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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 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
Continuing resolution (CR) funding for the FDA at fiscal 2021 levels denies the FDA increased funding as Congress intended, limits new program starts and makes it difficult for the agency to plan its policy, program and personnel needs. Read More
Gilead Sciences will pay GlaxoSmithKline (GSK) $1.25 billion plus royalties to end a four-year-old patent fight between Gilead and human immunodeficiency virus (HIV)-focused ViiV Healthcare, a company launched in 2009 by GSK with drugmakers Pfizer and Shionogi as shareholders. Read More
The program enables U.S. and EU regulators to engage in scientific discourse with sponsors during the development phase of new medicinal products. Read More
In its latest annual report on Drug Safety Priorities released yesterday, the FDA’s Center for Drug Evaluation and Research (CDER) noted that much of its focus in 2021 remained on pandemic-related products. Read More
The National Institutes of Health (NIH) will decide this month whether Pfizer’s patent on Xtandi (enzalutamide), a prostate cancer drug’s that’s five times pricier in the U.S. than it is in other countries, is subject to so-called “march-in rights.” Read More