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Regulatory
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Regulatory actions for Aug. 7, 2023

Aug. 7, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Basilea, Mesoblast, Sanofi.
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Regulatory actions for August 7, 2023

Aug. 7, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Trinity Biotech, Venus Medtech.
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Illustration of antibodies binding to human cell receptors
Cancer

FDA accepts Biocity IND for bispecific antibody BC-3448

Aug. 7, 2023
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.
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340B stakeholders find common ground in pointing a finger at PBMs

Aug. 4, 2023
By Mari Serebrov
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.
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Stem cells

Mesoblast’s hopes dashed again with second FDA complete response letter for remestemcel-L

Aug. 4, 2023
By Tamra Sami
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.
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Regulatory actions for Aug. 4, 2023

Aug. 4, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 180, Aardvark, ABM, Orchard, Taiho.
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US FDA expands sterilization standards recognition as litigation rolls on

Aug. 4, 2023
By Mark McCarty
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.
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Regulatory actions for August 4, 2023

Aug. 4, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irhythm Technologies, Quanta Dialysis Technologies.
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Doctor examining child in wheelchair
Neurology/Psychiatric

Satellos’ DMD candidate awarded US orphan drug and rare pediatric disease designations

Aug. 4, 2023
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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Jeanne-Marrazzo, NIAID-director

Academic researcher named to fill Fauci’s shoes at NIAID

Aug. 3, 2023
By Mari Serebrov
While U.S. politics continues to delay Senate confirmation of the NIH director, other crucial positions at the agency that don’t require Senate action are being filled. Acting NIH Director Lawrence Tabak announced Aug. 2 that he has named Jeanne Marrazzo as director of the agency’s National Institute of Allergy and Infectious Diseases (NIAID).
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