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STAT+: Supreme Court justices appear to signal ‘skinny labeling’ can survive
After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver.
At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
This tactic has been a key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling is one way that Congress attempted to foster more competition and benefit consumers.
After months of anticipation, Supreme Court justices heard arguments about a long-standing tactic used by generic companies to carve out a distinct market for a medicine, and did not appear inclined to alter legal standards for the maneuver.
At issue is skinny labeling, which refers to moves by generic companies that seek regulatory approval to market a drug for a specific use, but not other patented uses for which a brand-name medicine is prescribed. For instance, a generic drug could be marketed to treat one type of heart problem but not another. In doing so, the generic company seeks to avoid lawsuits claiming patent infringement.
This tactic has been a key tool for generic companies ever since the Hatch-Waxman Act was signed into law more than four decades ago. The law established the mechanisms by which generic drugs can more readily enter the marketplace. And skinny labeling is one way that Congress attempted to foster more competition and benefit consumers.
Uncategorized
STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
WASHINGTON — The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply.
A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT.
She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco.
WASHINGTON — The Food and Drug Administration has named Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research, which regulates vaccines, gene therapies, and the blood supply.
A Health and Human Services official confirmed the move, which was first reported by Politico, to STAT.
She is replacing Vinay Prasad, who left the agency on Thursday after a tumultuous tenure during which he issued a series of controversial decisions on rare disease drugs and vaccines. FDA Commissioner Marty Makary said in March that Prasad would return to the University of California San Francisco.
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STAT+: In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA
Now that Casey Means is no longer the Trump administration’s choice for Surgeon General, attention is turning to the third nominee for the position.
Nicole Saphier, whose candidacy was announced Thursday, is a licensed physician — unlike Means, whose license lapsed. A radiologist at the Memorial Sloan Kettering Cancer Center, Saphier (pronounced SAA-fire) is director of breast imaging at MSK Monmouth in New Jersey. She may be more widely known as a regular contributor to Fox Business, where she has said that the overwhelming majority of “good research” disputes the notion that vaccines are linked to autism, but has expressed an openness to alternative childhood vaccine schedules.
Saphier has weighed in on many other concerns shared by the Make America Healthy Again movement promoted by health secretary Robert F. Kennedy Jr., agreeing with Kennedy on some but also clearly questioning on others. In her own words, here are her views on vaccines, peptides, Tylenol in pregnancy, dietary guidelines, breast cancer, and also, Casey Means.
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STAT+: Hair-raising trial results, and Servier’s M&A wishlist
Why are investors excited about hair loss drugs? Will artificial intelligence make clinical trials run more smoothly? And how does a nonprofit pharma company compete in the M&A arena?
We get into all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast.
Veradermics CEO Reid Waldman joined us to discuss his company’s data, and why hair loss is such a trendy topic in biotech. Then, Servier Pharmaceuticals CEO David Lee joined us to discuss the company’s acquisition of Day One Biopharmaceuticals. The hosts also discussed the latest news in biotech.
Why are investors excited about hair loss drugs? Will artificial intelligence make clinical trials run more smoothly? And how does a nonprofit pharma company compete in the M&A arena?
We get into all that and more on this week’s episode of “The Readout LOUD,” STAT’s weekly biotech podcast.
Veradermics CEO Reid Waldman joined us to discuss his company’s data, and why hair loss is such a trendy topic in biotech. Then, Servier Pharmaceuticals CEO David Lee joined us to discuss the company’s acquisition of Day One Biopharmaceuticals. The hosts also discussed the latest news in biotech.
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STAT+: Katherine Szarama named acting director of FDA’s vaccines and biologics center
STAT+: In her own words: Surgeon general nominee Nicole Saphier expresses enthusiasm and caution for MAHA
STAT+: Hair-raising trial results, and Servier’s M&A wishlist
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