Policy
An unnamed FDA official also told reporters that it would be good for Moderna to “show some humility” and admit that it didn’t follow the regulator’s recommendations in testing its mRNA flu vaccine.
FEATURED STORIES
Bristol Myers Squibb, GSK and Merck are contributing drug ingredients as part of their deals with the White House but are keeping many of the terms of their agreements private.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
The FDA’s rare pediatric disease priority review voucher program missed reauthorization at the last minute in 2024; advocates have been fighting to get it back ever since.
Subscribe to BioPharm Executive
Market insights and trending stories for biopharma leaders, in your inbox every Wednesday
THE LATEST
Vocal skeptics of COVID-19 vaccinations gave mRNA a bad name and government funding for mRNA research is now being cut. On the flip side, at least one CEO said the pandemic also provided “elevated acceleration” for the field, which also holds promise in therapeutics for cancer and rare diseases.
The report takes from HHS Secretary Robert F. Kennedy Jr’s playbook, calling out rising autism rates, the vaccine schedule and over medication of children as reasons for chronic diseases.
In an opinion issued late Thursday night, U.S. District Judge Susan Illston wrote that the president and department agency heads do not have the authority to reorganize the government without Congress’ input.
The “One Big Beautiful Bill Act” includes negotiation exemptions for orphan drugs approved to treat more than one rare disease and has implications for PBMs. Also on Thursday, the White House released its MAHA report with a mission to “make our children healthy again.”
Canada’s health agency says it has been “taking all necessary action safeguard the drug supply and ensure Canadians have access to the prescription drugs they need.”
The CMS last month declined to include anti-obesity medications in its Medicare coverage for Part D, a move that Lilly says could interfere with patients getting the appropriate medical care.
After a tense exchange, Senator Patty Murray (D-WA) told Kennedy that by implementing sweeping cuts to the HHS, he is “enacting his budget,” which “Congress has not passed.”
Drugmakers will be expected to commit to aligning U.S. prices with the lowest price set in a group of peer nations for all brand products across all markets that do not currently have generic or biosimilar competition.
The Most Favored Nation order is unlikely to deliver broad, sustained savings without triggering legal challenges, administrative friction and unintended consequences for both the healthcare sector and patient access.
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.