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FDA Commissioner Marty Makary intends to resign on Tuesday, according to several sources. This report follows a tumultuous 13-month tenure in which Makary oversaw the controversial rejections of several rare disease drugs and “predictable volatility” within the agency.
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New guidelines from two leading medical associations suggest that efforts to reduce bad cholesterol should focus on maintaining low levels of two key lipoproteins. Big pharma is all in, looking to improve on the standard statins to help vanquish America’s number one killer: heart disease.
The FDA’s decision last year to make complete response letters public provides new insight into why therapies sometimes fail to get the regulatory greenlight. Analysts say the information could help sponsors refine their regulatory strategies.
The Department of Health and Human Services is spinning its wheels, unable to establish steady leadership at three major divisions—the CDC and the FDA’s two primary review units.
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Robert F. Kennedy Jr.’s health department has consistently touted radical transparency as being key to its mission. Recent instances—the FDA’s decision not to disclose the recipients of three Commissioner’s National Priority Vouchers and FDA and CDC choices not to publish vaccine-related papers—call this intent into question.
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As we near the end of second quarter of 2024, the initial public offerings among biotechs have slowed, but the market is still going strong.
Amid shortages of its Mounjaro and Zepbound blockbuster drugs, Eli Lilly on Friday said it is investing an additional $5.3 billion in its production site in Lebanon, Indiana, to boost output of their active ingredient.
Aiming to compete in the lucrative weight-loss drug market, Zealand Pharma on Thursday posted topline results showing its dapiglutide led to only a slight weight reduction in low doses.
CEO Pascal Soriot on Tuesday heralded a “new era of growth” for AstraZeneca with plans to launch 20 new medicines in six years. He’s delivered before but can he do it again?
Full data from the FLOW study show that Novo Nordisk’s top-selling GLP-1 receptor agonist semaglutide can significantly reduce the risk of death by 20% in diabetes patients with chronic kidney disease.
After selling off its oral TYK2 blocker to Takeda for $4 billion, Nimbus Therapeutics has posted strong early-stage data for its other clinical candidate, NDI-101150, in solid tumors.
Phase I/II data for Regeneron Pharmaceuticals’ costimulatory bispecific antibody were disappointing, with only one complete response when used as a combination treatment with Libtayo for solid tumors.
Johnson & Johnson’s radiopharma candidate JNJ-6420 returned mixed results in an early-stage study, demonstrating strong biochemical and radiographic response but also resulting in four patient deaths.
Tango Therapeutics reported Thursday that solid tumor patients who stayed in the Phase I study for more than eight weeks developed Grade 3 and 4 liver function abnormalities.
Orna Therapeutics announced Thursday it is acquiring ReNAgade Therapeutics, which launched in May 2023 with $300 million in Series A financing and is on BioSpace’s NextGen Class of 2024 startups to watch this year.