Category: 3. Business

Lowering the prices of prescription drugs has been high on United States President Donald Trump’s agenda since he took office in January. He has taken a number of steps, including striking deals with pharmaceutical companies, to lower the costs of prescription drugs.

Trump has also directed the Food and Drug Administration (FDA) to streamline its regulation process to boost cheaper copycat drugs, such as generic and biosimilar drugs.

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Biosimilars are highly similar versions of biologics, a group of drugs produced through biological processes. One of the most widely used biologic drugs is insulin, which is used to treat diabetes.

Biologics, which make up just 5 percent of prescriptions, account for more than half of the total expenditures on medicines in the US, according to the health data analysis company IQVIA.

The Trump administration said it hopes to make these medications more affordable, partly by increasing access to biosimilars.

So what are biologics and biosimilars, and will the administration’s proposals help drive down their costs?

What are biologics?

Biologics is short for biological medications or products. It’s a broad category of products that include vaccines, blood and blood components, gene therapy and tissues. They are a class of complex drugs produced through biological processes or from living organisms, such as proteins and genes. They treat cancer, autoimmune diseases and other rare disorders.

Biologics are typically administered by injection or through an intravenous infusion, said Alex Keeton, executive director of the Biosimilars Council at the Association for Accessible Medicines, an industry group that advocates on behalf of biosimilar manufacturers.

The FDA approval process for these products is rigorous and typically takes 10 to 15 years, said Brian Chen, a University of South Carolina health law and economics expert. Speedier timelines are possible in extraordinary circumstances: Federal agencies worked with vaccine manufacturers and scientists to expedite COVID-19 vaccines, for example.

What are biosimilars?

As the name suggests, these medications are similar to the original biologics approved by the FDA. Biosimilars are developed and sold after the original biologic has lost its patent exclusivity, Keeton said. Biosimilars for Humira, a drug used by people with rheumatoid arthritis, include Cyltezo, Amjevita and Idacio.

“They still work the same way clinically, but they’re not exactly the same,” Keeton said.

That’s because, unlike with generic versions of brand name drugs, it’s impossible to make exact copies of biologics. Biologics have complicated production processes and their components are derived from live organisms.

“Biologics are like strands of flexible, cooked spaghetti folded in very specific ways, making exact replication nearly impossible,” Chen said.

The FDA evaluates proposed biosimilar products against the original biologic to determine whether the product is extremely similar and has no meaningful clinical differences. It is expected to have the same benefits and risks as the original biologic. To be approved, biosimilar manufacturers must show patients using their products don’t have new or worsening side effects compared with patients using the original biologic.

FDA approval for biosimilars often takes five to six years, Keeton said.

Biosimilars increase market competition, incentivising brand name drug manufacturers to lower their prices.

How much do biologics and biosimilars usually cost?

They’re pricey, and exact costs vary.

One 2018 study found that biologics and biosimilars can cost a US patient $10,000 to $30,000 each year on average.

Humira is more. It was listed at $6,922 for a month’s supply in early November. The Humira biosimilar Cyltezo advertises for 5 percent off Humira’s cost. The makers of Cyltezo also offer a non-brand name option for people who pay cash at pharmacies while using the GoodRx app at a price of $550.

The actual amount insured patients pay also depends on their plan and their insurer’s negotiated rates.

Biosimilar prices typically run 15 percent to 35 percent lower than their brand name biologic counterparts, one 2024 study found. The FDA found biologics produce a more dramatic cost savings of 50 percent on average.

Why are these medications so expensive?

Biologics and biosimilars are difficult to develop and produce, which adds to their expense.

Making a standard over-the-counter medication such as aspirin requires five ingredients. Making insulin, a biologic, requires genetic modifications to living organisms.

These complex manufacturing procedures and proprietary information make it difficult for competitors to create alternatives.

To put this in perspective, there were 226 marketed biologics in the US as of July, and the FDA had approved 76 biosimilars such as insulin. When it comes to non-biologic medications, the FDA has approved more than 32,000 generic drugs. That’s more than the number of approved brand name drugs.

Can biosimilars be used in place of the original, FDA-approved biologics?

Yes. All biosimilars must meet FDA requirements and must be highly similar and have no clinically meaningful differences from their existing FDA-approved biologic counterpart.

So how does the Trump administration hope to change the FDA approval process for biosimilars?

Under its draft guidance, the administration proposed reducing some of the tests required as part of the FDA process used to prove a biosimilar drug is as safe and effective as its biologic counterpart.

Currently, a manufacturer requesting a biosimilar licence has to provide clinical study data proving its product’s similarity. The FDA’s new proposal would no longer require drug developers to conduct these comparative clinical trials.

Manufacturers would still be required to test proposed biosimilars. Other data – including comparative analysis, immune response data and human study data showing how the drug moves through the body – could sufficiently demonstrate the drug’s similarity to an existing biologic, the FDA said.

Why does the FDA want to change the biosimilar approval process?

Ultimately, the agency said it aims to incentivise drug manufacturers to quickly develop biosimilars by eliminating redundant, costly and time-consuming clinical studies, Keeton said.

Saving that time might increase the number of biosimilar alternatives.

It would almost certainly lower the front-end development costs for drugmakers, Chen said.

Will that change lower the costs of these medications for patients who need them?

Regulatory changes alone may not significantly drive down prices for many Americans.

