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). Source: Drug Industry Daily
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.…
About 100 generic medicines are likely to get their European marketing authorizations yanked following revelations of flaws in their bioequivalence studies conducted at one particular contract research organization. Source: Drug…
The FDA approved Sanofi and Regeneron’s blockbuster monoclonal antibody, Dupixent (dupilumab), for patients 12 years and older with eosinophilic esophagitis, a rare chronic inflammatory disorder — making it the first…
The FDA has approved use of Celgene’s chemotherapy Vidaza (azacytidine) in advance of stem cell transplant for children newly diagnosed with a rare form of leukemia. Source: Drug Industry Daily
The FDA sent a warning letter to Newbury Park, Calif.-based Colorful Products citing serious quality control violations at the company’s over-the-counter (OTC) drug manufacturing facility. Source: Drug Industry Daily
A proposed regulation issued by the FDA today would add two new parts to drug manufacturing regulations for medical gases focusing on labeling, current Good Manufacturing Practice (cGMP), certification and…
The FDA issued a warning letter to Specialty Process Labs for significant deviations from current good manufacturing practices (cGMP) for active pharmaceutical ingredients (API), including failure to validate manufacturing processes…
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 —…
In a new draft guidance, the FDA presses drug manufacturers to develop risk management plans to further shore up the country’s drug supply chain. Source: Drug Industry Daily