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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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Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures.
Launched in 2020 to more quickly bring to market an effective medicine for amyotrophic lateral sclerosis, the HEALEY Platform Trial has generated disappointing results for many but also continuing programs from Clene and Prilenia.
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
The potential of mRNA vaccines was established during the COVID-19 pandemic. Now, a new wave of candidates could soon hit the market for cancer, influenza and more.
It’s time for Congress to step up and fund America’s supply chain independence from Chinese companies by bolstering our domestic manufacturing capabilities.
Oncternal Therapeutics will lay off about 10 workers as it explores “strategic alternatives” that could include asset sales or an M&A.
Analysts expressed skepticism about plans detailed by Moderna’s R&D chief Stephen Hoge to trim research spending in preparation for the launch of up to 10 new products.
Bicara Therapeutics, Zenas BioPharma and MBX Biosciences are seeking a combined $700 million-plus in IPO filings this week.