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Third Member of US FDA Advisory Panel Resigns Over Alzheimer's Drug Approval

A third member of a panel of outside advisers to the U.S. Food and Drug Administration has resigned in protest over the agency's decision to approve Biogen's Alzheimer's disease treatment despite the committee's recommendation against doing so. Reuters reports: Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA's advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel. "My rationale was that t...
Tags: US, Tech, Fda, Reuters, U S Food and Drug Administration, Harvard Medical School, Washington University, Biogen, Aaron Kesselheim, Kesselheim, FDA Advisory Panel, David Knopman, Joel Perlmutter, Aduhelm Mayo Clinic


A third member of a prestigious FDA panel has resigned over the approval of a controversial new Alzheimer's drug

Atthapon Raksthaput/Shutterstock A third member of an FDA expert panel has resigned over the agency's accelerated approval of a new Alzheimer's drug. The committee voted against approving the treatment. The FDA isn't required to follow the panel's recommendation but usually does. Aduhelm failed one of its late-stage clinical trials and didn't produce conclusive results in another trial. See more stories on Insider's business page. A third member of a Food and Drug...
Tags: Science, News, US, Trends, Healthcare, Food And Drug Administration, Alzheimer's, Fda, Mayo Clinic, Cnbc, Harvard Medical School, Biogen, Washington University in St Louis, Aaron Kesselheim, Knopman, Kesselheim


Precision medicine approvals and rare disease treatment incentives evaluated

The senior author of two separate articles published in Health Affairs on May 7, Kesselheim, members of the PORTAL research group and co-authors, examine the fast approvals of precision medicines in one paper while evaluating the impact of the Orphan Drug Act's seven-year market exclusivity in the other.
Tags: Kesselheim


From 3 to 16: Behind U.S. Paralympics Nordic’s Medal Leap in PyeongChang

Two American flags and a Belarusian flag being hoisted to honor the medalists in the men’s sitting cross-country sprint at the 2018 Winter Paralympics in PyeongChang, South Korea. Americans Andy Soule and Dan Cnossen placed first and second, respectively, and Dzmitry Loban of Belarus finished third. (Photo: U.S. Paralympics/Joe Kusumoto) Success to failure. Failure to success. Two trends of two extremes on the performance metrics on the international cross-country skiing spectrum. There are ma...
Tags: London, General, News, Interviews, Navy, Sport, Afghanistan, Harvard, Racing, Skiing, Korea, Army, Belarus, Thor, North America, Sochi


Wilkie, McKeever, Masters All Win Gold in Last Individual Race of Paralympics

Canada’s 17-year-old Natalie Wilkie being awarded gold after she won her first Paralympic race on Saturday, the women’s 7.5 k standing classic, in PyeongChang, South Korea. (Photo: Dave Holland/Canadian Paralympic Committee) 2018 Winter Paralympics (PyeongChang, South Korea): 5/7.5/10 k cross-country races Saturday marked the last day of individual racing at the PyeongChang Paralympics, and as they have over the last week, the U.S. and Canadian teams did not disappoint, with the U.S. Paralymp...
Tags: South Korea, Japan, General, News, Sweden, Germany, Sport, Ukraine, Canada, Racing, Skiing, Belarus, Paralympics, Young, Kennedy, Navy SEAL


LTP collects $313 mln for maiden fund

Leerink Transformation Partners has raised $313 million for its debut fund beating its $250 million target. Leerink Transformation Fund I LP focuses on healthcare information technology and services companies. Snowbridge Advisors LLC was the financial adviser and North American institutional placement agent for the fund. PRESS RELEASE Boston – September 28, 2017 – Leerink Transformation Partners (LTP) announced the formation of its inaugural fund – Leerink Transformation Fund I L.P. (LTF I) – wi...
Tags: Ge, Boston, Massachusetts, Trends, KoL, Harvard, Healthcare, Funds, Sequoia Capital, Bain Capital Ventures, Bain, Sequoia, Jared, Massachusetts General Hospital, Todd, UnitedHealth Group