Tag: Academic research

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Rates of Treatment-Related Blood Cancers Are Increasing in Japan

Research led by Osaka International Cancer Institute in Japan shows that rates of therapy-related acute myeloid leukemia, linked to treatment for an earlier cancer, are going up as the overall number of cancer survivors increases.

As reported in the journal Cancer, the researchers showed the rates of treatment-related acute myeloid leukemia (AML) almost tripled between 1990 and 2020. The share of overall AML cases taken up by these patients has also increased from 4.4% to 8.2% over a similar time period.

With increasing numbers of cancer survivors in the U.S. and elsewhere, understanding the adverse effects of cancer treatment is becoming increasingly more important. Therapy‑related AML is a rare but serious complication of cytotoxic chemotherapy, and different chemotherapy drugs carry different levels of leukemia risk. Radiotherapy can also lead to this condition, but the risk is considered lower than that of chemotherapy.

“Several population‐based studies have analyzed the long‐term trend of therapy-related AML incidence, and the results are controversial,” write lead author Kenji Kishimoto, MD, PhD, a researcher at the Osaka International Cancer Institute, and colleagues.

“A national population‐based study did not demonstrate an increase in the incidence of therapy-related AML in Denmark between 2000 and 2013. In contrast, a significant increase in therapy-related AML incidence between 1997 and 2015 was identified in a Swedish nationwide study.”

As few such studies have been carried out in Asia, Kishimoto and colleagues analyzed how such rates have changed over time and whether the initial cancers leading to therapy-related AML have changed in Japan.

The researchers identified 9841 patients with AML in the Osaka Cancer Registry, 636 (6.5%) of whom had therapy-related AML. These patients were older when diagnosed than other AML patients at a median of 69 versus 66 years. There were also slightly more women with therapy-related AML than standard AML at 45% versus 40%. The time lag between first cancer and resultant AML was between two and 11 years (median five years).

In 1990, the incidence of therapy related AML was 0.13 per 100,000 people, but this had increased to 0.36 per 100,000 people by 2020. The share of all AML cases made up by therapy-related cases almost doubled from 4.4% in 1990 to 8.2% after 2010.

The most common earlier cancers before therapy-related AML were blood cancers (23%), breast cancer (15%), colorectal cancer (12%), and gastric cancer (9%). The mix shifted over time and gastric cancer became less common as the first cancer, while breast, head‑and‑neck, and lung cancers became more prominent.

“The study provides an important step towards better understanding how the nature of therapy-related AML is changing with the increasing number of cancer survivors,” said Kishimoto in a press release.

“Findings from this study lay the foundation for further studies to elucidate the mechanism of the change in therapy-related AML epidemiology,” add the authors.

The post Rates of Treatment-Related Blood Cancers Are Increasing in Japan appeared first on Inside Precision Medicine.

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Validity of Smartphone-Based Measurement for Assessing Lower Limb Power for Sarcopenia and Frailty Discrimination: Cross-Sectional Study

Background: Increasing life expectancy has increased focus on the health-related consequences of aging, such as sarcopenia and frailty. Given the prevalence of these conditions among older individuals and the frequent resulting long-term care needs, early detection and intervention are crucial. Objective: This study aimed to validate a novel smartphone-based system measuring acceleration during the sit-to-stand movement to detect sarcopenia and frailty. Methods: Participants were 587 individuals from the Otassha study cohort who underwent health assessments in 2023, of whom 569 (96.9%) completed 2 supervised sit-to-stand trials while holding a smartphone on the lower abdomen. Sarcopenia and frailty were diagnosed using the Asian Working Group for Sarcopenia 2019 criteria and the revised Japanese Cardiovascular Health Study criteria, respectively. Peak force, rising time (T1), and stabilization time (T2) were extracted from acceleration signals, and reproducibility was examined using the intraclass correlation coefficient (ICC(2,1)). Predictive models were developed using elastic net penalized logistic regression, and model performance was evaluated using 500 bootstrap resamples. Benchmark models using age and sex, walking speed, and grip strength were also constructed for comparison. Results: Sarcopenia and frailty were identified in 16.7% (95/569) and 9% (51/569) of the participants, respectively. Peak force demonstrated excellent reliability (ICC=0.863), whereas T1 and T2 showed lower reproducibility (ICC<0.30). For sarcopenia, the smartphone model achieved a bootstrap area under the receiver operating characteristic curve (AUC) of 0.800 and an optimism-corrected AUC of 0.781 (95% CI 0.733‐0.826), outperforming walking speed (0.663) and age and sex (0.656) and ranking second only to grip strength (0.845). For frailty, the smartphone model showed moderate discrimination, with an optimism-corrected AUC of 0.659 (95% CI 0.587‐0.736), exceeding age and sex (0.604), whereas walking speed remained the strongest predictor (0.751). Conclusions: Smartphone-derived sit-to-stand acceleration provides a practical and scalable approach for screening for sarcopenia and frailty in community-dwelling older adults. While traditional indicators such as grip strength and walking speed remain the most accurate predictors, smartphone-based measurements offer meaningful complementary information and may support large-scale functional screening and early detection initiatives in superaged societies.
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Development and Evaluation of a German Suicide Prevention Website for Men: Exploratory Study

