💉 Eli Lilly on a buyout spree; Sanofi optimistic about vaccine sales; Aurobindo Pharma’s quality lapses
#374 | Giving up on sugar substitutes; Predicting type 1 diabetes; Enabling AMR with microplastics
Hello and welcome to The Friday Kable, where we continue to hate on sugar substitutes, Indian pharma manufacturers continue to mess up, and semaglutide continues to prove its appeal.
But first, some Big Pharma updates. Eli Lilly is acquiring the cell therapy developer Sigilon Therapeutics for an upfront payment of a little under $35 million. The two companies have already been partners on a preclinical type 1 diabetes therapy since 2018.
Eli Lilly is also acquiring the German biotech Emergence Therapeutics, which focuses on antibody-drug conjugates. Terms of the deal haven’t been disclosed, but Emergence’s founding investor Heidelberg Pharma will receive $7 million for its stake. This would be Lilly’s third acquisition this month, after Dice and Sigilon.
CEPI is partnering with the mRNA tech platform company RVAC Medicines. CEPI will provide up to $3 million to support process improvements for RVAC’s next-gen platform. The eventual goal is to accelerate mRNA vaccine manufacturing in case of future epidemics.
A new WHO and UNICEF report highlights the need to invest more in nurturing care during the first years of a child’s life, especially in low-income countries. It tracks global progress against a framework which promotes an integrated approach towards early childhood development. It also highlights the importance of the new Early childhood development index 2030 and the Global scales for early development to assess early childhood development.
In Colorado, USA, an adult has tested positive for the plague.
In Michigan, USA, at least two humans and three macaques tested positive for tuberculosis at a biomedical research facility earlier this year.
A new study reiterates the connection between a person’s blood group and SARS-CoV-2’s ability to infect their cells. It turns out that type A blood proteins are more attractive to SARS-CoV-2 than type O.
And finally, the first participants in a trial for a Sudan ebolavirus vaccine candidate have been inoculated in the US.
The Week That Was
The last week of June kicked off with news of a new Health Impact Investment Platform, with the WHO, the African Development Bank, the European Investment Bank, and the Islamic Development Bank on board. The platform has been launched with the objective of investing in and strengthening essential and climate- and crisis-resilient primary health care (PHC) services in LICs and LMICs.
In Indonesia, police are conducting preliminary inquiries into whether any actions by officials of the Indonesian Food and Drug Agency could amount to criminal wrongdoing in the tainted cough syrup case.
We discovered that even as the Covid emergency ends, COVAX has quite a fat bank balance of $2.6 billion. Donors like the US, Germany and the BMGF don't want their money back. These funds will likely be redirected to prepare for future pandemics or to support vaccine manufacturing in Africa.
The WHO and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH, for short) announced a new collab to enhance the medical product registry and sharing of regulatory information around the world. The goal is to come up with a unified language to streamline global regulatory decision-making regarding the safety and efficacy of medical products.
Reports emerged that India's Marion Biotech used industrial-grade ingredients to make the cough syrups implicated in the deaths of 19 children in Uzbekistan.
Gavi, WHO, and CEPI announced their collaboration on a Global Virtual Pooled Inventory (GVPI) to investigate stockpiling experimental vaccines for rare infectious diseases. The objective is to have a stock ready for testing when outbreaks happen; to begin with, the focus is on Marburg and the Sudan ebolavirus.
Wellcome and the Bill & Melinda Gates Foundation committed $550 million to fund the phase 3 clinical trial of the TB vaccine candidate M72/AS01E. If the M72 shot turns out to be effective, it would be the first new vaccine against active TB in over a century.
Gavi, meanwhile, wants to take on 6 diseases in one shot. The Board okayed Gavi's investment in a hexavalent vaccine which combines the pentavalent shot, which protects against diphtheria, tetanus, whooping cough, hep B and Haemophilus influenzae type b, and the inactivated polio vaccine.
In South America, Brazil's Lula is reviving the Union of South American Nations, or UNASUR, in order to further pharma trade and improve disease response standards in the region. Brazil is leading efforts to improve pharma R&D and production and minimize the region's reliance on medical imports.
And finally, a new study says that global warming is transforming heavy snowfall into extreme rainfall over mountains. Such extreme rainfall intensifies flooding, threatens one in four people living in or near these areas, and impacts food production and water supply. And this isn't just a future problem; it's already occurring.
Newsworthy
Sanofi confident about bringing in the $$$. Sanofi is expecting some big bucks to come in by 2030. The company is relying on its RSV, pneumococcal disease and flu vaccines to contribute towards its projected €10 billion in annual sales. It also has some promising mRNA candidates in the pipeline to supplement earnings from the above vaccines. The company wants to launch at least five phase 3 vaccine programmes by 2025 under an “accelerated pace of innovation”.
Not that Sanofi hasn’t been doing well lately. From 2018 to 2022, Sanofi’s vaccine revenues grew by 8%, primarily because of its Fluzone High Dose and paediatric vaccine Penta/Hexaxim. In 2022, Sanofi earned about $7.9 billion in vaccine sales. And now, to develop new vaccines supporting Sanofi’s ambitions, the company has nine distinct platforms to offer to its scientists. It also has a five-pronged plan, including goals to lead the RSV market.
