Patients infected with hepatitis C have had the ability to rid their livers of the virus for some time, while patients with chronic hepatitis B virus infection have been required to take medications for the rest of their lives in the hopes of just dampening damage to the liver caused by the virus. But, at The Liver Meeting 2024, Arbutus presented data from the phase IIa Im-prove study suggesting a cure might be on its way with its DNAi drug, which binds to the viral mRNA promoting its cutting, leading to loss of translation of the viral proteins.
In a historic first, the U.S. Centers for Medicare & Medicaid Services (CMS) sent out its opening offers Feb. 1 for the first round of prescription drug price negotiations.
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
Continuing its efforts to reduce prescription drug prices in the U.S., the Senate Finance Committee turned up the heat on pharmacy benefit managers (PBMs), voting overwhelmingly, 26-1, to send the bipartisan Modernizing and Ensuring PBM Accountability (MEPA) Act to the full Senate.
Public companies registered with the U.S. SEC will soon have to disclose material cybersecurity incidents and annually report material information regarding their cybersecurity risk management, strategy and governance.
Following a comment-and-review process waylaid by the COVID-19 pandemic, the U.S. FTC is finalizing its revised guides on the use of endorsements and testimonials in advertising.
The U.S. Court of Appeals for the Federal Circuit declined an invitation in United Therapeutics Corp. v. Liquidia Technologies Inc. to expand the enablement and written description bar for biopharma claims into the realm of regulatory approval.
Rather than waiting on the courts to sort out the 340B dispute between the U.S. Department of Health and Human Services (HHS) and prescription drug manufacturers, a group of senators is looking for bipartisan legislative solutions that would infuse the drug discount program with more accountability, certainty, oversight and transparency.
In its first untitled letter in more than a year, the U.S. FDA’s Office of Prescription Drug Promotion (OPDP) took Xeris Biopharma Holdings Inc. to task for two webpages promoting the company’s Recorlev.
