Carl's Drug Store celebrates 200 years as America's oldest pharmacy still in operation
As a significant piece of the community's past, present and future, Carl's Drug Store is highlighted with a place of honor on this year's badge for the town's 42nd Triennial Old Home Week being held on Aug. 2 to 9. The celebration is held every three years with the aim of uniting residents and alumni to honor its storied heritage.
An anniversary celebration is planned at the store, now located at 145 N. Antrim Way, during Old Home Week. It will include remarks by pharmacist Wayne Myers, who has owned Carl's since 2023.
The drug store also is featured in an exhibit at Allison-Antrim Museum from the collection of pharmacist Frank Ervin, the first non-Carl family member to own the drug store.
Carl's Drug Store in Greencastle: Oldest drug store in U.S. remains independent under new ownership
Learn about the history of Carl's Drug Store
Adam Carl was born in Hanover on Dec. 16, 1800, and later lived in Carlisle, where he became interested in medicine, according to information on the Allison-Antrim Museum website compiled by Ervin and Bonnie Shockey, the museum president.
After moving to Greencastle and opening Carl's Drug Store in 1825, he went on to graduate from Washington Medical College in Baltimore in 1829.
An 1851 advertisement in the Conococheague Herald, Greencastle's weekly newspaper, indicated Dr. A. Carl and his son, William, had 'a full and well selected assortment of fresh drugs, medicines, oils, paints, glassware, cigars, chewing tobacco' etc. and assured the public that they 'made the sale of medicines a matter of conscience and not of profit.'
William Carl assumed management of the store when his father turned to medicine full-time in 1854. Adam Carl treated wounded Confederates as they passed through Greencastle following the Battle of Gettysburg.
In ensuing years, family members leading the store included Adam Carl's son-in-law, Dr. Franklin A. Bushey; grandson, Charles B. Carl; and great-grandson Edward R. Carl, who operated it from 1935 until selling to Ervin.
Ervin's father, the late Richard J. Ervin, was a pharmacist at Carl's for many years, and Frank Ervin was a pharmacy tech and clerk when he was young. He purchased the business, then located at 6 E. Baltimore St., on Jan. 1, 1974, while in his senior year at Philadelphia College of Pharmacy.
Ervin moved the business in 1999 and sold it to Rodger Savage in 2013. Ten years later, Savage sold the drug store to Myers, who also operates Norland Avenue Pharmacy in neighboring Chambersburg.
Carl's Drug Store was identified as third among the oldest continuously operating drug stores in an article 'Drug Topics: Voice of the Pharmacist' did for the bicentennial of the United States in 1776.
The other two no longer exist, Ervin said. The 2007 article 'America's oldest pharmacy: Carl's Drug keeps on ticking' by the same trade publication said, 'Its amazing 182-year longevity has earned it the unofficial honor of being America's oldest pharmacy continuously serving the same community.'
What to know about the Old Home Week badge
Every three years, a piece of local history is highlighted on the OHW badge to reflect the celebration's mission: 'Honor the past, encourage the present and grow the future.'
The 2025 badge features a picture of Adam Carl's grandson Charles B. Carl outside the store. It is accented with green and burgundy ribbons.
A badge costs $6 and provides admission to 99% percent of the planned events.
Here's what's planned at Carl's Drug Store
A 200th anniversary celebration will be held on Friday, Aug. 8, from 9 a.m. to 6 p.m. at Carl's Drug Store.
'This isn't just a celebration of our store – it's a celebration of independent pharmacy, community, history and the generations of families who have trusted us with their care,' said Myers. 'We are deeply honored to carry forward this tradition.'
At noon, there will be a program featuring a message from Myers and a presentation by state Sen. Doug Mastriano honoring Carl's Drug Store for its service and legacy.
There will be free ice cream from Scoops for the first 200 guests, and local food trucks will be on hand.
'Serving the community since 1825, Carl's Drug Store has remained a pillar of trusted care, personalized service and hometown pride,' says a news release for the event. 'The public is invited to join in this once-in-a-lifetime celebration, packed with special events, local flavor and heartfelt appreciation.
