DUBLIN - Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), is voluntarily recalling one lot of Treprostinil Injection 20mg/20mL (1mg/mL) to the consumer level. The product is being recalled due to the potential for the presence of silicone particulates in the product solution.

Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. To date, Par has not received any reports of adverse events related to this recall.

Treprostinil Injection is formulated for subcutaneous or intravenous infusion.  The product is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension to diminish symptoms associated with exercise and for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

Treprostinil Injection 20mg/20mL (1mg/mL) is distributed in 20mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01.  Only Lot 57014, expiration date 04/2024 is affected by this recall.  The lot was distributed nationwide to wholesalers and hospitals from June 16, 2022, through October 17, 2022.

The image included with this release shows the vial label of the affected lot.

Par is providing written notification to wholesale accounts and the hospital location that have received the affected lot and is arranging for return of all existing inventory of Lot 57014 through Inmar, Inc. Wholesale distributors and hospital pharmacies that have the product being recalled should immediately discontinue use and stop distribution immediately.  If you have further distributed the recalled product, please notify your accounts or any additional locations which may have received the recalled product.

For information regarding the recall process, call Inmar, Inc. at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm ET.  For medical or technical product information or to report a product complaint or adverse event please call 1-800-828-9393.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

RAHWAY, NJ - Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the completion of the acquisition of Harpoon Therapeutics, Inc. (Nasdaq: HARP). Harpoon is now a wholly-owned subsidiary of Merck, and Harpoon’s common stock will no longer be publicly traded or listed on the Nasdaq Stock Market.

“We continue to augment and diversify our oncology pipeline with innovative approaches to help people with cancer worldwide,” said Dr. Dean Y. Li, president, Merck Research Laboratories. “We are pleased to welcome our Harpoon colleagues to Merck and look forward to working together to advance a novel portfolio of T-cell engagers, including MK-6070.”

Harpoon’s lead candidate, MK-6070 (formerly known as HPN328), is a T-cell engager targeting delta-like ligand 3 (DLL3), an inhibitory canonical Notch ligand that is expressed at high levels in small cell lung cancer (SCLC) and neuroendocrine tumors. The safety, tolerability and pharmacokinetics of MK-6070 is currently being evaluated as monotherapy in a Phase 1/2 clinical trial (NCT04471727) in certain patients with advanced cancers associated with expression of DLL3. The study is also evaluating MK-6070 in combination with atezolizumab in certain patients with SCLC. In March 2022, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to MK-6070 for the treatment of SCLC.

Additional pipeline candidates include HPN217, a T-cell engager targeting B-cell maturation antigen (BCMA), currently in Phase 1 clinical development for the treatment of patients with relapsed/refractory multiple myeloma, and several preclinical stage candidates, including HPN601, a conditionally activated targeting epithelial cell adhesion molecule (EpCAM) for the treatment of certain patients with EpCAM expressing tumors.

Transaction details

Under the terms of the merger agreement, Merck, through a subsidiary, has acquired all outstanding shares of Harpoon. As previously disclosed, this transaction is being accounted for as an asset acquisition. Merck is recording a non-tax deductible charge to R&D expense of approximately $650 million. The impact of the transaction on expected full-year non-GAAP EPS is approximately $0.26 per share, which was included in Merck’s full-year 2024 financial outlook issued on February 1, 2024.

Merck’s focus on cancer

Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit https://www.merckclinicaltrials.com/.

INDIANAPOLIS, IN - Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) to discuss the Phase 3 TRAILBLAZER-ALZ 2 trial, which evaluated the efficacy and safety of donanemab in early symptomatic Alzheimer's disease. 

The FDA has informed Lilly it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design of the TRAILBLAZER-ALZ 2 study, including its limitedduration dosing regimen that allowed patients to complete treatment based on an assessment of amyloid plaque and the inclusion of participants based on tau levels. 

The date of the advisory committee meeting for donanemab has yet to be set by the FDA, and, as a result, the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024. While it is unusual for an advisory committee to occur after the anticipated FDA action date, the advisory committee meeting for donanemab follows similar meetings for the two other amyloid plaque-targeting therapies the FDA has approved. 

"We are confident in donanemab's potential to offer very meaningful benefits to people with early symptomatic Alzheimer's disease. It was unexpected to learn the FDA will convene an advisory committee at this stage in the review process, but we look forward to the opportunity to further present the TRAILBLAZER-ALZ 2 results and put donanemab's strong efficacy in the context of safety. We will work with the FDA and the stakeholders in the community to make that presentation and answer all questions," said Anne White, executive vice president of Eli Lilly and Company, and president of Lilly Neuroscience. 

TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants ages 60-85 years with early symptomatic Alzheimer's disease (MCI or mild dementia due to Alzheimer's disease) with the presence of confirmed Alzheimer's disease neuropathology. Alzheimer's disease is a progressive and fatal disease that in its early symptomatic stages affects 6-7.5 million Americans. The trial enrolled 1,736 participants, across eight countries, selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by positron emission tomography (PET) imaging. 

Compared to participants in similar trials of other amyloid plaque-targeting therapies, the TRAILBLAZER-ALZ 2 participants were more progressed in their disease. All groups of trial participants, regardless of tau level, benefited from treatment with donanemab, with patients in earlier stages of the disease experiencing the strongest results. Donanemab also demonstrated clinical benefits using a limited-duration treatment regimen, with nearly half of clinical trial participants completing their course of treatment in six or 12 months. The key risk associated with donanemab is amyloid related imaging abnormalities, or ARIA, which can be serious and life-threatening. Other most commonly reported risks include infusion-related reactions, headache and nausea. 

The Phase 3 TRAILBLAZER-ALZ 2 study results were published in the Journal of the American Medical Association (JAMA). Lilly continues to study donanemab in multiple clinical trials.

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.”