Welcome to the Weekly Rundown where the DDN editors cover this week’s top biotech and pharma news.
Moderna agrees to record settlement over COVID vaccine patents
Moderna has agreed to a $2.25 billion global settlement with Arbutus Biopharma and Roivant’s Genevant over patent claims tied to its COVID-19 vaccine Spikevax, including an upfront payment of $950 million due in July and an additional $1.3 billion contingent upon a favorable resolution of Moderna’s Section 1498 appeal. If the $1.3 billion payment is realized, this settlement will be the largest disclosed patent settlement paid in the pharmaceutical industry and the second largest in any industry. The deal resolves US and international disputes over Genevant and Arbutus’ lipid nanoparticle delivery technology, and Moderna consented to a court judgment of infringement and no invalidity on four of the companies’ patents. As part of the agreement, Genevant granted Moderna a global non-exclusive license to the technology for infectious disease mRNA vaccines and a covenant not to sue on certain patents, ending all litigation against Moderna tied to Spikevax. Roivant said in a press release that the settlement validates its intellectual property and provides a major cash infusion while the company continues its ongoing patent suit against Pfizer and BioNTech, whose Comirnaty vaccine represents roughly two-thirds of remaining global COVID-mRNA vaccine sales. – Bree Foster
FDA launches pilot program to reward speed in drug reviews
The FDA plans to offer bonuses to drug reviewers who complete their work ahead of schedule, in a pilot program aimed at speeding approvals for prescription drugs and vaccines. Commissioner Marty Makary unveiled the initiative at a staff meeting last week, saying the first quarterly bonus payments could begin as early as August. The program will reward employees and teams based on “weighted time savings” while also considering work quality and complexity. “This program values speed, but never at the expense of quality,” one slide stated, according to presentation materials obtained by The Associated Press. However, the plan has raised concerns, with critics warning that financial incentives could pressure reviewers to rush critical safety steps. The bonuses would not apply to staff outside of drug review, such as inspectors, and it remains unclear how payments would be allocated among large teams. The move comes amid a 20 percent staff loss at the FDA’s drug and biologics centers since 2017 and ongoing efforts by Makary to accelerate approvals, including shorter review timelines for drugs of “national interest” and relaxed clinical trial requirements in certain cases. – Bree Foster
Aging does not equate to an inevitable decline, study shows
In society, aging is often synonymous with a decline in physical and cognitive function. However, a new study from researchers at Yale University is challenging this notion. Their study, published in Geriatrics, found that people can and do improve in cognitive and physical function, and that mindset about aging plays a role. They tracked the cognition and physical function of 11,000 participants over 12 years using a global performance assessment and walking speed, respectively. They found that 45 percent of participants improved in either physical or cognitive function over the 12-year period, with about 28 percent improving physically and 32 percent improving cognitively. However, when they included those who remained stable with no reduction in cognition, more than half defied the inevitable decline stereotype. “If you average everyone together, you see decline. But when you look at individual trajectories, you uncover a very different story. A meaningful percentage of the older participants that we studied got better,” said Becca R. Levy, a social and behavioural scientist at Yale School of Public Health and co-author, in a press release. Additionally, the researchers examined why some people improved while others did not. They found that participants with a more positive view of aging at the start of the study were more likely to show improvements in both domains, even after accounting for factors such as age, sex, and chronic disease. These findings build on previous studies and Levy’s stereotype embodiment theory, which says that age stereotypes absorbed from culture are biologically and self-relevant. – Melissa Kay
Saliva test shows promise for early detection of neurological disorders
Researchers in South Korea have developed a saliva-based diagnostic technology that can detect structural changes in proteins linked to neurological disorders, potentially enabling early diagnosis using only a small sample. The approach, developed by teams at the Korea Institute of Materials Science (KIMS), Korea University, and The Catholic University of Korea, uses a galvanic molecular entrapment surface-enhanced Raman spectroscopy (GME–SERS) platform to amplify weak molecular signals from neural proteins captured on gold–copper oxide nanostructures. The system boosts Raman signals more than a billionfold and, combined with machine learning analysis, can identify protein structural states associated with disorders such as Parkinson’s disease, schizophrenia, and epilepsy. In a study involving saliva samples from 44 patients with neurological conditions and 23 healthy controls, the method classified the disorders with reported accuracy exceeding 90 percent, reaching up to 98 percent in some cases. The findings, published in the journal Advanced Materials, suggest that analyzing protein fibrillation states in saliva — rather than measuring total protein levels — could provide a noninvasive alternative to conventional diagnostics such as PET imaging or cerebrospinal fluid testing, with potential future applications in portable or home-based testing devices. – Andrea Corona
Antifibrotic drug may restore fertility in premature ovarian insufficiency
Researchers from Juntendo University and collaborators reported that the antifibrotic drug finerenone may help restore follicle development in women with premature ovarian insufficiency (POI), a condition affecting roughly one to three percent of women of reproductive age and characterized by infertility, low estrogen, and elevated follicle-stimulating hormone levels. In a study published in Science, the team found that fibrosis in the ovarian cortex can act as a mechanical barrier that prevents residual primordial follicles from developing. Finerenone, a mineralocorticoid receptor antagonist approved for chronic kidney disease, reduced collagen accumulation in ovarian tissue and enabled follicle growth in mouse models, leading to increased fertility and offspring production. The researchers also conducted a small experimental study in 14 women with POI, where oral finerenone treatment for three to seven months led to follicle development in all participants; seven produced mature oocytes suitable for in vitro fertilization with quality comparable to that of age-matched women without POI. The findings suggest that reducing ovarian fibrosis may represent a noninvasive strategy to stimulate follicle activation, though larger clinical trials will be needed to confirm the approach. – Andrea Corona
Microbial exposure in adulthood may worsen allergic inflammation
A study from Cornell University suggests that exposure to diverse microbes later in life may aggravate allergic disease rather than protect against it, challenging assumptions underlying the hygiene hypothesis. In research published in the Journal of Immunology, scientists exposed pathogen-free mice raised in clean environments to microbes by co-housing them with conventionally raised mice and then challenged them with house dust mite allergens, a common model for studying asthma-like airway inflammation. The team found that adult mice exposed to new microbial environments developed more severe allergic airway inflammation than newborn mice exposed under similar conditions, suggesting that the timing of microbial exposure may shape immune responses differently across life stages. The findings indicate that while early microbial exposure can influence immune development, exposure later in life may exacerbate allergic disease under certain conditions, highlighting the need for further studies to determine when microbial exposure shifts from protective to harmful. — Andrea Corona
