Industry News
Today, the U.S. Food and Drug Administration approved a new indication for use for Wegovy (semaglutide) injection to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight. Wegovy should be used in addition to a reduced calorie diet and increased physical activity. Cardiovascular disease is a group of diseases of the heart and blood vessels.
“Wegovy is now the first weight loss medication to also be approved to help prevent life-threatening cardiovascular events in adults with cardiovascular disease and either obesity or overweight,” said John Sharretts, M.D., director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “This patient population has a higher risk of cardiovascular death, heart attack and stroke. Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health.”
Obesity or overweight affect approximately 70% of American adults. Obesity and overweight are serious health issues that increase the risk for premature death and a variety of health problems, including heart attack and stroke.
Wegovy contains semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist. Therefore, Wegovy should not be used in combination with other semaglutide-containing products or other GLP-1 receptor agonists.
Wegovy’s efficacy and safety for this new indication were studied in a multi-national, multi-center, placebo-controlled double-blind trial that randomly assigned over 17,600 participants to receive either Wegovy or placebo. Participants in both groups also received standard-of-care medical treatment (e.g., management of blood pressure and cholesterol) and healthy lifestyle counseling (including diet and physical activity). Wegovy significantly reduced the risk of major adverse cardiovascular events (cardiovascular death, heart attack and stroke), which occurred in 6.5% of participants who received Wegovy compared to 8% of participants who received placebo.
The prescribing information for Wegovy contains a boxed warning to inform health care professionals and patients about the risk of thyroid C-cell tumors. Because of this risk, Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2.
Wegovy should not be used in patients with a history of a severe allergic reaction to semaglutide or to any of the other ingredients. Patients should stop Wegovy immediately and seek medical help if a severe allergic reaction is suspected.
Wegovy also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, hypersensitivity reactions, diabetic retinopathy (damage to the eye's retina), increased heart rate and suicidal behavior or thinking. Patients should discuss with their health care provider if they have symptoms of pancreatitis or gallstones. If Wegovy is used with insulin or with a medication that causes insulin secretion, patients should speak to their health care provider about the risk of low blood sugar. Healthcare professionals should monitor patients for kidney disease, diabetic retinopathy and depression or suicidal behaviors or thoughts.
The most common side effects of Wegovy include nausea, diarrhea, vomiting, constipation, abdominal (stomach) pain, headache, fatigue, dyspepsia (indigestion), dizziness, abdominal distension, eructation (belching), hypoglycemia (low blood sugar) in patients with diabetes, flatulence (gas buildup) and gastroesophageal reflux disease (heartburn).
Wegovy received Priority Review designation for this indication.
The FDA granted the approval to Novo Nordisk A/S.
Wegovy is also approved to reduce excess weight and maintain weight reduction long term in certain adults with obesity or overweight and certain children with obesity, for use in addition to a reduced calorie diet and increased physical activity.
A member of Cardinal Health’s executive leadership team have been named to Reuters’ Trailblazing Women lists, announced today to coincide with International Women’s Day. These lists recognize women who have made significant contributions to their fields.
Debbie Weitzman, CEO of our Pharmaceutical and Specialty Solutions Segment, is included among Reuters’ 20 Trailblazing Women in Healthcare.
Debbie Weitzman, CEO, Pharmaceutical and Specialty Solutions Segment
Weitzman has a long track record of breaking barriers, including becoming the first woman to hold a CEO position at Cardinal Health. She is responsible for driving the growth and impact of Cardinal Health’s Pharmaceutical and Specialty Solutions Segment.
Recently, she has spearheaded the creation and launch of Navista Network, a new offering that will provide community oncology practices with the tools they need to remain independent and better serve their patients. In addition, she has led and championed a variety of programs and solutions that empower pharmacists to improve their patients’ medication adherence, which is directly connected to better health outcomes in older adults and those with multiple chronic conditions.
Weitzman also serves as executive sponsor of the Women’s Impact Network, an employee resource group at Cardinal Health, and seeks to advance goals for gender representation, engagement, equity and allyship.
“I believe in the power of sponsorship, and I hope that women who have been successful will pay it forward to help other women break down barriers and consider new opportunities. Putting your own credibility on the line to vouch for another woman is a powerful endorsement.”
