TOKYO and BASKING RIDGE, NJ – Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. 

Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and AstraZeneca. 

The Prescription Drug User Fee Act (PDUFA) date, the U.S. Food and Drug Administration (FDA) action date for its regulatory decision, is January 29, 2025. 

The BLA is based on results from the pivotal TROPION-Breast01 phase 3 trial, which were presented at a Presidential Symposium at the European Society for Medical Oncology (#ESMO23) 2023 Congress and in an oral presentation at the 2023 San Antonio Breast Cancer Symposium (#SABCS23). In the trial, datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to investigator’s choice of chemotherapy in patients with unresectable or metastatic HR positive, HER2 negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. For the dual primary endpoint of overall survival (OS), interim results numerically favored datopotamab deruxtecan over chemotherapy but were not mature at the time of data cut-off. The trial is ongoing and OS will be assessed at future analyses. The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified. The most common grade 3 or higher treatment-related adverse events in the datopotamab deruxtecan and chemotherapy arms, respectively, were neutropenia (1% vs. 31%), stomatitis (6% vs. 3%), fatigue (2% vs. 2%) and anemia (1% vs. 2%). 2 

“The FDA’s acceptance of the BLA brings us closer to providing patients with previously treated HR positive, HER2 negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Following our recently accepted application for advanced nonsquamous non-small cell lung cancer in the U.S., along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world.” 

“Despite marked progress in the treatment of HR positive, HER2 negative breast cancer, most patients with advanced disease develop endocrine resistance and face the prospect of one or several lines of chemotherapy,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy.” 

An additional BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Lung01 phase 3 trial is under review in the U.S. for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.

BRIDGEWATER, NJ - Amneal Pharmaceuticals, LLC. (Amneal) is voluntarily recalling 4 lots (see table below) of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the Consumer Level.  Some bottles may have been overfilled which can result in an over potent dosing regimen.   The recommended maximum daily dose allowance for this product is up to 2gm/day and patients prescribed a dosing regimen of 500 mg/10mL would exceed this daily allowance, which may be harmful to patients with renal insufficiency.   The error occurred during the manual bottle filling stage of manufacturing. 

Risk Statement:  Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of Vancomycin Hydrochloride for oral solution, USP 250 mg/5mL, may receive up to 4 grams of oral vancomycin per day because of the overfilled bottle.  Some patients with inflammatory disorders of the intestinal mucosa also may have significant systemic absorption of vancomycin. These patients may be at risk for the development of adverse reactions associated with higher doses of vancomycin oral solution. Worsening renal function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.  To date, Amneal has not received any reports of adverse events that have been confirmed to be directly related to this recall.

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL, is administered orally for treatment of enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic- associated pseudomembranous colitis caused by C. difficile. 

The Vancomycin HCl for Oral Solution, USP, 250 mg/5mL subject to the recall, are identified by the NDC numbers stated on the product label.  The following lot numbers of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL are included in this recall.  

Vancomycin Hydrochloride for Oral Solution, USP, 250mg/5mL

The affected Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL lots were distributed Nationwide in the USA directly to Wholesalers and Distributors.  The Lots were distributed between 11/09/2023 and 2/20/2024.   

Amneal is notifying its direct customers via mail (UPS Standard Overnight) by mailing a recall notification letter and is arranging for the return of the recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately.

Customers who purchased the impacted product directly from Amneal may call Amneal at
1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email to Vancomycin_Recall@amneal.com for further information.   

Retailers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5mL, which are being recalled, should examine their inventory and cease dispensing any of the impacted lots and contact Amneal directly via email at Vancomycin_Recall@amneal.com or by telephone 1833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, for information and instructions for the product return.   

Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, cease using the product if the lot number is listed on the recall and contact Amneal via telephone or email for recall information and for product return instructions.  Consumers may call Amneal at 1 833-582-0812 Monday – Friday, 8:00 am – 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions for the product return.  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.

If you would like to report any adverse reactions or quality problems experienced with the use of this product you may contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or via e-mail at DrugSafety@amneal.com. 

