News, Resources, and Events Tagged "Jonathan Darrow"
Gilead and ViiV Healthcare reach settlement over HIV drug
Gilead Sciences to pay US$1.25 billion, and royalties, settlement to ViiV Healthcare over patent infringement of the HIV drug, dolutegravir. Nayanah Siva reports.
Expedited Approval of Medications Calls Evidence Standards into Question
Expedited FDA approval processes pose multiple ethical concerns, according to the authors of a recent paper.1 The authors sought to “illustrate the overarching trend in drug approval over the…
Two views of cancer medicines: Imagery versus evidence
Despite advertising imagery portraying cancer medicines as offering substantial improvement or cure, most patients can expect modest or no incremental benefit from most new treatments, according to pre-specified criteria. When…
Every drug should be labelled to tell you how well it works
When buying over- the-counter drugs or being prescribed medication by your GP, what’s the one thing you want to know? The answer is obvious, of course: how well…
Vaccines, Regulation, and Patents: A Conversation with Harvard Medical School Professor Dr. Jonathan J. Darrow
HHPR Senior Editor James Jolin interviewed Jonathan Darrow, S.J.D., LL.M., J.D., M.B.A, an Assistant Professor of Medicine at Harvard Medical School and a Faculty…
Simplify drug labelling to show benefits clearly
Aducanumab, an Alzheimer’s disease treatment, was approved by the US Food and Drug Administration (FDA) in June this year despite a lack of robust evidence that it actually…
Dems resurrect a scaled back plan for Medicare drug price negotiations
Only a few days after President Joe Biden seemed to signal that drug pricing reforms were left for dead, Democrats are already circulating plans for a scaled-back version of what…
To Incentivize COVID-19 Vaccination, Give Vaccinated Individuals A Discount On Their Insurance Premiums
Although Covid-19 vaccines have been available in the US under Emergency Use Authorization since December 11, 2020, more than 119 million (36 percent) of the US population of 332 million have not received a dose…
‘He Thought What He Was Doing Was Good For People’: Why is it so difficult to prevent unnecessary medical procedures in the U.S. health-care system?
Unlike prescription drugs or medical devices, which are regulated by the FDA, the tens of millions of surgical procedures performed in the U.S. each year are not subject to…
Assessing the Impact of US Food and Drug Administration Breakthrough Therapy Designation Timing on Trial Characteristics and Development Speed
The US Congress created the Breakthrough Therapy designation in 2012 to expedite drug development and review through efficient clinical trial design and intensive interaction with US Food and Drug Administration (FDA)…