Drug Topics Top 10: Most Read Stories From September 2024

FDA Clears First Digital Therapeutic for Treatment of Generalized Anxiety Disorder

Drug Topics Top 10: Most Read Stories From September 2024 / Pixel-Shot - stock.adobe.com

The FDA granted clearance to the digital therapeutic DaylightRX for the treatment of generalized anxiety disorder (GAD) as an adjunct to usual care in patients aged 22 years and older. The therapy is the first digital treatment approved to treat GAD in the United States.

FDA Approves Updated Novavax COVID-19 Vaccine

The FDA has granted emergency use authorization (EUA) to an updated COVID-19 vaccine from Novavax to prevent the disease in individuals aged 12 years and older. The protein-based vaccine, called NVX-CoV2705, is an updated 2024-2025 formula that includes a monovalent component corresponding to the Omicron variant JN.1 strain.

FDA Clears New Disposable Insulin Patch Pump for Patients With T1D and T2D

Embecta received 510(k) clearance from the FDA for its proprietary disposable insulin delivery system indicated for adults with type 1 (T1D) and type 2 diabetes (T2D) and informed by feedback from people with T2D.

How the Big 3 PBMs Utilize Various Market Strategies

Regarding the 3 major pharmacy benefit managers (PBMs) significantly controlling the US drug supply chain—CVS Caremark, Express Scripts, and Optum Rx—their concentration varied noticeably amongst commercial insurance, Medicare Part D, and Medicaid managed care markets.

NCPA Calls on CMS to Establish PBM Protection for Independent Pharmacies

With Medicare open enrollment fast approaching for the 2025 plan year, the National Community Pharmacists Association (NCPA) addressed the Centers for Medicare & Medicaid Services (CMS), urging them to create guardrails for independent pharmacies to stay protected against predatory pharmacy benefit manager (PBM) contracts.

Cigna’s PBM Express Scripts Files Lawsuit in Response to July FTC Report

On September 17, Cigna’s pharmacy benefit manager (PBM) subsidiary Express Scripts filed a lawsuit against the Federal Trade Commission (FTC) claiming that its interim staff report released on July 9 was misleading and presented false claims against the PBM industry and its interests towards US health care consumers.

FTC Files Lawsuit Against ‘Big 3’ PBMs for Drug Price Inflation

Just days after Cigna’s pharmacy benefit manager (PBM), Express Scripts, filed a lawsuit against the Federal Trade Commission (FTC) for defamation regarding the Commission’s July interim staff report, the FTC countered and filed a lawsuit against the “Big 3” PBMs— CVS Caremark, Express Scripts, and Optum Rx—for using unfair practices to inflate insulin prices.

Abbott’s OTC Lingo CGM for Wellness Now Available

Following clearance by the FDA in June of this year, Abbott has announced the availability of Lingo, the company’s first continuous glucose monitoring (CGM) system available without a prescription. The wearable is intended for consumers 18 years and older who are interested in improving their overall health and wellness and is not intended for diagnosis of diseases, including diabetes.

Positive Topline Data From 31-Valent Pneumococcal Conjugate Vaccine Clinical Study Announced

Vaxcyte has announced positive topline data from a phase 1/2 clinical study of VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) for the prevention of invasive pneumococcal disease.1 The study evaluated the safety, tolerability, and immunogenicity of VAX-31.

AI-Optimized Cash Pricing Can Help Pharmacies Thrive

Nearly one-third of independent pharmacies may close their doors by the end of this year, leaving many patients who may already struggle to access their prescription drugs in peril. Already 1 in 4 neighborhoods are considered “pharmacy deserts,” a problem that is especially acute in rural areas where pharmacies double as de facto health clinics, providing medical advice and critical services such as immunizations, diabetes screening and more.

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