Policy
Leerink analysts hailed the deals as a sign that President Trump “is unlikely to attack the industry in 2026.”
FEATURED STORIES
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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A draft executive order obtained by The New York Times purports to clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, along with a number of other proposed reforms.
New draft guidelines suggest the FDA is open to exercising regulatory flexibility for non-opioid drugs being developed for chronic pain.
Former CDC director Susan Monarez and former chief medical officer Debra Houry will appear in front of the Senate HELP Committee on Sept. 17.
In a livestreamed meeting Tuesday afternoon, Health Secretary Robert F. Kennedy Jr. drew a dark portrait of the state of America’s health while addressing the MAHA Commission’s most recent report, which includes plans to research potential links between vaccines and rising rates of chronic disease.
Ori Biotech’s CEO said the prioritization of review by FDA, coupled to the impact of the technology, could shave up to three years off development timelines.
While a win for consumers, the regulatory action did nothing to stem the manufacture of compounded versions of the popular obesity drugs that are made by Novo Nordisk and Eli Lilly. In fact, the FDA seems to be signaling that “some level of compounded product is acceptable,” according to BMO Capital Markets.
The World Health Organization’s Essential Medicines list guides high-level procurement and coverage decisions for over 150 countries.
Robert F. Kennedy Jr. repeated a series of anti-vaccine talking points during his appearance in front of the Senate finance committee on Thursday, as Democratic and Republican senators alike hammered the Health Secretary on recent COVID-19 vaccine restrictions and his views on Operation Warp Speed.
Ousted CDC Director Susan Monarez claimed in an op-ed published in The Wall Street Journal Thursday that she was fired for refusing to rubber-stamp COVID-19 recommendations to be made by an advisory panel that has expressed “antivaccine rhetoric.”
In coordination with the United States President’s Emergency Plan for AIDS Relief, Gilead will make its twice-yearly HIV prophylactic Yeztugo available to resource-limited countries “at no profit.”