Category: 3. Business

Understanding what patients and caregivers value most in cancer treatment is increasingly essential for delivering personalized and patient-centered care, particularly in the context of high-cost, long-term oral targeted therapies such as ALK inhibitors for non–small cell lung cancer (NSCLC). At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, Christopher Danes, PhD, scientific director of Global Medical Affairs Oncology at Takeda in Boston, Massachusetts, presented findings from a discrete choice experiment that explored the trade-offs patients with ALK-positive (ALK+) NSCLC and their caregivers are willing to make when evaluating treatment options.

In this interview with Pharmacy Times®, Danes discusses how the study’s insights can inform pharmacist-led shared decision-making, improve adherence strategies, and support value-based care planning by highlighting the nuanced preferences that shape treatment decisions in real-world oncology practice.

Pharmacy Times: How might the findings from this discrete choice experiment inform shared decision-making in pharmacy practice, particularly in patient counseling for ALK+ NSCLC treatments?

Christopher Danes, PhD: Our findings highlight that both patients and caregivers place the greatest value on maximizing 3-year progression-free survival (PFS) but are also willing to make trade-offs for reduced risk of certain adverse events (AEs) when considering potential treatment options for ALK+ NSCLC. The results shed light on the differences in treatment preferences between these groups and underscore the importance of engaging both patients and caregivers in open, individualized conversations about what matters most to them. Pharmacists should use this evidence to frame discussions with patients and caregivers, helping them understand the clinical benefits and potential risks of treatment and guiding shared decision-making that aligns with their preferences.

Pharmacy Times: The study showed that both patients and caregivers prioritized 3-year PFS but were also willing to trade some PFS to reduce certain risks. How should pharmacists help navigate those trade-offs during clinical consults?

Danes: Our data suggest that while most value PFS highly, many are open to trading some PFS for improvements in quality of life. Pharmacists can use these insights to tailor counseling, ensuring discussions about treatment options explicitly address both efficacy and AE profiles and helping support patients and caregivers in making choices that reflect their unique priorities. This is especially important for people living with ALK+ NSCLC, who are often still working or caring for children and may be on therapy for extended periods of time.

As a next step, we will be conducting additional analyses to gain clarity on distinct populations, including how they value tradeoffs and how preferences differ from group to group.

Pharmacy Times: Which specific AEs had the greatest impact on patient vs caregiver willingness to trade PFS, and how might that influence supportive care strategies?

Danes: According to our results from the full population of participants, both patients and caregivers were most willing to trade PFS to reduce the risk of any grade cognitive/mood effects, grade III or higher abnormal lab results, and grade III or higher lung complications. Interestingly, patients, but not caregivers, also valued reducing grade III or higher weight gain and any grade myalgia. This suggests supportive care strategies should prioritize early identification and management of cognitive/mood disturbances and serious lab or lung complications.

Notably, there were sub-populations of both patients and caregivers that were willing to accept any burden of AEs for improved efficacy, however, there were similar sized sub-populations of patients and caregivers that preferred a more balanced clinical profile. We are conducting further analyses on these populations to better understand what drives these preferences, which we hope to share in the future.

Pharmacy Times: Did the preferences differ significantly between patients with and without brain metastases? How might this subgroup variation affect treatment selection discussions?

Danes: We did evaluate the difference in attribute values in patients with or without brain metastases. Patients with brain metastases were willing to trade 3-year PFS more than others, which was interesting. We are doing further evaluation to assess why this might be and hope to share insights in the future.

Pharmacy Times: What role do you see pharmacists playing in eliciting and documenting patient and caregiver treatment preferences, especially in oral targeted therapy regimens such as ALK inhibitors?

Danes: Pharmacists are essential in eliciting, documenting, and communicating patient and caregiver preferences—particularly for oral ALK inhibitors that require ongoing adherence and monitoring. By routinely asking about patient goals, prior experiences with AEs, and personal values, pharmacists can ensure these preferences are incorporated into the care plan and communicated to the broader care team.

Pharmacy Times: Were there any surprises in the data about what risks patients and caregivers were most willing—or unwilling—to accept in exchange for longer PFS?

Danes: The importance of abnormal laboratory values was surprising, as it often can have little clinical manifestation. We investigated a little more and realized that patients and caregivers were concerned that abnormal laboratory values would lead to dose modifications, which in turn, could affect efficacy. This can induce anxiety for both patients and caregivers and underscores the importance of setting expectations for patients and caregivers at the onset of treatment.