(Sanofi)
Sweeter than sugar, worse for your health. Remember the research that said the sugar-substitute erythritol could cause blood clotting, strokes and heart attacks? And the time we told you how sucralose could potentially weaken your immune responses? Now aspartame is coming under attack.
Aspartame is one of the world’s most common artificial sweeteners. You consume it every time you drink a Diet Coca-Cola. We hate to break this to our First Kabler, who is likely crying copiously as she reads this; two sources have revealed that the WHO’s International Agency for Research on Cancer (IARC) will list the substance as “possibly carcinogenic to humans” in July. The WHO had already issued guidelines last month recommending against using non-sugar sweeteners to control weight.
Despite its ruling on aspartame, the IARC does not say anything about how much of the substance a person can safely consume. That’s the job of the Joint WHO and Food and Agriculture Organization's Expert Committee on Food Additives, or JECFA. So this IARC ruling may confuse the public, as has happened with other substances in the past. But JECFA is also currently meeting and discussing aspartame. JECFA is due to announce its findings on July 14, the same day the IARC will officially announce its ruling too. So hopefully, public confusion will be avoided.
Nonetheless, industry, national regulators and associations have issues with IARC’s review methods. Meanwhile, sources close to IARC say this listing for aspartame is only intended to encourage further research, which could lead to more firm conclusions in the future.
(Reuters)
Quality concerns everywhere. As the pharmacy of the world, India’s quality issues in pharma have had consequences in several countries abroad. They have led to adverse health events and drug shortages as plants shut down and drugs are recalled. Aurobindo Pharma is the latest company to be reprimanded for quality lapses.
US FDA officials have found several faults at a plant where India’s second-largest drugmaker produces APIs. Auditors visited the plant in Anakapalli in eastern India last month, uncovering what they found to be “deficient” manufacturing equipment cleaning and storage controls. Sampling tools weren’t cleaned and maintained. Lab controls hadn’t established scientifically sound and appropriate specifications to assure drug conformity to appropriate standards. Raw materials were stored in sweltering and humid conditions, not complying with label storage requirements. Aurobindo has claimed it is working to address and respond to the FDA’s concerns.
(The Economic Times)
R&D
Patience you must have. A nine-year-long study by scientists at the US Department of Energy’s Pacific Northwest National Laboratory has yielded some results about the onset of autoimmunity in people with diabetes. The scientists examined hundreds of proteins in over 8,000 blood samples from nearly 1,000 children at six sites in North America and Europe. They have identified altered proteins that can predict islet autoimmunity, a sign that a person will eventually develop type 1 diabetes. These findings mark a step towards predicting who will develop type 1 diabetes months before symptoms appear. The team highlights that more work must be done to verify their results to see if they apply to everyone, not only the genetically predisposed children they studied. Their ultimate goal is to prevent diabetes altogether.
(Cell Reports Medicine)
More semaglutide, fewer kilos. Diabetes worsens over time, but treatments like Semaglutide, a GLP-1 receptor agonist, can help manage it. New research has revealed that new high-dose formulations of Semaglutide are more effective in blood sugar control and weight loss. The study found that daily doses of 25 mg and 50 mg of oral Semaglutide were more effective at reducing blood sugar levels and promoting weight loss than the 14 mg dose. This aligns with other studies advocating for oral GLP-1 receptor agonists in obesity treatment. The trial involved 1,606 average-aged male participants who took varying Semaglutide doses for a year, with those on 25 mg and 50 mg more likely to reach a healthy A1C level (<7.0%) and lose weight. The common side effects reported included nausea, vomiting, diarrhoea, and constipation, especially among those on higher doses.
(The Lancet)
The Kibble
Give 'em kids a book. In the great "book versus screen" debate, books scored a major point! Research reveals that starting a love affair with reading early doesn't just introduce kids to Harry Potter sooner; it's like a secret brain workout - boosting cognitive test scores and preparing them to handle the emotional rollercoaster of teenage years. There's a catch, though - the sweet spot is 12 hours of reading per week, just enough to keep the brain gym membership without becoming a recluse. So, sorry, parents, encouraging your kids to read doesn't mean you can skip the playground trips. But make reading fun early on - it's like planting the seed for a lifetime of literary love and ninja-like cognition. Who knew bedtime stories could be so powerful?
(Psychological Medicine)
Bottom line
The plasticity of AMR. A research team from Australia has uncovered a troubling link between microplastics and antimicrobial resistance. Their research shows that chemicals seeping from microplastic marine pollution can change the composition of microbial communities, leading to an increase in virulence and antimicrobial resistance. The lab-based study mixed seawater with leachates from polyvinyl chloride (PVC) and monitored the changes in the bacteria's DNA over six days. While the exact mechanism remains unclear, they discovered that bacteria exposed to these plastic additives carry more genes related to virulence and resistance. The effects varied for different classes of antimicrobials and virulence types, with specific genes becoming more prevalent and others less so. The concern is not limited to known human pathogens, as bacteria can share genes across different lineages. Further research is required, but it appears that exposure to plastic selects for more robust microbes, inadvertently enhancing antimicrobial resistance.
(Environmental Pollution)
Oh, and Gopal Nair doesn't want you to see this.