FDA Tracker: 2024 Ends With Lilly’s Landmark GLP-1 Sleep Apnea Approval

Anti-aging Drug As Good For Cell Health As Dieting Or Fasting

A large meta-analysis has found that the drug leading the charge in anti-aging science is just as effective in protecting cells and cognitive function as cutting calories or intermittent fasting (IF). It's the most comprehensive study of rapamycin yet.

In the largest study of its kind, researchers from the University of East Anglia (UEA) and the University of Glasgow looked at 167 studies conducted on lifespan-extending therapies on eight different vertebrates – including primates, rodents and fish – to see how rapamycin compared to traditional methods of healthy aging like cutting calories or fasting.

"Dietary restriction – for example through intermittent fasting or reduced calorie intake – has been the gold standard for living longer," said co-lead researcher Dr Zahida Sultanova, from UEA's School of Biological Sciences. "But it's difficult for most of us to maintain long-term.

"We wanted to know if popular anti-aging drugs like rapamycin or metformin could offer similar effects without the need to cut calories."

Rapamycin is not new – it was identified in 1972, in soil samples taken from Rapa Nui, or Easter Island, as European explorers coined it, in 1964. But it would be decades before scientists unlocked its multifaceted promise. Isolated from the Streptomyces hygroscopicus bacterium, rapamycin rose to prominence as an anti-fungal and anti-cancer drug and an immunosuppressant. Several decades later, it became the target compound in geroscience – now a burgeoning field studying the biological mechanisms of aging and age-related diseases.

It's now the subject of numerous studies, including testing it for the potential treatment of chronic fatigue syndrome.

Without getting too deep in the science, rapamycin (also known as sirolimus) is an mTOR (mechanistic Target Of Rapamycin) inhibitor, which regulates crucial biological functions like cell growth and repair. Rapamycin essentially signals to mTOR to send out the message to slow down and do some clean-up (autophagy). This makes cells better at responding to stress and presses pause on unchecked cell growth, which can lead to the build-up of damaged material – and trigger diseases like cancers and dementia.

While it doesn't reverse aging, it delays the biological aging process to promote healthy aging. It's gained US Food and Drug Administration (FDA) approval in other areas, including to prevent transplanted organ rejection and to treat rare lung disease lymphangioleiomyomatosis (LAM) and some rare cancers.

In this latest study, the data showed that rapamycin extended lifespan across the eight vertebrate groups on par with eating less and/or fasting. Meanwhile, another drug that's been targeted for its potential healthy aging properties, metformin, wasn't as effective. Metformin has shown early promise, particularly in people with type 2 diabetes, potentially lowering the risk of cancer and cognitive decline. It's also the focus of a current study known as The Targeting Aging with Metformin (TAME) trial, a US-wide six-year clinical trial with more than 3,000 people aged 65-79 taking part. However, that's ongoing (but certainly one to watch).

The UEA scientists found that "dietary restriction" – either through cutting calories or intermittent fasting – extended the lifespans of all eight vertebrates in the 167 studies. However, rapamycin was also consistent in doing this, while metformin wasn't. What's more, rapamycin's healthy aging biomarkers were consistent across males and females.

"These findings don't suggest we should all start taking rapamycin," said co-lead researcher Edward Ivimey-Cook, from the University of Glasgow. "But they do strengthen the case for its further study in aging research and raise important questions about how we approach longevity therapeutics."

While there's no silver bullet for stopping the aging process, the researchers highlighted that current interventions can prove challenging for many – long-term calorie-restricted diets and intermittent-fasting regimens can be challenging to maintain. If medical treatment could achieve the same healthy-aging results, regardless of diet, rapamycin's appeal is pretty clear.

"Our findings show that drug re-purposing is a promising approach to improving people's health and lifespan," added Sultanova.

While the researchers' findings are based on studies on non-human vertebrates, rapamycin is currently under investigation in human trials, which will assess the drug for safety as well as efficacy.

The study was published in the journal Aging Cell.

Source: University of East Anglia

Intas Gets SEC Nod To Import, Market Anti-Cancer Drug Serplulimab, Phase IV Trial Mandated

New Delhi: Intas Pharmaceutical has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the anti-cancer drug Serplulimab.

In addition, the committee recommended the firm to Phase IV Clinical Trial protocol of the anti-cancer drug Serplulimab.

This came after the firm presented the additional data for seeking approval to import and market Serplulimab Concentrate for Solution for Infusion 100 mg/10 ml Vial based on the safety and efficacy data generated from global clinical studies along with a request of local clinical trial waiver.

The committee noted that drug is now approved in EMA and the drug falls under the category of Orphan Drug.

Serplulimab is a fully humanized IgG4 monoclonal antibody that targets the PD-1 receptor, an immune checkpoint protein. It's designed to block PD-1, preventing cancer cells from shutting down the immune system's ability to attack them. Serplulimab has demonstrated promising anti-tumor activity and a manageable safety profile in various clinical trials, particularly in lung cancer.

