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Implemented as part of a broader initiative to make more targeted and efficient use of inspection resources, the pilot program will use artificial intelligence to enable shorter, focused screenings to complement standard FDA inspections.
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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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Abecma made $406 million in 2024, of which BMS paid $43 million to 2seventy bio as part of their profit-sharing agreement.
While there are benefits of having employees on-site, the limited workplace flexibility at some companies following the COVID-19 pandemic can affect not only employees but also organizations’ retention and attraction efforts.
In this deep dive, BioSpace explores the diverse therapeutic modalities now in development, as well as the opportunities and battles for market dominance in this emerging space.
Mineralys’ shares got a more than 50% boost Monday morning as new data showed its hypertension drug reduced blood pressure in a pair of clinical trials.
The latest data showed 15.7% weight loss in patients with diabetes after 68 weeks. In December 2024, CagriSema returned another disappointing readout for Novo, eliciting weight-loss of 22.7% in patients without diabetes, below the pharma’s prior projection of 25%.
In the plaque psoriasis arena, Sotyktu is facing off against Amgen’s Otezla and is facing the threat of upcoming competition from Alumis’ investigational TYK2 inhibitor.
Late-stage data also showed that Johnson & Johnson’s icotrokinra was superior to Bristol Myers Squibb’s Sotyktu at clearing skin and easing symptom severity in patients with plaque psoriasis.
In September 2024, a readout from a separate trial of rocatinlimab elicited mixed reactions from analysts, who found the antibody’s efficacy in that study to be underwhelming.
While the job market is tough for life sciences professionals right now, it won’t always be. Employers must continue striving to create fulfilling work environments, as the market won’t always be in their favor, say biopharma execs.
While drug developers work to mitigate the side effects associated with GLP-1–based obesity drugs, recent studies reveal that myriad variables are causing patients to stop treatment.