RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin, for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC). The approval was based on results from the Phase 3 KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in the study’s primary endpoint of overall survival (OS), reducing the risk of death by 17% (HR=0.83 [95% CI, 0.72-0.95]; one-sided p=0.0034) compared to chemotherapy alone at the trial’s pre-specified final analysis for OS. Median OS was 12.7 months (95% CI, 11.5-13.6) for KEYTRUDA plus chemotherapy versus 10.9 months (95% CI, 9.9-11.6) for chemotherapy alone. This approval marks the sixth indication for KEYTRUDA in gastrointestinal cancers.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and can affect more than one body system simultaneously. Immune-mediated adverse reactions can occur at any time during or after treatment with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions. Early identification and management of immune-mediated adverse reactions are essential to ensure safe use of KEYTRUDA. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or permanently discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see “Selected Important Safety Information” below.

“Cancers of the biliary tract can be highly aggressive tumors, underscoring the need for additional treatment options for the growing number of patients facing this challenging disease,” said Dr. Robin Kate Kelley, professor of clinical medicine in the division of hematology/oncology, University of California, San Francisco. “Today's approval of pembrolizumab in combination with chemotherapy offers patients with locally advanced unresectable or metastatic biliary tract cancer a new immunotherapy regimen that has demonstrated the potential to help these patients live longer.”

“Many patients with biliary tract cancer are diagnosed with locally advanced or metastatic disease, at which point they are not eligible for surgery and face poor survival outcomes with limited treatment options,” said Dr. Marjorie Green, senior vice president and head of late-stage oncology, global clinical development, Merck Research Laboratories. “With this approval, Merck is proud to offer a new treatment option to certain patients with locally advanced unresectable or metastatic biliary tract cancer, and their healthcare providers, that has shown an overall survival benefit compared to chemotherapy alone.”

Study design and additional data supporting the approval

KEYNOTE-966 is a multicenter, double-blind, randomized, placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT04003636) evaluating KEYTRUDA in combination with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic BTC who had not received prior systemic therapy in the advanced disease setting. The trial enrolled 1,069 patients.

Patients were randomized (1:1) to KEYTRUDA (200 mg) on Day 1 plus gemcitabine (1,000 mg/m²) and cisplatin (25 mg/m²) on Day 1 and Day 8 every three weeks (n=533), or placebo on Day 1 plus gemcitabine (1,000 mg/m²) and cisplatin (25 mg/m²) on Day 1 and Day 8 every three weeks (n=536). Study medications were administered via intravenous infusion. Treatment continued until unacceptable toxicity or disease progression. For KEYTRUDA, treatment continued for a maximum of 35 cycles (or approximately 24 months). For gemcitabine, treatment could be continued beyond eight cycles, while for cisplatin, treatment could be administered for a maximum of eight cycles. Administration of KEYTRUDA with chemotherapy was permitted beyond RECIST-defined disease progression if the patient was clinically stable and considered by the investigator to be deriving clinical benefit. Assessment of tumor status was performed at baseline and then every six weeks through 54 weeks, followed by every 12 weeks thereafter.

The major efficacy outcome measure was OS. Additional efficacy outcome measures were progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

At the trial’s pre-specified final analysis for PFS and ORR, KEYTRUDA plus chemotherapy reduced the risk of disease progression or death by 14% (HR=0.86 [95% CI, 0.75-1.00]) compared to chemotherapy alone. Median PFS was 6.5 months (95% CI, 5.7-6.9) for KEYTRUDA plus chemotherapy versus 5.6 months (95% CI, 5.1-6.6) for chemotherapy alone; however, this result did not reach statistical significance at this analysis. The ORR for KEYTRUDA plus chemotherapy was 29% (95% CI, 25-33), with a complete response (CR) rate of 2.1% (n=11) and a partial response (PR) rate of 27% (n=142), and the ORR for chemotherapy alone was 29% (95% CI, 25-33), with a CR rate of 1.3% (n=7) and a PR rate of 27% (n=146). At the trial’s pre-specified final analysis for OS, median DOR was 8.3 months (95% CI, 6.9-10.2) for KEYTRUDA plus chemotherapy (n=156) versus 6.8 months (95% CI, 5.7-7.1) for chemotherapy alone (n=152).