In addition, there were a few differences between how patients and caregivers weighed certain attributes that we found interesting. For example, there was a subset of caregivers who were unwilling to trade any PFS for reduced toxicity, reflecting a strong focus on extending the life of their loved one regardless of AEs. Additionally, while patients were willing to trade a reduction in PFS to reduce risk of grade III or higher weight gain or any grade myalgia, caregivers were not. This makes sense when you think about it from the individual perspectives—significant weight gain and muscle soreness could have a significant impact on a patient’s daily life and self-esteem but may be viewed as only minor concerns by their caregivers, who would rather prioritize extending PFS. These nuances reinforce the importance of individualized discussions with both parties when making treatment decisions.

Pharmacy Times: Given that a subset of caregivers were unwilling to trade any PFS for reduced toxicity, how can pharmacists mediate potential differences in priorities between patients and their caregivers?

Danes: In partnership with health care providers, pharmacists can help serve as neutral facilitators, ensuring both patient and caregiver perspectives are heard. By providing balanced, evidence-based information and encouraging open dialogue, pharmacists can help identify shared goals or clarify areas of divergence, supporting consensus-building or compromise when needed.

Pharmacy Times: How can pharmacy teams use tools like discrete choice experiments to better tailor education and adherence support for long-term users of ALK inhibitors?

Danes: Discrete choice experiments can help us provide actionable insights into what patients and caregivers value most when evaluating potential treatment options. A discrete approach also allows you to avoid potential biases surrounding available treatment options by focusing on attributes vs brand names. Pharmacy teams can use these findings to proactively address the AEs that matter most to patients, personalize education materials, and design adherence interventions that reflect patient concerns and priorities.

Pharmacy Times: The study included patients recruited through an advocacy group—do you think these findings are generalizable to broader populations, and how might that influence pharmacist interpretation of these data?

Danes: While recruiting through an advocacy group may introduce some selection bias, our sample included a range of patients and caregivers representative of the ALK+ NSCLC community. However, pharmacists should interpret the findings with some caution, recognizing that preferences may vary in broader or more diverse populations and should always individualize discussions.

Pharmacy Times: How do these preference data inform value-based decision-making for specialty pharmacy services or formulary management when dealing with high-cost ALK inhibitors?

Danes: Our results suggest that value in ALK+ NSCLC treatments goes beyond survival outcomes and should also account for quality of life and patient/caregiver preferences about AEs. Specialty pharmacy services and formulary decisions should consider these dimensions to ensure access to therapies that best align with what patients and caregivers value most.

• Health Wave Partners strategy will focus on compelling investment opportunities in the senior housing sector
• Strategic partnership with Macquarie Asset Management enables investment in high-quality properties and partnerships with experienced operators in regions with strong demographic and economic fundamentals

Today, Macquarie Asset Management announced the launch of Health Wave Partners, a senior housing platform with a strategy aimed at targeting investments in modern senior housing assets alongside established operators.

The platform will be led by a management team that comprises:

• John Cobb, Chief Executive Officer
• Philip Kayden, Chief Investment Officer
• Elliot Pessis, Chief Operating Officer
• Sean O’Malley, Managing Director, Finance
• Holden Torrens, Director of Investments.

The management team collectively brings more than 75 years of experience in the senior housing sector and has collectively been involved in over $US50 billion worth of healthcare real estate transactions.

Health Wave Partners will aim to capitalize on the strength of Macquarie Asset Management’s extensive experience and demonstrated track record of growing and institutionalizing specialist operators by partnering with global institutions in an effort to seize this opportunity and deliver attractive risk-adjusted returns. Macquarie Asset Management’s real estate team believes the senior housing sector is poised for growth given a shift in demographics driving demand and a current undersupply. In the U.S., the aging baby boomer generation is set to expand the population aged 80+ at the fastest pace in history, materially outpacing new senior housing supply. This shift comes as higher interest rates and building costs have led to a rapid deceleration in construction.

“We have extensive experience in targeting sectors bolstered by structural tailwinds and selecting the optimal team within those sectors to partner with,” said Eric Wurtzebach, Head of Real Estate for Macquarie Asset Management. “We believe Health Wave Partners is uniquely positioned to access pipeline and mitigate execution risks.”

“Health Wave Partners will focus on investing in what it views to be high-quality properties and partner with experienced operators in regions with strong demographic and economic fundamentals,” said John Cobb, CEO of Health Wave Partners. “We believe our team’s expertise and strategic partnership with Macquarie Asset Management positions us for success and are excited to pursue what we believe is a strong opportunity in the market.”

Macquarie Asset Management has over 35 years of experience in the real estate sector and a current network of 15 specialist operator investments globally, offering clients access to a differentiated approach and local market expertise by investing in and partnering with specialist operators to create opportunities in hard-to-access sectors.

