with phrases like “a torrent of fake news, lies, and conspiracy theories,” should one sit up and take notice? Well, if the collective trauma and financial hangover from the pandemic just past, the absence of consensus on a new pandemic treaty should not be breaking news. As the clock ticks down to the World Health Assembly, the stark divide between rich and poor nations, geopolitical squabbles, and the ever-greedy private sector interests are turning what was once a promising agreement into a potential blockbuster disaster.
(El Pais)
Oh and, Gopal Nair doesn't want you to see this.