USFDA warns Bengaluru-based Resonance Labs of manufacturing norms violations
US health regulator USFDA has red-flagged significant deviations from manufacturing norms at the Bengaluru-based API facility of Resonance Laboratories, including failure to have adequate cleaning procedures to prevent contamination of products. Summarizing the deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), USFDA said it had inspected the drug manufacturing facility on May 2-6, 2016. Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Resonance Laboratories at the Bengaluru plant into the United States, it added.
Vitamin B3 prevents glaucoma according to researchers in US.
Researchers from The Jackson Laboratory (JAX), US, have found that vitamin B3, when added to drinking water, is effective at preventing glaucoma. The research was carried out by a team led by professor and Howard Hughes medical investigator Simon John. Glaucoma is one of the most common neurodegenerative diseases and affects an estimated 80 million people worldwide. By administering the vitamin, the majority of age-related molecular changes were eliminated, providing a protection against glaucoma. New interventions can be developed to protect from common age-related disease processes in many people by understanding general age-related mechanism, the research noted.
Zydus Cadila receives USFDA nod to market fluconazole tablets
Zydus Cadila has received the final approval from the United States Food and Drug Administration to market fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg and Clobetasol Propionate spray, 0.05 per cent. Fluconazole tablet, which is used to treat fungal infections, will be produced at the group’s formulation manufacturing facility at Baddi. The group now has more than 105 approvals and has so far filed over 300 abbreviated new drug applications (ANDAs) since the commencement of the filing process in 2003-04 fiscal.
U.S. experts soften on DNA editing of human eggs, sperm, embryos
The report from the National Academy of Sciences (NAS) and the National Academy of Medicine said scientific advances make gene editing in human reproductive cells “a realistic possibility that deserves serious consideration.” The statement signals a softening in approach over the use of the technology known as CRISPR-Cas9 that has opened up new frontiers in genetic medicine because of its ability to modify genes quickly and efficiently. In December 2015, scientists and ethicists at an international meeting held at the NAS in Washington said it would be “irresponsible” to use gene editing technology in human embryos for therapeutic purposes, such as to correct genetic diseases, until safety and efficacy issues are resolved. Though the technology is still not ready, the latest NAS report says clinical trials for genome editing of the human germline could be permitted, “but only for serious conditions under stringent oversight.”