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Court dismisses part of Lilly lawsuit against Empower, some claims can proceed

Court dismisses part of Lilly lawsuit against Empower, some claims can proceed

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A federal judge has dismissed part of Eli Lilly’s lawsuit alleging Empower Pharmacy misled customers about its compounded versions of the obesity drug tirzepatide.

But the court said some of Lilly’s claims involving whether Empower …​ ​Read More

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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. 

Continue to STAT+ to read the full story…

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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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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.

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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.

Continue to STAT+ to read the full story…

Read More

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