Policy
Incoming PhRMA Chair Paul Hudson, a day before the White House announcement, pledged to work with the administration as the president turns to insurers as a source of cost savings for prescription medicines.
FEATURED STORIES
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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.
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The U.S. CDC has issued new travel warnings as surges of COVID-19 continue throughout the country and the world. For that and other COVID-19 news, read below.
After months of ongoing testimony from various whistleblowers and investors, Elizabeth Holmes, Theranos founder and CEO, has finally taken the witness stand in her fraud trial.
News on COVID-19 vaccine developments and disease studies continue to deliver highs and lows. Here are some of the more recent happenings.
The beginning of booster vaccines for adults was in news for a long time. Well, CDS authorized it now, and here’s the reason behind the authorization.
A Chinese professor at the University of Copenhagen in Denmark is under scrutiny over undisclosed ties to the Chinese military.
BioMarin Pharmaceutical scored a first on Friday and provided an option for patients with a rare disease for which there is little recourse.
The two dominant theories over the origins of COVID-19 are that the virus developed naturally, probably from bats in a wet market in Wuhan, China, and the “lab leak.”
The U.S. Food and Drug Administration approved COVID-19 vaccine booster shots for all Americans ages 18 and over Friday morning.
While COVID-19 appears to be battling back in cold-weather states in the U.S. and parts of Europe, researchers continue to study vaccine efficacy and new approaches to dosing. Here’s a look.
The FDA and CDC will soon decide on Pfizer-BioNTech’s request for an Emergency Use Authorization for the booster shot for their COVID-19 vaccine.