Category Archives: Orphan Drugs

Orphan Drug Adoption: the More Regulation, the Better

New survey research indicates that a country with a strong regulatory commitment for advancing drugs for rare diseases does better in getting orphan drugs to patients than countries with lesser regulatory frameworks. In his study, ‘The Effect of Market-Based Economic Factors on the Adoption of Orphan Drugs Across Multiple Countries,’ John Matthews, Associate Director of […]
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FDA’s New Breakthrough Designation Process: A Patient Perspective

With the FDA holding its first patient-focused drug development meeting in October of last year, regulators are starting to take notice of the impact disease-based organizations can have in improving drug trial design for new therapies—particularly for rare diseases. According to Teresa Barnes, Vice President of Patient Outreach & Program Support for the Coalition for […]
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FT Healthcare Conference: Society as Stakeholder

Speakers at the 2nd annual Financial Times US Healthcare and Life Sciences conference in New York last week discussed the cost of health, and the implications of an increasingly vocal and influential stakeholder group: the local populace. After opening remarks from Andrew Jack, FT’s prolific pharmaceuticals correspondent, Pfizer CEO Ian Read took the stage at […]
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FDA: From Risk Aversion to Approval Activism

During the Rutgers Business School’s annual healthcare symposium, an FDA official encouraged industry to put its drugs on the reviewing table and be prepared for good news. On a panel titled “Activist FDA: Transformation Agent,” Prevision Policy founder and former Pink Sheet editorial head Cole Werble relayed the tale of Acadia Pharmaceuticals, a San Diego-based […]
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Drug Pipelines in Canada: Is There a Buyer for Future Innovation?

Last week, Canada’s National Prescription Drug Utilization Information System (NPDUIS), a federal-provincial fact-finding panel that works closely with the Patented Medicines Prices Review Board (PMPRB), issued its fourth New Drug Pipeline Monitor (NDPM) looking at drugs currently under development that may have an impact on future drug expenditures. The report is another example of how […]
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