At the recent SEC meeting for Oncology held on 13th May 2025, the expert panel reviewed the additional data for seeking approval to import and market Serplulimab Concentrate for Solution for Infusion 100 mg/10 ml Vial based on the safety and efficacy data generated from global clinical studies along with a request of local clinical trial waiver.

After detailed deliberation, the committee recommended for the grant of permission to import and market the drug with the condition to conduct Phase-IV clinical trial in India. "Accordingly, firm shall submit Phase IV Clinical Trial protocol to CDSCO within 03 months of grant of marketing authorization,m" the expert panel noted.

Also Read: Parexel successfully completes CRO registration with CDSCO

Samsung Biologics Sees Big Things Ahead With Spin-off, CDMO Momentum And New Anti-cancer Drugs

Samsung Biologics CEO John Rim speaks to the press about the company's future road map at a luncheon in Boston on June 17. Samsung Biologics is exhibiting at the 2025 BIO International Convention held between June 16 and 19. [SAMSUNG BIOLOGICS]

 BOSTON — Samsung Biologics CEO John Rim pledged to expand the company's core contract manufacturing business as it undergoes a major corporate restructuring with the planned spin-off of its biosimilar unit. At the same time, the company is stepping into early-stage drug discovery with the launch of a new organoid-based screening platform. Speaking to Korean media at a luncheon on Tuesday, the CEO said the decision to divest Samsung Bioepis was driven by the need to streamline operations and address client concerns over competitive overlap. "Many of our clients, while signing deals with us, requested contract clauses asking us not to manufacture biosimilars if we were producing for them," Rim said. "Now, 17 of the top 20 global pharmaceutical companies are our clients. We saw this as the right time to make the move." Samsung Bioepis will be transferred to the newly formed Samsung Epis Holdings by Oct. 1, with both entities expected to be relisted on the market by the end of that month following an interim period.CDMO market momentum Rim dismissed concerns about overcapacity in the contract development and manufacturing organization (CDMO) sector, noting that demand is rising as biopharma pipelines diversify beyond traditional therapeutic areas. "Previously, it was mostly immunology and oncology, but now we're seeing growth in neurological diseases like Parkinson's and amyotrophic lateral sclerosis," he said. "There's also a growing wave of anti-aging investments, and biotechs are driving much of this pipeline expansion." Samsung Biologics aims to achieve 1.5 trillion won ($1.1 billion) in annual operating profit this year, and has already secured over 3.35 trillion won in cumulative orders this year, already surpassing half of its total order volume in 2024. According to U.S.-based consulting firm Frost & Sullivan, the global CDMO market is projected to reach $43.9 billion by 2029, growing at an annual rate of 15 percent between 2024 and 2029. To meet the surge in demand, the company continues to expand its manufacturing footprint. Plant 5, located at its second bio campus, was completed in April and is now fully operational, bringing Samsung Biologics' total production capacity to 784,000 liters (207,110 gallons). Construction of a sixth plant is pending board approval, and the company is bidding on additional land in Songdo to establish a third bio campus. "We are already producing antibody-drug conjugates [ADCs] and actively negotiating new contracts," Rim said. "In terms of modalities, we're preparing to handle a broader range — including bispecific antibodies, ADCs and antibody-oligonucleotide conjugates — all within our existing facilities. We've also begun working with adeno-associated viruses, though we're still in the early stages." Samsung Biologics also plans to offer clinical-stage contract development organization (CDO) services, though no new facilities will be built. Development capacity for these projects will be limited to 200 liters.Entry into research and organoid services The company's newly launched Samsung Organoid platform marks its first major step into contract research organization (CRO) territory. 

Lee Sang-myung, executive vice president and head of business strategy, speaks during a press conference held with the Korean media at the Boston Convention & Exhibition Center on June 17. [SAMSUNG BIOLOGICS]

 Developed in partnership with Samsung Medical Center, the platform uses patient-derived 3-D cell cultures — commonly referred to as organoids or artificial organs — to screen for anti-cancer drug candidates, which have higher predictive accuracy than conventional animal models. "In fact, based on our analysis using representative drugs, these organoids showed up to 85 percent consistency with actual patient responses," said Lee Sang-myung, vice president and head of business strategy. "Once an organoid is banked, we can thaw, culture and process it to deliver testing results in just about five weeks — dramatically shortening the timeline compared to animal models. It costs are about one-tenth, and there are no ethical concerns." Although the organoid service is not expected to generate revenue on par with Samsung's CMO and CDO businesses, the company sees long-term value in the data it generates, particularly for personalized drug development and early-stage decision-making. "Testing drugs with organoids alone is one-dimensional," Lee said. "But now, there is a vast amount of related data — imaging like CT and MRI, genomic profiles, treatment histories, recurrence outcomes — that has been accumulated but largely unused until now. "The emergence of AI as a powerful tool allows us to combine organoids with this multidimensional data to enhance drug development. That technological momentum is what we see as the biggest driver." Samsung Biologics is also exploring partnerships with overseas hospitals to broaden its patient-derived organoid bank and is considering future data licensing models. While its organoid unit may start small, the company views it as a strategic foothold in precision medicine and an eventual bridge to broader CRO capabilities. 

BY LEE JAE-LIM [[email protected]]

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