STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

Boehringer Ingelheim is the latest pharma company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices.

Aug 23, 2023 - 20:00
STAT+: Pharmalittle: FDA approves Pfizer’s RSV vaccine for newborns; Boehringer sues over IRA

Good morning, one and all. Damian Garde here, filling in for Ed Silverman once more on another day of aberrant weather and out-of-office autoreplies. Here’s hoping yours ends with fewer open browser tabs than it began. Below find a few items to get you started, and, as always, let us know if you hear anything interesting out there.

The Food and Drug Administration approved a Pfizer vaccine that aims to protect newborns against RSV by vaccinating pregnant people, STAT tells us. The vaccine, marketed as Abrysvo, previously won approval for adults over the age of 60. Pfizer’s product won’t be available to pregnant people until wins the recommendation of a panel of advisers to the CDC, which is expected to happen before RSV season begins in the winter.

German drugmaker Boehringer Ingelheim is the latest pharmaceutical company to sue the federal government over a law that would allow Medicare to negotiate certain drug prices, Reuters reports. Echoing earlier lawsuits brought by Merck, Johnson & Johnson, and PhRMA, Boehringer claims the Inflation Reduction Act would violate the First, Fifth, and Eighth Amendments by effectively seizing the company’s property, forcing it to call the agreement fair, and then levying excessive fines for noncompliance. Jardiance, a diabetes medicine co-marketed by Boehringer, is expected to be among the first drugs to face negotiation once the law takes effect in 2026.

Continue to STAT+ to read the full story…

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