Government

Pfizer CEO Albert Bourla directly credited the threat of tariffs with leading to the deal, in which the company will offer drugs on a soon-to-be-launched website called TrumpRx.

Without naming Aurinia Pharmaceuticals, the CDER director in a now-deleted LinkedIn post claimed that for lupus nephritis, companies have not conducted post-approval studies “to demonstrate a benefit on hard clinical endpoints.”

Companies that have broken ground on or are actively constructing manufacturing facilities in the U.S. are exempted from the tariffs, according to President Donald Trump’s social media post on Thursday.

The Trump administration’s recently announced fee for new H-1B visa petitions is “completely unreasonable,” an immigration attorney told BioSpace. Attorneys and talent acquisition experts discuss how the fee could impact biopharma and confusion around the proclamation.

Three draft recommendation documents published on Wednesday are intended to guide drug sponsors and accelerate the development of cell and gene therapies.

The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss startup Metsera for nearly $5 billion after suffering a hat trick of R&D failures; psychedelics are primed for M&A action and Eli Lilly may be next in line; RFK Jr.’s revamped CDC advisory committee met last week with confounding results; and Stealth secured its Barth approval.

The agency also pointed to the use of Tylenol and other acetaminophen products during pregnancy as being potentially linked to neurological and developmental defects in children, following a press conference Monday in which President Donald Trump did the same.

After a tension-packed two days that saw recommended changes to the MMRV vaccine schedule and COVID-19 vaccine access, as well as a delayed hepatitis B vaccine vote, policy experts expressed concern with the reconstituted committee’s dearth of previous experience and understanding of their role.

BMO Capital Markets analysts said the first day of the CDC vaccine advisory committee meeting Thursday had anti-vaccine overtones as the panel, which was revamped by Health Secretary Robert F. Kennedy, Jr. in June, voted to recommend that children under four receive the measles, mumps, rubella (MMR) vaccine separately from a chickenpox vaccine. Today the advisors will vote on changing the childhood schedule for the hepatitis B and COVID-19 vaccines.

The House Committee on Energy and Commerce has cleared proposed legislation that could bring back the FDA’s rare pediatric priority review voucher program, which allows for expedited drug reviews.