During her 19-year career with Cardinal Health, Weitzman has served in many leadership roles across sales and distribution operations, most recently as president, Pharmaceutical Distribution and The Medicine Shoppe International, Inc., leading the company’s distribution efforts to thousands of pharmacies. She also previously served as the SVP and general manager of Cardinal Health Puerto Rico.
Weitzman serves on the Board of Directors for the Healthcare Distribution Alliance. She also serves as a director on the Board of Outcomes™ and as an independent director for Filtration Group. She earned her bachelor’s degree in history from Dartmouth College and a master’s degree from Kellogg Graduate School of Management at Northwestern University.
FRANKLIN, TN - Community Health Systems, Inc. (NYSE: CYH) (CHS) will become the first national healthcare system to purchase select pharmaceutical supplies from Mark Cuban Cost Plus Drug Company (Cost Plus Drugs) as part of a new, collaborative relationship that promises to bring high-quality, lower cost drugs into the hospital setting.
The onset of the partnership coincides with the opening of a state-of-the-art, 22,000-square-foot, fill and finish drug manufacturing plant, owned and operated by Cost Plus Drugs, in Dallas, Texas. The plant is equipped with aseptic robotic filling lines that produce lifesaving injectable medications.
Initially, CHS-affiliated hospitals in Texas and Pennsylvania will purchase pharmaceuticals such as epinephrine and norepinephrine, drugs that are often used to treat life threatening conditions and serious illnesses, especially in emergency departments and intensive care units. The Food and Drug Administration includes epinephrine on its list of current drug shortages due to increased demand and manufacturing delays.
CHS and Cost Plus Drugs will work collaboratively to address critically important issues related to drug supply in the hospital setting, including:
- Rising costs of pharmaceuticals – Cost Plus Drugs is committed to supplying drugs at a lower price point with minimal mark-up, which helps hospitals manage inflationary pressures as the cost of providing patient care continues to climb.
- Drug shortages – Cost Plus Drugs is focused on manufacturing drugs that are often in limited supply, threatening patient treatment and outcomes when shortages occur. CHS and Cost Plus Drugs are working together to identify, prepare for, and mitigate potential future drug shortages in the hospital setting.
- Pharmaceutical waste – Cost Plus Drugs offers CHS-affiliated hospitals more flexible ordering opportunities, including alternative vial sizes for drug administration, which can reduce waste and help hospitals order and maintain drug supplies in quantities that are most efficient for their unique needs and the specific services they offer.
- Patient safety and medication error prevention – Because Cost Plus Drugs will provide drugs in vial sizes that many other drug manufacturers won’t offer, there is less potential for dosage errors when drugs must be measured prior to administration at the bedside.
“There are many opportunities for innovation in the healthcare industry, including rethinking, and even disrupting, the way providers purchase products and services,” said Lynn Simon, MD, President of Healthcare Innovation and Chief Medical Officer at Community Health Systems. “Our relationship with Mark Cuban Cost Plus Drug Company has the potential to generate significant advantages for our affiliated hospitals and for other forward-looking hospital organizations that also want to reduce costs, reduce waste, avoid drug shortages, and improve patient care.”
With a footprint of more than 70-acute care hospitals and hundreds of other care locations, including ambulatory surgery centers, freestanding ERs, and physician practices, CHS and Cost Plus Drugs expect to scale the partnership in numerous and meaningful ways.
“Community Health Systems has stepped forward to consider important issues related to drug supply, drug costs, patient care and outcomes,” said Alex Oshmyansky, MD, PhD, Chief Executive Officer of Mark Cuban Cost Plus Drug Company. “This partnership has the potential to shine a light on all of the ways Cost Plus Drugs can work with like-minded providers to create a better approach to drug delivery in hospitals and in multiple care delivery environments.”
Commenting on the strategic partnership, Mark Cuban said, "We are excited to start shipping our first sterile injectables from our Cost Plus Factory. Our mission is to end drug shortages and this is just the first step. Our partnership with CHS will give them access to epinephrine and norepinephrine at a transparent cost plus price. This is the start of what we know will be an amazing partnership that will reduce drug shortages and drug costs and enhance the care CHS hospitals provide for their patients."
