Tag Archives: fda

Q&A: What to know about new Alzheimer’s drug Leqembi

senior adult

Photo by Tim Doerfler via Unsplash

The FDA granted full clinical approval to Leqembi (lecanemab) on Thursday, July 6, making it only the second new drug approved to fight Alzheimer’s disease and the first to receive full authorization from the agency. 

The approval follows unanimous endorsement of the drug’s safety, efficacy and clinical benefit by an independent advisory committee in June. The anti-amyloid drug had already received accelerated approval in January 2023. Full FDA authorization is a big step for potentially thousands of people with mild to moderate Alzheimer’s, who may be eligible for treatment.

Continue reading

6 prescription digital therapeutics story angles to explore

Photo by William Fortunato via pexels

The news that Highmark, a Pittsburgh-based large commercial insurer, plans to expand its coverage of several prescription digital therapeutics cleared by the FDA made headlines recently in STAT, Fierce Healthcare and other outlets. The payer is not the first to cover some prescription digital therapeutics (PDTs) but it is the first to announce it intends to pay for claims for the use of some apps and other technologies that help treat psychiatric disorders and other complex conditions.

With digital therapeutics expected to be a $56 billion global opportunity by 2025 (according to Insider Intelligence), there are multiple avenues for stories for journalists to explore (see list at end).

Continue reading

Evaluating concerns about accelerated FDA drug approvals

House Energy and Commerce Chairman Frank Pallone (Photo courtesy of The House Committee on Energy and Commerce website)

Congress has a chance in September to try to speed the pace of studies needed to confirm whether drugs sold in the U.S. under accelerated approvals are helping people live better or longer. Journalists covering this issue may want to take a look at two recent papers on this subject.

In the first section of this two-part blog, we yesterday explained the politics of this issue. U.S. lawmakers are under pressure to reauthorize the Prescription Drug User Fee Act (PDUFA) by the end of this month. Work on the Senate version of the bill stalled during the summer. The House in June passed its version of the bill, 392-28, with strong bipartisan support. 

Continue reading

Rise in naloxone costs for uninsured, a significant access barrier to life-saving drug

Photo courtesy of the FDA website.

The cost of naloxone has risen sharply for people lacking insurance, even as laws have made it easier to prescribe and obtain the treatment for opioid overdoses, a new report found.

A study of claims data showed the mean out-of-pocket cost of naloxone for the uninsured rising to $249.97 in 2018 from $35.39 in 2014, according to a study published in JAMA Health Forum in August.

Continue reading

How to use COVID-19 rapid tests to avoid misleading results

Photo by Jernej Furman via Flickr.

Rapid antigen tests are now the standard way for people to determine if they have COVID-19, but studies show they are less sensitive than laboratory tests and can result in a false negative for infection, creating public confusion about about how to use rapid tests.

Continue reading