Denise Myshko

FDA has approved a new therapy for HR positive breast cancer and announces plan to hold advisory meeting for Abecma in earlier treatment of multiple myeloma. In addition, Janssen has submitted a supplemental application for Rybrevant in NSCLC.

A new gene therapy administered directly to the brain aims to preserve dopamine neurotransmission in patients with multiple system atrophy.

One notable change: CVS Caremark has removed the Humira biosimilar Amjevita and now prefers Hyrimoz and an unbranded biosimilar.

Beovu led to greater improvement in retinal thickness and reduction of retinal fluid in patients with diabetic macular edema, a secondary endpoint in this head-to-head trial.

This is the latest offering by Express Scripts that aims to bring transparency to prescription drug costs.

Bimzelx is the first dual IL-17 A/F inhibitor to treat moderate-to-severe plaque psoriasis. It launches with a list price of $7,200 per syringe.

First in class, biosimilars, oncology drugs and even some generics have been added to Optum Rx’s list of exclusions for 2024.

A post-hoc analysis of the SCORED clinical trial identified early benefit for patients taking Inpefa in both heart failure and major adverse cardiovascular events (MACE) related outcomes

An analysis estimated the clinical and economic impact of Inpefa using inputs from a phase 3 trial of the heart failure drug.

In a phase 2 trial, abelacimab achieved a 99% inhibition of Factor XI and a 67% reduction in major or clinically relevant non-major bleeding events.

A study with a unique trial design and a newer endpoint shows Farxiga can improve cardiometabolic outcomes in a subset of patients.

Tirzepatide, with the brand name Zepbound, is expected to be available by the end of the year in six doses at a list price of $1,059.87, which is about 20% lower than semaglutide.

Precision medicine will lead to fewer cases of ocular cancers, earlier diagnosis, and more targeted and sight-saving treatments.

In real-world experience, Tepezza benefits patients with moderate-to-service thyroid eye disease, but adverse events can lead to discontinuation.

Racial disparities in glaucoma care persist, regardless of socioeconomic status, finds new research presented at the annual meeting of the American Academy of Ophthalmology.

In a late breaking session, a one-time gene therapy was found in a phase 2 trial to provide sustained release of dexamethasone in patients with diabetic macular edema and retinal vein occlusion. The trial is ongoing.

Innovations have allowed retinal procedures to be completed more rapidly with better patient outcomes. One speaker at AAO argues, however, that reimbursement should also consider the complexity of the procedure and not just the time it to takes to complete.

Researchers caution that popular chatbots, while having the potential to improve access and quality of patient education, provide unreliable medical advice.

The Institute for Clinical and Economic Review’s fair access report found that it was difficult to determine how well policies translate into real-world access and affordability for patients.

Sarepta Therapeutics plans to submit an application for full approval of Elevidys to treat all ages of patients with Duchenne muscular dystrophy. Company officials said the FDA is open to evaluating the application based on the totality of the evidence.

Almost 80% of patients in an extension study maintained clear or almost clear skin, and 90% of patients saw continued improvements in itch.

Mirikizumab — now with the brand name — Omvoh is the first therapy that targets interleukin-23p19, which plays a role in inflammation. It has a list price of $9,593 per month for the IV formulation and $10,360 per subcutaneous administration.

RP-L201 (marnetegragene autotemcel) is a one-time gene therapy that delivers a functional copy of the ITGB2 gene, which provides instructions for immune response to infections. The Prescription Drug User Fee Act (PDUFA) target action date is March 31, 2024.

New results demonstrate seladelpar can reduce alkaline phosphatase and itching in patients with primary biliary cholangitis, a chronic liver disease.

Celltrion’s Zymfentra is subcutaneous version of infliximab.

Researchers at the Yale School of Medicine have invented a new delivery technology that has the potential to create one-time treatments for a range of neurological disorders.

Research continues to develop new therapies for rare cancers and to provide options that allow for fewer toxicities. At the same, however, more new drugs are launching with high price tags.

Using an AI platform, Magellan Health was able to better support providers in prescribing behavioral health medications and addressing medication problems, which reduced pharmacy costs and increased adherence.

The results of a recent feasibility study on the outpatient administration of cell therapies is creating growing interest in whether home-based management may be possible in the future.

In her review of the specialty drug pipeline, Evernorth's Aimee Tharaldson said upcoming approvals for Crohn’s and colitis drugs could further shift the drug spend from the medical benefit to the pharmacy one.