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The FDA has granted Merck priority reviews for its blockbuster cancer drug Keytruda (pembrolizumab) alongside Lenvima (lenvatinib) for endometrial and renal cell carcinoma. Read More
First to receive Emergency Use Authorization (EUA) for their highly effective COVID-19 vaccine, Pfizer and BioNTech have now become first to submit a biologics license application (BLA) with the FDA for full approval of their inoculation. 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
The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. 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