Anniversary highlights during the day also include 20% off all regularly priced items in the storefront, a free commemorative ornament with every purchase and door prize giveaways, including a $200 cash grand prize.
'Whether you're a longtime customer or a first-time visitor, all are welcome to come enjoy the festivities, take part in the giveaways and help mark a truly historic milestone,' the new release says.
Going back in time
Part of Ervin's collection of Carl's Drug Store memorabilia is being featured in the museum's summer exhibit.
Visitors can see old-time pharmacy items including mortars and pestles and other items used to compound or mix drugs, as well as scales, signs, prescriptions, bottles, vials, ledgers, advertising promotions, drug containers and more.
Hanging on the walls are diplomas and licensing documents for the various men involved in the operation of Carl's Drug Store over the years, highlighted by an 1829 image of a young Dr. Adam Carl.
For more information, visit the website at www.greencastlemuseum.org or follow the museum on Facebook at Allison-Antrim Museum, Inc.
Hashtags

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Business Wire
a day ago
- Business Wire
HealthStream Announces Second Quarter 2025 Results
NASHVILLE, Tenn.--(BUSINESS WIRE)--HealthStream, Inc. (the "Company") (Nasdaq: HSTM), a leading healthcare technology platform company for workforce solutions, announced today results for the second quarter ended June 30, 2025. Revenues of $74.4 million in the second quarter of 2025, up 4.0% from $71.6 million in the second quarter of 2024, setting a new Company record for quarterly revenue Operating income of $5.9 million in the second quarter of 2025, up 33.4% from $4.4 million in the second quarter of 2024 Net income of $5.4 million in the second quarter of 2025, up 29.3% from $4.2 million in the second quarter of 2024 Earnings per share (EPS) of $0.18 per share (diluted) in the second quarter of 2025, up from $0.14 per share (diluted) in the second quarter of 2024 Adjusted EBITDA 1 of $17.6 million in the second quarter of 2025, up 11.3% from $15.8 million in the second quarter of 2024 Board of Directors authorized a share repurchase program on May 8, 2025 to repurchase up to $25.0 million of outstanding shares of common stock, with $18.1 million repurchased during the second quarter Board of Directors declared a quarterly cash dividend of $0.031 per share, payable on August 29, 2025 to holders of record on August 18, 2025 1 Adjusted EBITDA is a non-GAAP financial measure. A reconciliation of adjusted EBITDA to net income and disclosure regarding why we believe adjusted EBITDA provides useful information to investors is included later in this release. Expand Financial Results: Second Quarter 2025 Compared to Second Quarter 2024 Revenues for the second quarter of 2025 increased by $2.8 million, or 4.0%, to $74.4 million, compared to $71.6 million for the second quarter of 2024. Subscription revenues increased by $2.9 million, or 4.2%, and professional services revenues decreased by $0.1 million compared to the second quarter of 2024. Operating income was $5.9 million for the second quarter of 2025, up 33.4% from $4.4 million in the second quarter of 2024. The improvement in operating income was primarily attributable to increased revenues, sublease income associated with the sublease that commenced during the second quarter of 2025, and lower bad debt expense. These improvements were partially offset by higher expenses to support investments in several areas of the business, primarily in our platform and SaaS applications, resulting in higher labor costs, cloud hosting, third-party software, and amortization of capitalized software costs, along with increased royalties. Net income was $5.4 million in the second quarter of 2025, up 29.3% from $4.2 million in the second quarter of 2024, and EPS was $0.18 per share (diluted) in the second quarter of 2025, up from $0.14 per share (diluted) in the second quarter of 2024. Adjusted EBITDA was $17.6 million for the second quarter of 2025, up 11.3% from $15.8 million in the second quarter of 2024. At June 30, 2025, the Company had cash, cash equivalents, and marketable securities of $90.6 million. The Company does not have any outstanding indebtedness from borrowed money. Capital expenditures incurred during the second quarter of 2025 were $9.2 million. Year-to-Date 2025 Compared to Year-to-Date 2024 For the six months ended June 30, 2025, revenues were $147.9 million, an increase of 2.5% over revenues of $144.3 million for the first six months of 2024. Operating income for the first six months of 2025 increased by 1.6% to $10.3 million, compared to $10.1 million for the first six months of 2024. The increase in operating income was primarily attributable to higher revenues, sublease income associated with the sublease