 

About Health Wave Partners

Health Wave Partners is a Chicago-based housing platform, investing to deliver modern, best-in-class accommodation for seniors alongside experienced operators. It is supported in this goal through its strategic partnership with Macquarie Asset Management (MAM). MAM’s differentiated real estate strategy focuses on investing into specialist operating platforms. Through the partnership, Health Wave Partners is supported by access to MAM’s deep resources and expertise.

Health Wave Partners’ highly experienced team invests in high-quality properties and experienced operators in regions with strong demographic and economic fundamentals to deliver compelling risk-adjusted returns.

By Vivien Lou Chen

‘The big risk is that market participants balk at the amount of bills that are coming to the market,’ said strategist Lawrence Gillum of LPL Financial

Investors have been enjoyed a more than monthlong rally in the 30-year U.S. government bond that pushed its yield below 5% in June, partly as the result of growing expectations for 2025 rate cuts by the Federal Reserve.

June’s bond-market rally, however, could give way to a different trading dynamic in July that results in a fresh round of volatility in the government’s shortest-term debt obligations, known as Treasury bills.

This volatility showed signs of beginning to surface on Monday, with a spike in the yield on the 1-month Treasury bill BX:TMUBMUSD01M to almost 4.19%.

For much of this year, longer-duration U.S. government bonds took the brunt of investors’ concerns about the fiscal outlook and a rising federal deficit, as demonstrated by the sharp selloff seen in the 30-year bond in April and May. Bond yields and prices move in the opposite direction.

Helping to ease those concerns lately have been stable inflation data, expectations for a wobbly labor market going forward, rising market-implied probabilities of Fed rate cuts starting as soon as July, and speculation that President Donald Trump may pick a successor to Fed Chair Jerome Powell who might lean more toward lowering interest rates sooner, said Derek Tang, an economist at Monetary Policy Analytics in Washington.

Now, changes being made in the Senate to Trump’s big bill of tax breaks and spending cuts could increase the national deficit by almost $3.3 trillion between 2025 and 2034, according to the nonpartisan Congressional Budget Office. Government deficits require increased issuance of Treasurys to finance the shortfall between government spending and revenue. One of the most important questions now is how much of that issuance will come in the form of short-term T-bills that mature in a year or less, or longer-dated maturities anywhere between two to 30 years out. Trump, who wants to sign a final version of the bill by July 4, indicated during a press conference last week that he favors using T-bills over longer-dated Treasurys, saying that “I’ve instructed my people not to do any debt beyond nine months or so.” Read: A 2-month rally pushed the stock market to record highs – but watch for these risks in JulyIf the president’s bill gets through Congress and signed into law, concerns about too much supply of Treasurys and possibly not enough demand will be back in play, albeit in the shortest-term part of the market, said Lawrence Gillum, the Charlotte, North Carolina-based chief fixed-income strategist for broker-dealer LPL Financial. These issues have the potential to translate into higher short-term T-bill rates than would otherwise be the case, and a lack of investor demand at future bill auctions, he said. However, yields on longer-dated Treasurys could fall, offering some relief for investors, Gillum added. “The big risk is that market participants balk at the amount of bills that are coming to the market,” he said via phone. “They may not want to digest all of that. This could be disruptive to the front end of the curve and move yields there higher.” He notes that the Treasury Borrowing Advisory Committee, which advises the U.S. Treasury, has recommended that up to 20% or slightly higher, of the government’s outstanding debt be in the form of bills, but this number could increase. If the bill doesn’t make it through Congress or into law, “then we have to worry about the debt-ceiling limit,” Gillum said, noting that the U.S. risks running out of enough cash to fund all its obligations in August without a new debt-limit deal. The debt ceiling is the limit placed on the total amount of money that the government is authorized to borrow to meet existing obligations. If Congress fails to increase or suspend this limit, “Treasury won’t have the money to pay its bills,” potentially at some point in August, which could have the most negative impact on bills set to mature that month, the strategist said

Monday’s trading session was relatively quiet due to a lack of major data releases, and appeared to be largely driven by month-end buying that pushed one- BX:TMUBMUSD01Y through 30-year yields BX:TMUBMUSD30Y lower. Meanwhile, all three major U.S. stock indexes DJIA SPX COMP advanced in New York afternoon trading.

According to Tang of Monetary Policy Analytics, “we might be heading into a very choppy period” for the Treasury market.

The recent decline in bond yields gives the Trump administration “a little more wiggle room in terms of financing costs so that if there is a plan to increase borrowing, you could argue that the overall cost could be lower because yields are so low,” Tang said via phone on Monday.

