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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A day after the FDA authorized a COVID-19 booster dose of the Pfizer-BioNTech vaccine, a U.S. Centers for Disease Control and Prevention advisory committee voted in support.
FDA authorizes Pfizer-BioNTech COVID-19 booster shots for individuals 65 and over, those at high risk for severe disease and front-line healthcare workers.
As the COVID-19 pandemic hit a grim milestone, marking more U.S. deaths than were reported in the 1918–19 Spanish flu pandemic, research and breakthroughs continue.
On the tailcoat of Tuesday’s United Nations General Assembly, President Biden is hosting a virtual COVID-19 summit Wednesday, calling for the end of the pandemic globally.
The company announced Friday that clinical studies have been placed on hold following the development of tumors in mice in a non-clinical study.
The vote to offer a booster to those 65 and older, as well as immunocompromised individuals at high risk of developing severe COVID-19, was a unanimous “yea” at 18-0.
From time to time, the U.S. FDA requests additional data from companies who have submitted an application for a new drug or biologic. What’s a bit unusual is every single PDUFA date this week had that happen.
COVID-19 remains relentless in challenging the community as it continues to evolve. Here are some of the top news for the week.
A trustee with the DOJ filed a request for an “expedited stay” in order to prevent the initiation of the bankruptcy plan.
NTLA-5001 is being developed for the treatment of acute myeloid leukemia (AML).