Pharmacyte Biotech Inc. is now in a series of 30-day cycles with the FDA as a planned phase IIb study of its lead candidate has been placed on hold. On Sept. 2, Pharmacyte submitted its IND for a phase IIb trial of its product, known as Cypcap, in locally advanced, inoperable pancreatic cancer and, on Oct. 2, the company said the FDA placed the application on hold.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biomarin, Bluebird, Innovation, Kyowa Kirin, Mesoblast, Optibiotix Health, Ovoca, Pharmacyte, Sanofi, Seed Health.
PERTH, Australia – Regenerative medicine company Mesoblast Ltd. saw its stock drop 37% on the news that it received an FDA complete response letter to its BLA for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft-vs.-host disease.
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and updates affecting biopharma, including: FDA finalizes guidance for opioid use disorder drug R&D; FDA releases draft guidance for PK models, cancer drugs.
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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTI, Diurnal, I-Mab, Iterum, Janssen, Johnson & Johnson, Lantheus, Regenxbio.
RSS