Background: Men face a substantially higher risk of suicide. Effective suicide prevention strategies for men should specifically target gender-related risk factors, such as their lower likelihood of seeking professional help. Objective: This study investigates the use and impact of a suicide prevention website for men between March 1, 2023, and December 31, 2024. The Männer Stärken website is the first suicide prevention platform for men in Germany, with the primary aim of facilitating help-seeking behavior. The development of the platform was informed by interviews with men who had attempted suicide, as well as by existing evidence on effective communication strategies for engaging men at risk. Methods: This exploratory study combines quantitative web analytics and survey data with a qualitative analysis of open-ended responses from a feedback form. Using the web analytics tool Matomo, data were collected on the number of visits to the website and the subpages they accessed. In addition, 291 anonymous feedback forms were analyzed regarding visitors’ perceptions of the website’s helpfulness and its potential to support help-seeking behavior. A further component involved an online survey (n=40) examining whether a short suicide prevention film featured on the website could increase the intention to seek help. Results: During the study period, the website recorded 29,279 visits. A majority (n=291) of the respondents reported via the feedback form that they found the website helpful (n=201, 69.1%) and believed it could encourage help-seeking behavior (59.8%). In the evaluation of the short film, a significant increase in participants’ intentions to seek help was observed in situations involving suicidal ideation and personal difficulties and when considering professional support services. This effect was not observed with regard to informal sources of support, such as friends or family. Conclusions: The data suggest that the website is being used. Among those who completed the anonymous survey form (N=291), a majority reported that the website fulfills its primary aim of providing helpful pathways to support services. The evaluation of the short film further supports this conclusion. However, certain limitations must be acknowledged: since the data were collected in a field setting, the ability to draw firm conclusions about the characteristics or representativeness of the visitor sample is limited. In addition, the sample size for the short film evaluation was small. Nevertheless, the findings point to a clear need for gender-specific suicide prevention initiatives. They indicate promising directions for the development of effective, low-threshold measures, which merit further investigation in future research.
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<![CDATA[A relationship between inflammatory skin disease and depression revealed in new research.]]>
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Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer

Extracting cytoplasmic material such as proteins, RNA, and mitochondria often relies on cell lysis using detergents or enzymes, which destroy the cells. Ultrasound and other sophisticated physical disruption methods need to be carefully tuned to avoid damaging biomolecules, potentially rendering them too time-consuming.

Delivering material into cells presents further challenges. Lipid-based carriers are limited to small molecules, viral vectors are costly, and microinjection techniques are difficult to scale. To date, no approach allows for controlled and efficient cytoplasmic transfer without compromising cell viability, according to researchers from Waseda University in Japan.

The team published a study “A Nanotube Injector for Cytoplasmic Transfer and Enhanced Mitochondrial Function” in Small Science that reports the development of a nanotube membrane-based injector—a platform that combines nanomaterials and fluid physics to directly transfer cytoplasmic contents between cell populations. The system consists of a thin gold membrane with vertically aligned nanotubes mounted on a glass tube. When this membrane is carefully pressed against cultured cells, the nanotubes penetrate the phospholipid bilayer of the living cells without causing significant damage. By adjusting the internal air pressure of the glass tube, the researchers can “suck up” cytoplasmic material from the source cells, hold it as the tube is repositioned over the target cell culture, and gently flush it into this new population using microliters of a buffer solution.