Still, volatility in T-bills can’t be completely ruled out if Trump’s bill is enacted into law. However, “you could convince the market that short-term yields will be lower even with greater supply, while longer-run yields could rise on any loss of Fed credibility or if inflation expectations blow up.”

Read: The wrong kind of Fed rate cuts are coming, says JPMorgan. What that means for stocks, bonds and the dollar.

-Vivien Lou Chen

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

  (END) Dow Jones Newswires

  06-30-25 1339ET
Copyright (c) 2025 Dow Jones & Company, Inc.

VANCOUVER, British Columbia, June 30, 2025 (GLOBE NEWSWIRE) — Cornish Metals Inc. (AIM/TSX-V: CUSN) (“Cornish Metals” or the “Company”), is pleased to announce the results of its 2025 Annual General and Special Meeting of the shareholders of the Company held via live audio teleconference on June 30, 2025 (the “Meeting”). A total of 909,699,906 common shares of the Company were voted at the Meeting, representing approximately 72.64% of the issued and outstanding common shares as at the record date of the Meeting. All resolutions were passed.

Meeting Results

Capitalised terms not otherwise defined in this news release shall have the meanings ascribed thereto in the Company’s Management Proxy Circular dated May 16, 2025.

The voting results of the business of the Meeting are summarised as follows:

MOTION	Votes For	% For	Votes Against	% Against	Votes Withheld	% Withheld
Number of directors set at eight	856,399,865	94.14	53,270,628	5.86	0	0
Election of Lodewyk Daniel Turvey	876,314,283	96.58	31,025,459	3.42	0	0
Election of Patrick F.N. Anderson	854,070,569	94.13	53,269,172	5.87	0	0
Election of Kenneth A. Armstrong	907,264,038	99.99	75,703	0.01	0	0
Election of John F.G. McGloin	854,076,294	94.13	53,263,447	5.87	0	0
Election of Stephen T. Gatley	907,252,657	99.99	87,085	0.01	0	0
Election of Anthony Trahar	907,257,380	99.99	82,362	0.01	0	0
Election of Samantha Hoe-Richardson	854,077,020	94.13	53,262,721	5.87	0	0
Election of James Whiteside	907,264,210	99.99	75,531	0.01	0	0
Appointment of Auditors	909,630,842	99.99	0	0.00	69,062	0.01
Approval of General Share Authority	907,107,016	99.97	255,447	0.03	0	0
Approval of Pre-Emptive Disapplication Authority	850,587,460	93.74	56,775,004	6.26	0	0

ABOUT CORNISH METALS

Cornish Metals is a dual-listed mineral exploration and development company (AIM and TSX-V: CUSN) that is advancing the South Crofty tin project towards production. South Crofty:

• is a historical, high-grade, underground tin mine located in Cornwall, United Kingdom and benefits from existing mine infrastructure including multiple shafts that can be used for future operations;
• is permitted to commence underground mining (valid to 2071), construct a new processing facility and for all necessary site infrastructure;
• would be the only primary producer of tin in Europe or North America. Tin is a Critical Mineral as defined by the UK, American, and Canadian governments as it is used in almost all electronic devices and electrical infrastructure. Approximately two-thirds of the tin mined today comes from China, Myanmar and Indonesia;
• benefits from strong local community, regional and national government support with a growing team of skilled people, local to Cornwall, and could generate up to 320 direct jobs.

ON BEHALF OF THE BOARD OF DIRECTORS

“Don Turvey”
Don Turvey
CEO and Director

Engage with us directly at our investor hub. Sign up at: https://investors.cornishmetals.com/link/0PQ9GP     

For additional information please contact:

Cornish Metals	Fawzi Hanano Irene Dorsman	investors@cornishmetals.com info@cornishmetals.com Tel: +1 (604) 200 6664
SP Angel Corporate Finance LLP (Nominated Adviser & Joint Broker)	Richard Morrison Charlie Bouverat Grant Barker	Tel: +44 203 470 0470
Hannam & Partners (Joint Broker)	Matthew Hasson Andrew Chubb Jay Ashfield	cornish@hannam.partners Tel: +44 207 907 8500
BlytheRay (Financial PR)	Tim Blythe  Megan Ray	cornishmetals@blytheray.com Tel: +44 207 138 3204

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Caution regarding forward looking statements

