News
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.
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.
FROM OUR EDITORS
Read our takes on the biggest stories happening in the industry.
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.
THE LATEST
The company on Wednesday reported nearly 50 billion euros, or $53.3 billion, in revenue with zero cash flow. Several layers of management will be eliminated as structural split-off strategies are considered.
This week, in (our inaugural episode!) BioSpace’s Greg Slabodkin, Tyler Patchen and Lori Ellis discuss the good, the bad and the ugly of biopharma’s reported Q3 earnings. They also tackle what’s going on at Pfizer, ADCs, deals and more.
The third-quarter growth of Gilead’s HIV, oncology and cell therapy businesses was completely offset by declining COVID-19 and liver disease sales, with revenue flat compared to the same period last year.
A failed rare disease clinical trial brings social media expertise to the pharma industry and patient recruitment: A discussion with Bryan Manning, founder of Clinical Enrollment and Two Blind Brothers
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024.
Activist hedge fund investor Elliott Investment Management has bought over a $1 billion stake in BioMarin as the biotech grapples with a leadership change and disappointing sales of its hemophilia A gene therapy.
Newer hiring models based on skills applicants have learned and their general potential for growth could avoid the drawbacks of relying on degrees and experience.
A combination of Gilead Sciences’ domvanalimab and Arcus Biosciences’ zimberelimab, along with chemo, has shown an “encouraging” overall response rate in a mid-stage study.
Although it hit primary and secondary endpoints in a Phase II study, Ventyx Biosciences concluded that the results weren’t strong enough to face the stiff competition for the indication.
BioSpace has published its annual 2024 Best Places to Work list.