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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 past year saw the slowest year-over-year growth in biopharma salaries in the past five years, according to the BioSpace 2024 Life Sciences Salary Report.
Bayer bagged another late-stage victory for its menopause drug candidate Tuesday, setting up a potential showdown with Astellas’ Veozah which was approved last year by the FDA for the treatment of hot flashes.
Engrail Therapeutics’ latest financing round will give it enough funds to advance its candidates for neuropsychiatric and neurodevelopmental disorders through clinical development.
GenAI, the youngest of the AI family, is evolving quickly. The global life sciences industry is attempting to evolve with it. However, as a keynote session at DIA’s MASC suggests, taking a pause to understand AI risks and to prepare to comply with the EU AI Act is what is needed.
The biotech Tuesday reported that 56% of patients taking paltusotine in a late-stage trial achieved the primary endpoint of IGF-1 levels for their rare hormonal disorder. An NDA submission is slated for later this year with a launch anticipated in 2025.
Following in the footsteps of Bristol Myers Squibb and Eli Lilly, AstraZeneca on Tuesday jumped into the radiopharmaceuticals space by acquiring Fusion Pharmaceuticals in a deal worth $2.4 billion.
To help support the launch of Lyfgenia, bluebird bio on Monday entered into a five-year term loan deal with Hercules Capital that will extend the biotech’s cash runway through the first quarter of 2026.
An appellate court sided with Regeneron versus Novartis on Monday, agreeing that anti-VEGF pre-filled syringes constitute a distinct market than those sold in vials. The case involves Regeneron’s Eylea and Novartis’ Lucentis eye treatments.
Orchard Therapeutics on Monday secured the FDA’s first approval for an autologous gene therapy to treat the rare metabolic disease metachromatic leukodystrophy in children.
BioSpace’s 2024 Salary Report explores the average salaries and salary trends of life sciences professionals.