We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The FDA has finalized its guidance to help drug sponsors develop population pharmacokinetic (PK) analyses used in drug development to fine-tune dosing regimens. Read More
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
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