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...

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...

Aug. 14, 2026 PUBLICATIONS FDA Decisions Expected: September 2026 Your monthly synopsis of new drugs expected to hit the market Drug pipeline for September 2026 At Prime Therapeutics (Prime), we...

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 Journal of Managed Care (AJMC): The growing list of insurers dropping coverage for costly GLP-1 weight loss drugs leaves patients to bear even higher out-of-pocket expenses while still...

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...

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...

publications Trending Topics & Drug Approvals: July 2026 Your source for the latest drug information highlights Specialty Glossary June 17, 2026 — azilsartan medoxomil (Edarbi) Lupin...

Managed Healthcare Executive: Use of GLP-1 drugs and weight-loss care management programs need to focus on adherence and persistency for better health outcomes, suggests Prime...

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...

March 27, 2026 – vanzacaftor/tezacaftor/deutivacaftor (Alyftrek) Vertex; combination of deutivacaftor (a CFTR potentiator) and tezacaftor/vanzacaftor (CFTR correctors); expanded indication is based...

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

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...

July 15, 2026 publications Summer 2026 Prime Therapeutics Report Explore timely specialty insights for managed care, including autoimmune biosimilars, policy developments, pipeline activity,...

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;...

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...

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...

SAVINGS PER CASE $11,500 An employer group with 7,000 lives implemented HighTouchRx. They saw savings of $194,300, with HighTouchRx providing an ROI of 5:1.4 Since its launch, HighTouchRx has saved...

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...

The American Gastroenterological Association (AGA) has released a clinical practice guideline on management of gastroparesis, including recommendations for diagnosis and effective treatment (e.g.,...

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:...

The Minnesota-based pharmacy benefit manager says a program that resulted in patients switching from two incretin therapy prescriptions to one yielded $7,500 in savings per patient and a total of...

Jan. 26, 2026 – folic acid oral solution (Quiofic) 505(b)(2) NDA approval; other formulations of folic acid include the following: oral capsule, oral tablet, solution for injection and an OTC oral...

BioPharma Dive: There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.

Understanding your data INO-3107 is a DNA immunotherapy composed of a plasmid encoding for antigens from both HPV-6 and HPV-11 as well as a plasmid encoding for an interleukin-12 (IL-12) immune...

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...

New biosimilars Feb. 26, 2026 – zongertinib (Hernexeos) Boehringer Ingelheim; kinase inhibitor; Accelerated Approval, Assessment Aid, Breakthrough Therapy, Commissioner's National Priority Voucher...

Drug information happenings publications Trending Topics & Drug Approvals: June 2026 Your source for the latest drug information highlights May 15, 2026 — baxdrostat (Baxfendy) NDA approval;...

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

Clemidsogene lanparvovec (RGX-121) is an investigational, one-time intracisternal adeno-associated virus serotype 9 (AAV9) gene therapy delivering the iduronate-2-sulfatase (IDS) gene directly to...

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...

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....

New report explores traditional, specialty therapy trend impact to employers

Gene therapy harnesses the body’s capacity to heal itself

Prior authorization using integrated medical claims data helps diabetes patients get medications faster, with two-thirds processed automatically by July 2025 in this Prime Therapeutics analysis

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)...

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

Prime Therapeutics research shows that persistence with GLP-1 weight-loss therapies continues to improve, offering new insights into long-term treatment trends and outcomes