The median duration of exposure to KEYTRUDA was six months (range, 1 day to 28 months). KEYTRUDA was discontinued due to adverse reactions in 15% of patients. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA (≥1%) was pneumonitis (1.3%). Adverse reactions leading to interruption of KEYTRUDA occurred in 55% of patients; the most common adverse reactions or laboratory abnormalities leading to interruption of KEYTRUDA (≥2%) were decreased neutrophil count (18%), decreased platelet count (10%), anemia (6%), decreased white blood count (4%), pyrexia (3.8%), fatigue (3.0%), cholangitis (2.8%), increased alanine aminotransferase (ALT) (2.6%), increased aspartate aminotransferase (AST) (2.5%) and biliary obstruction (2.3%).

In the KEYTRUDA plus chemotherapy versus placebo plus chemotherapy arms, there was a difference of ≥5% incidence in adverse reactions between patients who received KEYTRUDA versus placebo for pyrexia (26% vs. 20%), rash (21% vs. 13%), pruritus (15% vs. 10%) and hypothyroidism (9% vs. 2.6%). There were no clinically meaningful differences in incidence of Grade 3-4 toxicity between arms.

There was a difference of ≥5% incidence in laboratory abnormalities between patients who received KEYTRUDA plus chemotherapy versus placebo plus chemotherapy for decreased lymphocytes (69% vs. 61%). There were no clinically meaningful differences in incidence of Grade 3-4 toxicity between arms.

Today, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications:

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
• active psoriatic arthritis;
• moderately to severely active Crohn’s disease; and
• moderately to severely active ulcerative colitis.

Pediatric patients 6 years of age and older with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
• active psoriatic arthritis.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”

Biological products include medications for treating many serious illnesses and chronic health conditions. A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA (also called the reference product). An interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs.

All biological products are approved only after they meet the FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” said Sarah Yim, M.D., director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness). This evidence included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data, and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions with ustekinumab products are nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.

The labeling for Wezlana, like Stelara, contains a warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization. There is also a warning that some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome  have been reported in patients who received Wezlana in clinical studies. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

The FDA granted the approval of Wezlana to Amgen, Inc.

NASHVILLE, TN – In a show of unity and determination, pharmacy staff at CVS and Walgreens stores across the nation have embarked on a three-day walkout to demand fair wages and improved working conditions. The walkout, which began this morning, is expected to have a significant impact on both pharmacy giants as employees seek better compensation and benefits.

PARIS, FRANCE - Sanofi, a global pharmaceutical giant, has unveiled a comprehensive update to its "Play to Win" strategy, highlighting a renewed focus on research and development (R&D) investments, a separation of its Consumer Healthcare Business, and ongoing cost-saving initiatives. These strategic moves aim to accelerate innovation and long-term growth while enhancing shareholder value.

Twin Cities, MN - For more than 30 years, section 340B of the Public Health Service Act has required drug manufacturers to sell outpatient drugs at discounted prices to certain safety-net hospitals and health care organizations that serve uninsured or low-income patients. 340B-eligible health care providers (called “covered entities”) contract with pharmacies to dispense the discounted drugs — a mutually beneficial relationship that increases revenue for providers and pharmacies. Today, about 40% of retail pharmacies across the country have at least one contract with a 340B-eligible health care provider.  

A new study from the University of Minnesota School of Public Health (SPH) examines recent trends in the relationship between pharmacies and 340B-eligible covered entities (CEs). The study takes an in-depth look at pharmacies’ relationship with health care providers by developing new measures to describe alternative forms of contract pharmacy growth beyond simple participation rates.  

Specifically, the study looked at how pharmacies’ involvement with 340B has changed between 2009 and 2022 in three key metrics developed by the researchers:

• Depth, which measures the number of contracts each pharmacy in the US holds.
• Spread, which measures how far pharmacies are geographically from the covered entity.
• Safety-net composition, which is the proportion of a pharmacy's contracts that are with covered entities that are "essential community providers", as measured by the Medicaid and Children's Health Insurance Program Payment and Access Commission.    

