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USFDA warns; Vit B3 prevents glaucoma; Zydus Cadila receives nod; U.S. experts soften on DNA editing

Feb 21, 2017

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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.

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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.”