Any 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

NORTH CHICAGO, IL & NEW YORK, NY - AbbVie Inc. (NYSE: ABBV) ("AbbVie") and Landos Biopharma, Inc. (NASDAQ: LABP) ("Landos") today announced a definitive agreement under which AbbVie will acquire Landos, a clinical stage biopharmaceutical company focused on the development of novel, oral therapeutics for patients with autoimmune diseases. Landos' lead investigational asset is NX-13, a first-in-class, oral NLRX1 agonist (a member of the NOD-like receptor family) with a bimodal mechanism of action (MOA), which is anti-inflammatory and facilitates epithelial repair.

"With this acquisition, we aim to advance the clinical development of NX-13, a differentiated, first-in-class, oral asset with the potential to make a difference in the lives of people living with ulcerative colitis and Crohn's disease," said Roopal Thakkar, M.D., senior vice president, chief medical officer, global therapeutics, AbbVie.

"This announcement is a testament to Landos' talented team and their commitment to our mission of creating oral treatments that can address a therapeutic gap," said Gregory Oakes, president and chief executive officer, Landos. "NX-13 and its bimodal MOA have the potential to provide a novel approach to the treatment of ulcerative colitis and Crohn's disease. With AbbVie's therapeutic area leadership and expertise in global development, they are the right company to further advance NX-13."

NLRX1 regulates immunometabolism and inflammation, and its activation impacts multiple mechanisms of inflammatory bowel disease (IBD) pathogenesis. The randomized controlled Phase 2 NEXUS clinical trial evaluating NX-13 in UC is currently enrolling patients in the United States and Europe (NCT05785715).

Under the terms of the agreement, AbbVie will acquire Landos at a price of $20.42 per share in cash upon closing, or approximately $137.5 million in the aggregate, plus one non-tradable contingent value right per share with a value of up to $11.14 per share, or approximately an additional $75 million in the aggregate, subject to the achievement of a clinical development milestone. The proposed transaction is expected to close in the second calendar quarter of 2024, subject to customary closing conditions, including approval by Landos' stockholders.

An artificial intelligence tool West Virginia University health data scientists are developing could lessen medication errors that send recently discharged patients back to the hospital while reducing health care costs.

At least 1.5 million people are harmed by medication errors every year, according to the Academy of Managed Care Pharmacy, and the cost for treating these drug-related injuries occurring in hospitals alone is estimated at $3.5 billion annually.

“Because of this we need to provide better tools to our clinicians,” said Abdullah Al-Mamun, assistant professor in the WVU School of Pharmacy Department of Pharmaceutical Systems and Policy, who is leading the project. “We will develop a tool where we’ll go through each of the patient’s records for the medication reconciliation process. Our goal is to build an alert system that shows if the patient has a higher chance of getting readmitted.”

Medication reconciliation is a standard practice clinicians perform before patients are discharged from the hospital. The process is a review of prescriptions and over-the-counter treatments they were taking prior to and during their stay. The result should be a comprehensive list of what to take — and not take — along with specific dosages when they return home. However, Mamun said since information is gathered from multiple clinicians to make care recommendations, the procedure oftentimes becomes convoluted.

“This is where 85% of the errors happen,” Mamun said. “During a patient’s time in the hospital, medications are changed to improve the outcome. The patient cannot go home with the same amounts of medications they were given in the hospital. There should be an adjustment.”

As a remedy, Mamun points to studies showing a 50% reduction in 30-day readmission rates when a transition-of-care pharmacist took over medication reconciliation. His project aims to make the pharmacist’s job more efficient and effective through this AI-driven tool.

Mamun explained hospitals use electronic data systems containing information on medications and billing, along with notes from physicians, nurses and pharmacists. For medication reconciliation, a pharmacist spends between 30 to 50 minutes reviewing those records for each discharge patient, which can number around 200 a day in a facility the size of J.W. Ruby Memorial Hospital.

Mamun and members of his HealBig research lab want to streamline the process.

“That’s where the AI comes in,” Mamun said. “It will pull all these data and using different algorithms will build a profile for the patient. That will make the process more accurate and much faster and improve medication safety.”

The HealBig team will employ the AI method of deep learning for natural language processing to allow the program to understand certain words and phrases in clinicians’ notes. Based on factors — such as medical history and current physical condition — in each patient’s profile, the tool will also be able to determine the risk of readmission and create an alert system for pharmacists.