Several non-brand name options need to be available to produce significant price drops, according to a US Department of Health and Human Services report.

But prices could remain the same even with more options.

A 2024 study in the JAMA Health Forum, a health policy journal, found that annual out-of-pocket costs either increased or remained stable for most biologics even after biosimilars were available. Patients who used biosimilars didn’t pay less than those who used the original biologics.

That’s at least partly because biologic manufacturers often offer substantial rebates to pharmacy benefit managers, companies that work with insurers, employers and others to manage prescription drug plan benefits. In exchange, insurers give the name brand biologics preferred or exclusive placement on their lists of insurance-covered drugs, Chen said. Rebate walls ultimately prevent the sale of cheaper biosimilars, he said.

Are there any other obstacles to getting more biosimilars on the market?

Yes, another key hurdle remains: Name brand biologic manufacturers often hold many patents and file lawsuits blocking approved biosimilars from being commercially marketed.

A 2018 study conducted by Chen found that of 12 FDA-approved biosimilar products, five were commercially available as of October 2018. Six others were unavailable because of patent disputes.

PolitiFact researcher Caryn Baird contributed to this report.

Scott Bessent, the US treasury secretary, returned from South Carolina last week brandishing a small piece of metal, proclaiming that it was the first rare-earth magnet made in the US in a quarter of a century.

It was, he indicated to Fox Business, proof that the US is ending “China’s chokehold on our supply chain”. Thanks to the South Carolina company eVAC’s new rare-earth mineral processing center, Bessent added: “We’re finally becoming independent again.”

Breaking China’s processing and manufacturing dominance in these materials, essential for some semiconductors, batteries and armaments, is a top priority for the Trump administration that has made a bet, via tariffs and other economic tools, that it can return the industry to US shores.

Those tariffs led China to restrict rare-earth exports to the US and pushed Donald Trump to sign deals with Australia, Malaysia, Cambodia and Japan.

The US and China have now brokered a trade truce on rare earths but China, with approximately 70% of global mining and over 90% of global processing capacity, has a head start that Trump will struggle to erode.

There’s no easy fix for the US to reset its dependence on Chinese production of minerals critical to national security, semiconductor production, and the transfer of energy production from fossil fuels to wind and solar. The US imported 80% of the rare earths it used in 2024, according to the US Geological Survey.

For some rare-earth minerals such as dysprosium, used in chip production, and samarium, essential to military applications, Chinese refinement dominance rises to 99%. Dysprosium and terbium are used in magnets essential for electric engines in electric vehicles and generators in wind turbines, along with uses in cellphones, high-intensity lighting and nuclear reactors.

“These materials are used in electric motors for EV cars but also in guidance systems that have obvious applications for the defense department,” says Adam Webb, head of energy raw materials at Benchmark Mineral Intelligence. “Anything that has a decent magnet in it uses rare earths.”

Trump’s efforts to reduce the US’s dependence on Chinese production on rare-earth minerals could take years. “‘Rare earths’ is somewhat of a misnomer because they’re not that uncommon in terms of abundance in the earth’s crust,” Webb says, but many deposits, including in Ukraine, where Trump made a deal earlier this year, are only in the early stages of extraction.

“It’s not that there’s a shortage per se, it’s that China can limit how much is exported,” Webb said, adding that getting export licenses from China can be a lengthy, difficult process.

Greenland, another focus of Trump’s attention, and Brazil, are two other countries where there are significant rare-earth deposits. In the continental US, there are deposits in California, Wyoming and Missouri, with the largest operational mine operating at Mountain Pass, California, about 60 miles from Las Vegas.

In July, the Pentagon became the largest shareholder in MP Materials, the operator of the California mine, with plans to open a new “mine-to-magnet” plant, called 10X, to make magnets crucial in F-35 fighter jets, drones and submarines, according to the department.

In North America, measured and indicated resources of rare earths were estimated to include 3.6m tons in the US and more than 14m tons in Canada, according to the geological survey data – far less than the 44m tons estimated in China.

Mirroring direct investment and stakes in the steel industry and US chipmaker Intel, the interior department said it was prepared to make direct investments in critical mineral companies.

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“You’re competing against state capital because China is picking these strategically as areas that they want to invest in,” Doug Burgum, the US secretary of the interior, said during a speech at the Hamm Institute for American Energy in April.

Burgum floated that the US could utilize a sovereign wealth fund to speed production. “Why wouldn’t the wealthiest country in the world have the biggest sovereign wealth fund?” he asked.

US efforts to support domestic production have floundered in the past when China lowered prices, rendering unsupported rare-earth development uneconomic against China’s lower cost of production and long-term strategic outlook.

Five years ago, Simon Moores, managing director of Benchmark Mineral Intelligence, testified before the US Senate committee on energy and natural resources that “those who invest in battery capacity and supply chains today are likely to dominate this industry for generations to come. It is not too late for the US but action is needed now.”

Five years on, a scramble to assemble trading alliances around rare earths is accelerating.

“In about a year from now, we’ll have so much critical mineral and rare earths that you won’t know what to do with them,” Trump told reporters. That came eight months after Trump demanded $500bn of Ukraine’s minerals to compensate the US for the military aid. In September, the government of Pakistan signed a $500m deal with the American company US Strategic Metals, giving it access to minerals such as antimony and copper.

