Policy
Project 2025, a blueprint for a potential second Trump term that highlights the IRA as a potential target, took a starring role in this week’s Democratic National Convention.
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For the Biden-Harris administration to compare the newly announced negotiated Medicare prices to the list prices for these drugs is, at best, not very meaningful. At worst, it’s disingenuous.
The Biden administration on Thursday touted discounts of up to 79%, but many of these first 10 drugs are already sold well below list price.
The new Medicare prices for the first 10 drugs negotiated under the Inflation Reduction Act are expected soon. Analysts and researchers are divided on the long-term effects of the law.
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In June, the regulator placed a partial clinical hold on a Phase I trial of the companies’ antibody-drug conjugate after three patient deaths were reported.
In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.
Just months after a jury ordered payment to Pfizer in the patent infringement case, a Delaware judge has nullified the award and invalidated the patents behind the lawsuit involving AstraZeneca’s blockbuster lung cancer drug.
The Biden administration on Thursday announced that the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will save the U.S. government around $6 billion in its first year of implementation.
The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
As the U.S. moves away from reliance on Chinese CDMOs, Southern cities provide a model for how we can bolster domestic production capacity.
On the heels of the FDA’s denial of its petition, a Delaware district court on Monday handed Novartis another loss in its efforts to keep the market free of Entresto copycats.
At a private event held amid the fallout from the CrowdStrike incident, cybersecurity issues took a front seat, with the consequences of the evolving EU AI Act and the Loper Bright and Corner Post decisions also raising concerns for quality assurance and regulatory affairs professionals.
With Medicare expenditures on Stelara increasing nearly tenfold, a new report from the HHS Office of Inspector General has found major differences in drug payment amounts under Part B versus Part D.
In the latest setback for the pharma industry and its allies, the United States District Court for the Southern District of Ohio dismissed a U.S. Chamber of Commerce lawsuit on the grounds of improper venue.