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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.
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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The FDA has approved Jemperli as an add-on to chemotherapy for patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient or microsatellite instability-high.
The Federal Trade Commission seeks to codify its heavier-handed approach, already displayed by its actions regarding Amgen’s acquisition of Horizon, among other deals.
Ulotaront failed to meet primary endpoints in two studies. The companies said high COVID-19 placebo effect “may have masked molecule’s therapeutic effect” and plan to discuss next steps with the FDA.
Amid U.S. shortages in crucial drugs, House Republicans have filed their own draft bill that seeks to increase the accountability of the FDA and provide more flexibility for generics manufacturers.
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies.
Following a sweeping cost-cutting plan announced earlier this week, including an 11% workforce reduction, Biogen is acquiring Reata Pharmaceuticals to bolster its neurological and rare disease pipeline.
The British drugmaker’s rare disease subsidiary Alexion will take on a number of Pfizer’s preclinical gene therapy programs and technologies to advance its genomic medicines pipeline.
Despite beating analyst expectations, Takeda sustains a mid-stage defeat in a rare genetic disorder, leaving the fate of an investigational enzyme replacement therapy uncertain.
Two late-stage trial wins for Merck’s V116 investigational pneumococcal vaccine could make it a serious challenger to Pfizer’s Prevnar 20 in the space.
Data from two late-stage studies show that participants on Eli Lilly’s tirzepatide, which targets both GIP and GLP-1 receptors, achieved up to 26.6% mean weight loss.