Government
With the biopharma industry’s looming wave of gene therapy submissions and potential approvals, the senior senator is laying the groundwork for a legislative initiative to improve access to these expensive treatments.
The agency on Tuesday said it is investigating the “serious risk” of T cell malignancy outcomes, including hospitalization and death, and evaluating the need for potential regulatory action.
The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety.
The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.
The country is considering restricting the use of Novo Nordisk’s Ozempic to just type 2 diabetes and prohibiting its prescription for weight loss as the company struggles with continued supply constraints.
A revised Paxlovid supply agreement with the U.S. government has pushed Pfizer to launch a “cost realignment” program including layoffs, though it is still unclear how many employees will be affected.
An increase in funding share and available lab space helps to keep the Bay State’s biotech and pharma sectors strong.
The European Commission on Thursday ordered Illumina to divest Grail, opening the next chapter in the years-long regulatory saga. Illumina is reviewing the order, Reuters reported.
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