Infographic from Waseda University in Japan
Credit: Waseda University

Through several experiments using fluorescent dyes and protein assays, the researchers say they confirmed that cytoplasmic contents could be extracted in a pressure-dependent manner. They also found that careful selection of nanotube diameter, nanotube density, and applied pressure was key to minimizing cellular damage. Notably, under optimized conditions, cell viability hovered around 95%, with a cytoplasmic transfer efficiency of well over 90%, note the scientists.

To further test the capabilities of their platform, the team investigated whether it could transfer intact mitochondria. To this end, they labeled mitochondria in donor cells with a fluorescent tag and observed them in the recipient cells via confocal microscopy. They found that dozens of mitochondria could be reliably delivered per cell.

Most importantly, according to Takeo Miyake, PhD, team leader, these mitochondria remained functional, as evidenced by markedly higher levels of adenosine triphosphate (ATP) produced in recipient cells compared to controls.

“This technology establishes a new paradigm for cell manipulation—transforming cells not by genetic modification but by reconstructing intracellular composition itself,” explains Miyake, adding that such controlled cytoplasmic engineering, enabled by the proposed nanotube injector, could support the development of next-generation cell therapies, improved disease models, and more precise drug screening platforms.

“Directly transferring healthy mitochondria or cytoplasmic components into target cells is particularly relevant for regenerative medicine, where therapeutic cells often suffer from reduced metabolic activity or functional heterogeneity after isolation and expansion,” highlights Miyake, “By restoring or augmenting mitochondrial function without genetic modification, the technology offers a new strategy to improve cell quality prior to transplantation.”

Overall, this innovative system paves the way for a new level of control in cell biology research, as well as bioengineering and biomedical applications, points out the research team.

The post Nanotube Injector Boosts Mitochondrial Performance Through Cytoplasmic Transfer appeared first on GEN – Genetic Engineering and Biotechnology News.

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AI is changing how small online sellers decide what to make

For years Mike McClary sold the Guardian LTE Flashlight, a heavy-duty black model, online through his small outdoor brand. The product, designed for brightness and durability, became one of his most popular items ever. Even after he stopped offering it around 2017, customers kept sending him emails asking where they could buy it. 

When McClary decided to revisit the Guardian flashlight in 2025, he didn’t begin the way he might have in the past, by combing through supplier listings and sending inquiries to factories. Instead, he opened Accio, an AI sourcing and researching tool on Alibaba.com.

For small entrepreneurs in the US, deciding what to sell and where to make it has traditionally been a slow, labor-intensive process that can take months. Now that work is increasingly being done by AI tools like Accio, which help connect businesses with manufacturers in countries including China and India. Business owners and e-commerce experts told MIT Technology Review that these AI tools are making sourcing more accessible and significantly shortening the time it takes to go from product idea to launch. 

McClary, 51, who runs his business from his Illinois living room, has sold products ranging from leather conditioner to camping lights, including one rechargeable lantern that brought in half a million dollars. Like many small online merchants, he built his business by being extremely scrappy—spotting demand for a product, tweaking existing designs, finding a factory, doing modest marketing, and getting the goods in front of customers fast. 

This time, though, he began by telling Accio about the flashlight’s original design, production cost, and profit margin. Then Accio suggested several changes, making it smaller and slightly less bright and switching its charging method to battery power. It also identified a manufacturer in Ningbo, China, that McClary said could cut the manufacturing cost from $17 to about $2.50 per unit.

McClary took the process from there, contacting the supplier himself to discuss the revised design. Within a month, the new version of the Guardian flashlight was back up for sale on Amazon and on his brand’s website.

The new factory hunt

Although Alibaba is better known for owning Taobao, the biggest shopping site in China, its first business was Alibaba.com, the primary website that lists Chinese factories open for bulk orders. Placing an order with a manufacturer usually requires far more than clicking “Buy.” Sellers often spend days or weeks browsing listings, comparing suppliers’ reviews and manufacturing capacities, asking about minimum order quantities, requesting samples, and negotiating timelines and customization options. 