This news release may contain certain “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”). Forward-looking statements include predictions, projections, outlook, guidance, estimates and forecasts and other statements regarding future plans, the realisation, cost, timing and extent of mineral resource or mineral reserve estimates, estimation of commodity prices, currency exchange rate fluctuations, estimated future exploration expenditures, costs and timing of the development of new deposits, success of exploration activities, permitting time lines, requirements for additional capital and the Company’s ability to obtain financing when required and on terms acceptable to the Company, future or estimated mine life and other activities or achievements of Cornish Metals. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “forecast”, “expect”, “potential”, “project”, “target”, “schedule”, “budget” and “intend” and statements that an event or result “may”, “will”, “should”, “could”, “would” or “might” occur or be achieved and other similar expressions and includes the negatives thereof. All statements other than statements of historical fact included in this news release, are forward-looking statements that involve various risks and uncertainties and there can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements.

Forward-looking statements are subject to risks and uncertainties that may cause actual results to be materially different from those expressed or implied by such forward-looking statements, including but not limited to: risks related to receipt of regulatory approvals, risks related to general economic and market conditions; risks related to the availability of financing; the timing and content of upcoming work programmes; actual results of proposed exploration activities; possible variations in Mineral Resources or grade; projected dates to commence mining operations; failure of plant, equipment or processes to operate as anticipated; accidents, labour disputes, title disputes, claims and limitations on insurance coverage and other risks of the mining industry; changes in national and local government regulation of mining operations, tax rules and regulations. The list is not exhaustive of the factors that may affect Cornish’s forward-looking statements.

Cornish Metals’ forward-looking statements are based on the opinions and estimates of management and reflect their current expectations regarding future events and operating performance and speak only as of the date such statements are made. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ from those described in forward- looking statements, there may be other factors that cause such actions, events or results to differ materially from those anticipated. There can be no assurance that forward-looking statements will prove to be accurate and accordingly readers are cautioned not to place undue reliance on forward-looking statements. Cornish Metals does not assume any obligation to update forward-looking statements if circumstances or management’s beliefs, expectations or opinions should change other than as required by applicable law.

Salmonella-Related Recalls

June 4: TGD Cuts, LLC of Jessup, Maryland, recalled fresh cucumbers and related products containing cucumbers from Bedner Growers Inc. due to potential Salmonella contamination. These items, with use-by dates from May 19 to 28, 2025, were distributed across Maryland, Virginia, Pennsylvania, New Jersey, and North Carolina. The products are believed to be past their shelf life, and no illnesses have been reported.¹

June 6: August Egg Company in Hilmar, California, recalled approximately 1.7 million dozen brown cage-free and organic eggs due to possible contamination with Salmonella Enteritidis. Distributed between February 3 and May 15, 2025, these eggs bore plant codes P-6562 or CA-5330 and were sold in multiple western and midwestern states, including at major retailers such as Walmart and Safeway. The company ceased sales of fresh shell eggs and redirected eggs to pasteurization facilities.²

June 13: Fuentes Farms LLC of McAllen, Texas, recalled 71 boxes of fresh cucumbers (Lot #357) potentially contaminated with Salmonella. Distributed through flea markets in McAllen and Alamo, Texas, between May 31 and June 3, these cucumbers were packaged in 40 lb boxes with Fuentes Farm labels. No illnesses were reported. This recall was prompted by an FDA routine sample detecting the bacteria.³

Salmonella infections can cause fever, diarrhea, nausea, vomiting, and severe complications, especially in young children, elderly, and immunocompromised individuals.^1,2,3

Listeria-Related Recalls

June 10: Bornstein Seafoods Inc, Bellingham, Washington, recalled 44,550 pounds of cooked and peeled ready-to-eat coldwater shrimp due to potential Listeria monocytogenes contamination. Distributed mainly in the Pacific Northwest and British Columbia, these products were pulled after routine testing. No illnesses were reported.³

June 11: Hofood99 Inc. of Brooklyn, New York, recalled 200g packages of Enoki mushrooms nationwide following detection of Listeria monocytogenes by Michigan state authorities. Packaged in green plastic bags, these mushrooms are marked with UPC 6 976532 310051. Consumers were advised to destroy or return the product.⁴

June 21: Face Rock Creamery of Bandon, Oregon, is voluntarily recalling two lots of its Vampire Slayer Garlic Cheddar Curds sold at Trader Joe’s in Northern California and Northern Nevada due to potential contamination with Listeria monocytogenes, which can cause serious illness, especially in vulnerable populations. No illnesses have been reported. Consumers are urged not to eat the product and to return it for a full refund. The recall follows routine testing that detected the bacteria, and the company is working with regulators to address the issue.⁵

