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If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
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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.
FDA
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.
In Salt Lake City, biotech founders new and seasoned reflect on ways to ride out the industry’s challenges, such as sending cold emails to investors and learning to address leadership weaknesses.
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Expanding volumes of data point to mechanisms beyond weight loss and blood sugar control that contribute to cardiovascular benefits in the world’s fastest-growing drug class.
Effectively treating and preventing this common form of dementia will require a cocktail of drugs and a combination of approaches, as well as a drive toward early detection.
M&A didn’t return as hoped for in 2024. The biopharma industry is heading into the J.P. Morgan Healthcare Conference next week in a grim mood.
Novo Nordisk’s GLP-1s outsell Eli Lilly’s thanks to its superior marketing. Here’s how.
Eli Lilly’s request to intervene in a suit filed by compounding pharmacies against the FDA reflects a belief the outcome could affect its business and that the FDA does not adequately represent its interests.
Job postings in California took a dip in December during the holiday period, but activity is expected to pick up in January.
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis, Miguel Forte and Ali Pashazadeh discuss the industry’s need to catch up with women’s health issues and the innovative lead the APAC region has taken in clinical trials.
With two earlier trials meeting their primary endpoints, Axsome claimed it has the data to support a filing for FDA approval in the second half of 2025.
As market values increase for computational biology and data science, biopharma companies are looking to hire R&D professionals in those areas. A biotech talent acquisition expert shares his insights on these in-demand roles.
Roche has once again returned to China to bolster its antibody-drug conjugate pipeline, this time striking a licensing deal with Innovent for $1 billion in biobucks.