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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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For $80 million upfront and the promise of more than $1.2 billion in milestones, Novartis has bought the global rights to develop an oral HDAC6 inhibitor from Chong Kun Dang Pharmaceutical.
The cell therapy-focused biotech will use most of the net proceeds from its initial public offering to fund Phase II clinical trials for its lead program, a novel CAR T-cell candidate.
In the third quarter, Vertex Pharmaceuticals reported revenue of $2.48 billion, a 6% increase from the same period in 2022. However, these figures fell short of Wall Street’s consensus estimates.
The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.
Although Kodiak Sciences initially scrapped its development of tarcocimab tedromer after late-stage failures, new data has convinced the company to give the eye drug another shot.
After its deal with Tubulis in April 2023, Bristol Myers Squibb is continuing its antibody-drug conjugate buying spree by acquiring an asset from South Korea’s Orum Therapeutics.
Seeking to weather declining sales from its COVID-19 business in the third quarter, Pfizer is laying off approximately 200 employees at its manufacturing facility in Kalamazoo, Michigan.
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
Novo Nordisk’s Wegovy and Eli Lilly’s Mounjaro drove blockbuster sales in the third quarter and the sky’s the limit for the duopoly. The only limiting factor is that the frenzied demand for their respective drugs is outpacing supply.
BioSpace spoke with representatives of the two top-place finishers in our Best Places to Work list about their approaches to fostering an engaging workplace.