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.
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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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Heading into fall, with the COVID-19 pandemic surging again and researchers tracking new variants, there’s plenty of news. Here’s a look.
The Biden administration announced plans for a new biopreparedness initiative that is part of the ongoing Building Back Better plan.
Concerns about Mu and Lambda are growing, but data suggests that Delta is still the biggest problem. The U.S. is also struggling with infections this year. Here’s the latest news.
The oncogenicity and neurotoxicity risks of AAVs and possible mitigation strategies were the primary focus on Thursday.
Heading into the Labor Day weekend in the U.S., there’s still plenty of COVID-19 news. Here’s a look.
Lilly’s most recent legal woes come from a proposed class-action lawsuit filed on Wednesday, accusing the company of age bias.
Henceforth, all JAK-inhibiting drugs like AbbVie’s Rinvoq, Pfizer’s Xeljanz, and Lilly’s Olumiant, have been ordered to include a warning label on the medicine to be sold in the U.S.
The Sacklers did not admit to any wrongdoing and have never been charged directly for the issue. Still, Purdue Pharma has pleaded guilty twice in its erroneous marketing efforts for OxyContin.
Multiple reports suggest an exodus of BIO team members over price control issues. BIO reorganized its leadership structure to provide what was expected to be “long-term stability for the organization.”
New data is coming out every day about COVID-19 and the body’s response to vaccines. Here’s a look at some of the top stories.