The study, published in JAMA Health Forum, found:

• The overall number of pharmacies participating in 340B increased dramatically, from 789 in 2009 to 25,775 in 2022. In 2009, 1.3% of retail pharmacies participated in 340B, compared to 40.9% in 2022.
• Depth increased. In 2009, 81% of retail pharmacies had only one contract, and by 2022, 40% had one, 23% had two, 27% had three to five, 7% had six to nine, and 3% had 10 or more.
• Spread also increased. In 2009, the farthest CE was within the same zip code for 48% of pharmacies. By 2022, only 9% of CEs were in the same zip code.
• Safety-net composition decreased. In 2009, 95% of pharmacies contracted exclusively with safety-net hospitals and clinics. By 2022, only 54% of pharmacies contracted exclusively with safety-net facilities, and 16% contracted with no safety-net facilities.

“The 340B Drug Pricing Program aims to improve access to care for patients who rely on the health care safety net,” said Sayeh Nikpay, SPH associate professor and lead author of the study. “Historically this program has involved the hospitals and their clinics that participate in the program. However, our study documents that pharmacies are playing a growing role in the program. Whether this growing participation furthers the program’s goals of increasing access to the care for patients who rely on the safety-net has yet to be seen.”  

Limitations of the study include the lack of data on the volume of 340B drugs dispensed through retail pharmacies, which would have allowed the researchers to differentiate contracts by profitability. Also, the study’s focus on retail pharmacies meant that data on mail-order and specialty pharmacies was not included. Nikpay is currently working on research that would address specialty and mail-order pharmacies. 

WALTHAM, MA - The United States Pharmacopeia (USP) recently revised General Chapters <795>, <797>, and <800> that dictate compliance standards for sterile and nonsterile pharmaceutical compounding, with enforcement starting November 1, 2023. But as this date draws near, only 31% of pharmacies are prepared for full compliance with the 2023 USP 797 reference standards. Taking action to ensure compliance amid this transition, Midwest Surgical Hospital has selected Wolters Kluwer Health’s Simplifi 797^® technology, alongside the full Simplifi+^® Pharmacy Compliance suite of solutions, to replace manual processes and support patient safety at its 25-bed ambulatory surgical center in Omaha, Nebraska.

Improving documentation efficiency to uplevel pharmacy teams

Prior to this shift, Midwest Surgical was utilizing paper-based records in its pharmacy for compounding documentation and medication inventory management across the facility. This placed an extreme administrative burden on pharmacists and led to inefficiency in medication compounding practices. By implementing the full suite of Simplifi+ Pharmacy Compliance solutions, including Simplifi 797, Simplifi+ MedTrays and Simplifi+ MedStorage, Midwest Surgical can proactively manage USP compliance, medication storage, and emergency cart medication inventory on one common platform.

“Pharmacists are an underutilized resource in many health systems and healthcare centers, and this is largely due to the inability to extract them from the daily documentation and minutiae in the pharmacy. With a lean pharmacy team, we’re always looking for ways to streamline our processes – and ultimately their workloads,” said Michael Labadie, PharmD, Director of Pharmacy at Midwest Surgical Hospital. “By bringing in automated solutions from Wolters Kluwer, we are able to minimize our manual documentation, limit medication waste, and allow our pharmacists to become more involved in patient care needs.”

“Healthcare facilities are being pushed to find new efficiencies in their current processes to balance increasing regulatory scrutiny and patient care responsibilities” - Karen Kobelski, Vice President and General Manager of Clinical Surveillance Compliance & Data Solutions, Wolters Kluwer Health

Midwest Surgical compounds many of its intraoperative medications on-site and, in light of the latest USP guidelines, was looking for a solution that would allow them to worry less about documentation requirements and focus on patient care. With Simplifi 797 in place, their pharmacy team now has a comprehensive view of their compounding compliance, including where they can take action to make improvements in real-time. The fully automated platform and expert guidance ensures the proper documentation is in place in case of a regulatory audit and allows for better tracking of wasted medication volumes, allowing their team to optimize compounding based on current usage levels.

