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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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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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Novo Nordisk has also spoken out strongly against Hims & Hers’ compounded Wegovy pill, with CEO Maziar Mike Doustdar telling investors the knockoff version is a waste of money.
Biopharma’s obsession with the weight loss sector—projected to exceed $130 billion in revenue by 2035—shows no signs of slowing down as analysts gear up for a year that will test the oral market and provide key data on novel mechanisms.
The administration’s direct-to-consumer pharmaceutical sales platform will offer products from Eli Lilly, Pfizer, Novo Nordisk, Amgen and more at a discount, though the impact of such pricing remains to be seen.
Novo Nordisk and Eli Lilly have been battling head-to-head in an exploding obesity market. They should never have been compared apples to apples.
Bristol Myers Squibb delivered better than expected fourth quarter earnings, but Eliquis missed expectations while Cobenfy continues to struggle with uptake.
Despite the Phase 1 cull, CEO Vas Narasimhan on Wednesday maintained that Novartis continues to invest in its early-stage pipeline, looking for deals in the “sub-$2-billion range.”
The SPAC agreement values PrimeGen US at $1.5 billion in equity and gives it capital to advance its pre-clinical triple-activated mesenchymal stem cell pipeline into the clinic.
In this episode of Denatured, Jennifer C. Smith-Parker speaks to Erik Digman Wiklund, CEO of Circio and Jacob Becraft, Co-founder and CEO of Strand Therapeutics. They discuss how post-COVID, emerging platforms like circular and logic circuit RNA are expanding the field’s therapeutic horizons.
Regulatory challenges have been even more top of mind than usual given recent upheaval at the FDA. BioSpace spoke to three industry experts about key issues, which include applying new artificial intelligence guidance. The experts also shared advice for working with regulators.
Biopharmas are less focused on local job candidates and are more open to recruiting regardless of location, according to the new BioSpace employment outlook report. Even employers who prefer to hire locally would consider remote hires for some roles.