A roundup of Prime's award-winning presentations and insights at AMCP Nexus in National Harbor, Maryland

Managed Healthcare Executive

USA Today

Reuters

Insider

CNBC

Formulary Watch

Star Tribune

Business Insider

Endpoint News

Reuters

Washington Post: Doctors and patients struggle with starting and stopping medications with little guidance.

Reuters

Reuters

NBC News: Patients weren't asked why they quit taking the weight loss drugs

Reuters

Learn with Biosimilar Basics. Part 2 covers biosimilar naming conventions and other nomenclature including common drug pipeline content acronyms.

Prime Therapeutics’ Clinical Insights is your trusted resource for timely, evidence based perspectives on emerging therapies and managed care strategy. The Summer 2025 issue focuses on metabolic...

Hear some of the latest insights from the annual managed care pharmacy event, where Prime Therapeutics clinical and health outcomes teams presented leading research findings

Drug Approvals Monthly Update: January 2024 Traditional New drugs 1/05/2024 Zelsuvmi™ (berdazimer): The FDA approved Zelsuvmi for the topical treatment of molluscum contagiosum (MC) in adult and...

Drug Approvals Monthly Update: February 2024 Specialty New drugs 2/16/2024 Amtagvi™ (lifileucel) The United States (U.S.) Food and Drug Administration (FDA) approved the first-in-class...

Novartis submitted an application to the FDA in 2Q 2025 for an intrathecal formulation (OAV101IT) of their one-time gene therapy onasemnogene abeparvovec (OAV101IT) for the treatment of spinal...

Annual conference gathers 2,500+ managed care leaders to discuss complex health care issues.

Identifying and managing diabetes and weight loss therapies earns AMCP platinum award

Maryam Tabatabai, PharmD, associate vice president of clinical information, shares more about how cell and gene therapies are transforming the treatment landscape, and how payers and providers can...

Home Newsroom Custom Content Publications Drug Approvals Drug Approvals Monthly Update: September 2024 1. ADvocate 1 and 2 trials: https://pubmed.ncbi.nlm.nih.gov/36920778/ 2. ADhere trial:...

Read Drug Approval Update Specialty New drugs 06/06/2024 Rytelo™ (imetelstat) The FDA approved the first-in-class oligonucleotide telomerase inhibitor, Rytelo, for the treatment of adults with low-...

Specialty New drugs 3/18/2024 Lenmeldy™ (atidarsagene autotemcel) Lenmeldy is an autologous hematopoietic stem cell-based gene therapy by Orchard Therapeutics, which was FDA approved for the...

Read Drug Approval Update Specialty New drugs 04/22/2024 Anktiva® (nogapendekin alfa inbakicept-pmln) The FDA approved Anktiva for use in combination with Bacillus Calmette-Guérin (BCG) for the...

Editor-In-Chief: Maryam Tabatabai, PharmD Executive Editor: Anna Schreck Bird, PharmD Deputy Editors: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES A retrospective propensity score-matched cohort...

Drug Approvals Monthly Update: August 2024 This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new...

Clinical deep dive Disease state overview SMA is a rare, debilitating, hereditary disease characterized by progressive motor function decline and muscular atrophy. Most commonly, SMA results from a...

Generic Name Brand Name Manufacturer Indication(s) Route of Administration Month Approved* aprocitentan Tryvio® Idosia Difficult-to-control or resistant hypertension Oral March budesonide Eohilia™...

Zolgensma, which was FDA approved in May 2019, is administered as an intravenous (IV) infusion, with dosing based on patient weight, in pediatric patients under 2 years of age with SMA caused by...

Editorial team The American College of Physicians (ACP) has released a clinical practice guideline on use of pharmacological treatment for prevention of episodic migraine, defined as one to 14...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status Tividenofusp alfa (DNL310) AstraZeneca IV a fusion protein ERT...

Critical updates in an ever-changing environment.

Critical updates in an ever-changing environment

Shortage Updates Eli Lilly’s tirzepatide (Zepbound) is reported as currently available in all strengths, as is the T2DM formulation of tirzepatide (Mounjaro). Additionally, all strengths of Novo...

Generic Name Brand Name Brand Manufacturer Indication Approval Month* chikungunya vaccine, live Ixchiq® Valneva Austria Prevention of disease caused by Chikungunya virus November meningococcal...

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...