But can the US make up its shortfall and loosen China’s hold on rare-earth supply chains? “The US has taken really significant steps already,” Webb says. The US, he adds, cannot be “self-reliant in the short term because it takes time to bring a mine online and build refining capacity.”

• SAR 600M investment: Agreement represents phased investment of SAR 600 million to establish a localized industrial gases production supply chain in Oxagon and across NEOM
• Strategic infrastructure readiness: Production and distribution facility will enable tenants to commence seamless production, signaling a move into the activation phase of Oxagon’s industrial development

NEOM, Kingdom of Saudi Arabia – 16 November 2025 – Oxagon, the reimagined industrial city of NEOM, has announced the signing of a land lease agreement between NEOM and Abdullah Hashim Industrial Gases & Equipment Co. Ltd (AHG) – a leading provider of industrial gases to industries across Saudi Arabia.

As part of a planned SAR 600 million investment, AHG will develop in multiple phases a state-of-the-art industrial gases production and distribution facility in Oxagon’s Industrial Quarter, the city’s dedicated industrial district. With groundbreaking scheduled for February 2026, the first phase will include essential industrial gases infrastructure, offices, warehousing and distribution capabilities. Operations are also due to commence in late 2026 with subsequent phases expected to start in 2028.

This strategic partnership signals Oxagon’s readiness as an industrial city, with the production and distribution of industrial gases paving the way for tenants to ramp up development and begin production from 2026 onwards.

“Our partnership with AHG exemplifies Oxagon’s readiness to welcome world-class tenants and accelerate the Kingdom’s transition to a diversified, future-ready economy,” said Vishal Wanchoo, CEO of Oxagon. “Leveraging AHG’s industrial gases expertise, we are developing a streamlined local supply chain that meets the demands of modern industry and supports the transition to sustainable energy solutions, enabling cleaner manufacturing practices.”

“We are excited to be part of Oxagon’s development plan and are keen to play our role in supporting the industrial gases requirements of international and local investors with cost competitive, high reliability products and services,” said Khalid Abdullah Hashim CEO of the AHG Group Companies. “The land lease agreement, followed by our investment plan in low carbon industrial gases production facilities, demonstrates our commitment to supporting the clean industrial transformation taking place in Oxagon.”

The demand for industrial gases in Oxagon is anticipated to grow as the region continues to attract industries across manufacturing, transportation and beyond. AHG’s new facility will play a vital role in localized production and distribution, reducing reliance on long-distance imports, minimizing supply chain disruptions and reducing carbon dioxide (CO₂) emissions from transport. Additionally, it will enhance cost competitiveness for tenants by providing them with more affordable and reliable access to essential industrial gases. This is a step forward in addressing some of the broader environmental impacts of manufacturing, including value chain (scope 3) emissions.

As part of its phased development plan, AHG plans to produce green oxygen, nitrogen, argon and hydrogen, further supporting Saudi Arabia’s broader renewable energy transition goals. This plan will offer a strategic advantage for global manufacturers seeking to lower operating costs while meeting environmental targets.

A long-term partner of NEOM’s development, AHG currently supports the broader construction underway in northwest Saudi Arabia by supplying industrial gases and equipment to contractors. This new facility will strengthen those efforts, while also enabling tenants in Oxagon to advance infrastructure projects more efficiently. In line with Saudi Vision 2030, development of the facility will also stimulate GDP growth through the creation of specialized roles in the industrial gases sector, equipping local talent with advanced skills and expertise.

Several therapeutic advances have reshaped the treatment landscape in small cell lung cancer (SCLC) over the past year, signaling a long-anticipated shift away from historically stagnant standards of care (SOC) and toward a more dynamic, targeted paradigm, according to Charles M. Rudin, MD, PhD, who added that the future of drug development for this disease has never been brighter.¹

In a presentation delivered during the 20th Annual New York Lung Cancers Symposium®, Rudin highlighted how new drug classes, such as antibody-drug conjugates (ADCs) and T-cell engagers, and cell surface–directed strategies are driving this evolution, demonstrating efficacy that would have been difficult to envision a decade ago.

“2025 has been a real banner year for SCLC research, with some promising data emerging,” Rudin, who is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center in New York, stated. “ADCs have the potential to displace platinum/etoposide in the first-line setting… [which] we’ve been giving for decades together with immune checkpoint blockade…and given the data [we’ve seen] with tarlatamab [Imdelltra], a T-cell engager can be added here, potentially changing the first-line SOC.”

Rudin also serves as deputy director of the Cancer Center, co-director of the Druckenmiller Center for Lung Cancer Research, and the Sylvia Hassenfeld Chair in Lung Cancer Research.

Rudin Spotlights Key Advances in the Small Cell Lung Cancer

• SCLC treatment is rapidly evolving, with ADCs and T-cell engagers delivering efficacy once thought unattainable and signaling a shift away from long-standing standards.

• Tarlatamab is emerging as a new standard, demonstrating strong survival benefits in second-line ES-SCLC and promising activity in frontline maintenance combinations.

• Next-generation ADCs like I-DXd and ABBV-706 show high response rates, positioning them as potential future challengers to platinum/etoposide in the first-line setting.

How Has Checkpoint Inhibition Changed the SOC in SCLC?