Listeria monocytogenes poses serious risks to young children, elderly, pregnant women, and immunocompromised individuals, causing symptoms such as high fever, headache, nausea, and, in pregnant women, miscarriage or stillbirth.^3,4,5

Other Recalls

June 10: P East Trading Corp, Bronx, New York, recalled uneviscerated salted smoked split herring sold in New York, New Jersey, and Connecticut due to possible contamination with Clostridium botulinum. The product, packaged in 18-pound wooden boxes and made in Canada, was found to be over 5 inches long and improperly eviscerated, increasing botulism risk. Clostridium botulinum produces a toxin that causes botulism, a severe and potentially fatal illness characterized by symptoms including muscle weakness, dizziness, double vision, difficulty speaking or swallowing, and respiratory failure. Consumers were warned not to consume the product regardless of appearance or odor.⁶

June 17: Medtech Products Inc of Tarrytown, New York, announced a nationwide recall of five lots of Little Remedies Honey Cough Syrup due to contamination with Bacillus cereus. Distributed from December 2022 through June 2025, these syrups can cause foodborne illness with nausea, vomiting, and diarrhea; though typically mild, high exposure can be fatal.⁷

References
1. US Food and Drug Administration. Company Announcement: Tgd Cuts, LLC Initiated Voluntary Recall of Cucumber from Bedner Growers Inc., Which Had the Potential to Be Contaminated with Salmonella. FDA.gov. Published June 4, 2025. Accessed June 30 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/tgd-cuts-llc-initiated-voluntary-recall-cucumber-bedner-growers-inc-which-had-potential-be

2. US Food and Drug Administration. Company Announcement: August Egg Company Recalls Shell Eggs Because of Possible Health Risk. FDA.gov. Published June 6, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/august-egg-company-recalls-shell-eggs-because-possible-health-risk

3. US Food and Drug Administration. Company Announcement: Fuentes Farms, LLC Recalls Product Because of Possible Health Risk. FDA.gov. Published June 16, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fuentes-farms-llc-recalls-product-because-possible-health-risk

4. US Food and Drug Administration. Company Announcement: Bornstein Seafoods Inc Recalls Cooked & Peeled Ready-To-Eat Coldwater Shrimp Meat Because of Possible Health Risk. FDA.gov. Published June 10, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bornstein-seafoods-inc-recalls-cooked-peeled-ready-eat-coldwater-shrimp-meat-because-possible-health

4. US Food and Drug Administration. Company Announcement: Hofood99 Inc Recalls Enoki Mushroom Due to Possible Health Risk. FDA.gov. Published June 11, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/hofood99-inc-recalls-enoki-mushroom-due-possible-health-risk

5. Face Rock Creamery voluntarily recalls Vampire Slayer Garlic Cheddar Curds due to potential Listeria contamination. FDA. Published June 21, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/face-rock-creamery-voluntarily-recalls-vampire-slayer-garlic-cheddar-curds

6. US Food and Drug Administration. Company Announcement: P. East Trading Corp Distributors Issues Alert on Uneviscerated ‘Salted Smoked Split Herring’ Due to Potential Clostridium Botulinum Contamination. FDA.gov. Published June 10, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/p-east-trading-corp-distributors-issues-alert-uneviscerated-salted-smoked-split-herring-due

7. US Food and Drug Administration. Company Announcement: Medtech Products Inc. Issues Nationwide Recall of Little Remedies® Honey Cough Syrup Due to Microbial Contamination. FDA.gov. Published June 18, 2025. Accessed June 30, 2025. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/medtech-products-inc-issues-nationwide-recall-little-remediesr-honey-cough-syrup-due-microbial

Renier Brentjens, MD, PhD, one of the pioneers of cellular therapies for cancer, gave invited talks at national events this month for the Damon Runyon Cancer Research Foundation and The New York Academy of Sciences.

At their annual breakfast on June 11, the cancer research foundation honored Dr. Brentjens for his critical role in the impact on cancer research, specifically CAR T cell therapy. Dr. Brentjens, a past recipient of the Damon Runyon Clinical Investigator Award, gave an invited address as featured honoree at the event.

“A founder of CAR T therapy, he was among the first to demonstrate that a patients immune cells could be ‘trained’ to target their cancer cells- a premise that now underlies the work of many current Damon Runyon scientists,” the Damon Runyon Cancer Research Foundation says. “Some (resarchers) are working to develop CAR T cells that persist longer in the body; others are using big data to optimize CAR T cell design and lower costs; all stand on the shoulder of Dr. Brentjens and his colleagues, whose impact extends beyond their scientific contributions.”

