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The FDA updates recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday. Read More
Two phase 3 trials presented at Digestive Disease Week in San Diego, May 21-24, confirmed the benefit of immunomodulators in moderate to severe ulcerative colitis (UC). Read More
Troriluzole, Biohaven’s investigational therapy for spinocerebellar ataxia (SCA), didn’t hit its primary endpoint in the topline analysis of its phase 3 study, but the company remains optimistic about some results. Read More
Rocket Pharmaceuticals reported that its trial of a gene therapy targeted toward an aggressive and fatal rare disease in children had a 100 percent survival rate at one year — and the company expects to file for regulatory approval of the treatment in the first half of 2023. Read More
In a congressionally mandated report on diversity in clinical trials, the National Academies of Sciences, Engineering and Medicine (NASEM) recommends the FDA require drug sponsors to file an in-depth recruitment strategy, either before or with their investigational new drug (IND) or investigational device exemption (IDE) applications, that details how they intend to make their trial population reflective of the disease or condition’s demographics. Read More
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 patients with untreated unresectable or metastatic urothelial cancer. Read More
The novel combination of albuterol and budesonide in AstraZeneca’s PT027 reduced the risk of severe asthma flare-ups by 27 percent in patients with moderate-to-severe asthma, according to results from a late-stage study. Read More
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. 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