that commenced during the second quarter of 2025, and lower bad debt expense, partially offset by higher expenses to support investments in several areas of the business, primarily in our platform and SaaS applications, resulting in higher labor costs, cloud hosting, third-party software, and amortization of capitalized software. Net income for the first six months of 2025 increased to $9.7 million, compared to $9.4 million for the first six months of 2024. Earnings per share were $0.32 per share (diluted) for the first six months of 2025, compared to $0.31 per share (diluted) for the first six months of 2024. Adjusted EBITDA increased by 2.8% to $33.8 million for the first six months of 2025, compared to $32.9 million for the first six months of 2024. Other Business Updates On May 8, 2025, the Company announced a share repurchase program approved by the Board of Directors under which the Company is authorized to repurchase up to $25.0 million of its outstanding shares of common stock. Pursuant to this authorization, repurchases may be made from time to time in the open market, including under a Rule 10b5-1 plan, through privately negotiated transactions, or otherwise. During the second quarter of 2025, the Company repurchased shares valued at $18.1 million pursuant to this authorization, and the Company continued to repurchase shares pursuant to this authorization during the third quarter, completing the program in July by repurchasing shares valued at $6.9 million. The share repurchase program terminated in July when the maximum dollar amount was expended. On August 4, 2025, the Board of Directors approved a quarterly cash dividend under the Company's dividend policy of $0.031 per share, payable on August 29, 2025 to holders of record on August 18, 2025. Financial Outlook for 2025 The Company is updating its guidance for 2025 for certain of the measures set forth below. For a reconciliation of projected adjusted EBITDA, a non-GAAP financial measure defined later in this release, to projected net income (the most comparable GAAP measure) for 2025, see the table included on page nine of this release. The Company's guidance for 2025, as set forth above, reflects the Company's assumptions regarding, among other things, expectations for new sales and renewals. This consolidated guidance does not include the impact of any acquisitions or dispositions that we may complete during 2025, gains or losses from changes in the fair value of non-marketable equity investments, or impairment of long-lived assets. Commenting on HealthStream's results, Robert A. Frist, Jr., Chief Executive Officer, HealthStream, said, 'Our financial performance in the second quarter of 2025 showed year-over-year increases in each of the major categories we highlight in our earnings release, including record quarterly revenues of $74.4 million, up four percent over the second quarter of last year. As we kick-off the second half of the year, I believe HealthStream's solutions are well positioned to continue helping healthcare organizations achieve greater workflow efficiencies, which, at this time, is of heightened focus throughout the healthcare industry.' A conference call with Robert A. Frist, Jr., Chief Executive Officer, Scott A. Roberts, Chief Financial Officer and Senior Vice President, and Mollie Condra, Head, Investor Relations and Communications, will be held on Tuesday, August 5, 2025, at 9:00 a.m. (ET). Participants may access the conference call live via webcast using this link: To participate via telephone, please register in advance using this link: A replay of the conference call and webcast will be archived on the Company's website in the Investor Relations section under 'Events & Presentations.' Use of Non-GAAP Financial Measures This press release presents adjusted EBITDA, a non-GAAP financial measure used by management in analyzing the Company's financial results and ongoing operational performance. In order to better assess the Company's financial results, management believes that net income before interest, income taxes, stock-based compensation, depreciation and amortization, and changes in fair value of, including gains (losses) on the sale of, non-marketable equity investments ('adjusted EBITDA') is a useful measure for evaluating the operating performance of the Company because adjusted EBITDA reflects net income adjusted for certain GAAP accounting, non-cash, and/or non-operating items which may not, in any such case, fully reflect the underlying operating performance of our business. We believe that adjusted EBITDA is useful to investors to assess the Company's ongoing operating performance and to compare the Company's operating performance between periods. In addition, certain short-term cash incentive bonuses and performance-based equity awards are based on the achievement of adjusted EBITDA (as defined in applicable bonus and equity grant documentation) targets. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as a measure of financial performance under GAAP. Because adjusted EBITDA is not a measurement determined in accordance with GAAP, adjusted EBITDA is susceptible to varying calculations. Accordingly, adjusted EBITDA, as presented, may not be comparable to other similarly titled measures of other companies and has limitations as an analytical tool. This non-GAAP financial measure should not be considered a substitute for, or superior to, measures of financial performance, which are prepared in accordance with GAAP. Investors are encouraged to review the reconciliations of adjusted EBITDA to net income (the most comparable GAAP measure), which is set forth below in this release. About HealthStream HealthStream (Nasdaq: HSTM) is the healthcare industry's largest ecosystem of platform-delivered workforce solutions that empowers healthcare professionals to do what they do best: deliver excellence in patient care. For more information about HealthStream, visit or call 615-301-3100. HEALTHSTREAM, INC. Condensed Consolidated Balance Sheets (In thousands) (Unaudited) June 30, December 31, 2025 2024 ASSETS Current assets: Cash and cash equivalents $ 52,102 $ 59,469 Marketable securities 38,517 37,748 Accounts and unbilled receivables, net 31,467 35,322 Prepaid and other current assets 22,310 20,583 Total current assets 144,396 153,122 Capitalized software development, net 44,580 43,370 Property and equipment, net 11,914 10,741 Operating lease right of use assets, net 16,262 17,453 Goodwill and intangible assets, net 240,710 246,768 Other assets 42,286 39,312 Total assets $ 500,148 $ 510,766 LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities: Accounts payable, accrued, and other liabilities $ 27,002 $ 31,466 Deferred revenue 88,376 84,227 Total current liabilities 115,378 115,693 Deferred tax liabilities 15,101 14,596 Deferred revenue, noncurrent 1,198 1,655 Operating lease liability, noncurrent 15,891 17,366 Other long-term liabilities 2,013 2,101 Total liabilities 149,581 151,411 Shareholders' equity: Common stock 235,041 252,432 Accumulated other comprehensive loss (1,278 ) (2,049 ) Retained earnings 116,804 108,972 Total shareholders' equity 350,567 359,355 Total liabilities and shareholders' equity $ 500,148 $ 510,766 Expand HEALTHSTREAM, INC. Condensed Consolidated Statements of Cash Flows (In thousands) (Unaudited) Six Months Ended June 30, June 30, 2025 2024 Operating activities: Net income $ 9,721 $ 9,394 Adjustments to reconcile net income to net cash provided by operating activities: Depreciation and amortization 21,621 20,706 Stock-based compensation 1,940 2,154 Amortization of deferred commissions 6,017 5,956 Deferred income taxes 467 (542 ) Provision for credit losses 391 1,802 Loss on equity method investments 107 82 Other (776 ) (746 ) Changes in assets and liabilities: Accounts and unbilled receivables 3,465 449 Prepaid and other assets (10,324 ) (5,569 ) Accounts payable, accrued, and other liabilities (4,224 ) (9,282 ) Deferred revenue 3,692 2,985 Net cash provided by operating activities 32,097 27,389 Investing activities: Purchases of marketable securities, net of proceeds (27 ) (5,330 ) Proceeds from sale of non-marketable equity investments — 765 Purchase of other investments (500 ) — Purchases of property and equipment (3,372 ) (914 ) Payments associated with capitalized software development (14,500 ) (13,552 ) Net cash used in investing activities (18,399 ) (19,031 ) Financing activities: Taxes paid related to net settlement of equity awards (1,075 ) (861 ) Payment of cash dividends (1,890 ) (1,700 ) Repurchases of common stock (18,121 ) — Net cash used in financing activities (21,086 ) (2,561 ) Effect of exchange rate changes on cash and cash equivalents 21 1 Net (decrease) increase in cash and cash equivalents (7,367 ) 5,798 Cash and cash equivalents at beginning of period 59,469 40,333 Cash and cash equivalents at end of period $ 52,102 $ 46,131 Expand Reconciliation of GAAP to Non-GAAP Financial Measures (1) Operating Results Summary (In thousands) (Unaudited) Three Months Ended June 30, Six Months Ended June 30, 2025 2024 2025 2024 GAAP net income $ 5,389 $ 4,168 $ 9,721 $ 9,394 Interest income (958 ) (944 ) (1,889 ) (1,848 ) Interest expense 25 25 50 49 Income tax provision 1,478 1,132 2,393 2,448 Stock-based compensation expense 836 1,094 1,940 2,154 Depreciation and amortization 10,867 10,370 21,621 20,706 Adjusted EBITDA $ 17,637 $ 15,845 $ 33,836 $ 32,903 (1) This press release presents adjusted EBITDA, which is a non-GAAP financial measure used by management in analyzing its financial results and ongoing operational performance. Expand This press release includes certain forward-looking statements (statements other than solely with respect to historical