URBANA, IL - A new CarleRx pharmacy location is officially open at Carle Foundation Hospital. This location expands access to pharmacy resources and extends the holistic healthcare experience for patients.
“We’re proud to be extending CarleRx’s services with our newest location here at Carle Foundation Hospital,” said Linda Fred, Vice President, Pharmacy Services, at the March 4 ribbon-cutting ceremony to celebrate the opening. “This CarleRx is a locally-owned option for the community, modeled after our first location at Carle Champaign on Curtis. We can’t wait to offer this added support for our patients and bring more access to the region.”
The CarleRx at Carle Foundation Hospital will be staffed with pharmacists and pharmacy technicians to meet the level of demand anticipated for this new location. Patients who regularly receive care at the hospital now have an on-site location to pick up their prescriptions. Patients can also receive help with questions they may have about new or current prescriptions after an appointment.
Carle Health team members will also have the convenience of picking up prescriptions before or after their shift without having to leave the campus.
The CarleRx team will continue to listen to community needs and develop the best methods of providing services to patients as the pharmaceutical landscape continues to change.
“We know there have been some challenges in recent months with access to retail pharmacy support. A new location for patients is another way Carle can be there for those we serve at every point of their healthcare journey,” Fred said.
The CarleRx pharmacy, the Director of Retail Pharmacy Operations, Katie Koch, and Manager of Pharmacy Retail, Lauren Klemp joined Linda Fred to cut the ribbon and official open the new location.
“A big thank you to those who have assisted in making this space,” said Fred. “Our pharmacy team, and to Nick Crompton, our Vice President of Facilities and Construction Services and his team who did a great job of refurbishing the space.”
Hours of operation are Monday through Friday, 8 a.m. to 9 p.m. On Saturday and Sunday, hours of operation are 9 a.m. to 5:30 p.m., with a half-hour closure between 1 p.m. and 1:30 p.m.
Community members receiving their prescriptions from CarleRx can also visit the CarleRx location at Carle Champaign on Curtis. This location, 1701 W. Curtis Rd, Champaign, is a full-service pharmacy that is open until midnight seven days a week with drive-thru capabilities.
To contact CarleRx, patients can call (217) 326-5500. For more information, visit Carle.org.
Pharmacolog announces that the currently appointed CEO Lars Gusch will step down from his position on April 30, 2024. This resignation is by mutual agreement with the Board of Directors, which in the meantime is working on the recruitment of a successor CEO, who will be announced in due course.
Lars Gusch, CEO comments: "I would like to thank the Board of Directors for the trust they have placed in me and the good cooperation. Pharmacolog has gone through challenging times in the past year and it has been an honor to lead the company. I am sure that the path we have taken will be successfully continued with new leadership after my departure and I wish the company the best of luck."
Erik Hedlund, Chairman of the Executive Board, comments: "Lars Gusch took over as CEO of Pharmacolog in a turbulent situation for the company. It soon became clear that the conditions for running the business further were lacking. Instead of developing, Lars Gusch's main task was to wind down the business. Lars Gusch has carried out and completed this task in an exemplary manner.
With a new direction for Pharmacolog, we have jointly decided that Lars Gusch will leave his position at the end of April this year. We wish Lars Gusch good luck in his new challenges.”
DUBLIN, OH - Today, Cardinal Health (NYSE: CAH) released its 2024 Biosimilars Report: insights on a pivotal year of evolution and expansion, an analysis of key recent economic, competitive, legislative and societal developments in biosimilars. The publication highlights legislative developments and new treatments, including adalimumab biosimilars. The report also provides the perspectives of retina specialists on biosimilars, ahead of the expected launch of multiple new biosimilars for retinal diseases.
"It is more important than ever that all stakeholders of the healthcare ecosystem understand the significant benefits biosimilars offer to patients, providers, practices and payers alike," said Fran Gregory, PharmD, MBA, VP, Cardinal Health Emerging Therapies. "The savings generated by biosimilars will play an increasingly important part in creating a balance between funding innovative new treatments and reducing the overall financial burden on the healthcare system. This report offers critical context on this rapidly changing clinical and market landscape, and the role biosimilars will play in increasing the accessibility and affordability of care."
