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Clinical Insights: January 10, 2024

Posted on January 10, 2024 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

Zelsuvmi™ (berdazimer sodium) Topical Gel – New Drug Approval – January 5, 2024 – Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announced that the U.S. Food and Drug Administration (FDA) has approved Zelsuvmi™ (berdazimer topical gel, 10.3%) for the treatment of molluscum contagiosum (molluscum) in adults and pediatric patients one year of age and older. The FDA approved Zelsuvmi™ as the first novel drug for the treatment of molluscum infections. Zelsuvmi™ is the first and only topical prescription medication that can be applied by patients, parents, or caregivers at home, outside of a physician’s office, or other medical setting to treat this highly contagious viral skin infection. <Read More>

New Indication/Dosage/Formulation Approval

Zoryve® (roflumilast) Cream and Foam – New Label Expansion – January 15, 2024 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), an early commercial-stage company focused on developing meaningful innovations in immuno-dermatology, announced the U.S. Food and Drug Administration (FDA) has approved the new drug application (NDA) for Zoryve® (roflumilast) topical foam, 0.3% for the treatment of seborrheic dermatitis in individuals 9 years of age and older. <Read More>

Yescarta® (axicabtagene ciloleucel) Suspension for Intravenous Infusion – New Label Expansion – December 21, 2023 – Kite, a Gilead Company (Nasdaq: GILD), announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta® in OS versus standard of care (SOC) as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy. <Read More>

Brukinsa® (zanubrutinib) Capsules – New Label Expansion – December 21, 2023 – BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, announced the U.S. Food and Drug Administration (FDA) has approved a label update for Brukinsa® (zanubrutinib) to include superior progression-free survival (PFS) results from the Phase 3 ALPINE trial comparing Brukinsa® against Imbruvica® (ibrutinib) in previously treated patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL). <Read More>

New Drug Shortage

January 8, 2024

Updated Drug Shortage

January 09, 2024

January 08, 2024

January 05, 2024

January 02, 2024

New Drug Recall and Safety Alerts

Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags by Leiters Health – New Voluntary Recall – January 8, 2024 – Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain twice the labeled amount of drug. <Read More>

New Generic/Biosimilar Approval and Launch

Udenyca® Onbody™ (pegfilgrastim-cbqv) Injection Kit – New Biosimilar Approval for Neulasta® Onpro® (pegfilgrastim) – December 26, 2023 – Coherus BioSciences, Inc. (Coherus, Nasdaq: CHRS), a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer, announced that the U.S. Food and Drug Administration (FDA) approved Udenyca® Onbody™, the company’s on-body injector (OBI) presentation of Udenyca® (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. <Read More>

Clinical and Pharmacy News

How Pharmacists Can Successfully Navigate the FDA’s New DSCSA Stabilization Policy – January 9, 2024 – In August, the FDA issued a 1-year stabilization policy on the final enhanced drug distribution security requirements under the DSCSA. What exactly does that mean for pharmacists? The Drug Supply Chain Security Act (DSCSA) was set into motion nearly 10 years ago, becoming law on November 27, 2013. The law aims to help the FDA protect consumers from exposure to drugs that may be harmful by improving the detection of potentially dangerous drugs in the US supply chain. The DSCSA outlines steps that manufacturers, wholesalers, and dispensers need to follow to achieve electronic tracing of products at the package level as they are distributed. <Read More>

Adapting to the FDA’s Phenylephrine Status Change in OTC Cold and Congestion Medications – January 8, 2024 – The realm of OTC medications, often considered a quick and accessible remedy for common ailments, is currently undergoing a transformative phase. The catalyst for this change is the revised status of phenylephrine, a key ingredient in numerous OTC cold and congestion medications, as mandated by the FDA. Phenylephrine, a nasal decongestant, has long been used to alleviate nasal congestion in various OTC formulations. Its mechanism involves narrowing blood vessels in the nasal passages, effectively reducing swelling and facilitating easier breathing. Widely used and believed to be safe and effective, phenylephrine has been a staple ingredient in many cold and congestion medications available without a prescription. However, only 38% of the phenylephrine dose is bioavailable after ingestion, resulting in insufficient concentration to reach systemic circulation, and hence ineffective when taken orally. <Read More>