fact), including statements regarding expectations for financial performance for 2025 and our quarterly dividend policy, that involve risks and uncertainties regarding HealthStream. These statements are based upon management's beliefs, as well as assumptions made by and data currently available to management. This information has been, or in the future may be, included in reliance on the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause the actual results, performance, or achievements to be materially different from future results, performance, or achievements expressed or implied by the forward-looking statements, including as a result of negative economic conditions, changes in U.S. policy, adverse developments impacting the healthcare industry, tariff and trade-related developments, inflationary pressures, geopolitical instability, legal requirements and contractual restrictions which may affect continuation of our quarterly cash dividend policy and the declaration and/or payment of dividends thereunder, which may be modified, suspended, or canceled in any manner and at any time that our Board may deem necessary or appropriate, as well as risks referenced in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, filed on February 28, 2025, the Company's Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed on May 9, 2025, and in the Company's other filings with the Securities and Exchange Commission from time to time. Consequently, such forward-looking information should not be regarded as a representation or warranty or statement by the Company that such projections will be realized. Many of the factors that will determine the Company's future results are beyond the ability of the Company to control or predict. Readers should not place undue reliance on forward-looking statements, which reflect management's views only as of the date hereof. The Company undertakes no obligation to update or revise any such forward-looking statements.


Business Wire
a day ago
- Business Wire
Bristol Myers Squibb's Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL)
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi ® (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The FDA has granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 5, 2025. BMY announces an FDA acceptance of the regulatory filing with priority review for their personalized treatment option for adult patients with relapsed or refractory marginal zone lymphoma #MZL Share 'While initial therapy for MZL can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,' said Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb. 'This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.' The application is based on results from the primary analysis of the MZL cohort in TRANSCEND FL, an open-label, multicenter, Phase 2, single-arm study, which was shared in an oral presentation during the 2025 International Conference on Malignant Lymphoma (ICML) in June 2025. The development progress of Breyanzi reflects BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy. Recently, the FDA approved streamlined patient monitoring requirements and the removal of the REMS program for Breyanzi, easing known barriers to treatment and administration while maintaining patient safety. About TRANSCEND FL TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival. About MZL Marginal zone lymphoma (MZL) is the third most common lymphoma, accounting for about 7% of all non-Hodgkin lymphoma cases. Most patients with MZL are at a median age of 67 years when they are diagnosed. MZL develops when white blood cells cluster together to form lumps in a person's lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large-B-cell lymphoma, a more aggressive lymphoma. About Breyanzi Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient's own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T-cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring. Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy and relapsed or refractory follicular lymphoma (FL) in the third-line plus setting, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) in the third-line plus setting. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, the United Kingdom, and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; and in the EU for the treatment of relapsed or refractory FL after two or more lines of systemic therapy. Bristol Myers Squibb's clinical development program for Breyanzi includes clinical studies in several types of lymphoma. For more information, visit Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Breyanzi (lisocabtagene maraleucel) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether Breyanzi for such indication will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that acceptance of the sBLA does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.


