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In a 269-page submission to U.S. Trade Representative, Katherine Tai, the Pharmaceutical Research and Manufacturers of America (PhRMA) spelled out the group’s objections to efforts by the World Health Organization (WHO) and other organizations to expand COVID-19 vaccines and treatments at the expense of intellectual property rights. Read More
To try to avoid supply chain disruptions based on licensing uncertainties, the FDA has issued a proposed rule on the standards for licensing wholesale drug distributors and third-party logistics providers. Read More
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
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
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