Rx Drugs

The Centers for Disease Control and Prevention on Thursday (May 13) announced that anyone who is fully vaccinated can participate in indoor and outdoor activities, large or small, without wearing a mask or physical distancing.

Coronavirus booster shots will be free to everyone if they’re needed before the end of the pandemic, White House Chief Science Officer David Kessler said Tuesday (May 11) at a Senate hearing, but it’s not clear how much people will have to pay for coronavirus vaccinations, or what the price will be, once the pandemic is over.

Proponents of march-in rights view the Biden administration’s support for waiving international patent protections on coronavirus vaccines as an indication the administration might reverse the Trump administration’s proposal to undermine domestic patent march-in powers under the Bayh-Dole Act.

The Centers for Disease Control and Prevention on Wednesday (May 12) revealed that it will amend its clinical guidance to allow for COVID-19 vaccines and other childhood vaccinations to be co-administered on the same day or within 14 days of each other, coming just two days after Pfizer and BioNTech’s two-shot product became the first COVID-19 vaccine to be authorized by FDA for use in kids under the age of 16.

House Majority Leader Steny Hoyer (D-MD) next week will bring back to the House floor a bipartisan bill that aims to close a loophole in the Orphan Drug Act, after Republicans blocked the bill’s passage Tuesday evening (May 11) due to a fallout between the measure’s lead Democratic sponsor and former GOP co-sponsor Rep. Buddy Carter (GA).

Ten House Democrats are urging Speaker Nancy Pelosi (D-CA) to pursue bipartisan, bicameral drug pricing legislation that focuses on affordability, instead of prices.

FDA reveals in an inspection roadmap that, in the best-case scenario, the agency likely will only be able to complete 27% of the 15,514 domestic inspections it would need to conduct this year to catch up from the surveillance lag caused by the COVID-19 pandemic.

FDA on Monday (May 10) authorized Pfizer and BioNTech’s COVID-19 vaccine for use in kids ages 12 to 15 after data found it to be 100% effective for that age group a week after the second shot, which means the vaccine is now authorized for everyone ages 12 and older.

In a joint statement Friday (May 7), the International Coalition of Medicines Regulatory Authorities and World Health Organization call on drug makers to make clinical trial information about new medicines and vaccines accessible to the public by publishing clinical trial reports without redactions.