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Biosimilar sales appear generally strong, despite market struggles for Hadlima, Samsung Bioepis’ biosimilar challenger for AbbVie’s Humira (adalimumab), and other Humira challengers, according to the company’s first quarter biosimilar market report. Read More
The Department of Justice (DOJ) filed a complaint under the False Claims Act (FCA) against Regeneron Pharmaceuticals alleging that the company knowingly submitted average sales price (ASP) reports to CMS that resulted in inflated Medicare reimbursements to the company. Read More
A new chapter emerged this week in the contentious issue of patent thickets, a web of overlapping patents filed on a single existing product to create barriers to competition and extend effective patent life. Read More
Despite the introduction of eight Humira (adalimumab) biosimilars last year, AbbVie is still holding on to its gargantuan 96 percent market share, largely because pharmacy benefit managers (PBM) are suppressing biosimilar competition, according to two new reports. Read More
President Biden continued to push for extending the prescription drug cost-cutting provisions of the Inflation Reduction Act (IRA) beyond Medicare recipients in a speech broadcast on YouTube on Wednesday. Read More
This edition of Quick Notes reviews the regulatory and/or judicial status of four drugs, including an add-on therapy for a rare blood disorder, a drug to treat forms of pulmonary arterial hypertension, a new drug to treat a pediatric metabolic disorder and an IV maintenance drug for patients with early Alzheimer’s disease. Read More
Guest columnists Darius Lakdawalla and Charles Phelps write on the need for a new way to evaluate the value of drugs and therapies. Darius Lakdawalla is the Quintiles Chair in Pharmaceutical Development and Regulatory Innovation at the University of Southern California and cofounder of EntityRisk, and Charles Phelps is a professor at the University of Southern California and provost emeritus of the University of Rochester. Read More
This edition of Quick Notes reviews Merck’s pulmonary arterial hypertension treatment with Winrevair, a fourth approval for AstraZeneca’s Ultomiris, Akebia approval for Vafseo tablets and another clearance for Neuronetics’ Neurostar device. Read More
Americans are being gouged by the “outrageously high price” of a popular diabetes drug, charged Sen. Bernie Sanders (I-Vt.) Wednesday in a scathing rebuke of Novo Nordisk. Read More