Despite the U.S. FDA’s approval of Sage Therapeutics Inc.’s priority NDA for postpartum depression, the accompanying complete response letter (CRL) for major depressive disorder has undercut the company’s plans. Withholding the approval for MDD slices away a huge amount of the potential market for Sage and its collaborator, Biogen Inc.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Basilea, Mesoblast, Sanofi.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Trinity Biotech, Venus Medtech.
Biocity Biopharma announced that the U.S. FDA has accepted its investigational new drug (IND) application for BC-3448, a bispecific antibody that targets the T cell marker CD3 and epidermal growth factor receptor (EGFR), bringing antitumor T cells in proximity to EGFR-expressing cells. To reduce the risk of cytokine release syndrome (CRS), a known risk of CD3-targeting antibodies, the bispecific has a higher affinity for EGFR than CD3.
When it comes to recommending reforms for the U.S.’ 30-year-old 340B Drug Discount Program, there’s one thing drug manufacturers and hospitals agree on – pharmacy benefit managers (PBM) and other middlemen should not be profiting from a program that’s intended to help uninsured and vulnerable patients gain access to affordable prescription drugs or other health care services.
Regenerative medicine company Mesoblast Ltd.’s stock sank nearly 57% on the news that it received a second U.S. FDA complete response letter (CRL) following the resubmission of its BLA for allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease. In the CRL, issued a few days after the Aug. 2 PDUFA date, the agency said it requires more data to support approval.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Aardvark, ABM, Orchard, Taiho.
The U.S. FDA recognized several new standards for sterilization of medical devices as part of an effort to reduce the use of ethylene oxide (EtO) for this purpose. While the recognition may stimulate adoption of alternative methods, Congress is applying yet more pressure on the EPA to act more decisively in regulating EtO, thus amplifying pressure on a system that device makers believe is already under stress.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irhythm Technologies, Quanta Dialysis Technologies.
Satellos Bioscience Inc. has received orphan drug designation and rare pediatric disease designation from the FDA for SAT-3153 for the potential treatment of Duchenne muscular dystrophy (DMD). The first-in-class oral small-molecule therapeutic is designed to restore the innate muscle regeneration process independent of dystrophin and regardless of exon mutation status.
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