The report examines a year of major developments in biosimilars, offering expert commentary and provider perspectives on a rapidly changing industry landscape. Featuring new research derived from surveys and expert interviews, the report offers new insights into market growth, drivers of biosimilar adoption and remaining barriers to widespread uptake.
With 2024 expected to be a critical year for retina biosimilars, Cardinal Health surveyed providers in ophthalmology to obtain perspectives that may influence adoption while highlighting continued obstacles to wider use of biosimilars. Nearly 80% of survey participants said they are "extremely" or "very" familiar with biosimilars, though fewer than 60% have prescribed a biosimilar for the treatment of a retinal disorder. 82% of retina specialists said they would be "very" or "somewhat" more likely to prescribe biosimilars if they became a payer's preferred drug. Notably, the research also suggests widespread belief in biosimilars' potential impact on healthcare system sustainability, with 75% of participants agreeing that biosimilars can improve healthcare system sustainability.
In addition to this new research, the report also includes in-depth analysis of:
- The evolving payer landscape
- Emerging best practices for managing biosimilar inventory
- How biosimilars are promoting access and healthcare system sustainability
- The biosimilars product pipeline
The report can be accessed at www.cardinalhealth.com/biosimilarsreport
Mary Beth Wimberly, a pharmacy tech specialist with the pharmacy department at Springfield Memorial Hospital, is the nonprofit hospital’s Colleague of the Month for February.
Colleagues appreciate and respect Wimberly for the way she handles difficult tasks, answers questions, displays her expertise in different areas of the pharmacy and demonstrates a strong commitment to patient safety. She raises questions and addresses any concerns regarding IV labels or instructions for compounded products.
Wimberly also independently pursues certifications to enhance her knowledge.
“Mary Beth is a truly go-to person for her colleagues, readily offering support and guidance,” wrote one of her nominators. “She readily accepts direction and works to rectify errors, bringing those lessons forward for future experiences. Pharmacists feel supported and confident when working alongside her.”
NORTH CHICAGO, IL - AbbVie Inc. (NYSE: ABBV) and OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), a clinical-stage immunotherapy company, today announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to resolve chronic and severe inflammation, currently in the pre-clinical development stage.
OSE-230 is a first-in-class monoclonal antibody designed to activate ChemR23, a G-Protein Coupled Receptor (GPCR) target. Activation of ChemR23 may offer a novel mechanism for the resolution of chronic inflammation, modulating functions of both macrophages and neutrophils.
"This collaboration underscores our commitment to expanding our immunology portfolio with the ultimate goal of improving the standard of care for patients living with inflammatory diseases globally," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "By leveraging our expertise in immunology drug development, we look forward to advancing OSE-230, which offers a novel mechanism-of-action to treat chronic inflammation."
"We are very pleased to collaborate with AbbVie, a global leader in the development and commercialization of innovative medicines, to drive our OSE-230 program forward," said Nicolas Poirier, chief executive officer, OSE Immunotherapeutics. "This partnership represents a major milestone in our company's progress and recognizes the value of our innovative R&D capabilities. I would like to thank all our employees who helped us reach this milestone through dedication and hard work."
Under the terms of the agreement, AbbVie will receive an exclusive global license to develop, manufacture and commercialize OSE-230. OSE Immunotherapeutics will receive a $48 million upfront payment and will be eligible to receive up to an additional $665 million in clinical development, regulatory and commercial milestones. In addition, OSE Immunotherapeutics will be eligible to receive potential tiered royalties on global net sales of OSE-230.
The transaction is subject to the satisfaction of customary closing conditions, including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
LEBANON, TN – Health Connect Partners, a leading organization for bringing hospital providers and suppliers together through industry-specific conferences, recently held its signature Online Reverse Expo with overwhelming success to kick off the 2024 conference season.
Over three days, February 6-8, Health Connect Partners was able to facilitate a total of 2,328 connections between providers and suppliers in the markets of Pharmacy, Radiology, Supply Chain, and OR/Surgical. With each meeting extended to 14-minutes this year, over 543 hours of one-on-one meetings were held within less than three business days (~24 hours in total).