“Let’s say patient X is feeling better, but my tool says he has a 90% chance of coming back to the hospital in 30, 60 or 90 days. That would raise a flag,” Mamun said. “The pharmacist could go back to the interprofessional care team so they could go over the patient’s profile one more time to see if they should keep him in the hospital a couple more days. Something like that could save a patient’s life.”

The use of AI technology will also benefit students in Mamun’s lab by giving them the experience of learning data science tools they can use later in their professional careers.

“They will learn different dimensions of how to ultimately improve patient outcomes,” Mamun said. “When they are exposed to projects like this, they become more motivated to do research.”

Ki Jin Jeun, a graduate research assistant majoring in health services and outcomes research, will work on the statistical analyses. Other students in the WVU Pharmacy doctoral programs will join the project as it progresses.

With a two-year, $100,000 grant from the American College of Clinical Pharmacy, Mamun is working on the project with Kazuhiko Kido, clinical associate professor.

The team will first develop an alert system prototype. Mamun said the next step will be to integrate the tool into a hospital’s electronic data system and run a pilot test. For that phase, the team plans to seek a larger grant.

“The next phase will be challenging because that’s where the real interaction comes into the system,” Mamun said. “We will need a lot of resources and clinical experts. It’s very exciting to bring health data science and AI technologies into the medical field, especially in pharmacy. This will help payers, medical providers and, ultimately, clinicians to make better decisions.”    

HENDERSON, NC - UNC Health Pardee is pleased to announce the opening of Pardee Rx, a community pharmacy for Pardee patients, teammates, and community members. Pardee Rx offers a wide variety of generic and brand-name drugs as well as a complete selection of over-the-counter medications, vitamins, health and wellness needs, pediatric care items, and common medical supplies. The pharmacy is now open adjacent to the Pardee BlueMD -1027 Fleming St. primary care office in Hendersonville.

With the opening of Pardee Rx, Pardee is also pleased to welcome pharmacists Bryce Caldwell, PharmD, and Kenesha Smith, PharmD, to the team. Caldwell and Smith are available for consultations, whether to provide an answer to a question or education about medication.

“Our commitment to the community is what makes Pardee Rx different from other pharmacies,” said Johnna Reed, Chief Administrative Officer, UNC Health Pardee. “We are built on the strength of a team that includes physicians, pharmacists, case workers, nurses, medical assistants, and others who are focused on the goal of a healthy community. From medical assistance programs to affordable prescriptions, Pardee Rx is here for you.”

Through Pardee’s affiliation with Pardee BlueMD and its federally qualified health center (FQHC) status, the pharmacy can offer services to all patients, regardless of ability to pay. The pharmacy is open Monday through Friday from 8am - 6pm. For more information or questions call 828-435-8142.

UNC Health Pardee is a not-for-profit community healthcare organization and is managed by UNC Health. The hospital, founded in 1953, is licensed for 222 acute care beds. Pardee has several locations separate from the main campus, including a comprehensive physician practice network, a cancer center, four urgent care locations and six orthopedic clinics. For more information or to find a physician, visit pardeehospital.org.

SCHAUMBURG, IL - Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Furosemide for Injection in the United States as a therapeutic equivalent generic for Lasix^® for Injection (furosemide) approved by the U.S. Food and Drug Administration. Furosemide is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. Furosemide is particularly useful when an agent with greater diuretic potential is desired.

“The launch of Furosemide for Injection builds on the two launches announced earlier this week and further demonstrates the speed at which we are progressing the business,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “The reception by potential partners and investors to Avenacy at DCAT has been outstanding and, with five products now launched since our formation in October, we look forward to continuing to execute against our goal of launching more than 20 products this year.”

Avenacy's Furosemide will come in packs of 25 units of 100 mg/10 mL doses. In line with Avenacy’s mission to champion patient safety and streamline patient care, Furosemide for Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Furosemide for Injection to wholesale partners next week. The Company is supported by a global network of development and FDA-approved cGMP-certified contract manufacturing partners.

Furosemide for Injection had U.S. sales of approximately $33 million for the twelve months ending in June 2023.¹

To learn more about Avenacy’s products or the Company’s exciting growth plans for 2024, please see the Avenacy management team at DCAT Week 2024 taking place in New York City from March 18-21st. To request a meeting with a member of the Avenacy team, please reach out to Avenacy@fticonsulting.com.

