Archive for May 2022
FDA Draft Guidance Gives More Direction for Developing Antibacterial Drugs for Unmet Needs
The FDA updates recommendations for drug development programs and clinical trial designs for antibacterial therapies in a revised draft guidance released yesterday. Source: Drug Industry Daily
Read MoreLilly, Pfizer Showcase Positive Pivotal Data in Ulcerative Colitis Trials
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
Read MoreFDA Warns Colorful Products for Quality Control Lapses
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
Read MoreCelgene’s Chemotherapy Approved for Rare Form of Leukemia in Pediatric Population
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
Read MoreFDA Approves Sanofi and Regeneron’s Dupixent for Eosinophilic Esophagitis
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 FDA-approved treatment for the disease. Source: Drug Industry Daily
Read MoreEMA Recommends Suspending 100 Generic Meds After Data Irregularities Found in Bioequivalence Studies
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 Industry Daily
Read MoreBiohaven Won’t Give Up Despite Falling Short on Phase 3 for Spinocerebellar Ataxia
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. Source: Drug Industry Daily
Read MoreFDA Proposes New Rules for Medical Gases
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 postmarket safety. Source: Drug Industry Daily
Read MoreThyroid API Manufacturer Gets Warning Letter for Validation, Conformance Lapses
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 and ensure uniform blends. Source: Drug Industry Daily
Read MoreRocket Reports 100 Percent Survival in Rare Pediatric Immunodeficiency Trial
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. Source: Drug Industry Daily
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