“Healthcare facilities are being pushed to find new efficiencies in their current processes to balance increasing regulatory scrutiny and patient care responsibilities,” said Karen Kobelski, Vice President and General Manager of Clinical Surveillance Compliance & Data Solutions, Wolters Kluwer Health. “By using our Simplifi+ suite, Dr. Labadie and his team at Midwest Surgical are creating a more agile and efficient backbone for their pharmacy, allowing them to quickly onboard new staff, focus on patient programs, or navigate a regulatory inspection with ease.”

Beyond medication compounding, Simplifi+ MedTrays and Simplifi+ MedStorage enable the surgery center to more easily and efficiently manage medication stored throughout the facility. Simplifi+ MedTrays automates and standardizes emergency cart restocking to ensure accuracy and optimize the utilization of short-dated drugs. By automating inventory checklists, Simplifi+ MedStorage ensures medications stored across the facility are safe for patient use and achieve compliance standards so teams are inspection-ready.

Visit Wolters Kluwer Health’s website to learn more about the Simplifi+ Pharmacy Compliance suite.

Clark, NJ – SoftWriters, Inc., the industry leader in long-term care (LTC) pharmacy technology, has announced a partnership with SDS Rx, the leading national provider of last-mile logistics solutions for the healthcare industry. This strategic alliance aims to streamline the delivery process for long-term care pharmacies by integrating SDS Rx’s cutting-edge technology with SoftWriters’ renowned long-term care pharmacy management software.

The integration will enable SDS and SoftWriters to seamlessly exchange all relevant Proof of Delivery (POD) data at the packing slip level, track delivery schedules, and confirm delivery status in real-time. The improved packing slip level data connectivity and POD association at the prescription level in FrameworkLTC will dramatically improve accountability and regulatory compliance. In addition, the integration will also support a more accurate and efficient delivery process, leading to heightened customer satisfaction and optimized pharmacy operations.

“We are thrilled to partner with SoftWriters to provide a seamless, end-to-end delivery solution for long-term care pharmacies,” said Drew Kronick, CEO of SDS Rx. “Our cutting-edge technology and logistics expertise combined with SoftWriters’ industry-leading software will revolutionize the way long-term care pharmacies operate. Our partnership will enhance efficiency, simplify compliance, and elevate patient care, creating an unparalleled customer experience for our clients.”

The synergistic combination of SDS Rx’s advanced technology and SoftWriters’ premier software empowers long-term care pharmacies to manage the delivery process with unprecedented precision and accuracy, thereby minimizing errors and enhancing patient safety. The integrated solution will be made available to FrameworkLTC customers through the FrameworkCourier API.

“Partnering with SDS Rx provides our customers with an innovative solution that streamlines their delivery process and optimizes overall operations,” stated Scott Beatty, President of SoftWriters, “By leveraging our collective strengths, we can offer a comprehensive solution tailored to the unique needs and challenges of long-term care pharmacies.”

Overall, the partnership between SDS Rx and SoftWriters represents another transformative step towards revolutionizing the delivery process for long-term care pharmacies. Through their combined expertise, they are committed to delivering exceptional value, operational efficiency, and outstanding customer experiences to their clients.

BROOMFIELD, CO - Swisslog Healthcare, a global industry leader in pharmacy and transport automation solutions, is hosting a free webinar designed to help central pharmacy leaders and healthcare executives realize the benefits of implementing consolidated service centers (CSCs), sometimes also called integrated service centers (ISCs), as part of their thought leadership sharing. The "CSCs & ISCs with SMEs" webinar will be held on November 1, 2023, at 1 PM EDT and will feature discussions from industry subject matter experts (SMEs) about the challenges, benefits, and best practices for centralizing supply chain and pharmacy operations at consolidated service centers.

A study from Swisslog Healthcare showed that healthcare facilities that implemented CSCs of all sizes saw improved inventory management and streamlined procurement processes. The study found that hospitals and healthcare systems are increasingly challenged to manage growing patient access demands, rising drug costs, increased regulatory oversight and outcomes-based reimbursement programs. With CSCs, hospitals and healthcare systems are enabled to automate and centrally manage inventory and associated management processes for all supply chain and ancillary support services.