Warning
Furosemide is a potent diuretic which, if given in excessive amounts, can lead to a profound diuresis with water and electrolyte depletion. Therefore, careful medical supervision is required and dose and dose schedule must be adjusted to the individual patient's needs.

Please see link for Full Prescribing Information including the Boxed Warning.

Furosemide is indicated as adjunctive therapy in acute pulmonary edema. The intravenous administration of furosemide is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema. If gastrointestinal absorption is impaired or oral medication is not practical for any reason, furosemide is indicated by the intravenous or intramuscular route. Parenteral use should be replaced with oral furosemide as soon as practical.

Lasix^® is a registered trademark of Sanofi S.A.

¹Source: IQVIA

SCHAUMBURG, IL - Avenacy, a specialty pharmaceutical company focused on supplying critical injectable medications, today announced it has launched Fosaprepitant for Injection and Fulvestrant Injection in the United States.

“Avenacy has had a strong start to 2024, with two product launches already executed and two more newly announced additions to our rapidly expanding portfolio. Since the Company’s launch in October, we have invested in bringing high-demand injectable products to market and strengthening our global network of development and manufacturing partners, and we are ready to build upon this important foundation as we prepare for significant growth,” said Jeff Yordon, Co-Founder and CEO of Avenacy. “We are looking forward to participating in DCAT 2024, where we will be discussing how Avenacy is well-positioned to continue addressing key gaps in the U.S. drug supply landscape through its differentiated portfolio, robust pipeline, and unwavering commitment to quality, safety, and patient care.”

Fosaprepitant for Injection is a therapeutic equivalent generic for Emend® (fosaprepitant) approved by the U.S. Food and Drug Administration. Fosaprepitant for Injection, in combination with other antiemetic agents, is indicated in adults for the prevention of:

• Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin
• Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC).

Fosaprepitant for Injection had U.S. sales of approximately $35 million for the twelve months ending in June 2023.¹ Avenacy’s product contains 150 mg of Fosaprepitant as a lyophilized powder in a single-dose vial for reconstitution.

Fulvestrant Injection is a therapeutic equivalent generic for Faslodex® (fulvestrant) approved by the U.S. Food and Drug Administration. Fulvestrant Injection is indicated for:

• Monotherapy use for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy; or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy.
• Combination therapy use for the treatment of HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy; or HR-positive, HER2-negative advanced or metastatic breast cancer in combination with palbociclib or abemaciclib in women with disease progression after endocrine therapy.

Fulvestrant Injection had U.S. sales of approximately $71 million for the twelve months ending in June 2023.¹ Avenacy’s product is supplied as 5 mL pre-filled syringes for injection containing 250 mg per 5 mL Fulvestrant.

Please see links for Full Prescribing Information of Fosaprepitant for Injection and Fulvestrant Injection.

In line with Avenacy’s mission to champion patient safety and streamline patient care, Fosaprepitant for Injection and Fulvestrant Injection will feature the Company’s highly differentiated packaging and labeling to support accurate medication selection. Avenacy will begin shipping Fosaprepitant for Injection and Fulvestrant Injection to wholesale partners this week.

Since launching in October of last year, Avenacy, backed by a robust global network of development and FDA-approved cGMP-certified contract manufacturing partners, has already brought four injectable products to the U.S. market. The company is poised to continue this trajectory with plans to pursue 20+ additional products for launch this year.

To learn more about Avenacy’s products or the Company’s exciting growth plans for 2024, please see the Avenacy management team at DCAT Week 2024 taking place in New York City from March 18-21st. To request a meeting with a member of the Avenacy team, please reach out to Avenacy@fticonsulting.com.

Emend® is a registered trademark of Merck & Co.
Faslodex® is a registered trademark of AstraZeneca.

¹Source: IQVIA

GRAND RAPIDS, MI - SpendMend, a leading provider of solutions to optimize the cost cycle for the healthcare industry, today unveiled the latest iteration of its pharmacy analytics and procurement software, Trulla. This upgraded release showcases numerous improvements to functionality and user experience.

