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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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In this episode BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss Zepbound, Wegovy, the weight loss race and the future of this drug class.
Watch this webinar to gain insights from expert speakers, Dr. Iris Alroy and Dr. Kristopher Brannan, who have made significant advancements in the field of RBPs.
Executives from Israel-based companies express concern about future investment and other operational impacts, as the war rages on in Gaza with tragic loss of life amid political and economic uncertainties.
In today’s challenging environment, here are some creative ways biotechs have found to survive and thrive.
Under the potential $770.5 million deal announced Tuesday, Autifony Therapeutics is licensing to Jazz Pharmaceuticals two ion channel targets associated with neurological disorders.
When given with chemoradiotherapy, Imfinzi in a late-stage non-small cell lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.
The Japanese biotechnology and food company has bought into the gene therapy space with its $620 million acquisition of Ohio-based CDMO and clinical-stage biotech Forge Biologics.
In a late-stage trial, treatment with Ipsen and Genfit’s elafibranor led to high rates of biochemical response and the normalization of alkaline phosphatase levels compared with placebo.
Pennsylvania-based Aclaris Therapeutics will stop development of zunsemetinib after it failed to meet the primary endpoint in a Phase II study for rheumatoid arthritis.
The UK-based nanomedicine biotech, previously known as SomaServe, has closed its Series A with some significant biopharma names attached.