But Accio has gained significant momentum by changing how that sourcing gets done. Launched in 2024, Accio exceeded 10 million monthly active users in March 2026, according to the company. That means about one in five Alibaba users consults with AI about product sourcing.

Accio’s interface looks a lot like ChatGPT or Claude: Users type a question into an empty box and choose between “fast” and “thinking” modes. But when asked about products, the tool returns more than text, offering charts, links, and visuals and asking follow-up questions to clarify the buyer’s needs. It then narrows the field to one or a handful of suppliers that appear capable of delivering. After that, the human work begins: Users still have to reach out to suppliers themselves and negotiate the details.

Zhang Kuo, the president of Alibaba.com, told MIT Technology Review that the tool is built on multiple frontier models, including the company’s own Qwen series, a popular family of open-source large language models. The system is able to pull from the site’s millions of supplier profiles and is trained on 26 years of proprietary transaction data.

For tasks like product research and sourcing analysis, the tool “blows it away” compared with general AI tools like ChatGPT, says Richard Kostick, CEO of the beauty brand 100% Pure.

Many websites have tried using AI to assist shopping, but Alibaba has been one of the most aggressive. In March, Eddie Wu, CEO of the site’s parent company Alibaba Group, told managers that integrating the company’s core services with Qwen’s AI capabilities is a top priority. During a Chinese New Year promotion of Qwen’s personal shopping AI agent, where the company gave away cash, customers placed 200 million orders, the firm says.

Vincenzo Toscano, an e-commerce seller and consultant, recommended Accio to his clients before deciding to try it himself for a new sunglasses brand. He came in with a rough vision: a brand shaped by his Italian heritage, his personal style, and a boutique aesthetic. He says the AI helped turn that concept into something more concrete, suggesting materials, refining the look, and pointing to design ideas that felt current.

But the tool has clear limits. McClary, who uses AI tools regularly, says Accio is strongest when it comes to product ideation, but less helpful on marketing questions such as advertising and social media outreach. To use it well, he says, buyers still need to challenge its recommendations, since some can be generic.

The rest of the business

As platforms become more AI-driven, manufacturers are adjusting too. Sally Yan, a representative at a makeup packaging company in Wuhan, China, says her firm has started writing more detailed product descriptions and adding information about its equipment and manufacturing experience on Alibaba.com because it suspects those details make its listings more likely to be surfaced by AI.

Yan says manufacturers cannot tell whether an inquiry from a customer was generated or guided by AI, and that her firm is not using AI to negotiate pricing or product details.

“AI agents are increasingly used by people to assist decision making or even directly making transactions, and in certain situations,  they can become extremely useful,”

“AI agents are increasingly used by people to assist purchase decisions and even directly making transactions, and with clear data guardrails, they can become extremely useful,” says Jiaxin Pei, a research scientist at the Stanford Institute for Human-Centered AI, “but agents need to act transparently, securely, and in the customer’s best interest.” Pei says developers of these tools should disclose the data they collect and the incentives built into them to ensure that the marketplace remains fair.

Zhang, of Alibaba.com, says Accio currently does not include advertising. Suppliers can pay for higher placement in Alibaba.com’s regular search results, but Zhang says Accio is “not integrated” with that system. “We haven’t had a clear answer in terms of how to monetize this tool,” he says. For now, users can pay for additional tokens to continue chatting with the agent after their free queries run out.

Sellers say that while AI tools have made it easier to come up with ideas and get a business off the ground, they do not replace the core skills that make someone good at e-commerce. McClary believes that even when sellers have access to the same market information, some are still better at making decisions, acting quickly, and actually delivering on orders. Those differences, he says, still go a long way.

Toscano, the brand founder and e-commerce consultant, feels good about officially launching his new brand of sunglasses in just a few months: “We [small business owners] always have to bootstrap a lot of decisions. Deciding what to sell often comes down to an educated guess,” he says, “And we’re now in an era when making those decisions is easier than ever.”