Checkpoint inhibitors have now become embedded in the management of extensive-stage SCLC (ES-SCLC), but their impact is complex, Rudin explained. In limited-stage SCLC, durvalumab (Imfinzi) has recently shifted a decades-long paradigm dominated by concurrent platinum-based chemoradiotherapy alone.

Data from the phase 3 ADRIATIC trial (NCT03703297), which supported the December 2024 FDA approval of durvalumab in LS-SCLC, showed a statistically significant improvement in overall survival (OS) with durvalumab (n = 264) vs placebo (n = 266), at a median of 55.9 months (95% CI, 37.3-not reached [NR]) and 33.4 months (95% CI, 25.5-39.9), respectively (HR, 0.73; 95% CI, 0.57-0.93; P = .0104).² The median progression-free survival (PFS) was similarly improved with durvalumab (HR, 0.76; 95% CI, 0.61-0.95; P = .0161).

“On the one hand, we do see real, long-term, transformative benefit [with checkpoint inhibitors] in a small subset of patients,” Rudin said about this “yin and yang” of immune checkpoint blockade in SCLC.¹ “We have patients with metastatic SCLC who are cured with immunotherapy. That is good for those patients, but it leaves out [approximately] 85% of the patients who [derive] no benefit from the addition of immune checkpoint blockade.”

Ultimately, checkpoint blockade has changed the SOC in SCLC, but only for a minority of patients, underscoring the need for additional strategies to broaden the benefit of immunotherapy, Rubin asserted.

Could Adding Chemotherapy to Maintenance Immunotherapy Improve Outcomes?

One emerging strategy for bolstering immunotherapy responses in SCLC is to intensify the maintenance phase by layering cytotoxic agents onto PD-L1 inhibition. The phase 3 IMforte trial (NCT05091567) explored the addition of lurbinectedin (Zepzelca) to atezolizumab (Tecentriq) vs atezolizumab alone as maintenance therapy in ES-SCLC after induction therapy.³

Primary results presented at the 2025 ASCO Annual Meeting showed that the combination (n = 242) significantly improved PFS vs atezolizumab alone (n = 241; HR, 0.54; 95% CI, 0.43-0.67; 2-sided P < .0001). The median PFS by independent review facility assessment was 5.4 months (95% CI, 4.2-5.8) with lurbinectedin plus atezolizumab vs 2.1 months (95% CI, 1.6-2.7) with atezolizumab monotherapy. The 12-month PFS rates were 20.5% vs 12.0%, respectively. Furthermore, the median OS was 13.2 months (95% CI, 11.9-16.4) with the combination vs 10.6 months (95% CI, 9.5-12.2) with atezolizumab alone (HR, 0.73; 95% CI, 0.57-0.95; 2-sided P = .0174). The 12-month OS rates were 56.3% vs 44.1%, respectively.

“This is a win. It’s a good drug and it works,” Rudin said. “However, I’m not sure this is as practice changing as I would like. One criticism that has been raised about this study is that only a minority of these patients on the control arm ever [received] lurbinectedin.”

Rubin also pointed out the clinical trade-off of introducing a cytotoxic agent at a time when patients might otherwise enjoy a chemotherapy break. In his view, a key goal of maintenance strategies should be to prolong survival outcomes, and he did not see compelling evidence from IMforte that the tail of the Kaplan-Meier curve was substantially altered.

“We need more follow-up from this trial, and we still need to work on better maintenance strategies.”

How Are T-Cell Engagers Reshaping Second-Line and Maintenance Therapy?

T-cell engagers represent one of the most promising new modalities in SCLC, particularly because they bypass some of the limitations of antigen presentation that constrain checkpoint blockade, Rubin explained. Tarlatamab (Imdelltra) is currently “the hot drug in this field,” although several other T-cell engagers are demonstrating comparable activity.

Tarlatamab in the Second-Line Setting

Rudin pointed to pivotal data from the phase 3 DeLLphi-304 trial (NCT05740566), which compared tarlatamab with chemotherapy in patients with previously treated ES-SCLC. Data published in the New England Journal of Medicine and presented at the 2025 ESMO Congress showed that the median OS was 13.6 months (95% CI, 11.1-NR) with tarlatamab (n = 254) vs 8.3 months (95% CI, 7.0-10.2) with chemotherapy (n = 255; HR, 0.60; 95% CI, 0.47-0.77; P < .001).⁵ In those with platinum-resistant disease, defined as a chemotherapy-free interval (CFI) of less than 90 days, the median OS with tarlatamab was 10.9 months vs 6.4 months with chemotherapy (HR, 0.60; 95% CI, 0.43-0.84).⁶ In those with platinum-sensitive disease, defined as a CFI of 90 days or longer, the median OS in the tarlatamab and chemotherapy arms was 17.1 months and 10.6 months, respectively (HR, 0.65; 95% CI, 0.45-0.93).

Importantly, prior exposure to PD-L1 blockade did not appear to negatively affect benefit with tarlatamab. In patients who had received prior anti–PD-L1 agents, the median OS was 14.1 months with tarlatamab vs 8.3 months with chemotherapy (HR, 0.61; 95% CI, 0.45-0.82). In those without prior anti–PD-L1 therapy, median OS was 13.6 vs 8.3 months, respectively (HR, 0.65; 95% CI, 0.42-1.03).