"Central pharmacies are traditionally considered a significant cost center in healthcare facilities, so they feel pressure to contribute to cost-cutting mandates; however, they can’t sacrifice service levels or compromise medication availability," said Jon Brown, webinar panelist and Director of Pharmacy System Operations and Logistics for Indiana University Health. "Our discussion focuses on how healthcare facilities can better streamline these processes to help address those issues. When done right, healthcare facilities can simplify processes, minimize costly waste, and refocus their teams back toward patient-facing work."

The "CSCs & ISCs with SMEs" webinar is one of many thought leadership offerings from Swisslog Healthcare designed to enable healthcare facilities to lead change for better patient care outcomes. Notably, Swisslog Healthcare has offered webinars featuring various industry experts discussing topics such as combatting labor shortages, maneuvering through digital transformation, and more.

"Ultimately, our goal is to better support our customers in their efforts to provide the best possible care for their patients," said Lindsey DeFendi, webinar panelist and Region Director from Swisslog Healthcare. "As an industry leader in healthcare automation, we have the opportunity to improve the healthcare industry as a whole. If we can provide best practices for implementing streamlined technologies and processes, we can help our customers deliver quality care for their patients."

Swisslog Healthcare is dedicated to optimizing workflows inside the complex systems of healthcare facilities, and particularly for those seeking to build or optimize a CSC. To learn more about Swisslog Healthcare and how its automation technology enables healthcare workers to deliver better patient care, visit Swisslog-Healthcare.com. To register for this webinar or watch it on demand after it airs on November 1^st, visit Swisslog Healthcare’s webinar webpage.

OSWEGO, NY - Oswego Health makes it a priority to recognize staff for their hard work and commitment to the organization and its patients. One key staff member who continues to shine and has truly stepped up is Sarah Driscoll.

Driscoll has been promoted to Director of Pharmacy at Oswego Health. Driscoll started at Oswego Health as a Staff Pharmacist in 2013, before transitioning in 2015 to the Pharmacy Operations Supervisor. In June of 2023 she was named Interim Director of Pharmacy.

Born and raised in Oswego, NY, Driscoll graduated with a Doctorate in Pharmacy in 2013 from Albany College of Pharmacy and Health Sciences. She has been a preceptor for the University of Buffalo School of Pharmacy, Albany College of Pharmacy, and St. John Fisher School of Pharmacy.

As the Director of Pharmacy, Driscoll will manage and direct the operations of the department to ensure that quality pharmaceutical services are provided to patients, in accordance with the mission and values of Oswego Health. Overseeing a department of seventeen, including six Pharmacists, Driscoll is looking forward to strengthening her team’s collaboration with providers and expanding the antibiotics stewardship program within the community.

The Oswego Hospital Pharmacy serves patients within the hospital, Fulton and Central Square Urgent Cares, Seneca Hill Manor, Lobdell Center for Mental Health & Wellness at Lakeview, as well as Physician Care, PC.

FRANKLIN LAKES, NJ - BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced it has been named to the 100 Best Corporate Citizens List by 3BL, which recognizes outstanding environmental, social and governance (ESG) transparency and performance among 1,000 of the largest U.S. public companies. This year, BD ranked second in the health care equipment and services industry.

"As a global organization serving health systems in nearly 200 countries around the world, we are contributing meaningful, positive change on the global societal and environmental issues most relevant to our business, customers and stakeholders," said Tom Polen, chairman, CEO and president of BD. "As we've done throughout our history, we continue to build on these contributions to enable a healthier, more equitable world - from minimizing our environmental footprint to empowering an inclusive workforce, and advancing health equity and access in under-resourced areas of the world."

The 100 Best Corporate Citizens ranking is based on 184 ESG factors in seven pillars – climate change, employee relations, environment, governance, human rights, stakeholders and society, and ESG performance.

Dave Armon, CEO of 3BL said, "Achieving the transformational targets of the Paris Agreement and UN Sustainable Development Goals in this decisive decade requires all companies to truly embed ESG issues into the core of their business. The 100 Best Corporate Citizens of 2023 are answering the call by demonstrating the societal and bottom-line value of leadership and transparency around ESG topics. They are setting ambitious goals outlining robust strategies for achieving them, disclosing data to measure progress."

BD continues to be recognized for its commitment to being an employer of choice, transparency and progress toward the company's 2030 ESG goals. For more information about these awards, visit news.bd.com/Award-news.