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Diabetes Drug Mimics Benefits of Exercise in Prostate Cancer Patients

Scientists have discovered that metformin, a widely prescribed diabetes drug, can have benefits similar to those of regular exercise in prostate cancer patients, whose movement may be limited by their condition or treatment. Published today in EMBO Molecular Medicine, their findings show that metformin increased levels of N-lactoyl-phenylalanine (Lac-Phe), a molecule naturally produced by the body after intense exercise. 

Exercise can significantly benefit prostate cancer patients both during and after treatment. These patients often receive hormone therapy, which can disrupt metabolism, contribute to weight gain, increase insulin resistance, and affect their overall cardiovascular health. While physical activity is key to supporting their recovery and addressing these side effects, fatigue, pain, and other common symptoms can limit the ability of prostate cancer patients to regularly exercise. 

“Cancer therapy often affects the body in ways that go beyond the tumor,” said Priyamvada Rai, PhD, professor of radiation oncology and co-leader of the Tumor Biology Program at Sylvester Comprehensive Cancer Center in the University of Miami Miller School of Medicine. “Supporting metabolic health can influence how patients tolerate treatment and how they feel over time, even if it doesn’t directly change tumor growth. This study was an opportunity to investigate molecular pathways that can be therapeutically activated for better outcomes to treatments that induce metabolic stress.”

Rai and colleagues found that metformin raises levels of Lac-Phe in prostate cancer patients, even in the absence of physical activity. Known for its role in regulating energy levels and weight gain, Lac-Phe is formed by combining lactate, a molecule produced during muscle contraction, and the amino acid phenylalanine. Previous preclinical and clinical studies have reported levels of Lac-Phe spiking after intense exercise and linked it to a reduction in appetite and improved weight control.

“Metabolism is involved in everything cells do,” said David B. Lombard, MD, PhD, professor of pathology and laboratory medicine and co-leader of the Cancer Epigenetics Program at the Miller School. “These findings suggest Lac-Phe may be a very informative signal for understanding how metformin affects metabolism in prostate cancer patients.”

Prostate cancer patients treated with metformin were found to produce similar levels of Lac-Phe compared to levels reported after intense exercise in previous studies of healthy volunteers. The benefits of Lac-Phe persisted even after hormone therapy began. 

“From a clinical standpoint, seeing a metabolic signal that mirrors what we associate with intense exercise was striking,” said Marijo Bilusic, MD, PhD, genitourinary medical oncologist and professor of medicine and medical oncology at the Miller School. “The result isn’t a new cancer biomarker, but a clearer understanding of how a widely used drug may support metabolic health during prostate cancer treatment—an outcome that matters to patients and clinicians alike.” 

Although a drug like metformin can never fully replace physical activity, these findings offer an alternative approach to accessing some of the benefits of exercise in patients with limited ability to engage in it. 

“What’s encouraging about this work is that it reminds us cancer care isn’t only about targeting tumors—it’s also about supporting the whole patient,” said Rai. “By better understanding how treatments affect metabolism, we can begin to identify ways to help patients maintain strength, resilience, and quality of life throughout their care.”

The post Diabetes Drug Mimics Benefits of Exercise in Prostate Cancer Patients appeared first on Inside Precision Medicine.

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What the peptide craze reveals about Americans’ relationship with risk

Robert F. Kennedy Jr. tends to favor health choices he sees as natural — whether that means eating “real food” like meat and vegetables instead of ultra-processed food or suggesting, falsely, that nutrition and vitamins are a good alternative for fighting off measles instead of vaccines.

But there’s at least one area where the health secretary breaks with his own tradition. He’s among the many influential voices in health and wellness in favor of people injecting themselves with experimental drugs known as peptides — much to the concern of mainstream public health experts, who warn that these drugs haven’t been sufficiently studied for efficacy or potential side effects, including higher cancer risk.

With demand for peptides on the rise and would-be self-optimizers seeking out the drugs on gray and black markets, Kennedy said on Joe Rogan’s podcast in February that he thought the Food and Drug Administration would take action within a couple of weeks to make them more accessible. That means reclassifying around 14 drugs so that compounding pharmacies can once again offer them after a 2023 rule change under the Biden administration. “I’m a big fan of peptides,” Kennedy said, having “used them myself to really good effect on a couple of injuries.” 

