Vanda Pharmaceuticals submitted the atypical antipsychotic agent milsaperidone to the FDA for the treatment of bipolar I disorder and schizophrenia. Milsaperidone is an active metabolite of Vanda’s...

Proposed indications Mucopolysaccharidosis type II (MPS II), also known as Hunter Syndrome FDA approval timeline April 5, 2026 (review extended) Breakthrough Therapy Fast Track Orphan Drug Priority...

Copy to clipboard Copied! September 27, 2024 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep...

Pipeline (late-stage development) NAME MANUFACTURER ROUTE OF ADMINISTRATION MECHANISM OF ACTION PROPOSED/STUDIED INDICATION STATUS Aurora-GT United IV Gene therapy; autologous endothelial...

Clinical deep dive Disease state overview RRP is a rare condition which manifests clinically as persistent wart-like growths (papillomas) within the aerodigestive tract, primarily in the larynx,...

Regeneron has resubmitted their fully human immunoglobulin G4 (IgG4)-based CD20 x CD3 bispecific antibody, odronextamab, to the FDA for the treatment of R/R follicular lymphoma (FL) after two or...

Event will feature David Lassen, chief clinical officer

Traditional Jun. 28, 2024 – Ahzantive™ (aflibercept-mrbb) Formycon received FDA approval for Ahzantive™ as a biosimilar to Regeneron’s Eylea® (aflibercept). Ahzantive™ is a vascular endothelial...

Drug pipeline for July 2026 At Prime Therapeutics (Prime), we have positioned ourselves to best prepare our clients to manage new drugs. Our clinical and trade relations teams keep a keen eye on...

cover image for Reimagine Cancer Care: Insights That Drive Smarter Decisions Explore the latest oncology trends, payer strategies and pipeline updates shaping the future of managed care. Prime...

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

Expert Clinical Network Insights Hemophilia Medication insights: marstacimab-hncq (Hympavzi) The U.S. Food and Drug Administration (FDA) approved marstacimab-hncq (Hympavzi) in October 2024 for...

HighTouchRx® Insert Link Learn more about biosimilars As part of our comprehensive drug management strategy, we actively promote the evidence-based use of FDA-approved biosimilars and other...

Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status Durvalumab (Imfinzi) AstraZeneca; MedImmune IV Programmed...

Proposed indications Hematological malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndromes (MDS). FDA approval timeline April 6, 2026...

July 2, 2026 Author: Abby Kim, PharmD, BCOP From potential new standards of care to unexpected innovations reshaping treatment paradigms, the 2026 American Society of Clinical Oncology (ASCO)...

Proposed indications Non-muscle invasive bladder cancer (NMIBC) FDA approval timeline March to May 2026 Standard Review Place in therapy Sasanlimab is a humanized immunoglobulin G4 (IgG4)...

cover image for summer 2025 New therapies, payer strategies and pipeline updates shaping the future of managed care  Prime Therapeutics /summer-2025-prime-therapeutics-report The Prime Therapeutics...

Jan. 28, 2025 – hydrochlorothiazide (Inzirqo) 505(b)(2) NDA approval; Standard Review; first oral suspension formulation of hydrochlorothiazide; previously available oral solutions are no longer...

publications High-Cost Therapy Profile: April 2025 Deramiocel Intravenous (IV) | Nippon Shinyaku Co., Ltd./Capricor Therapeutics, Inc. Clinical deep dive Disease state overview DMD is a severe,...

January 31, 2025 All brand names are property of their respective owners. Dec. 13, 2024 – cosibelimab-ipdl (Unloxcyt) Checkpoint’s Unloxcyt has received FDA approval for the treatment of adults...

May 15, 2025 Oncology-Gene therapy Pipeline (late-stage development) Name Manufacturer Route of administration Mechanism of action Proposed / studied indication Status Bifikafusp Alfa; Onfekafusp...

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

Kresladi, by Rocket Pharmaceuticals, is undergoing it’s second review by the FDA for the treatment of severe leukocyte adhesion deficiency type 1 (LAD-1). In June 2024, the FDA issued a CRL for...

Real-World Adherence and Persistence to Glucagon-Like Peptide-1 Receptor Agonists Among Non-Diabetic Obese Commercially Insured Adults Authors: A.M. Wilson, PharmD; B.D. Hunter, MS; K....

Abbvie is seeking Accelerated Approval of Teliso-V in adults with previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR) wild type, nonsquamous non-small cell...

Studies on GLP-1 drugs, specialty therapies and more help improve affordability in health care Click on the poster image to view the full-size version. Validation of Long-term Savings from a...

Read more about Prime’s leading research and insights Real-World 2-Year Clinical Outcomes Following Initiation of Glucagon-Like Peptide-1 Agonists to Treat Obesity Without Diabetes Among a...

May 1, 2024 Obesity is a global epidemic and major public health issue that has grown in prevalence over recent decades in adults, adolescents and children. This Clinical Insights white paper...

A roundup of Prime's award-winning presentations and insights at AMCP Nexus in Las Vegas.

13th annual report the preeminent source for medical benefit drug trend

Nov. 29, 2024 - ustekinumab-kfce (Yesintek) The FDA has approved Biocon’s Yesintek as a biosimilar to ustekinumab (Stelara). This human interleukin (IL)-12 and IL-23 antagonist is indicated for all...

The Spring 2026 Prime Therapeutics Report delivers a forward-looking view of specialty and rare disease management—highlighting breakthrough approvals, expanding pipelines and the payer strategies...

Managed Healthcare Executive

Real-World 3-Year Cost Impact Assessment of Glucagon-Like Peptide-1 Agonists to Treat Obesity Among Commercially Insured Members without Diabetes This study earned a silver award from AMCP. It...

More than 300 pharma representatives attended this annual gathering to learn more about what Prime/MRx has to offer

*select countries included adolescents 12 years and older weighing 30 kg or more Autoimmune/immunology Proposed indications Treatment of Steroid-Refractory Acute Graft vs. Host Disease (SR-aGVHD) –...

Biobetters are just a nickname; they’re based on existing biologics but with a few key differences