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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
President Biden will support a World Trade Organization (WTO) proposal to waive patent protections for COVID-19 vaccines during the pandemic, marking a seismic shift in U.S. policy on intellectual property protections. Read More
House members dug into their respective trenches during two subcommittee hearings this week, with Democrats and Republicans lining up witnesses to tout and criticize each side’s bills. Read More
The drugmaker, whose pipeline focuses on skin disease treatments, is seeking the FDA’s approval for tralokinumab as a treatment for adults with moderate-to-severe atopic dermatitis. Read More
The FDA said the agency “did not find any evidence that HHS consulted with, otherwise involved or even notified [the] FDA before issuing the notice.” Read More