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StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod

Eli Lilly (NYSE: LLY) won the approval it sought when the FDA authorized the company’s oral obesity drug Foundayo™ (orforglipron), but the pharma giant’s post-approval stock bounce was short-lived.

Lilly shares rose 4% from $919.77 to $954.52 on the day of the announcement. But the momentum reversed into a 2% loss to $935.58 on Thursday, and for one important reason beyond simply the overall market decline triggered by investors losing confidence in a speedy end to the Iran war.

Investors (as reflected in analysts’ mixed observations) appeared divided on how quickly Lilly can generate sales this year for Foundayo, a small molecule glucagon-like peptide-1 (GLP-1) receptor agonist. That division results from the competition shaping up on the drug’s price with obesity arch-rival Novo Nordisk (shares traded on Nasdaq Copenhagen as NOVO-B; ADRs traded on NYSE as NVO).

Novo Nordisk got a jump on Lilly in the oral obesity drug front in December when the Danish biotech giant won FDA approval for oral Wegovy® (semaglutide), a once-daily 25 mg tablet indicated for chronic weight management. Analysts consider oral Wegovy sales to have started strong, with total prescriptions reaching 577,000 and 52,000 filled during the week ending March 20.

Lilly is expected to make Foundayo available directly to patients through its LillyDirect direct-to-consumer services and support platform starting Monday. There, a starting dose of 0.8 mg is being priced at $149/month, rising to $199/month for 2.5 mg, $299/month for the 5.5 mg and 9 mg doses, and up to $349/month for the highest doses of 14.5 mg and 17.2 mg. However, high-dose patients will automatically receive the $299/month price on their first purchases and keep it if they refill their prescription within 45 days of their previous prescription.

Patients paying through commercial insurance plans will be eligible for discounts that reduce Foundayo’s out-of-pocket cost to patients for 1-, 2-, or 3-month prescription fills to $5 a month.

“A positive surprise is that the approval was for a tablet formulation, which is less expensive to manufacture” than the capsule versions studied by Lilly during clinical trials, David Risinger, a senior managing director and senior research analyst covering diversified biopharmaceuticals at Leerink Partners, shared in a research note.

Lilly told Risinger that it conducted a bioequivalence study comparing capsules to tablets, which, according to the company, can be manufactured more efficiently than capsules and use less active pharmaceutical ingredient. The high dose studied in Lilly’s Phase III trials of orforglipron, 36 mg, corresponds to the highest capsule dose of 17.2 mg.

Price competition

Lilly has sought to price its oral obesity drug competitively with Novo Nordisk’s oral Wegovy, which starts at $149/month for the lowest dose of 1.5 mg, then rises to $199/month for the 4 mg dose, with new patients paying $149/month through August 31. Prices rise to $299/month for 9 mg and 25 mg doses.

However, patients who sign up for a 12-month subscription to oral Wegovy through Novo Nordisk’s telemedicine partner-providers enjoy a $50 discount that brings their monthly cost down to $249. And commercial insurance patients who agree to local pharmacy pickup with a savings offer can pay as little as $25/month, subject to a maximum savings of $100/month.

The price competition explains why buyers of securities for themselves or clients—the “buy side” in Wall Street jargon—have lowered their 2026 forecasts for Foundayo sales by more than half, from about $4 billion to less than $2 billion, Trung Huynh, an analyst with RBC Capital Markets, wrote in a research note. Huynh cited a consensus of analysts which is projecting approximately $1.6 billion in 2026 sales, though a Reuters spot check of investment brokerages found a range for this year’s projected sales of $1.5 billion to $2.8 billion.

“Although there have been headwinds on pricing erosion in the GLP-1 space, we believe there is substantial upside with the expected Medicare Part D expansion later this year,” Huynh added. The expansion of sales to the Medicare Part D program would cap patient copays at $50 per month.

Huynh and RBC Capital have projected Foundayo will reach peak-year sales of $36 billion—14% above the $31.68 billion racked up by last year’s best-selling prescription drug, the multi-indication cancer immunotherapy blockbuster Keytruda® (pembrolizumab) marketed by Merck & Co. (NYSE: MRK).

