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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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Telix abruptly pulled the plug on its initial public offering plans to begin trading Friday on the Nasdaq, saying the company “did not feel that the proposed discounts were aligned with its duty to its existing shareholders.”
The European Commission has tagged India-based pharma Alchem as being part of a global cartel that coordinates the pricing of a pharmaceutical ingredient in the antispasmodic drug Buscopan.
The U.S. Supreme Court on Thursday upheld access to the abortion pill mifepristone, unanimously rejecting a challenge by a group of anti-abortion doctors seeking to undo the FDA’s approval of the drug.
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors.
Moderna said Thursday it plans to talk to regulators about the next steps after showing its next-generation candidate is more efficacious in adults than the biotech’s existing Spikevax COVID-19 shot.
Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design.
With Versant Ventures as a founding investor, Santa Ana Bio emerged from stealth Thursday with $168 million in combined Series A and B funding to support plans to have two programs in the clinic by next year.
Results of a large Stanford Medicine study, published Wednesday in The New England Journal of Medicine, finds CAR-T therapies carry a low risk of secondary malignancies not related to the T cells.
Coherus BioSciences and Junshi Biosciences’ PD-1 inhibitor Loqtorzi significantly boosted progression-free and overall survival in a late-stage study of patients with advanced hepatocellular carcinoma.
Pfizer’s investigational Duchenne muscular dystrophy gene therapy, fordadistrogene movaparvovec, failed in a late-stage study to significantly improve motor function in patients versus placebo.