Three Methods for Effectively Training the Next Generation of Pharmacy Leaders – January 8, 2024 – To develop the next generation of pharmacy leaders, pharmacists should receive effective training from the beginning of their careers. Training the next generation of health care leaders is crucial for the future of pharmacy, which is an ever-changing and ever-expanding field. Pharmacists are an important facet of health care leadership and, to develop the next generation of pharmacy leaders, these professionals require training from the beginning of their careers. To support this need, there are a few methods of training available. <Read More>

Colorado System Turns to Apprenticeships to Ease Tech Shortage – January 3, 2024 – Children’s Hospital Colorado did not have the resources to pay pharmacy techs more or create a training program, so it established apprenticeships to solve the workforce shortage. Hospitals have dealt with a pharmacy tech shortage for at least a decade. In 2021, the turnover rate was 20%, and 1 in 10 pharmacy directors said they had lost 40% or more of their pharmacy technicians, according to a Jan. 2 post from the American Society of Health-System Pharmacists. In the post-pandemic landscape, occupational burnout and costs of living have risen while pharmacy tech pay has stagnated. Jennifer Hamner, PharmD, director of pharmacy professional development at the health system, said a pharmacy technician who was leaving Children’s Hospital told her he made more money working for Uber. <Read More>

340B in the News

Increasing Transparency in the 340B and Medicaid Drug Rebate Programs – January 9, 2024 – Recent court rulings have thrust the 340B Drug Pricing Program back in the headlines, and it is worth examining some of the lesser-known aspects of how this program interacts with state and federal Medicaid dollars, specifically through the Medicaid Drug Rebate Program (MDRP). While well-intentioned and created with bipartisan support, both initiatives have now morphed, decades later, into an opaque tapestry—and as such, are facing increasing scrutiny from lawmakers and the public. Here, we make a case that the MDRP can be used as one avenue for reforming 340B by increasing transparency to ensure it continues to meet the intent of the original legislation. <Read More>

FDA Authorizes Florida’s Drug Importation Program – January 5, 2024 – The FDA authorized the Florida Agency for Health Care Administration’s drug importation program to enable Florida to import bulk quantities of certain prescription drugs from Canada, which the state claims will lower drug costs. The ASHP, however, opposes state importation of drugs from Canada because it could disrupt the pharmacist-patient relationship, particularly for patients with complex medication regimens, and because it is not a meaningful response to drug pricing, the association said. “This drug importation proposal is not a real solution. The Canadian market cannot supply anywhere close to the amount of medication needed to bring down U.S. drug prices. Patients also need to know that this approach undermines the protections that pharmacists and physicians rely on to keep our drug supply safe,” said Tom Kraus, ASHP vice president of government relations. <Read More>

AHA Comments on Proposed Medicare Advantage Policies for 2025 – January 5, 2024 – AHA Jan. 5 voiced strong support for Centers for Medicare & Medicaid Services proposals to increase oversight and enhance consumer protections in the Medicare Advantage program for contract year 2025, which would strengthen data collection and reporting, MA appeals rights and processes, and network adequacy for behavioral health services. AHA also urged CMS to ensure that MA plans accurately report appeals measures data used to calculate star ratings and plan utilization management committees conduct an annual health equity analysis. In addition, AHA pressed CMS to make hospitals whole for past MA underpayments to 340B hospitals and establish guardrails on the use of AI tools that may facilitate automatic claim denials. <Read More>

Once Again, Gilead Attacks the Healthcare Safety Net – January 4, 2024 – Gilead Sciences furthers its assault on safety-net healthcare providers by expanding its 340B contract pharmacy restrictions to include clinics that serve the poor with in-house pharmacies.  AIDS Healthcare Foundation condemns the maneuver driven entirely by Gilead’s greed.  The drug maker will increase profits by limiting access to branded hepatitis C medications available at legally mandated 340B prices.  Wrapping itself in the flag of transparency, Gilead aims to reduce the number of prescriptions it must sell at the 340B discount price to access the lucrative, taxpayer-subsidized Medicaid prescription drug market. <Read More>