UCB drew a Complete Response Letter (CRL) from the FDA rejecting the company’s Biologics License Application (BLA) for its investigational monoclonal antibody drug bimekizumab in adult patients with moderate-to-severe plaque…
Merck’s oral COVID treatment molnupiravir lacks adequate evidence to support claims that it’s any more effective than symptomatic care. Source: Drug Industry Daily
A two-week course of Gilead’s investigational HIV-1 drug, lenacapavir, followed by twice-yearly injections, almost completely suppressed viral load in patients with multidrug-resistant infections. Source: Drug Industry Daily
A group of generic drugmakers pledged to manufacture versions of Pfizer’s COVID-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir) for use in the developing world and agreed to price them at $25 or…
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…
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…
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. Source: Drug Industry Daily
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. Source: Drug Industry Daily
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). Source: Drug Industry Daily
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. Source: Drug Industry Daily