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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.
FEATURED STORIES
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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Neal and Azbee awards have validated our approach to reporting on the industry at a time of unprecedented shifts at the FDA and other federal agencies.
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The FDA turned away Ebvallo in January, taking issue with the design of the registrational trial. In a recent meeting, however, the agency agreed that the study could in fact support the cell therapy’s approval. The news comes a week after the departure of controversial biologics Director Vinay Prasad.
Catalyst Pharmaceuticals comes with a trio of approved drugs as Angelini Pharma expands its neuroscience offerings.
Entrada Therapeutics saw a 2.36% dystrophin increase in patients treated with its oligonucleotide asset—a number that fell short of the company’s prior guidance of a double-digit improvement.
Acting Center for Drug Evaluation and Research Director Tracy Beth Høeg reportedly disagreed with staff who wanted to approve Sanofi’s type 1 diabetes drug. It’s far from the first time a political appointee has allegedly meddled in a recent FDA decision.
Sarepta Therapeutics has put in place several initiatives to help its gene therapy Elevidys return to growth, but recovery will take a long time, according to company executives.
With Siran Biotechnology under its fold, GSK will have access to a long-acting siRNA therapy that could induce weight loss while preserving lean mass, in addition to addressing other weight-related comorbidities.
In this episode of Denatured, you’ll be hearing from Georg Vo Beiske, CEO of Tribune Therapeutics and Jonas Hallén, co-founder and Chief Medical Officer of Calluna Pharma. We dive into IPF and fibrosis challenges, unpacking treatment hurdles, emerging targets, unmet needs and expansion paths beyond the lung.
Panel interviews can play a major role in getting jobs. Two career coaches discuss what to do before and during the interview, including identifying how to differentiate yourself, engaging in true conversations and not overlooking a key panel member.
Sanofi’s investment will support a Canadian site’s efforts to apply AI to drug production, while Amgen has unveiled the second expansion of its Puerto Rico plant in quick succession.
Analysts and investors alike had been eagerly awaiting sales figures for Novo Nordisk’s Wegovy pill. The answer blew past expectations by 86%.