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FDA veteran Richard Pazdur outlined his priorities for the next FDA commissioner but stopped short of putting himself forward as a candidate to lead the agency at an RBC Capital Markets event on Tuesday.
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BioSpace analyzed the pay ratio across 10 major pharmaceutical companies to determine which CEOs were paid the most relative to typical employees. J&J, Eli Lilly and Pfizer once again topped the list.
Biotech is increasingly financed, governed and regulated as though it were a mature pharmaceutical industry rather than a discovery system built around scientific uncertainty. Structural changes are needed to sustain the sector’s strategic innovation.
BioSpace examines how the FDA approval of Eli Lilly’s oral obesity drug Foundayo has ignited a key race with Novo Nordisk.
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Read our takes on the biggest stories happening in the industry.
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.
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Following an initial rejection in 2023, Ascendis Pharma on Tuesday said it faces another regulatory bump in the road for TransCon PTH with a three-month delay in the ongoing FDA review.
After missing their initial target in March 2024, Eisai and Biogen have initiated a rolling BLA for a subcutaneous maintenance formulation of Leqembi, which could offer a more convenient dosing schedule for Alzheimer’s disease patients.
Bayer joined BMS in announcing major overhaul; Takeda drops up to $2 billion for an anti-amyloid drug from AC Immune; and BioSpace reflects on last week’s ASGCT meeting—the good, the bad and the ugly.
Learn how to discuss career gaps and how to be a great hiring manager and interviewer.
Dynavax Technologies announced Tuesday that the FDA issued a Complete Response Letter to the company’s sBLA to include a four-dose regimen of Heplisav-B vaccine for adult hemodialysis patients.
In Tuesday’s first-quarter 2024 financial results, Bayer reported a slight drop in sales amid its sweeping companywide restructuring that resulted in workforce reductions, while lowering its full-year earnings outlook.
With Monday’s agreement, AbbVie joins the industry’s growing interest in next-generation psychiatric therapies and looks to leverage Gilgamesh Pharmaceuticals’ research platform to discover novel neuroplastogens.
Cytokinetics released data Monday on aficamten, an oral small molecule inhibitor of cardiac myosin, showing it significantly boosted exercise capacity in patients with obstructive hypertrophic cardiomyopathy.
Presented at this week’s European Congress on Obesity, the two studies also demonstrate that Novo Nordisk’s Wegovy (semaglutide) provides cardiovascular benefits irrespective of starting weight and the amount of weight lost.
Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?