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In the wake of a controversial court ruling affecting orphan drug pricing, Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wisc.) this week introduced legislation that would codify orphan drug exclusivity protections. Read More
A recent FDA warning letter to Brigham and Women’s Hospital cites the Boston, Mass., drug manufacturing facility for lack of aseptic conditions observed during an inspection from August through September 2021. Read More
AbbVie earned some boasting rights this week with positive phase 3 data investigating Rinvoq (upadacitinib) as maintenance therapy for people with moderate-to-severe Crohn’s disease. Read More
In the wake of strongly positive data and an FDA go-ahead, Veru will seek an Emergency Use Authorization (EUA) for sabizabulin, its investigational COVID-19 therapy. Read More
Roche has run into another roadblock for its investigational dual-agent chemotherapy regimen targeting PD-L1-high locally advanced or metastatic nonsmall-cell lung cancer (NSCLC). Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is launching a new initiative to speed and increase the development of treatments for rare diseases. Read More
The troubled manufacturing plant Emergent BioSolutions concealed proof of quality problems at its Baltimore, Md., location just a month and a half before it told the FDA that 15 million COVID-19 vaccine doses manufactured there had been contaminated. Read More