Trulla, by SpendMend, is a cloud-based application that leverages proprietary AI algorithms to highlight financial leakage and dark data in pharmacy spend. To date, Trulla has saved hospitals and health systems over $250 million in drug costs. In 2023, clients averaged an annual savings of 1.6% of their pharmacy spend – which equated to an average daily cost savings of over $12,000, per client.

Developed by pharmacy professionals, Trulla software enables pharmacy leaders to leverage in-depth analytics in real-time while automating the correct pharmacy contract with the most preferred NDC (National Drug Code) and supplier for pharmacy buyers. This cutting-edge solution empowers pharmacy buyers to work effortlessly across all locations within a single, user-friendly system.

Previously focused solely on large integrated delivery networks, the Trulla platform now extends its services beyond this threshold, catering to institutions of varying sizes within the healthcare landscape. This expansion democratizes access to cost-saving solutions in the pharmacy domain, ensuring that smaller healthcare providers can benefit from Trulla's advanced capabilities. By broadening its reach, SpendMend is further reinforcing its commitment to driving tangible cost savings across the healthcare sector.

"We are thrilled to unveil the latest iteration of Trulla, designed to serve a broader spectrum of pharmacies within the healthcare landscape," says Curtis McEntire, VP of Trulla Solutions at SpendMend. "Having witnessed firsthand the challenges faced by pharmacies in optimizing pharmacy procurement, I am proud that Trulla can now contribute to enhancing patient care by empowering smaller institutions with the tools they need to thrive."

"The potential impact of this new release is very exciting," remarks Jake Thompson, VP of SpendMend Pharmacy. "Trulla has supported smaller hospitals when a part of a large IDN, but our new release allows us to support even small IDNs and small independent facilities.”

For more information about Trulla and SpendMend's suite of cost-saving solutions, visit https://www.spendmend.com/solutions/pharmacy-solutions/pharmacy-procurement-software/.

Approximately 98 million American adults—about one in three—have prediabetes, nearly 40 million Americans have diabetes, and more than 40% of adults in the U.S. are obese. Treatments for diabetes and obesity-related conditions show promise to help alleviate a growing disease burden, but access to newer, clinically proven medications remains limited.

To help patients being treated for diabetes, obesity, and migraine, Amazon Pharmacy is now offering home delivery of select medications through LillyDirect. Lilly has selected Amazon Pharmacy to serve as a third-party dispensing provider for LillyDirect Pharmacy Solutions, delivering prescribed Lilly medications directly to a patient’s home.

At Amazon Pharmacy, we believe access to high-quality pharmacy support is essential to good health care. Our clinical pharmacists review each incoming prescription for accuracy, appropriateness, and drug interactions. We offer 24/7 access to a clinical pharmacist for patients who have questions about their care. And, our world-class logistics and supply chain management enable customers to get their prescribed medications delivered on time and directly to their door, with ongoing tracking updates and access to customer care teams.
 

High-quality clinical support

or many patients who start using insulin, or injectable medications for migraine or obesity, this will be the first time they administer an injection. Amazon pharmacists can support medication management by providing guidance on administration techniques, drug interactions, side effects, and cost considerations. Pharmacists can also assist with reminder tools to help patients stay consistent with their medication schedule. Amazon Pharmacy’s clinical team remains available 24/7 to respond to care questions and support care.

Treating diabetes and obesity can slow or prevent the onset of cardiovascular disease, reducing the risk of heart attack or stroke, as well as reducing the risk of some cancers, osteoarthritis, and more. We’re pleased to work with Lilly to reimagine a pharmacy experience that can support better care outcomes. Physicians may send prescriptions to LillyDirect Pharmacy Solutions or to Amazon Pharmacy.
 

What medications are available through LillyDirect?

A full list of Lilly medicines currently available via LillyDirect can be found at https://lillydirect.lilly.com/medicines.
 

What medications are available through Amazon Pharmacy?

Amazon Pharmacy is a digital-first, full-service pharmacy on Amazon.com. We carry most medications prescribed at the doctor’s office, and deliver right to your door, with free two-day delivery for Prime members. Amazon Pharmacy accepts most insurance plans, and offers additional ways to save with PrimeRx and RxPass.