The FDA approved Astellas’s Vyloy as a treatment for advanced cases of gastric or gastroesophageal junction (GEJ) adenocarcinoma positive for a protein called claudin 18.2. It’s the first FDA-approved therapy for this target. The post Astellas Pharma Lands a First-in-Class Drug Approval in Rare Gastrointestinal Cancer appeared first on MedCity News.
Likely ‘no‘. While CMS can consider drug prices as part of IRA’s Medicare Drug Price Negotiation, it is limited to considering only U.S. market data. Here is an excerpt from the IRA text: For purposes of negotiating the maximum fair price of a selected drug under this part with the manufacturer of the drug, the…
Merida Biosciences is developing antibody-like drugs designed to selectively eliminate disease-driving autoantibodies while sparing healthy components of the immune system. Graves disease, which stems from the immune system’s attack on the thyroid gland, is the startup’s lead disease target. The post Immunology Startup Merida Bio Unveils $121M and a Lead Program for Graves’ Disease appeared…
Startup finalists competed in four tracks: biopharma; devices and diagnostics; health tech aimed at consumers and self-insured employers; and health tech aimed at payers and providers. Investor judges in each track selected the winners. The post Who Won MedCity INVEST Pitch Perfect? appeared first on MedCity News.
This analysis examines the extent to which large private and non-federal public employers that offer retiree health benefits are turning to Medicare Advantage and why they are making this shift, using data from the 2024 Employer Health Benefits Survey. We find that slightly more than half (56%) of large employers offering retiree health benefits to…
Lynda Brown-Ganzert is CEO of RxPx. The company is the 2022 merger of the company she founded, Curatio, which was a support system for rare disease patients, with RxMx, a complementary service that helped clinicians manage patients on treatment or clinical trials. Lynda says that somehow I inspired the merger! (Although I don’t remember it,…
The FDA asked Cytokinetics for the Risk Evaluation and Mitigation Strategy after it had already accepted the application for aficamten, a potential competitor to Bristol Myers Squibbs heart drug Camzyos. Analysts say this development could signal a change in FDA thinking about risk management for the broader drug class. The post FDA Pushes Out Decision…
In this JAMA Health Forum post, Executive Vice President Larry Levitt recalls the mid-1990s’ public backlash against Health Maintenance Organizations (commonly known as HMOs) – all of which preceded the recent outpouring of health insurance concerns – as well as how consumer protections against coverage restrictions have evolved and fallen short.
To improve the affordability of abortion services, many states have passed laws that require state-regulated plans to cover the full cost of abortion services for their enrollees. This data note documents the costs associated with abortion care in private plans. Also, KFF analyzes how out of pocket spending has been affected by state laws that…
Precision medicine relies on understanding how differences affect drug response. Researchers can develop more precise treatments that are effective for more patients when prioritizing diversity. The post Why Accessible, Worldwide Biomanufacturing Solutions are Paramount appeared first on MedCity News.