Paxlovid isn't associated with COVID rebound, in which patients test positive or have symptoms days after a course of the drug is completed, Food and Drug Administration staff said in briefing documents released Tuesday.
Why it matters: This is the first time the FDA has publicly discussed if the phenomenon is actually due to the antiviral — a question that’s swirled around its use since Pfizer's drug was granted emergency use authorization in December 2021.
The big picture: The documents were prepared ahead of a Thursday meeting of FDA advisers, who will vote on whether to give the pill full approval for patients at high risk of hospitalization or death.
FDA staff said that Pfizer’s clinical trials support the notion that Paxlovid’s benefits outweigh its risks.
Zoom in: Both the FDA and Pfizer concluded that rebound is likely part of the natural course of a COVID infection and that it does not lead to severe disease when it occurs.
Rebound has also been observed in the absence of Paxlovid treatment, with potential rates ranging from 10% to 16%.
The likelihood of rebound was not significantly different between patients who were sick with the omicron variant compared to the delta variant.
What’s next: FDA regulators acknowledged more research is needed to determine whether a longer-term dosage than the customary five-day Paxlovid course could be needed for moderate-to-severely immunocompromised patients.
One ongoing clinical trial is testing how common COVID rebound is among immunocompromised people.
Fifteen Democratic governors asked seven leading pharmacy retailers on Tuesday to clarify their plans for dispensing mifepristone — a pill used in medication abortions.
Driving the news: The move comes shortly after Walgreens announced that it would not dispense mifepristone in some Republican-led states where abortion remains legal.
The Environmental Protection Agency proposed drinking water regulations on Tuesday for certain types of "forever chemicals," a pervasive group of industrial chemicals that have affected drinking water quality across the U.S.
Why it matters: If the proposals become official, it'd be the first time the federal government would require utilities to remove the dangerous chemicals from drinking water before they reach households and businesses.
Activist investor Carl Icahn launched a proxy fight for three board seats at biotech giant Illumina, which he believes erred in competing its controversial $7.1 billion takeover of liquid biopsy firm Grail.
Why it matters: This is the latest high-stakes chapter in Illumina's complicated history with Grail, which it developed, spun out and then repurchased several years later.
A pair of big biotech deals is stirring some hope for a segment that's been in a deep funk and just starting to size up the aftereffects of Silicon Valley Bank's demise.
What's happening: Pfizer's $43 billion acquisition of cancer drug maker Seagen and Sanofi's $2.9 billion deal to buy diabetes drug manufacturer Provention Bio, both announced Monday, offer signs that pharmaceutical giants flush with cash and eager to reboot their pipelines could slow the sector's slide.
President Biden said former President Jimmy Carter asked him to deliver his eulogy after he dies, per a White House pool report Monday night.
Driving the news: Biden made the comments while discussing the health issues of Carter, who's receiving hospice care, during a Democratic National Committee fund-raiser in Rancho Santa Fe, California, which was attended by about 40 guests.
The U.S. government filed a lawsuit against Rite Aid on Monday, accusing the pharmacy chain of knowingly filling unlawful prescriptions for controlled substances, including opioids.
Driving the news: The Department of Justice alleged in the complaint that from May 2014 to June 2019, Rite Aid filled hundreds of thousands of prescriptions "that were medically unnecessary, lacked a medically accepted indication, or were not issued in the usual course of professional practice."
The Veterans Health Administration said Monday that it intends to pay for a $26,500-a-year experimental Alzheimer's drug that the Centers for Medicare and Medicaid Services has to date declined to cover.
The big picture: Eisai's Leqembi received accelerated approval from the FDA earlier this year after data suggested that it could slow the progression of the disease. However, Medicare administrators said they need to evaluate more data before deciding whether to change coverage guidelines for the drug and others in its class.
Black babies experienced an unexpected jump in unexplained deaths in 2020 despite a record-low infant mortality rate, according to a study published Monday in the medical journal Pediatrics.
The big picture: The findings, stemming from research from the Centers for Disease Control and Prevention, highlight a further increase to preexisting disparities in infant deaths and but the exact cause for the spike is unknown.
States around the nation are eyeing measures to curb the availability of products derived from hemp known as delta-8 THC due to concerns about consumption by kids.
Driving the news: There are proposed measures in Kentucky, Louisiana, Texas, Arizona and Virginia aimed at closing a loophole in hemp sales that allows the sale of products with the THC-containing compound.
Digital health and biotech firms made up a substantial part of Silicon Valley Bank's client base. And its historic failure is raising troubling questions about how much the fallout will hurt emerging health companies in need of capital.
