Antibiotics
Treatment for newborns
Newborns and young infants with possible severe bacterial infections (PSBI) can be safely and effectively treated with simplified antibiotic regimens outside hospital, according to results from three large trials from Africa and Bangladesh published in The Lancet and The Lancet Global Health journals. In the light of these findings, the WHO guidelines — recommending such infants be hospitalised and treated with injectable antibiotics for at least 7-10 days — should be modified, the authors said, in a press note from the journal.
Cancer
Agency approves coverage for HPV
The European Medicines Agency (EMA) has recommended Gardasil 9 (human papillomavirus vaccine) for the prevention of diseases caused by nine types of human papillomavirus (HPV). This means that Gardasil 9 covers five more HPV types than Gardasil, one of two HPV vaccines available in the European Union (EU). Infection with some types of HPV can cause abnormal tissue growth including warts, and changes to cells. Persistent infection with certain types of HPV can also cause cancers of the cervix, anus, vagina and vulva, as well as of the mouth and throat.
Drug
Anti-abuse opioid products
The US Food and Drug Administration (FDA) has issued a final guidance to assist the industry in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however, opioids also carry a risk of misuse, abuse and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high.
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