Policy

Shingrix sales in the U.S. took a 15% dive in the third quarter. GSK is now the second Big Pharma to report declining vaccine sales, after Sanofi reported a similar decline last week.

While the FDA continues to put out guidance documents and approve drugs, some companies are already reporting delays in dealings with the agency, while insiders warn of falling morale and a negative perception from the rest of the biopharma world.

The coming flu season is the clearest indication yet that biopharma’s long-standing assumptions about predictability, prevention and portfolio structure are no longer guaranteed.

Reporting third quarter earnings on Tuesday, Johnson & Johnson CEO Joaquin Duato said the healthcare giant has not yet secured a drug pricing deal with the White House, but discussions are ongoing.

The last few months have been tumultuous for the CDC, which has seen the ouster of Director Susan Monarez and all 17 members of the Advisory Committee on Immunization Practices.

A new version of the controversial bill removes the specific company names that were included in a previous iteration but still requires the industry to ditch Chinese biotech contractors in order to receive federal dollars.

The $48 million award, granted through the Advanced Research Projects Agency for Health, will help Kernal take its in vivo mRNA-encoded CAR T therapy forward.

Drug pricing criticism often fixates on a price at a single point in time but drug pricing is never static.

Cell and gene therapy experts question where the FDA designation fits in an environment that features a range of intersecting regulatory perks.

At the heart of the agreement is Pfizer’s $70 billion commitment to U.S.-based manufacturing and an exemption from tariffs for three years. While the reaction was mostly positive from Wall Street, other observers noted that the benefits for patients are unclear at best.