Dr. Brentjens also addressed The New York Academy of Sciences during its Frontiers in Cancer Immunotherapy symposium last week. The 12th annual event allows attendees to amplify research efforts, form professional connections and participate in conversations. Dr. Brentjens served on the scientific organizing committee for the event, and spoke on ways to deliver cellular therapies without depleting the immune system.

Prior to joining Roswell Park Comprehensive Cancer Center in 2021, Dr. Brentjens studied medicine at the University at Buffalo UB), completed a residency at Yale New Haven Hospital and served as a medical oncology fellow at Memorial Sloan Kettering Cancer Center. He then became the principal investigator of his own laboratory, where he focused on the development of CAR modified T-cells. He serves as Roswell Park’s Deputy Director, Chair of the Department of Medicine and The Katherine Anne Gioia Endowed Chair in Cancer Medicine. He holds a secondary appointment with UB’s Jacobs School of Medicine and Biomedical Sciences.

In 2024, Dr. Brentjens was one of four recipients of the prestigious Warren Alpert Foundation Prize for his role in the development of CAR T cells as a platform for treating cancer.

FOUR food manufacturers have pledged to eliminate synthetic dyes from products sold in the US by 2028, following on from health secretary Robert F Kennedy (RFK) Jr’s proposal to ban them entirely.

Kraft Heinz, General Mills, and Conagra Brands have announced plans to eliminate synthetic dyes from all US products by the end of 2027, while Nestlé said last week it would achieve this within the next 12 months.

Currently, seven certified Food, Drug, and Cosmetic (FD&C) dyes are approved for use in foods in the US by the Food and Drug Administration (FDA), including Yellow No. 5 (tartrazine). In March, RFK Jr warned food and drink manufacturers of his intent to ban all seven dyes entirely.  

Kraft Heinz said they will replace the synthetic dyes either with natural colourings, such as dyes from beetroots and grape skins, or by “reinventing” colours and shades if natural alternatives do not exist. They also said they will remove colourings without replacement “where it is not critical to the consumer experience”. Kraft Heinz says that around 90% of its US products by net sales are already free of synthetic dyes. General Mills, meanwhile, says 85% of its US products are already dye-free.  

In addition, Kraft Heinz will immediately cease the launch of new US products containing synthetic dyes.

Conagra, known for its Birds Eye and Healthy Choice brands, has also said it plans to remove synthetic dyes from all frozen products sold in the US by the end of 2025, while making a pledge to stop offering dye-containing products to US schools by the start of the 2026-27 school year. General Mills, which makes brands including Cheerios cereal and Häagen-Dazs ice cream, has made the same promise, adding that “nearly all” of its school products are already free of synthetic dyes.

Jeff Harmening, CEO of General Mills, said: “Across the long arc of our history, General Mills has moved quickly to meet evolving consumer needs, and reformulating our products portfolio to remove certified colours is yet another example”.  

Across the pond

The adverse health impacts of the seven FD&C dyes are debated. While the previous US administration banned Red No. 3 (erythrosine) in January, citing a 30-year-old study linking it to cancer in rats, the FDA maintained its belief that it was unlikely to have the link in humans.

The most cited health concern linked to synthetic dyes is their potential impact on children’s behaviour. A 2022 report by the National Institutes of Health reviewed 25 studies and found that just over half suggested a connection between food dye exposure and behavioural issues in children. However, only one of the seven dyes being phased out of US products – Green No. 3 (fast green) – is banned for use in food products in Europe.

More serious health risks are thought to arise from other food additives banned in Europe but certified in the US. These include potassium bromide, added to white flour to make dough rise higher and banned in the UK since 1990 owing to cancer links in animals; azodicarbonamide, a whitening agent used in dough and banned in the EU for over 15 years as a possible carcinogen; butylated hydroxyanisole and butylated hydroxytoluene, used as preservatives and banned in Europe as possible carcinogens.

The colouring titanium dioxide is also banned in Europe, owing to potential genotoxicity, but not in the US. It does not come under the FDA’s seven FD&C dyes and will be unaffected by the changes planned by the four food giants.  

Oxylanthanum carbonate (OLC) received a Complete Response Letter (CRL) from the FDA for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis, according to an announcement from Unicycive Therapeutics.¹ OLC is a next-generation lanthanum-based phosphate binder that utilizes proprietary nanoparticle technology.

“We plan to immediately seek a Type A meeting with the Agency to gain alignment on the best strategy to ensure rapid resolution of the CRL,” Shalabh Gupta, MD, chief executive officer of Unicycive, said in the statement.