“I would argue that this is, for most patients, the new SOC in this country,” Rudin said, adding that the magnitude and consistency of benefit make tarlatamab compelling in the second line.

Tarlatamab in Frontline Maintenance Therapy

Rudin also highlighted emerging data signaling the potential efficacy of tarlatamab as part of frontline maintenance regimens. Extended follow-up from the phase 1b DeLLphi-303 trial (NCT05361395), presented at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer and published in Lancet Oncology, showed that tarlatamab plus anti–PD-L1 therapy (n = 88) led to a median OS of 25.3 months (95% CI, 20.3-not evaluable [NE]) and a median PFS of 5.6 months (95% CI, 3.5-9.0).⁷ The disease control rate (DCR) was 60% and the median duration of disease control was 14.6 months (95% CI, 7.2-18.4). The objective response rate (ORR) was 24% and comprised 2 complete responses and 19 partial responses; the median duration of response (DOR) was 16.6 months (95% CI, 7.1-NE).

Additional cohort data from DeLLphi-303 presented at the 2025 ESMO Congress explored tarlatamab in combination with frontline chemoimmunotherapy (n = 96) in ES-SCLC.⁸ At a median follow-up of 13.8 months (95% CI, 12.5-15.0), the ORR was 71% (95% CI, 61%-80%), with a complete response (CR) rate of 5% and a partial response rate of 66%; 11% of patients had stable disease, 8% had progressive disease, and responses were not evaluable in 9%. The median DOR was 11.0 months (95% CI, 8.5-NE), the DCR was 82% (95% CI, 73%-89%), and the median duration of disease control was 10.7 months (95% CI, 7.7-18.8).

“These are really striking results,” Rudin remarked. “We have not seen these sorts of survival curves for patients with recurrent SCLC. Even in the maintenance setting, you could argue the start of these curves should be lower… but this looks really good. [These are] early data, but this is a 96-patient trial—that is not to be [discounted].”

Could ADCs Eventually Displace Platinum/Etoposide in the First-Line Setting?

ADCs are another major component of what Rudin described as a new wave of drug development in SCLC, specifically targeting cell surface proteins rather than driver oncogenes. He focused on 2 agents that he believes may ultimately challenge platinum/etoposide in the frontline setting: the B7-H3–directed ADC ifinatamab deruxtecan (I-DXd) and a seizure-related homolog protein 6 (SEZ6)–targeting ADC ABBV-706.¹

Ifinatamab Deruxtecan

In the phase 2 IDeate-Lung01 trial (NCT05280470), patients who received I-DXd at the 12-mg/kg dose (n = 137) achieved a confirmed ORR of 48.2% (95% CI, 39.6%-56.9%), which included a 2.2% CR rate. The DCR was 87.6% (95% CI, 80.9%-92.6%).⁹

The median PFS was 4.9 months (95% CI, 4.2-5.5), with 3-, 6-, and 9-month PFS rates of 68.0% (95% CI, 59.4%-75.2%), 35.3% (95% CI, 27.3%-43.4%), and 19.3% (95% CI, 12.9%-26.5%), respectively. The median OS was 10.3 months (95% CI, 9.1-13.3), and the 3-, 6-, and 9-month OS rates were 89.1% (95% CI, 82.5%-93.2%), 77.4% (95% CI, 69.4%-83.5%), and 59.1% (95% CI, 50.4%-66.8%), respectively.

In August 2025, ifinatamab deruxtecan was granted breakthrough therapy designation from the FDA for patients with ES-SCLC whose disease progressed on or after platinum-based chemotherapy.¹⁰

“We have not seen this sort of activity for a cytotoxic in SCLC in a long time,” Rudin commented. “This is delivering the cytotoxic to the tumor, and we are seeing response rates in the second-line setting of over 50%.”

ABBV-706

Updated data from the dose-optimization portion of a phase 1 trial (NCT05599984), presented at the IASLC 2025 World Conference on Lung Cancer, showed that ABBV-706 induced a confirmed ORR (cORR) of 58% in the total population (n = 80).¹¹

Responses were observed across key clinical subgroups, including patients with platinum-refractory or -resistant disease and those with brain metastases. Among patients who had received 2 prior lines of therapy (n = 30) or at least 3 prior lines (n = 50), the confirmed ORRs (cORR) were 77% and 46%, respectively. For patients with a CFI of at least 90 days (n = 30), less than 90 days (n = 41), and less than 30 days (n = 19), cORRs were 57%, 59%, and 53%, respectively. Among patients with (n = 28) and without (n = 36) brain metastases at baseline, cORRs were 57% and 69%, respectively. Notably, SEZ6 expression levels were similar between responders and nonresponders.

“These are also nice-looking data, with a large majority of patients benefiting,” Rudin added. “[Both of these ADCs] have [produced] high response rates and have the potential to displace platinum-etoposide as a first-line therapy. We will see if that happens.”

What Do All These Agents Have in Common?

Across checkpoint inhibitors, T-cell engagers, and ADCs, Rudin pointed to a unifying theme: All the most promising agents in SCLC are targeting the cell surface rather than oncogenic drivers.¹ “This is a very different strategy than what we have seen for, say, lung adenocarcinoma, where we made such progress by defining driver mutations and specifically subsetting disease and going after these driver mutations one by one,” he explained. “That does not work in SCLC.”

