After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than…
Nabriva Therapeutics drew a second complete response letter (CRL) from the FDA for its injected antibiotic Contepo (fosfomycin), but said the problem was not related to the drug’s safety or…
The FDA hit a La Habra, California compounding pharmacy with a warning letter for repeated violations, including dirty equipment and the presence of insects. Source: Drug GMP Report
The FDA hit five drugmakers for testing lapses and other quality failures observed during inspections of their manufacturing facilities. Source: Drug GMP Report
Cosmaceutical Research Lab was hit with an FDA warning letter for serious violations uncovered during an inspection of the firm’s manufacturing facility in British Columbia, Canada. Source: Drug GMP Report
The FDA hit Tokyo-based drugmaker Takeda with a warning letter after an inspection revealed that manufacturing problems for its drug Natpara (parathyroid hormone) uncovered last year were still not resolved.…
The FDA has unveiled a new compliance program for inspections of combination products. Source: Drug GMP Report
Gilead Sciences has gotten approval from the FDA to launch a phase 1 trial of an inhaled version of its antiviral remdesivir for the earlier treatment of COVID-19 patients. Source:…
Faced with mounting evidence that hydroxychloroquine is ineffective in treating COVID-19, three trials of the drug have been terminated. Source: Devices & Diagnostics Letter
Ridgeback Biotherapeutics in July will launch two phase 2 trials of its investigational antiviral EIDD-2801 as a potential COVID-19 treatment. Source: Devices & Diagnostics Letter