The highest peak sales forecast comes from Citi Research, where Geoff Meacham, PhD, the firm’s head of healthcare research and a managing director specializing in U.S. pharma and biotech research, has projected more than $40 billion. At the low end, a consensus of analysts surveyed by Bloomberg News expects Foundayo peak sales to reach $18 billion by 2030.

$50M upfront

Both ends are a far, far cry from the $50 million upfront that Lilly paid in 2018 to license orforglipron, then called OWL833, from Chugai Pharmaceutical, which discovered the drug and is owned by Roche Holding (SIX Swiss Exchange: ROP and RO; OTCQX: RHHBY). Lilly also agreed to pay Chugai up to $390 million in potential payments tied to achieving milestones.

At the time, OWL833 was deemed Phase I ready for clinical studies in type 2 diabetes—the indication for which Lilly markets its GLP-1/GIP (glucose-dependent insulinotropic polypeptide) receptor agonist tirzepatide as Mounjaro®, and Novo Nordisk markets its GLP-1 receptor agonist semaglutide as Ozempic®.

“Overall, we continue to believe that injectable anti-obesity medications will retain the majority of market share (roughly 80%, based on our estimates) in the United States due to the high potency of injectables coupled with a more elevated U.S. BMI population,” Andy T. Hsieh, PhD, a partner and biotechnology analyst with William Blair, wrote in a research note.

Beyond competitive pricing and lower manufacturing costs, Lilly has emphasized a convenience advantage over oral Wegovy—starting with its public announcement of the approval, whose headline referred to Foundayo as “the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions.”

While Foundayo can be taken morning, afternoon, or evening, oral Wegovy, by contrast, requires patients to take the pill with up to 4 ounces of water on an empty stomach as soon as they wake up, then fast for 30 minutes before they can eat or drink.

“Accordingly, we expect Foundayo to blunt the uptake of oral Wegovy upon its availability (starting on April 6), though oral Wegovy retains a pricing advantage,” Hsieh concluded.

Huynh of RBC Capital agreed, citing a survey by his firm of about 200 patients, payers, and prescribers: “Our recent survey indicated that Foundayo would be a preferred oral option amongst patients since it has no dosing restrictions.”

Not so, Novo Nordisk CEO Maziar (Mike) Doustdar told CNBC last month: “People are really interested because it’s the most efficacious pill right now in the market.”

Novo Nordisk cites efficacy

Novo Nordisk sought to reinforce that message via an announcement trumpeting that its 25 mg dose of oral Wegovy showed “significantly” greater mean weight loss than the 36 mg dose of Foundayo, according to a population-adjusted indirect treatment comparison using data from two clinical trials:

  • OASIS 4 (NCT05564117), a 307-patient randomized study which evaluated once-daily oral Wegovy 25 mg in overweight or obese adults with at least one self-reported unsuccessful dietary effort to lose body weight, to measure their percentage change in body weight and whether it was ≥5% at the end of treatment at week 64.
  • ATTAIN-1 (NCT05869903), a 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron (6 mg, 12 mg, and 36 mg) as monotherapy vs. placebo in 3,127 adults with obesity, or overweight with at least one of the following comorbidities: hypertension, dyslipidemia, OSA, or cardiovascular disease, who did not have diabetes.

Novo Nordisk plans to present details of its study, called ORION, at the Obesity Medicine Association’s annual Obesity Medicine 2026 conference, set for April 10-12 in San Diego.

News of the FDA approval for Foundayo caused Novo Nordisk shares to dip 0.1% Wednesday from DKK 231.15 ($35.65) to DKK 230.90 ($35.61). But the shares finished the trading week climbing nearly 3% Thursday to DKK 236.90 ($36.53).

U.S. and major European markets were closed on Friday in observance of Good Friday.

Foundayo is the fifth prescription drug to be authorized under the FDA’s Commissioner’s National Priority Voucher program, through which the agency awards vouchers to drug developers whose work will address a health crisis in the United States, deliver more innovative cures, address unmet public health needs, and increase domestic drug manufacturing as a national security issue.