“In today's crucial healthcare landscape, fostering connections is paramount, and our Health Connect Partners Online Reverse Expo platform facilitated just that,” said Jason Green, Partner & Chief Sales Officer. “A huge thank you to all the Hospital Leaders who actively participated, ensuring continued collaboration and innovation. Additionally, I would like to extend my gratitude to our HCP team who continue to masterfully orchestrate meaningful connections between the right people at the right time.”
Since 2020, HCP’s online platform has offered Suppliers the ease and access to key decision-makers they may not otherwise connect with given the fast-paced nature of healthcare. Michael Gitomer with Azurity Pharmaceuticals shared, “Thanks to HCP for what you have created in bringing Hospital Providers and Industry together to have meaningful discussions. The HCP team is always thinking of ways to improve its product and increasing the time from 9 to 14-minutes really helped to create opportunities to schedule follow-up meetings on our own. Companies are crazy if they do not see the value in Health Connect Partners meetings and conferences.”
Dr. Mark Cohen, President and Founder at the National Recall Alert Center added, “The Online Reverse Expo provides the most amazing opportunity we ever had in such a concentrated period. Imagine, where else could we ever spend 14 unadulterated minutes - audio and video - one-on-one - with the full attention of a potential hospital buyer? And then, within one full minute later, be in front of another hospital-confirmed buyer for another full 14 minutes? This repeated itself 20 plus times over three days. Although it is too early to determine the financial results, it might have been the best marketing spend with the greatest impact we've ever had with Health Connect Partners, and we strongly suggest others consider this amazing opportunity.”
Next for Health Connect Partners is its In-Person events scheduled for this spring in Dallas, Texas. With a full schedule of educational and networking opportunities, HCP will welcome the Hospital Pharmacy Industry to the Hilton Anatole, April 8-10 followed a month later by the Radiology, Supply Chain, OR/Surgical, and Nursing Home markets May 20-22, 2024. For more information regarding participation in or sponsorship of HCP in-person or online conferences, please visit www.hlthcp.com.
LEBANON, TN - In a significant blow to healthcare systems across the United States, Change Healthcare, a leading provider of healthcare technology solutions, has fallen victim to a cyberattack, resulting in widespread disruption to hospital pharmacies nationwide. The breach, which occurred last week, has sparked concerns over patient safety, prescription processing delays, and data security vulnerabilities.
The cyberattack targeted Change Healthcare's network infrastructure, compromising vital systems responsible for processing prescription orders, managing inventory, and facilitating communication between healthcare providers and pharmacies. As a result, hospitals relying on Change Healthcare's services have faced severe operational challenges, with many struggling to fulfill critical medication orders and maintain essential pharmacy services.
Amidst the chaos, hospital administrators and pharmacists have been forced to resort to manual methods for prescription processing and inventory management, leading to significant delays and disruptions in patient care. Moreover, the breach has raised serious concerns regarding the security of sensitive patient data, prompting healthcare organizations to reassess their cybersecurity protocols and safeguards.
The ramifications of the cyberattack extend far beyond individual hospital pharmacies, as healthcare providers grapple with the broader implications of compromised data security and operational integrity. With patient safety hanging in the balance, hospitals are under immense pressure to swiftly address the fallout from the breach and implement robust measures to prevent similar incidents in the future.
As hospitals work tirelessly to restore normalcy to their pharmacy operations, the incident serves as a stark reminder of the evolving threat landscape facing the healthcare sector. With cyberattacks becoming increasingly sophisticated and pervasive, healthcare organizations must remain vigilant and proactive in safeguarding their systems and protecting patient data.
In response to the breach, Change Healthcare has issued a statement acknowledging the incident and affirming its commitment to resolving the issue swiftly and transparently. The company has reassured its clients and partners of ongoing efforts to strengthen cybersecurity defenses and mitigate any further disruptions to services.
As investigations into the cyberattack continue, hospitals are left grappling with the aftermath, striving to balance the imperative of providing quality patient care with the pressing need to fortify their defenses against future cyber threats. The incident serves as a sobering wake-up call for the healthcare industry, highlighting the critical importance of cybersecurity in an increasingly digitized world.