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News From Around The Industry

CWWeekly Features

New Clinical Trial Guidelines Push for Broader Inclusion of Patients with Brain Metastases

With newer systemic oncology medicines beginning to demon­strate more activity within the brain, clinical trial designs need to be optimized to appropriately include patients with brain metas­tases and gather more reliable efficacy data, according to Response Assessment in Neuro- Oncology Brain Metastases, or RANO-BM.

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FDA & CTTI Launch Patient Forum to Boost Engagement in Drug Development

The Patient Engagement Collabora­tive is gearing up for a launch in early 2018. The new, external panel is being built by the FDA and the Clinical Trials Trans­formation Initiative (CTTI), a public-private partnership between the FDA and Duke University. The panel will act as a forum for discussing new methods to increase patient participation in the agency’s decisionmak­ing process.

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Trial Results & Briefs

OMB Issues New Notice on Common Rule Delay

The OMB Office of Information and Regulatory Affairs (OIRA) posted a notice on its website Jan. 5 noting that OIRA is reviewing a final rule titled “Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects.”

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Momenta Reports Positive Top-Line Phase I Data for M281 in Healthy Volunteers

Momenta Pharmaceuticals reported positive top-line data showing safety, tolerability and proof of mechanism for M281 in a Phase I single ascending dose (SAD) and multiple ascending dose (MAD) study of normal human volunteers.

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