Acetaminophen (Tylenol) update The United States (U.S.) Food and Drug Administration (FDA) announced the initiation of a safety label change for products containing acetaminophen (Tylenol, other...

Specialty May 23, 2025 – meningococcal (groups A, C, Y, W) conjugate vaccine (MenQuadfi) Sanofi Pasteur; meningococcal vaccine for active immunization Expanded indication: for the prevention of...

Editorial team The American Diabetes Association (ADA) has released the 2025 Standards of Care in Diabetes. In addition to new recommendations on nutrition and technology, additional guidance was...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status DNL126 Denali Therapeutics  IV SGSH RT using ETVto deliver SGSH...

BEHAVIORAL HEALTH CORNER The Psychopharmacologic Drugs Advisory Committee will convene on June 4, 2024 to discuss an NDA for midomafetamine (MDMA) capsules from Lykos Therapeutics. The psychedelic...

Want more information on this topic and more from our KOLs? On June 15, 2025, Sarepta, the manufacturer of Elevidys, issued a press release that announced a safety update for Elevidys and steps to...

Clinical News EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD EXECUTIVE EDITOR: Anna Schreck Bird, PharmD DEPUTY EDITORS: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES HCl = hydrochloride HCP = health...

The American Academy of Pediatrics (AAP) published its first clinical practice guideline on opioid prescribing for acute pain management in children and adolescents in outpatient settings. The...

Cover image for The evolution of GLP-1s Developing a holistic, individualized strategy to capitalize on opportunities and outcomes Prime Therapeutics /the-evolution-of-glp-1s About Prime...

July 14, 2025 Author: Abby Kim, PharmD, BCOP The DESTINY-Breast09 trial marked a pivotal moment in the treatment of HER2-positive metastatic breast cancer, offering the first major advancement in...

The Fall 2025 Prime Therapeutics Report delivers a comprehensive look at the evolving oncology landscape—from rising cancer rates in younger populations to the expanding role of...

Clinical deep dive Disease State Overview Metachromatic leukodystrophy (MLD) is a rare, autosomal recessive, genetic, eventually fatal lysosomal storage disorder. MLD is caused by mutations in the...

cover image for Summer 2025 Issue: Clinical Insights – MASH A new era in liver health: Treatment innovation, payer strategy, and pipeline momentum Prime Therapeutics...

This monthly approval update provides a review of newly approved specialty drugs, recent drug launches, generic updates, new indications and news of note on drugs in the approval process.

The American Thoracic Society, CDC, European Respiratory Society and Infectious Diseases Society of America (IDSA) have published updated clinical practice guidelines for tuberculosis (TB)...

New report explores traditional, specialty therapy trend impact to employers

The Prime Therapeutics Report is your trusted source for the latest in managed care strategies, specialty drug trends and payer-focused insights. The Summer 2025 issue features a cover story on HIV...

Tab 1 BEHAVIORAL HEALTH CORNER WEIGHT MANAGEMENT CORNER Clinical News EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD EXECUTIVE EDITOR: Anna Schreck Bird, PharmD DEPUTY EDITORS: Erik Hamel, PharmD;...

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care...

WEIGHT MANAGEMENT CORNER The American Heart Association (AHA) has published a Presidential Advisory forecasting the extent of cardiovascular disease (CVD) and stroke expected in the U.S. through...

New formulations Drug Approvals New drugs Trending Topics Oct. 20, 2025 – glycerol phenylbutyrate (Ravicti) Par/Endo launched a generic oral liquid to Horizon’s Ravicti Nitrogen-binding agent;...

The CDC is reporting influenza-like illness (ILI) for the week ending March 15, 2025 (week 11). Seasonal influenza activity remains increased across the U.S. but has decreased for five consecutive...

Gene therapy harnesses the body’s capacity to heal itself

Footnotes HighTouchRx has achieved a 50 Net Promoter Score (NPS).2 HighTouchRx was a Gold Award recipient at the AMCP Annual Meeting 2024, recognized for delivering an average savings of $73,142...

PUBLICATIONS FDA Decisions Expected: January 2026 Your monthly synopsis of new drugs expected to hit the market All brand names are property of their respective owners. References SERENA-6 trial:...

Managed Healthcare Executive: Prior authorization using integrated medical claims data helps diabetes patients get medications faster, with two-thirds processed automatically by July 2025 in this...

Oct. 29, 2025 – denosumab-desu (Jubereq) BLA approval; the 120 mg/1.7 mL single-dose vial for SC use has received FDA approval as an interchangeable biosimilar to the same presentation of denosumab...

Prime Therapeutics Report shares more about single-treatment gene therapies and proper management

From next-gen CFTR modulators to gene therapy and real-world drug impact, cystic fibrosis care is constantly evolving. Maryam Tabatabai, PharmD, of Prime Therapeutics, explains how innovative...

Annual meeting will feature industry research posters and educational sessions

publications Spring 2024 Prime Therapeutics Report March 15, 2024 The Prime Therapeutics Report is your source for innovative managed care strategies, trends and updates. Our cover story (Page 6)...

The information provided has been developed based on available information as of March 3, 2025. This therapy is NOT FDA approved, and content may change as more information becomes available....

References Abeona Therapeutics announces FDA accepts and grants Priority Review for Pz-cel biologics license application (BLA). November 27, 2023. Available at:...

With an established playbook for launching new union business, we ensure smooth transitions, clear communication and rapid implementation. Our Special Investigations Unit (SIU) uses advanced...

December 17, 2024 PUBLICATIONS FDA Decisions Expected Drug pipeline for January 2025 Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned...

Your monthly synopsis of new drugs expected to hit the market At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade...

PTC Therapeutics is awaiting the FDA decision for ataluren for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). The FDA granted ataluren Fast Track and Orphan Drug...

References Annual review of factor replacement products. Oklahoma Health Care Authority Review Board. Updated April 2016. https://oklahoma.gov/ohca.html. Accessed April 1, 2022. Burke T, Asghar S,...

publications What 2025 Revealed About the Future of Oncology Care January 14, 2026 Author: Simone Ndujiuba, PharmD, BCOP Over the past year, Oncology Insights highlighted the oncology topics...

Merck submitted a combination product containing pembrolizumab and berahyaluronidase alfa as a subcutaneous (SC) version of pembrolizumab (Keytruda) for approval across all previously approved...