EMA advises on how to prevent medicine shortages
EMA provides two guidance documents to address problems regarding the supply of medicine, ‘a key public health priority for the EU network’.
Archives for July 17, 2019
‘Rare disease studies require a spirit of innovation’: ARG
Atlantic Research Group implements Greenphire’s ClinCard and ConneX reimbursement solutions in an aim to ease the clinical trial experience for both sites and patients.
Regulations enable approvals and opportunities in rare disease drug development
Regulatory actions by the FDA have enabled rare disease drug development to become a compelling space with orphan drug designations and approvals trending upward, says life sciences industry attorney.
‘Major’ challenges require new approaches to rare disease research: Tufts
More than half of new drug approvals last year were for rare diseases – which face long cycle times and other operational challenges that are necessitating the rapid adoption of new solutions, per a recent Tufts report.
Natural history studies ‘essential’ for rare disease drug development
Natural history studies are essential for rare disease research and can potentially replace placebo arms in clinical trials, among several other benefits, says industry expert.
Genetic testing and drug development: Use cases, regulations, and misconceptions
Scientific advances and regulatory incentives are driving the use of genetics in drug development, though the industry’s ability to perform wide-scale testing has outpaced its understanding of the results, the misinterpretation of which can have...