Both Solid Biosciences Inc. and Pfizer Inc. got lifts to their Duchenne muscular dystrophy (DMD) programs from the FDA as the agency released a clinical hold and awarded a fast track designation to their respective adeno-associated viral (AAV) programs.
PERTH, Australia – Antisense Therapeutics Ltd. saw its stock bounce 26% following the news that the FDA has granted rare pediatric disease designation for ATL-1102 for the treatment of Duchenne muscular dystrophy (DMD), following submission of phase II data that showed its immunomodulatory therapy met primary disease progression endpoints.
FDA enforcement of clinical research regulations has often been "light-handed, slow-moving, and secretive," a new look at the agency's enforcement track record concludes. Published today in the journal Science, the analysis said the shortcomings may be harming both patients and trial integrity.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Aegle, Akari, Baylx, Ionis, Irlab, Kadmon, Pfizer, Provention, Solid, Teneobio, Zosano.
The latest global regulatory news, changes and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs.
The COVID-19 pandemic has not run its course, but the U.S. FDA is already working on a plan for handling devices in the period after the public health emergency ends. Bill Maisel, chief medical officer at the FDA’s Center for Device and Radiological Health (CDRH), said the agency is thinking through what would have to appear in a guidance for a transition that may span a number of months, providing industry with some much-needed breathing room.
Sentiar Inc. received U.S. FDA clearance for its holographic guidance system, known as Commandep, for use in cardiac ablation procedures. The system allows electrophysiologists (EPs) to visualize 3D electroanatomic models in real-time, using augmented reality (AR), to seamlessly navigate invasive procedures. “The Commandep is intended for use as a medical imaging system that allows the review, analysis, communication and media interchange of multidimensional digital images,” Berk Tas, Sentiar’s CEO, told BioWorld.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Becton Dickinson, Genetron, Ka Imaging, Perkinelmer, Sentiar, Vexos.
Rather than the in-your-face, blame-and-shame show that was expected, the Sept. 30 drug pricing hearing before the U.S. House Oversight Committee was more a reminder of the policy differences between Democrats and Republicans on how best to make prescription drugs more affordable.
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