💊 No early success for Moderna’s flu vaccine; Glenmark looks to sell API subsidiary stake; Sobi leaves AstraZeneca, redials Sanofi

#317 | Easing bird flu lets UK birds fly; Covid variant causes pink eye; African health systems left high and dry

Hello and welcome to another eventful day at The Kable, where Moderna is making news, as are lax manufacturing practices, and health worker crises.

For starters, Moderna celebrated a win against Arbutus as a US appeals court upheld the US Patent and Trademark Office tribunal’s 2019 ruling that Arbutus’ lipid nanoparticle (LNP) tech was invalid as the same claims were covered in the company’s 2008 patent filing. Another lawsuit that Arbutus has filed against Moderna, as well as a separate one against Pfizer and BioNTech, remain unaffected by this decision.

On the flu shot, however, Moderna is still some way from celebration. Its experimental mRNA flu vaccine cannot yet declare early success in a late-stage trial as there hasn’t been enough data available. Nonetheless, Moderna is optimistic about raking in revenue from the vaccine in 2024. Overall, it expects to have 6 major vaccines  - including for RSV and cancer - on the market in the coming years.

Meanwhile, Bristol Myers Squibb and Roche subsidiary Foundation Medicine are collaborating, with the latter developing its biopsy test as a companion diagnostic for BMS’ oral tyrosine kinase inhibitor Repotrectinib, which is currently in trials in patients with non-small cell lung cancer and advanced solid tumours.

Takeda is also entering a new collaboration, working on a small molecule programme targeting the tau protein for Alzheimer’s research with Canadian biotech Treventis.

Sobi has terminated an agreement with AstraZeneca and reached a new royalty agreement with Sanofi on US sales of the RSV antibody Nirsevimab.

GSK is handing two experimental cell therapies for cancer back to biotech Adaptimmune Therapeutics, along with about $37 million, as it recedes from the cell and gene therapy space.

Hispanic-American woman-owned company Rhodium Scientific is joining Bristol Myers Squibb on a flight to the International Space Station, as it is shipping microbes to test biomanufacturing in space.

Private biotech financing may have fallen in 2022, but funding levels are still above pre-pandemic levels. Fierce Biotech covers the top biotech investments from last year.

Debt continues to plague Glenmark. So much so that it is considering selling off a majority stake in its API subsidiary Glenmark Life Sciences.

Following a setback in confirmatory testing, AbbVie is voluntarily withdrawing indications for mantle cell lymphoma and marginal zone lymphoma for its drug Imbruvica which had earlier received accelerated approval. This decision doesn’t affect any of the drug’s approvals for other forms of blood cancer.

Meanwhile, the US FDA has released a guidance document for the risk-based monitoring of clinical trials.

Exposure to ethylene oxide, which is used widely to sterilise medical devices, has a fairly high cancer risk. The US Environmental Protection Agency is proposing restricting its use. 

Over in India, Reuters has covered the struggles of the birth control battle in the district with the highest fertility rate in the country.

Again, in India, two years of Covid lockdowns may have taken a toll on children’s immunity, as the country is seeing a sharp rise in children under 15 getting infected with adenovirus and Covid, exacerbated in some cases with complications like pneumonia.

The WHO has issued a medical product alert concerning falsified Defitelio, used in patients undergoing haematopoietic stem cell transplantation, in the UAE. There are no reports of any adverse events so far. 

In California, wastewater testing in LA County has revealed the presence of bacteria resistant to the last-resort antibiotic Colistin for the first time. Meanwhile, in the state’s Marin County, wastewater is being monitored for illegal opioids.

In Michigan, a paper mill is being linked to the spread of 93 confirmed or probable cases of blastomycosis, a rare fungal infection.
 

As the US’s Project NextGen reminds us, the fight against Covid is far from over. The WHO, Unitaid and Medicines Law & Policy have published a briefing document explaining the legal instruments that countries can use to promote public health and access to therapeutics.

If yesterday’s fear-mongering about the risks of research into new viruses wasn’t enough, here’s some more for you.

In the UK, birds can finally soak up some sun outdoors again as bird flu eases, and bird lockdown orders were lifted yesterday.

 Arcturus, the Covid variant that is fuelling the rise in cases in India, the US, Singapore and Australia has a new symptom: pink eye.

As Africa makes progress on its New Public Health Order, the World Economic Forum covers everything you need to know about improving health outcomes via better financing and digitalisation.

And finally, dengue cases in Argentina are going only one way. Up.