The Department of Justice has sued both OhioHealth and NewYork-Presbyterian Hospital this year, alleging that they use contracting tactics that limit competition and keep healthcare prices high. The cases mark a broader push by regulators to scrutinize how health systems use “all-or-nothing” contracts to shape insurance networks and patient access.
Jefferson Health in Philadelphia is suing Aetna over a new Medicare Advantage payment policy that hospitals say unfairly reduces reimbursements for legitimate inpatient stays. The case highlights a broader clash between providers and Medicare Advantage plans over “downcoding” short hospital stays and controlling costs.
MedCity News was at the Vive conference and spoke with executives who shared their insights for the healthcare industry.
GuardDog Telehealth admitted it misrepresented its services to access patients’ health information, marking the first major concession in Epic’s lawsuit against Health Gorilla and other defendants accused of exploiting interoperability networks. The broader case is still ongoing.
Under the settlement, Genevant Sciences and Arbutus Biopharma will grant Moderna a non-exclusive license to their lipid nanoparticle technology for mRNA delivery in infectious disease vaccines. If Moderna's full financial payout to the companies is reached, it would rank among the largest disclosed patent settlements in biopharmaceutical industry history.
Pfizer claims Metsera breached their merger agreement, adding that a tie-up of the biotech with GLP-1 drug giant Novo Nordisk would violate U.S. antitrust law. Metsera called the arguments “nonsense” and said Pfizer is trying to buy the obesity drug developer for less than what Novo is willing to pay.
Generic drugs don’t need lengthy clinical trials to support a submission seeking FDA approval. The regulator now proposes ending this testing requirement for biosimilars, products that reference complex biologic medicines.
By reducing administrative burden and redesigning workflows around human needs, it creates space for what matters most: connection between clinicians and patients.
Drugs selected for the FDA’s new Commissioner’s National Priority Review Voucher pilot program could receive a regulatory decision in two months or less. Qualifying product candidates must address a national priority, such as filling an unmet medical need or boosting domestic drug manufacturing.
Pharmaceutical tariffs are coming, part of President Trump’s stated goal of bringing drug manufacturing back to the U.S. Untangling the sprawling, global supply chain will be complicated and expensive, and could inadvertently compete with other administration goals regarding drug pricing and availability.
The FDA published more than 200 complete response letters, the first step in what it describes as part of its effort to modernize the agency and improve transparency. But there are some caveats to the release of the FDA correspondence.
Bispecific antibodies are already available for treating multiple myeloma. FDA approval of Regeneron Pharmaceuticals’ new drug, Lynozyfic, comes with dosing flexibility that sets it apart from others in its class.
How to turn analytics into actual policy outcomes.
The FDA has eliminated a safety monitoring requirement and eased certain restrictions that had been in place since CAR T-therapies first reached the market in 2017. The agency and financial analysts say the changes should improve patient access to these personalized cancer treatments.
Gilead Sciences drug lenacapavir, brand name Yeztugo, is now approved for HIV pre-exposure prophylaxis. The twice injectable medication is hoped to improve uptake and adherence to PrEP.
To be eligible for the FDA’s new Commissioner’s National Priority Voucher program, a drug must meet certain national health interests. Qualifying medicines could be reviewed in one to two months, down from the standard 10 months to a year.
In calling for more clinical testing of vaccines in younger people and those who face a low risk of severe disease from Covid-19, the FDA said its policy will compel generation of more evidence for these groups. Our roundup of regulatory news includes notable firsts for Alzheimer’s diagnosis and migraine treatment.
The FDA laid out a three-year roadmap to phase out animal toxicity testing in drug research. In addition to organoids and lab-on-a-chip tests, the agency is encouraging drug companies to use computer simulations and artificial intelligence to predict drug behavior.