Hyperphosphatemia, or high phosphate levels in the blood, impacts nearly all patients with end-stage renal disease and is linked to higher mortality among those on dialysis.² Untreated, it can lead to serious complications like cardiovascular disease. Despite available phosphate binders, about 75% of dialysis patients in the US do not meet recommended phosphorus levels.

If approved in the future, OLC has the potential to advance treatment by reducing the pill burden that currently impacts adherence among this patient population, who often face a regimen that can involve up to 12 pills daily, according to Unicycive. In addition to reduced pill count per dose, OLC is designed to be easily swallowed rather than chewed.

On June 10, Unicycive Therapeutics announced that the FDA had identified manufacturing deficiencies at a third-party subcontractor involved in producing OLC and that the agency had paused any label discussions related to the drug.³ At the time, Unicycive stated it was working with its partners to address the concerns; according to today’s statement,¹ this citation was unrelated to OLC and no other technical concerns related to the submitted CMC documentation or testing of OLC itself were noted by the FDA in the application review.

“With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA,” Gupta continued.

Reduced Treatment Burden; Improved Adherence

Patient-reported outcomes from the phase 2 UNI-OLC-201 study presented at the 2025 National Kidney Foundation Spring Clinical Meetings suggest that OLC may significantly improve treatment satisfaction, reduce pill burden, and enhance adherence among patients with CKD on dialysis.⁴ The open-label, single-arm, multicenter trial enrolled 86 dialysis patients with elevated serum phosphate levels to assess the impact of OLC on adherence and patient experience compared with their existing phosphate binder regimens.

At baseline, patients reported a median daily intake of six phosphate binder tablets, with only 58% indicating adherence to their prescribed treatment. After a washout period and a 10-week regimen of OLC, which included dose titration followed by a maintenance phase, patients reported taking a median of just three OLC tablets per day. Notably, 70% of patients were adherent to OLC treatment, reflecting a meaningful improvement over pre-trial adherence rates.

The results further showed that 79% of participants preferred OLC over their previous phosphate binder, and nearly all (98%) described OLC as easy to take, a stark contrast to the 38% who found their prior medication easy to use. Patient satisfaction with treatment also increased considerably, with 89% reporting satisfaction with OLC compared to 49% who were satisfied with their earlier phosphate binder.

The NDA for OLC was submitted under the FDA’s 505(b)(2) pathway, leveraging data from 3 clinical studies and multiple preclinical evaluations.² The product is protected by a broad global patent portfolio, with exclusivity extending through at least 2031 and possibly until 2035 with patent term extensions.

Unicycive received a waiver for the PDUFA application fees, saving the company approximately $4 million as it prepares for potential commercialization of OLC in the second half of 2025. The global market for hyperphosphatemia treatments is estimated to exceed $2.5 billion, with the US market accounting for over $1 billion of that total.

References

1. Unicycive Therapeutics announces receipt of Complete Response Letter for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. News release. Unicycive Therapeutics. June 30, 2025. Accessed June 30, 2025. https://www.globenewswire.com/news-release/2025/06/30/3107365/0/en/Unicycive-Therapeutics-Announces-Receipt-of-Complete-Response-Letter-for-Oxylanthanum-Carbonate-for-the-Treatment-of-Hyperphosphatemia-in-Patients-with-Chronic-Kidney-Disease-on-Di.html

2. Unicycive Therapeutics announces U.S. FDA acceptance of the New Drug Application (NDA) for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. News release. Unicycive Therapeutics. November 11, 2024. Accessed June 24, 2025. https://www.globenewswire.com/en/news-release/2024/11/11/2978178/0/en/Unicycive-Therapeutics-Announces-U-S-FDA-Acceptance-of-the-New-Drug-Application-NDA-for-Oxylanthanum-Carbonate-OLC-for-the-Treatment-of-Hyperphosphatemia-in-Patients-with-Chronic-K.html

3. Unicycive provides update on New Drug Application for oxylanthanum carbonate to treat hyperphosphatemia in patients with chronic kidney disease on dialysis. News release. Unicycive Therapeutics. June 10, 2025. Accessed June 24, 2025. https://www.globenewswire.com/news-release/2025/06/10/3096422/0/en/Unicycive-Provides-Update-on-New-Drug-Application-for-Oxylanthanum-Carbonate-to-Treat-Hyperphosphatemia-in-Patients-with-Chronic-Kidney-Disease-on-Dialysis.html

4. Brooks A. Oxylanthanum carbonate may offer desirable alternative to current phosphate binders. HCPLive. April 10, 2025. Accessed June 24, 2025. https://www.hcplive.com/view/oxylanthanum-carbonate-may-offer-desirable-alternative-current-phosphate-binders