Community health centers on Wednesday (Oct. 21) sued HHS for not putting forward regulations for a dispute resolution process and, as such, depriving the providers of their only way to take drug makers to task for making them pay full price for drugs through 340B contract pharmacies.

FDA approved Gilead Science’s remdesivir therapeutic, Veklury, on Thursday (Oct. 22) for the treatment of hospitalized COVID-19 patients 12 years and older, making it the first fully FDA-approved treatment for the novel coronavirus in the United States.

Dialysis patients are clashing with insurers in an ongoing lawsuit over whether a CMS rule inappropriately steers patients to in-home dialysis treatment by stating that Medicare Advantage plans no longer must cover treatments at clinics located near patients’ homes.

In a meeting with the White House budget office earlier this month, Juul urged the Trump administration and FDA to make it clear to states and tobacco retailers that the new national law setting 21 as the minimum age to purchase tobacco products preempts state laws that still have 18 as the minimum age.

A new World Health Organization-funded study that found remdesivir may not reduce mortality from COVID-19 could put pressure on its maker, Gilead, to cut the price of the antiviral, which is the only pandemic drug to receive an emergency use authorization.

Regeneron disputes allegations it did not disclose that the U.S. government funded development of the company’s coronavirus antibody in its patent for REGN-COV2.

FDA on Thursday (Oct. 22) will ask its vaccines advisors to consider whether COVID-19 vaccine sponsors should keep their phase 3 trials blinded even after an emergency use authorization is granted, coming as two of the leading vaccine developers, Pfizer and Johnson & Johnson, warn that if granted an EUA they might ethically need to unblind their studies to allow participants to access EUA vaccines or to cross over to the vaccine arm of a trial.

CMS Administrator Seema Verma announced on Wednesday (Oct. 21) that, after listening to stakeholder feedback, the agency will delay the mandatory radiation oncology demonstration until July, giving providers an extra six months before the model goes into effect.