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FDA’s oncology advisors vote against ‘new paradigm’ in AstraZeneca trial

FDA’s oncology advisors vote against ‘new paradigm’ in AstraZeneca trial

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In its first meeting in about nine months, the FDA’s advisory committee of oncology experts voted 6-3 Thursday that a late-stage trial for AstraZeneca’s oral SERD camizestrant didn’t show a “clinically meaningful” benefit.

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Remembering J. Craig Venter: a relentless scientist who changed biotech — and was all too easily misunderstood

J. Craig Venter, a scientist whose relentless ambition helped turn genetics from an artisanal trade into an industrialized information machine, died Wednesday at 79. The cause was side effects of a cancer treatment.

Along the way, he did things that can only be described as really cool. He raced against a government-funded project to sequence the first human genome, grabbing headlines around the world; traveled the ocean in his sailboat collecting genetic information about sea life; and removed a bacterium’s genome and rebooted the organism with an identical set of genes he and his team had synthesized. He drove fast cars, drank red wine, and pissed people off.

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J. Craig Venter, a scientist whose relentless ambition helped turn genetics from an artisanal trade into an industrialized information machine, died Wednesday at 79. The cause was side effects of a cancer treatment.

Along the way, he did things that can only be described as really cool. He raced against a government-funded project to sequence the first human genome, grabbing headlines around the world; traveled the ocean in his sailboat collecting genetic information about sea life; and removed a bacterium’s genome and rebooted the organism with an identical set of genes he and his team had synthesized. He drove fast cars, drank red wine, and pissed people off.

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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. 

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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

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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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