Laura Helbling
Latest From Laura Helbling
A Final Push For US Hepatitis C Eradication Plan In 2024
The Biden Administration is hoping that it can attach funding for a national hepatitis C ‘subscription’ program into the delayed fiscal 2024 appropriations bills.
Menopausal Status Is Another Focus For US FDA Trial Inclusion Efforts
US FDA is emphasizing the need to assess the effects of menopause on drug safety and efficacy as a continuation of the agency’s efforts to encourage clinical trial sponsors to look more systematically for differences in clinical trial subpopulations.
Gene Therapy Cost Effectiveness: US ICER Supports Million-Dollar Prices
Institute for Clinical and Economic Review continues to assign high values to novel gene therapies, suggesting that Orchard’s pending ‘arsa-cel’ for MLD could be cost effective at a price as high as $4 million per treatment.
Antibiotic Payment Incentives: Advocates Still Looking For More
After some success in enacting new regulatory and exclusivity incentives in the US over the past decade, antibiotic research advocates are urging action on the payment/reimbursement side. One start-up CEO argues that Medicare needs to rethink its approach to payment for hospital antibiotics.
Diversity Plans For US FDA: Oncology Experience Will Inform New Policies
US FDA will be transitioning from the ‘diversity plans’ outlined in recent guidance to the new, legislatively directed ‘diversity action plans’ by the end of 2023. The oncology group is leading the way in gathering early perspectives on industry approaches.
US FDA Outlines Psychedelic Drug Trial Principles, But It Won’t Be An Easy Trip
The US FDA is offering its first formal advice for potential approaches to develop psychedelic drugs for therapeutic indications. But it won’t be easy.