Tag: Harvard Medical School

FDA panel says preterm birth drug should be withdrawn

Volume 400, Issue 10362
29 October 2022 

 

WORLD REPORT  Makena has been given to hundreds of thousands of patients over the past 11 years. Susan Jaffe reports from Washington, DC.  

The only treatment in the USA to prevent premature births is ineffective and should be withdrawn from the market, according to the Food and Drug Administration’s (FDA) Obstetrics, Reproductive and Urologic Drug Advisory Committee. The recommendation has renewed scrutiny of a special drug approval process that raises patients’ hopes by allowing them to take medications that have not been fully tested for efficacy and safety [Continued here.] 

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US FDA defends approval of Alzheimer’s disease drug

Volume 398, Issue 10294
3 July 2021

 

WORLD REPORT An avalanche of criticism has forced the US Food and Drug Administration to defend its decision to grant accelerated approval for aducanumab, the first new Alzheimer’s disease treatment in two decades. “It will be a very long time before we ever figure out whether or not this drug really works”, said Aaron Kesselheim, professor of medicine at Brigham and Women’s Hospital and Harvard Medical School who resigned in protest from an FDA advisory panel that recommended against approval.[Continued here.]

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House Drug Price Hearing Takes Aim at Industry

By Susan Jaffe  | Contributing Writer | MedPageToday  | January 30, 2019

WASHINGTON — Pharmaceutical companies were pummeled during Tuesday’s hearing of the House Committee on Oversight and Reform. The panel’s first hearing of the 116th Congress examined the reasons for rising drug prices and follows committee chairman Elijah Cummings’ (D-Md.) launch of an aggressive investigation into pharmaceutical pricing issues.

“For the past decade I’ve been trying to investigate the actions of drug companies for all sorts of drugs — old and new, generic and brand name,” Cummings said. “We have seen time after time drug companies make money hand over fist by raising the prices of their drugs often without justification…”  [Continued at MedPageToday]

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