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 House on Tuesday failed to pass the Fairness in Orphan Drug Exclusivity Act, a bill that would have closed an orphan drug exclusivity loophole used to prevent competing drugs from hitting the market, with Republican opposition barring it from moving onwards to the Senate. Read More
The FDA has finalized guidance on post-approval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH). Read More
The Department of Justice and the American Civil Liberties Union (ACLU) have filed a joint motion calling on a U.S. district court in to wait until December to decide on a high-profile case over the abortion pill, Mifeprex (mifepristone), while the FDA reviews the drug’s risk evaluation and mitigation strategy (REMS). Read More
AstraZeneca (AZ) may forgo seeking Emergency Use Authorization (EUA) from the FDA and instead go for full approval for its COVID-19 vaccine off the bat. Read More
Sponsors of drug trials should publish clinical trial reports without redacting confidential information, the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) said in a statement last week. Read More
The FDA’s Arthritis Advisory Committee split evenly yesterday, 9-9, on whether the benefits of ChemoCentryx’s avacopan oral capsules support the drug’s approval for treating a rare autoimmune disease. Read More
The U.S. Department of Justice has cracked down on yet another drugmaker accused of paying kickbacks, reaching a settlement with Incyte and adding to the numerous agreements it’s reached in recent years with high-profile pharma companies over alleged kickbacks. Read More
President Biden made headlines this week by voicing strong support for waiving COVID-19 vaccine intellectual property (IP) rights during the pandemic, but any deal hashed out at the World Trade Organization (WTO) could come too late to make a significant impact. Read More