💊 Eli Lilly earns a Point; AstraZeneca settles in heartburn drug lawsuit; Mastercard, Africa CDC halt Covid programme funding
#442 | Simulating diseases; Catching obesity; Scorching September
Hello there. Welcome back to The Kable. Having recorded over 8,000 confirmed cases (6,000+ of which are in children under 15 years), Nigeria is seeing a rise in diphtheria infections. Unfortunately, only 42% of children under 15 are fully protected against the disease.
Diphtheria has company. The Nigeria CDC’s latest Lassa fever situation report reveals a total of 1,068 confirmed cases until 17 September this year, with 181 deaths. Promisingly, the last week for which data has been released saw no deaths. Plus, the case fatality ratio so far is lower than it was last year.
Healthcare systems across African countries have gaps which tech startups have emerged to plug. There are virtual consultation services, counterfeit drug detection measures, drone delivery services, and more. But they are facing challenges – in terms of funding, internet infrastructure, fragmented healthcare systems, and attitudes – in going mainstream.
In South Africa, the Department of Agriculture is considering vaccination, among other measures like issuing import permits, to ease the effects of the bird flu outbreak, which has already killed over 100,000 chickens so far.
In Kenya, 95 students from the same school have been hospitalised with a mysterious diseasethat allegedly resulted in paralysis in the leg.
Rwanda has reported an outbreak of peste des petits ruminants, also known as sheep and goat plague. 15 domestic goats have been infected with the highly contagious viral disease, while 120,000 are at risk.
In Colombia, the government has issued a compulsory license for Dolutegravir, an essential HIV treatment made by ViiV Healthcare. This move will make it easier for the country to obtain lower-cost generics of the drug.
Over in South Asia, Bangladesh is working on procuring Takeda’s Qdenga dengue vaccine, which the WHO recommended earlier this week.
In India, earlier this year, the Central Drugs Standard Control Organisation (CDSCO) had set an October 1 deadline to bring certain medical devices like ventilators, nebulisers, and X-ray equipment under regulation. Such class C and D devices can no longer be sold without a manufacturing license. Many manufacturers had filed for licenses in July, but there has been no communication from the authorities since then. So as they await audits as part of the license issue process, many high-risk medical device makers have had to pause manufacturing. Supply chain disruptions are expected.
Today isn’t the best day for Big Pharma. Takeda is voluntarily recalling its non-small cell lung cancer drug Exkivity in the US. It is also working with regulators in other countries where the drug is available. The drug had received accelerated approval in 2021, but after a confirmatory trial flopped this July, there are no signs of full approval in sight.
And AstraZeneca has agreed to pay $425 million to settle a meagre 11,000 lawsuits in the US. The lawsuits claimed that the company’s heartburn drugs caused chronic kidney disease. AZ is not admitting to any wrongdoing; it claims it only wants to avoid the continued high costs of litigation. AstraZeneca isn’t the only company under fire for proton pump inhibitors – GSK, Pfizer, and Procter & Gamble have also settled claims against their heartburn treatments, while Takeda currently faces claims.
Sanofi is collaborating with a US subsidiary of Israel’s Teva Pharmaceutical Industries to co-develop and co-commercialise a potential blockbuster treatment for inflammatory bowel disease. Sanofi is shelling out $500 million upfront for this project, which is currently in phase 2 trials. Teva can also expect up to another $1 billion if development and launch milestones are met.
The US FDA has granted de novo marketing authorisation for an in vitro diagnostic test which can detect hundreds of genetic variants associated with an increased risk of developing certain cancers. This first-of-its-kind test evaluates DNA extracted from blood samples to assess 47 genes.
Taiwan-headquartered PharmaEssentia has inked a license agreement with Wuxi Biologics Ireland to obtain exclusive global rights to develop, manufacture, and commercialise a myeloid immune checkpoint antibody candidate.
Eli Lilly is acquiring Point Biopharma Global, which has a pipeline of clinical and preclinical stage radioligand oncology therapies, for $1.4 billion. This deal marks the pharma biggie’s official entry into the radiopharmaceutical cancer therapy space, though it is trailing behind companies like Novartis and Bayer who’ve been in the space for a while.
Intellia Therapeutics and Regeneron Pharmaceuticals are expanding their existing liver-focused research collaboration to develop in vivo CRISPR-based therapies for neurological and muscular diseases.
Novartis’ experimental medicine, Iptacopan, has succeeded in a late-stage clinical trial, testing it against a rare kidney disease, IgA nephropathy. US and European regulators are already reviewing the drug as a potential treatment for the rare disorder paroxysmal nocturnal hemoglobinuria, or PNH.
The US FDA says that clinical efficacy studies should not be the default for all new biosimilars seeking market authorisation.
A proposed CDC guideline plans to endorse Doxycycline, a common antibiotic, as a morning-after pill for gay and bisexual men to avoid the transmission of STIs.
Meanwhile, researchers in Australia are planning to advance a biopolymer particle-based platform technology to develop vaccine candidates against biowarfare threats like Q Fever, tularemia, and melioidosis. Health Security Systems Australia is supporting this effort to establish the country’s capability to develop and produce emergency vaccines at an industrial scale.
Pasteur Institute and Tokyo University have inked a letter of intent to establish the Planetary Health Innovation Centre to address anthropogenic impacts on our ecosystems. The centre will support academic-private partnerships and connect health innovation stakeholders across France and Japan.
In Brazil, the carcasses of 120 river dolphins were found floating in an Amazon river tributary over the last week. Experts believe the severe heat and drought may be to blame, but they are still ruling out other causes.
In Iceland, a bird flu virus from the H5N5 strain which hasn't been detected in the country earlier, was found in an eagle, a sea urchin and an eider.
And finally, as Paris prepares to host the Olympics next year, bedbugs threaten to play spoilsport.