The approval came nearly 10 months ahead of Foundayo’s target decision date of January 20, 2027, under the PDUFA (Prescription Drug User Fee Act) program, and just 50 days after Lilly filed a new drug application (NDA) for the oral obesity drug with the FDA.

Leaders and laggards

  • Inovio Pharmaceuticals (NASDAQ: INO) shares nosedived 35% from $1.74 to $1.13 Thursday after the developer of DNA therapies to treat and prevent HPV-related diseases, cancer, and infectious diseases announced that it priced at $1.40 a share an underwritten public offering of 12.5 million shares of common stock, plus accompanying Series A and Series B warrants, each series enabling potential purchase of up to 12.5 million shares (or pre-funded warrants in lieu thereof). The dilutive offering is projected to raise $17.5 million in gross proceeds—$16 million in net proceeds, rising to $18.4 million if underwriter Piper Sandler exercises in full its 30-day option to purchase up to 1.875 million additional shares and all Series A and Series B warrants (1.875 million shares each series). Net proceeds are intended to fund a potential commercial launch of INO-3107, a recurrent respiratory papillomatosis candidate under FDA review with a target decision date of October 30, as well as a confirmatory trial for INO-3107 if required, pipeline development, and general corporate purposes.
  • Oric Pharmaceuticals (NASDAQ: ORIC) shares tumbled 19% from $12.67 to $7.47 Wednesday after the cancer drug developer said it will advance rinzimetostat (ORIC-944) into a 600-patient Phase III trial (Himalaya-1 ) after generating positive data from its Phase Ib trial (NCT05413421) assessing rinzimetostat plus the Bayer (XETRA: BAYN)-marketed Nubeqa® (darolutamide) as a once-daily treatment for metastatic castration-resistant prostate cancer (mCRPC) in patients previously treated with abiraterone acetate (abiraterone). At a median follow-up of 4.9 months, the combination showed radiographic progression-free survival (rPFS) rates of 93% at 3 months, 84% at 4 months, and 84% at 5 months—rates consistent, Oric said, with the competitor PRC2 inhibitor currently in Phase III in post-abiraterone mCRPC patients and superior to available standard-of-care therapies showing rPFS rates of approximately 60% to 75%. Also, 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed, while 71% of patients (10/14) achieving >50% circulating tumor (ctDNA) reduction. Jefferies analyst Maury Raycroft, PhD, reported that some investors viewed rinzimetstat as “a better fit strategically” with Johnson & Johnson (NYSE: JNJ)-marketed Erleada® (apalutamide).
  • Sangamo Therapeutics (NASDAQ: SGMO) shares climbed 20% from 25 cents to 30 cents between Tuesday and Thursday after the genetic medicine developer said it expects to complete this summer its rolling Biologics License Application (BLA) submission seeking FDA approval for isaralgagene civaparvovec (ST-920), a gene therapy candidate being developed to treat Fabry disease, subject to securing adequate additional funding, while continuing business development discussions for a potential Fabry commercialization agreement. Sangamo said it is advancing the chemistry, manufacturing, and controls (CMC) module ahead of completion of the rolling BLA submission. Since launching its rolling BLA submission in December under an Accelerated Approval pathway, Sangamo has submitted preclinical and clinical modules, as well as submitted its antibody assay companion diagnostic, designed to screen patients for eligibility with isaralgagene civaparvovec, to the FDA’s Center for Devices and Radiological Health (CDRH), seeking Premarket Approval (PMA).

The post StockWatch: Price War Dampens Lilly Surge After Oral GLP-1 Wins FDA Nod appeared first on GEN – Genetic Engineering and Biotechnology News.

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Social cognitive deficits and altered multi-brain dynamics during problem-solving in heroin abstainers: An fNIRS hyperscanning study

Despite extensive research on the neurobiology of addiction, little is known about how repeated drug use and withdrawal are related to social functioning impairments in humans, a highly social species. This obscures the broader societal impact of drug addiction and limits treatment efficacy. This study examined social cognitive impairment and its multi-brain neural underpinnings during socially interactive problem-solving in heroin use disorder (HUD), and further explored their co-occurrence with protracted withdrawal symptoms.