CSL Behring Announces Closing of Global Commercialization and License Agreement with uniQure for etranacogene dezaparvovec

• Etranacogene dezaparvovec (AMT-061) is an investigational gene therapy that may potentially provide people with hemophilia B with years of functional levels of Factor IX, a blood-clotting protein that prevents excessive bleeding.

• uniQure will complete the Phase 3 HOPE-B trial and scale up manufacture for initial commercial supply under an agreed plan with CSL Behring.

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Clouds Over the Capitol

TRIPS Waiver, MCIT, HR3.  If you are not familiar with these policy developments, you probably should be.

The United States medtech and biotech industries make a tremendous impact on people’s lives.   When policy makers and Federal Agencies work together, the impact is made even greater.  However, some policy decisions can have the opposite effect.

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Opinion: Now is absolutely not the time to be complacent

In the pandemic’s 17th month, we live in a world of vivid contrast between early-vaccinating countries that appear to be approaching an end to their epidemic and those falling rapidly into the abyss. Brazil and India are suffering escalating COVID caseloads exhausting health care resources. The long haul with the virus in the US and the current situation in Brazil and India have clearly underscored the importance of a strong, coordinated, and sustained public health response.

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AdvaMed Announces New Hybrid Structure for The MedTech Conference 2021

WASHINGTON, D.C. – The MedTech Conference, powered by AdvaMed, will host its trademark award-winning programming and networking opportunities in a new hybrid structure, combining the benefits of both in-person and virtual events, on September 27th – 30th. Attendees can participate in The MedTech Conference in a fully virtual environment, and they can also take advantage of limited-capacity in-person gatherings in Washington, D.C. and in Minneapolis, Minnesota.Continue reading