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The European Medicines Agency launched a new plan to streamline procedures for developing advanced gene and cell therapies, including adapting manufacturing requirements to products’ specific challenges. Read More
A sweeping tax overhaul bill approved by the House in a 227-205 vote Thursday would eliminate the orphan-drug tax credit, although the version of the legislation up for Senate consideration wouldn’t go that far. Read More
The FDA published new product-specific draft guidances for 30 active ingredients — including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives — outlining the agency’s preferred methods for supporting ANDA submissions. Read More
The FDA warned investigational medical device sponsor UVLrx Therapeutics for failing to obtain required authorization from its Institutional Review Board. Read More
The FDA finalized its guidance on developing direct-acting antivirals for chronic hepatitis C, outlining Phase III trial design options, enrollment criteria and safety evaluations for specific patient populations. Read More
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read More
The FDA issued a new draft guidance for sponsors developing treatments for gastroesophageal reflux disease in infants, children and adolescents — outlining clinical trial design considerations and the agency’s current thinking on extrapolating data in pediatrics. Read More
The European Medicines Agency outlined its thoughts on the use of evidence generated through clinical extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
Most life sciences companies plan to significantly step up their use of real-world data sources over the next three years, according to a new survey by the Tufts Center for the Study of Drug Development. Read More