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Daratumumab, a CD38 monoclonal antibody study in advanced multiple myeloma – an open-label, dose escalation followed by open-label extension in a single-arm phase I/II study

Daratumumab is a human CD38 monoclonal antibody being tested against multiple myeloma, but it could also have potential in a broad range of other hematological diseases.

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Highlights from the SWG

SWG AML Annual Scientific MeetingThe most recent SWG AML Annual Scientific Meeting took place during the annual EHA Congress in Frankfurt, Germany.

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Major bleeding in patients on treatment with NOACs or VKAs in real-life: clinical presentation, management and outcome

Major bleeding in patients on treatment with NOACs or VKAs in real-life: clinical presentation, management and outcome

Limited data are available on major bleeding (MB) occurring during treatment with vitamin K (VKAs) or non-vitamin K antagonist oral anticoagulants (NOACs) outside clinical…

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Daratumumab Shows Remarkable Benefit in Relapsed or Refractory Multiple Myeloma in the POLLUX Study

Daratumumab is a fully human monoclonal antibody that binds to a novel target on myeloma cells.

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EHA at ICH meeting: Excessive bureaucracy harms patient safety and innovation

To solicit input from a wide range of non-ICH members about the revision of ICH E8(R1), ICH held a Public Meeting on ICH E8(R1) “General Considerations for Clinical Studies” (Silver Spring, USA, October 31, 2019).

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Current status of the Clinical Trials Regulation

HemAffairs Article #2 – June 2019

In 2014 the European Parliament approved the Clinical Trials Regulation (CTR) that is supposed to replace the Clinical Trials Directive (CTD) from 2001. Five years later, the regulation has not yet become applicable.

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The HARMONY project: learning to work in BIG (DATA) teams

The HARMONY project: learning to work in BIG (DATA) teams

By Anna Kabanova PhD, YoungEHA committee member

On 26 and 27 September 2019 several YoungEHA members, including myself, had the chance to participate in the 4th General Assembly of the HARMONY Alliance…

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