Expert advisers to the Food and Drug Administration recommended authorization Tuesday of the first coronavirus pill to prevent high-risk people from developing severe illness in a divided vote that reflects the complicated mix of benefits and risks involved with a new and easy mode of treatment. Merck and Ridgeback Biotherapeutics developed the drug, molnupiravir, as a five-day regimen to be taken at home within five days of onset of coronavirus symptoms. The FDA is not bound by the 13-to-10 vote but typically follows its external advisers’ recommendations. The drug could have an immediate impact on the pandemic if authorized — just as the ominous new omicron variant has emerged, jolting the world with the prospect of a longer and more complicated pandemic. Merck has pledged to manufacture [...]

The heavily mutated omicron coronavirus variant is likely to spread further and poses a "very high" global risk, according to the World Health Organization (WHO), which warned today that surges of COVID infections caused by the variant of concern could have "severe consequences" for some areas. No Omicron-linked deaths had yet been reported, though further research was needed to assess its potential to escape protection against immunity induced by vaccines and previous infections, it added. In anticipation of increased case numbers as the variant, first reported last week, spreads, WHO urged its 194 member states to accelerate vaccination of high-priority groups and ensure plans were in place to maintain health services. "Omicron has an unprecedented number of spike mutations, some [...]

A federal jury on Tuesday found three of the nation's biggest pharmacy chains, CVS, Walgreens and Walmart, liable for helping to fuel the U.S. opioid crisis — a decision that's expected to have legal repercussions as thousands of similar lawsuits move forward in courts across the country. Jurors concluded that the pharmacies contributed to a so-called public nuisance in Lake and Trumbull counties in Ohio by selling and dispensing huge quantities of prescription pain pills. Some of those medications initially purchased legally wound up being sold on the black market. Tuesday's verdict is expected to resonate nationally, as the three chains face thousands of similar lawsuits filed by U.S. communities grappling with the opioid crisis. A separate legal proceeding will [...]

In response to urgent advocacy from the American Pharmacists Association (APhA), the College of Psychiatric and Neurologic Pharmacists, and other mental health organizations, the U.S. Food and Drug Administration (FDA) Friday announced that it is temporarily suspending specific Clozapine REMS program requirements. Health care professionals continue to alert FDA about ongoing difficulties with the Clozapine REMS program, including a high call volume and long call wait times for stakeholders since launch of the program on Nov. 15, according to an FDA press release. "We understand that this has caused frustration and has led to patient access issues for clozapine. FDA takes these concerns seriously. Continuity of care, patient access to clozapine, and patient safety are our highest priorities. We are working closely [...]

With CDC adding its approval just hours after FDA did the same on Friday, all U.S. adults are now eligible for COVID-19 vaccine boosters at least six months after their initial immunization. The hope is that there will be less confusion over who can and cannot get the extra dose and more protection of the public as infections begin to creep up again. "[Boosters] have demonstrated the ability to safely increase people's protection against infection and severe outcomes and are an important public health tool to strengthen our defenses against the virus as we enter the winter holidays," said CDC Director Rochelle Walensky, who signed off on the decision. Although anyone aged 18 years and older can now get a [...]