SCLC is characterized by loss of key tumor suppressor genes rather than discrete kinase drivers, making traditional targeted approaches unsuccessful. Accordingly, unconventional targets such as LSD1and EZH2, as well as a range of cell surface proteins, are now under investigation.

“It is a different, orthogonal strategy, but it is one that is increasingly exciting for this disease,” Rudin concluded.

Looking ahead, Rudin envisions a treatment paradigm in which frontline chemoimmunotherapy is followed by more effective maintenance combinations, second-line T-cell engagers become new standards, and ADCs like I-DXd and ABBV-706 potentially move into the first-line setting, transforming what has been one of the most therapeutically constrained areas in lung cancer.

References

1. Rudin CN. New drugs for small cell lung cancer. Presented at: 20th Annual New York Lung Cancers Symposium; November 15, 2025; New York, New York. Accessed November 15, 2025.
2. FDA approves durvalumab for limited-stage small cell lung cancer. News Release. December 4, 2024. Accessed November 15, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-limited-stage-small-cell-lung-cancer
3. Paz-Ares L, Borghaei H, Liu SV, et al. Lurbinectedin (lurbi) + atezolizumab (atezo) as first-line (1L) maintenance treatment (tx) in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC): primary results of the phase 3 IMforte trial. J Clin Oncol. 2025;43(suppl 16):8006. doi:10.1200/JCO.2025.43.16_suppl.8006
4. Rudin C, Mountzios G, Sun L, et al. Tarlatamab versus chemotherapy (CTx) as second-line (2L) treatment for small cell lung cancer (SCLC): primary analysis of Ph3 DeLLphi-304. J Clin Oncol. 2025;43(suppl 17):LBA8008. doi:10.1200/JCO.2025.43.17_suppl.LBA8008
5. Mountzios G, Sun L, Cho BC, et al. Tarlatamab in small-cell lung cancer after platinum-based chemotherapy. N Engl J Med. Published online June 2, 2025. doi:10.1056/NEJMoa2502099
6. Rocha P, Sun L, Cho BC, et al. Tarlatamab as second-line (2L) treatment for small cell lung cancer (SCLC): Outcomes by chemotherapy-free interval (CFI) and prior PD-(L)1 inhibitor use in the phase 3 DeLLphi-304 trial. Presented at: 2025 ESMO Congress; October 17-21, 2025; Berlin, Germany. Abstract LBA101.
7. Paulson KG, Lau SCM, Ahn M-J, et al. Safety and survival update of tarlatamab and anti-PD-L1 as first-line maintenance after chemo-immunotherapy for extensive-stage small cell lung cancer: DeLLphi-303 ph1b trial. Presented at: International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract OA13.01.
8. Wermke M, Lau SCM, Moskovitz M, et al. Tarlatamab with first-line chemoimmunotherapy for extensive stage small cell lung cancer (ES-SCLC): DeLLphi-303 study. Ann Oncol.2025; 36 (suppl 2):S1365: doi:10.1016/j.annonc.2025.08.3368 External Link
9. Rudin CM, Johnson ML, Paz-Ares L, et al. Ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer: primary analysis of the phase II IDeate-Lung01 trial. J Clin Oncol. Published online October 14, 2025. doi:10.1200/JCO-25-02142
10. Ifinatamab deruxtecan granted breakthrough therapy designation by U.S. FDA for patients with pretreated extensive-stage small cell lung cancer. News release. Merck. August 18, 2025. Accessed November 15, 2025. https://www.merck.com/news/ifinatamab-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-pretreated-extensive-stage-small-cell-lung-cancer/
11. Byers LA, Cho BC, Cooper AJ, et al. Safety and efficacy of ABBV-706, a seizure-related homolog protein 6–targeting antibody-drug conjugate, in R/R SCLC. Presented at: International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract OA06.04.

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JERUSALEM, Nov 16 (Reuters) – Israel’s economy grew an annualised 12.4% in the third quarter, the Central Bureau of Statistics said on Sunday, in data that showed a bounceback from a weak second quarter that was hit more by the Gaza war.

The gain in gross domestic product in the July-September period topped a Reuters consensus of an 8% expansion and was led by broad-based gains led by consumer spending, exports and investment.

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GDP in the second quarter was revised to a 4.3% contraction from a prior 3.9%.

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Paul Kelly’s family farm in England has been selling $500 heirloom turkeys for two generations. Now, after a decade breeding them in Virginia, KellyBronze birds are looking to gobble up America’s Thanksgiving market.

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After two decades of breeding what the Times of London once called the “Rolls-Royce of turkey,” Paul Kelly wanted to learn from experts with generations of knowledge in America, where turkey farming originated. But once the Briton arrived in 2003, and after spending several weeks visiting turkey farms across Virginia, West Virginia, North Carolina, Massachusetts and Pennsylvania, Kelly was “amazed” to find no farmer or butchery maintained the American traditions, including dry-plucking and hanging, that have set the Essex, England-based KellyBronze apart.

Then again, when a frozen American Butterball costs about a $1 a pound and you’re asking customers to pay around $15 a pound—or nearly $500 for a 32-lb. turkey—high quality has to come with more than a high price.

“I thought, it’s almost impertinent for an Englishman to take turkeys to America,” says Kelly. “But there’s an opportunity there. I started looking, and we took it big.”

