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Clinical Insights: March 6, 2024

Posted on March 6, 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

Letybo® (letibotulinumtoxinA-wlbg) Powder for Injection – New Drug Approval – February 29, 2024 – Hugel, a global total medical aesthetics company, announced that the company has received marketing approval from the U.S. Food and Drug Administration(FDA) on the 29th(local time) for 50 units and 100 units of its botulinum toxin Letybo®. The FDA approval of Letybo®, represents a strong recognition of Hugel’s product quality and credibility, meeting the rigorous standards by one of the world’s leading regulatory authorities. <Read More>

New Indication/Dosage/Formulation Approval

Rybrevant® (amivantamab-vmjw) Injection -New Label Expansion – March 1, 2024 – Johnson & Johnson (NYSE: JNJ) announced that following a priority review, the U.S. Food and Drug Administration (FDA) has approved Rybrevant® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test. This FDA action converts the May 2021 accelerated approval of Rybrevant® to a full approval based on the confirmatory Phase 3 PAPILLON study. <Read More>

New Drug Shortage

March 05, 2024

March 04, 2024

March 01, 2024

February 29, 2024

Updated Drug Shortage

March 05, 2024

March 04, 2024

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

New Federal Guidance is Hurting Cancer Patients, Especially Those in Rural Areas –March 1, 2024 – I recently started a patient with metastatic triple-positive breast cancer patient on a targeted therapy regimen consisting of capecitabine and neratinib, both oral chemotherapy pills that are dosed on a 21-day cycle. Given that her cancer also thrives on estrogen, I chose to continue her monthly fulvestrant injections (which targets estrogen) in my clinic in Dickson, Tennessee, a small town 40 minutes outside Nashville. Until last year, my patient would have been able to make the hour-long drive to my clinic every four weeks for the injection and have our medically integrated specialty pharmacy send her the oral chemotherapeutics every three weeks by courier to her home. <Read More>

CVS to Pay Ohio $1.5 Million in Penalties Over Understaffing and Other Safety Issues at Pharmacies – March 1, 2024 – CVS Health, one of the nation’s largest operators of retail chain pharmacies, will pay Ohio $1.5 million in penalties for problems largely related to understaffing and make changes that may soon be mandatory for all the state’s retail pharmacies, the Ohio Board of Pharmacy said Thursday. The penalties, the largest ever imposed by the state board, are part of the settlement of 27 safety cases the board was investigating at 22 CVS pharmacies. <Read More>

Cell and Gene Therapies: A Review of Current and Future Treatments – February 28, 2024 – In the last 15 years, cell and gene therapies (CGTs) have emerged as transformative treatments for diseases that previously had no approved therapy options. Gene therapy is defined as the repair, replacement, or deactivation of dysfunctional genes to reestablish normal function. Cell therapy is defined as the transfer of autologous (from oneself) or allogeneic (donor) cellular material into a patient for medical purposes. Not surprisingly, development of a gene or cell therapy is a very complex process. <Read More>

Older Adults Now Able to Receive Additional Dose of Updated COVID-19 Vaccine –February 28, 2024 – CDC Director Mandy Cohen endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for adults ages 65 years and older to receive an additional updated 2023-2024 COVID-19 vaccine dose. The recommendation acknowledges the increased risk of severe disease from COVID-19 in older adults, along with the currently available data on vaccine effectiveness. Previous CDC recommendations ensured that people who are immunocompromised are already eligible for additional doses of the  COVID-19 vaccine. Data continues to show the importance of vaccination to protect those most at risk for severe outcomes of COVID-19. An additional dose of the updated COVID-19 vaccine may restore protection that has waned since a fall vaccine dose, providing increased protection to adults ages 65 years and older. <Read More>

Local Pharmacies on the Brink, New Survey Reveals – February 27, 2024 – As rumors swirl in Washington, D.C., that lawmakers may once again be punting on PBM reform, the National Community Pharmacists Association released a survey showing many local pharmacies are running out of time. “Nearly a third of independent pharmacy owners may close their stores this year under pressure from plunging prescription reimbursements by big insurance plans and their pharmacy benefit managers,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “This is an emergency. And if Congress fails to act again, thousands of local pharmacies could be closed within months and millions of patients could be stranded without a pharmacy.” <Read More>

US Pharmacy Outage Triggered by ‘Blackcat’ Ransomware at UnitedHealth Unit, Sources Say – February 26, 2024 – Hackers working for the ‘Blackcat’ ransomware gang are behind the outage at UnitedHealth’s (UNH.N), opens new tab technology unit that has snarled prescription deliveries for six days, two people familiar with the matter told Reuters on Monday. The problems began last week after hackers gained access to Change Healthcare’s information technology systems and has led to disruptions at pharmacies across the United States. Change Healthcare and UnitedHealth did not immediately respond to requests for comment. Blackcat, also known as “ALPHV,” did not immediately respond when asked whether it was responsible. <Read More>

340B in the News

AHA Files Brief Defending Louisiana 340B Contract Pharmacy Law – February 29, 2024 – AHA filed a friend-of-the-court brief in support of a Louisiana law that prohibits drug companies from denying Louisiana hospitals the same 340B discounts for drugs dispensed at community pharmacies that would be provided via in-house pharmacies, its latest in a string of lawsuits claiming the federal law that created the 340B program preempts the state law. AbbVie, “like their fellow drug company AstraZeneca and the trade association representing their confederates, want to have their cake and eat it too,” AHA wrote. <Read More>