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Latest From Research & Development

Patient Experience Data: Industry Seeks US FDA Clarity On Submission Pathway And Labeling

Dedicated mechanism may be needed for biopharma sponsors and patient advocacy groups to talk to agency about patient experience data collection and analysis; industry wants FDA to clarify where such data will appear in product labeling, while advocates ask agency to be mindful of limited resources many patient groups have for conducting such research.

Drug Approval Standards Rare Diseases

Right-To-Try Bill In House Limits Process To Patients Facing 'Severely Premature Death'

Vote slated for Tuesday; legislation is somewhat narrower than Senate-passed bill, which applies to patients with a 'life-threatening disease or condition.'

Legislation Clinical Trials

CTI's Approval Prospects For Pacritinib In Myelofibrosis Look To Be Improving

Firm publishes final data from a Phase III study showing the safety-troubled JAK2/FLT3 inhibitor performs better than Jakafi in reducing spleen size. Ongoing dose-finding study will determine the regulatory path forward.

Drug Review Clinical Trials

Tie-Ups, Chronic Diseases Influence Korea Generic Regulatory Patterns

South Korean pharma firms are still heavily dependent on generics for revenues, but approvals for required bioequivalence tests continue to drop, indicating that more developers are opting for joint studies and co-development. By therapeutic area, chronic disease drugs led generic development in the country in 2017 amid an aging population and increasingly Westernized eating habits.

Research & Development Drug Review

PRIME Dry Spell Ends As EMA Takes On Eye Disease Gene Therapy

The first designation of 2018 under the European Medicines Agency’s PRIME scheme has gone to an advanced therapy for patients with the severe eye disorder, achromatopsia. In the meantime, most PRIME applications are still getting rejected.

Review Pathway Research & Development

Publisher's Spotlight: 2018 CARE Awards Finalists

Informa Pharma Intelligence is pleased to announce the shortlist of finalists for the 2018 Clinical and Research Excellence awards.

Clinical Trials Companies
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