Kelly, 62, is now the owner of the only USDA-approved turkey plant in the U.S. that dry-plucks and hangs its birds, which many believe creates crispier skin and better flavor. Since purchasing 130 acres in the foothills of the Blue Ridge Mountains in Crozet, Virginia a decade ago, Kelly has opened America’s first newly built turkey hatchery in years.

KellyBronze, which sells its turkeys at Eataly and other high-end retailers across America, had 2024 revenue of $28 million. About 4% of that comes from the U.S., but Kelly expects that to be 25% within three years as he increases production in Virginia—and he is aiming for annual revenue will hit $80 million by 2028.

Founded in 1971 by Kelly’s parents, Derek and Mollie, KellyBronze is 100% family-owned and has never taken any private investment, though there have been many offers over the years. The business has grown steadily for the past six decades with little debt, and it currently has none. “I have slept at night knowing that every decision we made, we could afford to make, rather than hoping it worked,” says Kelly, who admits that the business is challenging as the bulk of revenue comes in November, December and January. “But, in America, bang, we bought the farm, we built the plant, not having sold one turkey. We were taking risks but risks we could afford.”

Kelly acknowledges the high price of his turkeys can be a “problem” but he is quick to point out that his birds are also three times the age of the typical frozen turkey, and lose 3% of their weight during hanging, and it’s all done by hand, which increases labor costs.

“People aren’t buying it to save money, are they?” asks Kelly. “The sales of amazing wines and the best champagnes go through the roof at Thanksgiving in America, the same as here at Christmas. Not everyone can afford it, but for those that can, it’s there.”

In the U.K, KellyBronze supplies high-end butchers and retailers like Harrods and Selfridges. The Royal Family as well as chef and restaurateur Gordon Ramsay have also supported the brand for years.

The Eaten Path: “We are never going to be Butterball,” Kelly says. “We are a small niche player and we just want to be producing the best possible turkey we can for Thanksgiving.”

KellyBronze

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In addition to Kelly’s 130 acres in Virginia, the family owns 90 acres across Scotland and England, where it rents another 140 acres. There are also now 13 British farmers raising turkeys for KellyBronze, including British celebrity chef Jamie Oliver, who started raising a flock five years ago, after spending 25 years as a customer. Oliver calls KellyBronze “the turkey equivalent of Wagyu beef or Pata Negra ham—simply the best of its kind.”

“I became a turkey farmer not out of necessity, but to support an extraordinary artisan family and their craft,” Oliver tells Forbes. “The Kelly family are a shining example of what’s right in British farming. They brought back values and methods that were nearly lost to history.”

Now, after more than 50 years in business, KellyBronze is finally ready to feast on America’s high-end turkey market. “We are never going to be a Butterball. We are never going to be big,” says Kelly. “We are a small niche player and we just want to be producing the best possible turkey we can for Thanksgiving.”

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Kelly’s parents bought a small farm the year he was born in 1963. His father worked at a big poultry company and after many years he left so the family could start their own turkey business in 1971 when Kelly was 8 years old. Back then, the British turkey industry was producing what was known as “New York Dressed” birds because, as Kelly explains, “the whole tradition of what we do came from America.”

When Kelly returned to the farm after graduating from an agricultural college attached to Scotland’s Glasgow University in 1983, he pushed his family to take their farming to the next level. In 1984, he changed the family’s breed from a white Wrolstad turkey that originated in Oregon to “the old traditional bronze breed.”

Farm To Table: KellyBronze dry-plucks and hangs its turkeys in the American tradition, which many believe creates crispier skin and better flavor.

KellyBronze

He also started bringing the birds outside where they could roam, dust-bathe, and peck in peace. The Kellys also started dry-plucking and then hanging the birds—at first for 7 days and now for 2 to 3 weeks. It was an expensive approach to a type of poultry that is traditionally quite cheap.

“It was a race to the bottom,” he recalls of British turkey farmers at the time. “We were the laughingstock of the industry.”

That first year, the Kellys had an annual revenue around $300,000 (or about $930,000 today). Despite the slow sales, the family doubled down. In 1987, the Kellys bought a former dairy farm for $90,000 at 10% interest over 10 years. The buildings and 5 acres of grasslands (where Kelly later built a house and now lives) helped the family expand its breeding and allowed them to build a small processing facility. “It was a huge step for us but gave us the space to supply the increased demand that came,” Kelly says. “It proved to be the best investment ever.”

By 1990, “the butchers were phoning us,” and by 1994, sales had skyrocketed to $1.2 million. After adding local farmers to their network throughout the 1990s, in 2001, KellyBronze was appointed by then-Prince Charles’ organic food brand Duchy Originals to farm its Christmas turkeys.

In 2003, revenue reached $3.8 million and Kelly was ready to broaden his understanding of traditional techniques and learn from farms in the United States, where it all began. The first turkeys are said to have been imported to England back in 1526, when a trader named William Strickland brought back six birds he obtained from Native Americans during an early voyage across the Atlantic. Eating turkey at Christmastime became fashionable at King Henry VIII’s court, cementing the turkey’s place as a symbol of festivity. The birds then traveled back across the Atlantic, as the colonists at Jamestown in Virginia had shipments of domesticated turkeys arriving on boats from England.

