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ViiV Healthcare’s Apretude (cabotegravir), a recently approved long-acting injectable for preventing HIV in adults and adolescents, isn’t cost-effective despite offering new hope against the deadly disease, a new analysis contends. Read More
The United Nations-backed Medicines Patent Pool (MPP) announced yesterday that it signed an agreement with Cape Town, South Africa-based Afrigen Biologics “to allow Afrigen to establish itself as the global mRNA vaccine technology transfer hub.” Read More
Center for Drug Evaluation and Research (CDER) Director Patrizia Cavazzoni fielded questions from lawmakers yesterday on confirmatory trials for drugs that receive FDA’s accelerated approval, during a hearing on reauthorizing user fee programs for prescription drugs, generics and biosimilars. Read More
Johnson & Johnson (J&J) announced that it’s pulling the plug on atopic dermatitis trials for the drug bermekimab, a move that is costing the company $610 million. Read More
Four approved COVID-19 therapeutics are reasonably priced, offering not only improved patient outcomes but potentially saving tens of thousands of dollars in hospital costs associated with treating severe disease, according to a draft cost-effectiveness analysis by the Institute for Clinical and Economic Review (ICER). Read More
In an effort to better understand high prices for drugs and diagnostics, a group of doctors has called on the Biden administration to openly share the costs of clinical trials paid for by the federal government. Read More
The anti-kickback statute prohibits pharmaceutical distributors from offering or paying any compensation to induce physicians to purchase drugs for use on Medicare patients. Read More
The University of Pennsylvania is suing Genentech for patent infringement of four pharmacologically related breast cancer chemotherapy agents, alleging that the drugs were originally created by university researchers and fully patented by the institution. Read More
Drug wholesalers McKesson, AmerisourceBergen and Cardinal Health, and the Janssen subsidiary of Johnson & Johnson (J&J) have agreed to pay a combined $590 million to settle lawsuits with Native American tribes that accused the companies of fueling the opioid crisis. Read More