Hamilton Spectator
4 days ago
- Hamilton Spectator
Indigenous communities at far greater risk of death in domestic fires, survey finds
People living in Indigenous communities are five times more likely to die in a fire and 13 times more likely to die in a structure fire — and how nearly a quarter of the blazes started is a mystery, according to a survey of over 4,000 incidents across Canada. A study by the National Research Council (NRC) of Canada looked at 4,089 residential fires in Indigenous communities from 2005 to 2021. Those incidents resulted in 191 deaths and 179 injuries. Of the 4,089 fires examined, 967 had an unknown cause — that's 23.6 per cent. The source of ignition is unknown for 1,447 incidents. For comparison, the percentage of fires with unknown origins in non-Indigenous communities is 11 per cent and unknown source of ignition is 21 per cent. 'For too long, the true scope of fire risk in Indigenous communities has been obscured by a lack of specific, reliable data,' said National Indigenous Fire Safety Council chief operating officer Blaine Wiggins. 'This exploratory study, conducted in-kind by the NRC, provides invaluable initial insights, confirming that generic fire safety data cannot adequately inform targeted interventions for our communities. 'These findings are crucial as we build out the National Incident Reporting System (NIRS) to empower communities with the tailored information they need for effective fire risk reduction planning.' Smoke detectors were found to be inactive five times more frequently in Indigenous communities than in non-Indigenous communities. Particularly, 1,196 homes did not have a smoke alarm at all, and of the 664 homes that did, only 465 of them actually worked. The report notes that it was unknown whether 2,229 of the homes surveyed had smoke detectors or not — that's 55 per cent of the 4,089 residences. Smoking was found to be three times more likely to ignite a fire in Indigenous communities. Fires caused by cooking were nine times more frequent and fires cause by heating systems were 10 times more common. The vast majority of incidents — 3,195 — were in one-to-two family dwellings, with 384 incidents in mobile homes as the second largest number. Of those who were killed in fires or as a result of fires, roughly 60 per cent were adults, 26 per cent were children and 11 per cent were seniors. 'The statistics revealed in this report are not just numbers; they represent preventable tragedies and reflect the systemic challenges faced by our communities,' said Indigenous Fire Marshals Service spokesperson Arnold Lazare. 'Having accurate, community-specific data is fundamental to understanding these risks and developing strategies that genuinely resonate and protect our people.' The report recommends fire officials stop relying on non-Indigenous fire information trends to estimate risks in Indigenous communities, as the evidence shows the differences are substantial. A spokesperson for the NWT's Office of the Fire Marshal, under the Department of Municipal and Community Affairs (MACA), said officials are aware of the report and were taking the findings seriously. 'The focus of MACA's Office of the Fire Marshal, in collaboration with local authorities, is in educating residents in all NWT communities to recognize the fire risks in their homes and the at-risk behaviours that increase the potential of a fire occurring,' said MACA corporate affairs officer Alice Twa. 'Highlighting those risks that may exist and providing information on how best to minimize those risks while raising awareness and building capacity for residents to take action in support of their personal safety in their homes. 'Key educational initiatives focused on residential fire safety include the annual Fire Prevention Week campaign and Test your Smoke Alarm Day every Sept. 28,' Twa added. Error! Sorry, there was an error processing your request. There was a problem with the recaptcha. Please try again. You may unsubscribe at any time. By signing up, you agree to our terms of use and privacy policy . This site is protected by reCAPTCHA and the Google privacy policy and terms of service apply. Want more of the latest from us? Sign up for more at our newsletter page .