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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
Chinese authorities have arrested AstraZeneca China employees who are accused of tampering with gene-testing results of tumor patients in order to fraudulently claim reimbursement from national health care insurance funds. Read More
Deadlines are approaching for drugmakers to file their CARES Act Amount Information report, detailing the amount of listed drugs and biological products they’ve produced and sold over the year. Read More
The UK is providing booster doses to up to 1 million people every day, while “more than 3 billion people across the world have yet to receive their first dose,” the letter said. Read More