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Just a few days after FDA Commissioner Makary resigned, ally Tracy Beth Høeg is also leaving the agency. Her departure comes amid reports of tension over a commissioner’s voucher for Sanofi’s diabetes drug.
Follow along as BioSpace tracks job cuts and restructuring initiatives.
California life sciences jobs declined 1.8% last year, according to the new California Life Sciences sector report. While National Institutes of Health funding and venture capital investment rose, their growth slowed from the previous year.
Rina-S is the last candidate standing from Genmab’s $1.8 billion ProfoundBio acquisition two years ago, with the Danish drugmaker ending development of another clinical program stemming from the buyout.
A batch of a chemotherapy product made at a Sun facility with a history of quality and compliance issues is being withdrawn from the U.S. market.
If Biogen has shown that tau can impact cognition, Denali’s technology—validated with an FDA approval in Hunter syndrome—could ensure the medicine gets where it needs to be for the greatest therapeutic impact, analysts said.
Aardvark Therapeutics had previously voluntarily suspended studies of ARD-101—and a related asset called ARD-201—after detecting anomalous echocardiographic readings in healthy volunteers that could indicate reduced heart efficiency.
CREATE Medicines is working on a clinical-stage pipeline for cancer, while its autoimmune programs are still in preclinical testing.
Renewed pharma interest in GPCR biology and radioligand therapies is drawing attention to functional peptide screening platforms.
Shares of REGENXBIO declined 37% on a mixed data readout and other updates from the company’s first quarter earnings call Thursday.
While Biogen’s tau-targeting therapy didn’t demonstrate improvement on a dementia severity scale, the company touted biomarker and cognitive improvements from the Phase 2 study, leaving analysts eager for more data.
In a letter to President Donald Trump, a group of biotech executives recommended former cancer regulator Richard Pazdur to lead the agency after the departure of Marty Makary.
PRESS RELEASES
Company believes supportive U.S. policy momentum may strengthen the strategic value of its ketamine patch, KetaVault™ platform, retained ketamine programs, and prior FDA-approved ketamine ANDA transaction
Powered by Jona’s clinical-grade, AI-powered microbiome analysis.
Round positions Omeza to accelerate clinical development and scale nationwide commercialization of its FDA-cleared regenerative wound care platform
