FDA Commissioner Marty Makary has announced his intention to create a new pathway for drugs that treat ultrarare conditions. “We’re going to be rolling out a new pathway for drugs, which is a pathway based on a plausible mechanism,” Makary said in an interview Thursday with The Megyn Kelly Show. “If there’s a rare condition or a…
Most patients who enroll in the Lung-MAP precision medicine trial in non-small cell lung cancer can now be matched to a targeted investigational treatment based on the results of their prior genomic testing, without needing to submit new tumor or blood samples. This expanded screening process will help make Lung-MAP’s targeted treatment studies more accessible…
Friends of Cancer Research launched the AI-Based Measurement of Response Evaluation Criteria in Solid Tumors, or ai.RECIST, research partnership April 15, 2025. The effort brings together 27 entities across biopharma, tech and academia, though the FDA and other government agencies are conspicuously absent. The first priority: assessing tool capabilities using lung cancer trial data. Background:…
A proposal for reorganizing the US Food and Drug Administration into five offices and consolidating all product review functions is “a mindless approach to centralization and standardization” and would not adequately support the agency’s functions, former agency officials said. The proposal for a reorganized FDA that is being circulated by the Trump Administration “is a…
More than 200 biotech leaders have penned a letter voicing concerns over the FDA’s capacity after mass federal layoffs, specifically for small biotechs that depend on investor backing to meet agency standards. Certain biotechs have already seen the effects of the FDA restructure, according to the authors, who urge the government to “quickly preserve and…
During an April 7 session of the Biopharma Congress, Janet Woodcock, MD, former acting FDA Commissioner and former principal deputy commissioner of food and drugs, called the recent FDA staff cuts a “slow-moving catastrophe.” Dr. Woodcock was referring to drug development, but the same could be said for medical device development. Devices will still move…
‘A slow-moving catastrophe’: What we heard at the Biopharma Congress At this week’s Biopharma Congress in Washington, former FDA officials and industry leaders gathered to discuss the agency’s current turmoil, touching on workforce cuts and potential reorganizations. A rare bright spot: The first in a new series of rare disease workshops is expected to be…
Right off the bat, the high-profile departure of Peter Marks, M.D., Ph.D., former director of the FDA’s Center for Biologics Evaluation and Research, was linked to his advocacy for vaccines, which opposes certain viewpoints held by Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. Now, Marks is making it clear: His…
In the latest of a string of clawbacks, the Department of Health and Human Services (HHS) is now sharing plans to cut contract spending by 35% across all divisions. “Every agency within HHS is committed to reducing contract expenditures by this target,” an HHS spokesperson told Fierce Biotech. “These cuts are designed to ensure that…
Amy Comstock Rick joined the FDA last November, and she not only survived the widespread staff cuts last week, she’s one of only a handful of FDA officials to speak at a live conference since the Trump administration took over. Rick told a crowd of mostly pharma industry employees and analysts at the Biopharma Congress…
