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The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
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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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At some point in your research career, you may find yourself transitioning from academia to industry or vice versa. To best set yourself up for success, adapt your approach to the specific scientific culture where you work.
As drug candidates discovered via AI move into later-stage clinical trials, the technology seems to be doing as promised: speeding drug development.
Biohaven has suffered a few setbacks in recent months, including an FDA rejection and a missed $150 million benchmark payment, but CEO Vlad Coric looked for the brighter side at JPM, specifically emphasizing a serendipitous discovery that could get the company in the obesity game.
In November, Pfizer was reportedly looking to divest its stake in BioNTech, though the German biotech at the time denied these rumors.
The arrangement will boost AstraZeneca’s cell therapy portfolio as the pharma targets $80 billion in revenue by 2030.
The star of the acquisition, anti-IgE antibody ozureprubart, is being tested as a prophylactic treatment for food allergies, potentially setting up a competition for GSK with Roche’s Xolair.
The companies have an expansive clinical program for the mRNA neoantigen therapy intismeran autogene in combination with immuno-oncology heavyweight Keytruda.
BioSpace has revealed its new 2026 Hotbed Maps, showcasing seven regional life sciences hot spots.
The initiative could tackle the first-mover disadvantage some CDMOs believe deters early customers, but leaders at companies including Novo Nordisk see hurdles to implementing the changes.
Henry Gosebruch, who has $3.5 billion in capital to deploy, is thinking broad as he steers the decades-old biotech out of years of turmoil.