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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
Pfizer said yesterday that it plans to file for full approval of its COVID-19 vaccine by the FDA later this month — an approval that would allow the companies to market the vaccine directly to consumers and allow the product to stay on the market beyond the pandemic. Read More
Picking someone to helm the FDA is “legitimately difficult,” even in normal times, experts say, let alone during a pandemic, which may help explain why President Biden so far is keeping silent on when he will move to nominate a permanent agency commissioner. Read More
Sunstar Americas failed to file three years of annual product reviews with the FDA for an oral rinse and there were no product review protocols for the product, agency investigators said, in a Form 483, following an inspection of its drug and device manufacturing facility in Schaumburg, Ill. Read More
The number of gene, cell and RNA therapies continue to grow rapidly with almost 3,500 treatments in either the preclinical or clinical testing phases, a new report says. Read More