Bristol Myers Squibb (BMS) said that its late-stage trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) did not meet its goal of improving overall survival compared with standard-of-care treatment in certain…
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…
The FDA issued over-the-counter (OTC) drug and cosmetic manufacturer Allure Labs a four-observation Form 483 following a November to December 2021 inspection of its Hayward, Calif., facility, noting procedural lapses…
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
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