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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
Biogen’s potential blockbuster treatment candidate for Alzheimer’s disease (AD), aducanumab, would only be cost-effective if it costs between $2,500 and $8,300 per year, according to the Institute for Economic and Clinical Review (ICER), a nonprofit that assesses the value of new medicines. Read More
The FDA is proposing to create a program for BsUFA III modeled on the agency’s GDUFA regulatory science initiative that would enable research into scientific issues encountered during reviews of biosimilars. Read More