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News From Around The Industry

CWWeekly Features

Tufts: Facing Many Challenges, Orphan Drugs Take 18% Longer to Develop

Orphan drug development takes 15.1 years to go from first patent filing to product launch, 18 percent longer than the average time required for all new drugs, according to the Tufts Center for the Study of Drug Development. And development time for drugs to treat ultra-orphan diseases—which affect only a few hundred patients in the U.S.—is even longer: 17.2 years.

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Experts Debate Methods to Overcome Clinical Trial Enrollment Barriers

A recent FDA guidance clarifying that sponsors may reimburse travel or daycare costs for patients in clinical trials removed a barrier to patient enrollment, but significant barriers remain.

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Trial Results & Briefs

HHS Announces Planned Rules Affecting IRBs and Clinical Trials

HHS is planning to publish several new rules affecting IRBs and clinical trials over the next several months, according to the spring OMB Unified Agenda. Direct Final Rule: Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations – Scheduled for this month, this final rule will permit an Institutional Review Board (IRB) to waive informed consent under certain conditions for minimal risk clinical investigations.

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Alnylam Achieves Alignment with FDA on Accelerated Development Path for Lumasiran

Alnylam Pharmaceuticals announced that the company has reached alignment with the U.S. Food and Drug Administration (FDA) on a pivotal study design for lumasiran, an investigational RNAi therapeutic for the treatment of primary hyperoxaluria type 1 (PH1).

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