And while no turkey was ever formally recorded at the Pilgrims’ first Thanksgiving with the Wampanoag in Plymouth, Massachusetts in 1621, they were plentiful in the region. Benjamin Franklin once famously called the turkey “a much more respectable bird” than the bald eagle and “a true original Native of America. Eagles have been found in all countries, but the turkey was peculiar to ours.” He even described turkey as “a bird of courage.”

Born To Be Wild: KellyBronze is now producing 4,600 turkeys in the U.S. this year, and Kelly’s hatchery has the capacity to produce 15,000 “poults” every month.

Levon Biss for Forbes

Kelly says the stock he is raising in Virginia is inspired by “the original traditional turkey that was produced in America hundreds of years ago with the Pilgrims.” In 2014, he brought his turkeys back to the continent they originated on, buying his farm for $750,000, and spending another $2.75 million on infrastructure upgrades—with help from a $1 million bank loan that’s already been paid off.

KellyBronze is now producing 4,600 turkeys in the U.S. this year, and Kelly opened his own hatchery in 2018, which has the capacity to produce 15,000 “poults” every month. It’s currently at 5,500 per year and Kelly wants to open another on the East Coast and one on the West Coast.

Doing business in America isn’t easy. For one, sales are super lumpy—95% of Kelly’s U.S. sales occur at Thanksgiving—and KellyBronze might get hit with tariffs from the Trump Administration’s trade war. Kelly shipped turkey eggs from the U.K. to his U.S. hatchery just before the tariff start date. Next season, if the tariffs continue, the eggs could face charges of a few thousand dollars.

“My dream would be for people to order it in January or February of every year. They put their name on one and we’ll grow it to order,” says Kelly, whose son, Toby, 31, and daughter Ella, 28, are now running parts of KellyBronze. “The potential is huge.”

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Jewelry hasn’t lost its shine for gift-givers this holiday season, but business owners are expecting a bit more price sensitivity from customers after a surge in gold prices this year.

The holiday season remains a key period for the jewelry industry, with gift items accounting for a significant share of yearly revenues. But jewellers have had to raise prices as the cost of gold sharply increased — soaring roughly 55 per cent year-to-date to top the US$4,000 per ounce mark.

“Anybody and everybody I believe is raising prices and if they’re not, they should be. Because what you have in stock, you cannot replace for the same price if you’re going to reorder it today,” said Colin Nash, president of the Canadian Jewelry Group and owner of Nash Jewellers.

Based on what his business has seen, consumers are still spending so far this year, but by lesser amounts in the face of rising prices — not just for gold, but for the cost of living overall.

“I think that we’re still going to get the traffic, it’s just a question of how much and what are they going to be buying,” he said.

Nash said he thinks some price-sensitive consumers may avoid higher-end gold products altogether in favour of less expensive sterling silver items.

James Poag, co-owner of James O. Poag Jewellers, said he is also seeing consumers keeping a tighter grip on their wallets.

“Maybe some of the product mixes are changing, we’re seeing a lot of lab-grown diamonds and a lot of larger hollow pieces of jewelry as opposed to heavier cast pieces just due to the price of gold,” he said.

He’s also seen an increase in repairs, with people choosing to restore older pieces instead of replacing them, while other customers are trading in older pieces of jewelry and repurposing them into a new design.

Larger jewelry brands are also making adjustments.

Mejuri CEO and co-founder Noura Sakkijha said in a statement that the company introduced 10-karat solid gold products to provide more accessible price points. She added that offering a wide range of materials, including 10- and 14-karat gold as well as vermeil and sterling silver, gives consumers more choice.

“We also made selective and measured price adjustments on certain 14-karat pieces to reflect raw material increases. At the same time, we’re seeing customers explore different materials and gravitate toward more delicate pieces in gold, which we expect to continue during the holiday season,” she said.

But not all price adjustments come from decisions made at the store level.

Nash said that since his company works with higher-end brands like Rolex, Tudor and Roberto Coin, those brands dictate price increases and set their own manufacturer’s suggested retail price. He said once a brand decides that a price increase is needed, it notifies any stores carrying their product to follow suit.

“As soon as they (larger brands) say a 10 per cent price increase on each of the products, we have to follow suit because the prices here have to match what they’re selling for in Calgary, Vancouver, even in the (United) States,” Nash said.

Poag added that sharp rises in gold prices have made repricing difficult.

“It is a constant battle. We have 2,500 rings, so it literally takes months to go through to do repricing, so there certainly is a significant lag time,” he said.

Poag said since the run-up in the commodity price, an average consumer might be paying about 25 to 40 per cent more, depending on the gold content and the item they are purchasing.

There’s no doubt the holiday season is a key time for jewellers.

Poag said it’s typical in the industry for December sales to account for about 20 to 25 per cent of annual revenues.

As sales start to ramp up, Nash said it’s difficult to predict where the price of gold will go as it continues to trade above the US$4,000 mark. Prices hit US$4,300 in October.

“Maybe we hit our ceiling, maybe it’s coming down, but I don’t know. If I was a gambling man, I would still probably bet that gold will stay steady and keep moving just not at the pace that it has been,” he said.

Given the current price dynamics, Poag said he doesn’t think gold prices will come down significantly and it’s not worth it for consumers to delay purchasing in hopes of lower prices.

“I don’t think we’re going to see a significant downward trend,” he said.

This report by The Canadian Press was first published Nov. 16, 2025.

Daniel Johnson, The Canadian Press