News
If ultimately confirmed, Makary’s planned departure, broken by The Wall Street Journal Friday afternoon, would follow a controversial tenure in which his deputy and constant co-author Vinay Prasad riled biopharma feathers with myriad unexpected drug rejections. Prasad stepped down as biologics chief last week.
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 two-part formulation of subcutaneous nivolumab combined with Halozyme’s proprietary recombinant human hyaluronidase achieved two primary endpoints while also showing a noninferior overall response rate.
The non-alcoholic steatohepatitis space is still a “big mystery,” analysts tell BioSpace, but its connection to weight loss could provide an additional opportunity for contenders.
Despite increasing antitrust scrutiny across the biopharma industry, the European Commission on Thursday said it found no competitive issues with Pfizer’s buyout of the antibody-drug conjugate company.
Seeking to deepen its immuno-oncology business, Merck has closed a deal potentially worth $22 billion across three of Daiichi Sankyo’s DXd antibody-drug conjugates for various solid tumor indications.
Sail Biomedicines combines Laronde’s circular eRNA platform with Senda’s nanoparticle delivery technology in the pursuit of a new class of programmable medicines across therapeutic areas.
The trial, which is the first late-stage study of an in vivo CRISPR treatment in the U.S., will start by the end of 2023. Intellia’s NTLA-2001 is a treatment candidate for transthyretin amyloidosis cardiomyopathy.
The contracting COVID-19 market has led to lower third-quarter sales for the Swiss drugmaker, which made the decision to eliminate four clinical programs following underwhelming readouts.
Following a delay and an initial rejection, UCB’s IL-17A/IL-17F blocker bimekizumab was approved for moderate-to-severe plaque psoriasis, which will now be marketed with the brand name Bimzelx.
Early stage ALK-positive non-small cell lung cancer patients treated with Roche’s Alecensa saw an “unprecedented” 76% drop in the risk of recurrence or death, the company announced Wednesday.
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that.