STAT+: Pharmalittle: FDA commish calls U.S. drug prices ‘too high’; FDA staff says Eisai and Biogen’s Alzheimer’s drug has benefits
FDA Commissioner Robert Califf told a crowd of biotech leaders at the BIO convention that drug costs needed fixing.
Rise and shine, everyone, another busy day is on the way, although the smoky covering has certainly reduced the number of noisy vehicles that usually pass by at this time of the morning. Nonetheless, there is much to do. So as usual, we are firing up the trusty coffee kettle to brew a cup or three of stimulation. Our choice today is roasted coconut. As always, you are invited to join us. So time to get cracking. We hope your day is filled with accomplishment and joy. Meanwhile, do keep us in mind if you hear anything interesting. Have a smashing time. …
The pharmaceutical industry has spent the past year speaking out against new mechanisms that could limit how much governments or insurers pay for certain new medicines, but U.S. Food and Drug Administration Commissioner Robert Califf told a crowd of biotech leaders that drug costs needed fixing, STAT reports. “We don’t agree,” said Califf, referring to a conversation he had backstage with Ted Love, the new chair of the Biotechnology Innovation Organization, which held its annual convention this week in Boston. “I think the prices of drugs are too high in the U.S.”
FDA staff said that data from a late-stage trial of Eisai and Biogen’s Alzheimer’s drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval, Reuters reports. The FDA staff did not highlight any new risks linked to the drug, called Leqembi, in documents released ahead of an advisory committee meeting on Friday that will discuss an application for full approval. Wall Street analysts wrote investors that the documents seemed to suggest the agency will approve the drug. The FDA decision is expected by July 6.
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