Tuesday, February 7, 2023

561.316.3330

Biotechnology News Magazine

FDA Updates

ImmPACT Bio Announces FDA Clearance of IND for Novel Bispecific CAR to Treat Aggressive B-cell Lymphoma

Results from an investigator-led study evaluating this CAR T-cell therapy demonstrated that 70 percent of patients achieved a complete response with significant durability of remission. These initial efficacy results combined with the favorable safety profile show that IMPT-314 could potentially be a best-in-class treatment for patients with B-cell lymphomas.

DualityBio Announces DB-1303 Granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the Treatment of Advanced, Recurrent or Metastatic Endometrial...

DualityBio is currently evaluating DB-1303 in an ongoing Phase I/IIa clinical trial for preliminary safety and efficacy in advanced/metastatic solid tumors with Her2 expression, including both HER2 positive and HER2 low patients.  

Neurelis Announces Filing of Its Investigational New Drug Application for NRL-1049, a Rho Kinase (Rock) Inhibitor with Potential to Treat Cerebral Cavernous Malformations

"We are excited that the preclinical studies have shown that NRL-1049 is safe and efficacious in animal models," said Enrique Carrazana, M.D., Neurelis Chief Medical Officer. "Based on the significance of these data, Neurelis is developing further studies in humans to assess the safety of NRL-1049 in the treatment of chronic and acute conditions that affect the functioning of the blood-brain barrier. If successfully developed and approved, NRL-1049 has the potential to provide relief to people suffering from CCMs."

US FDA Grants Breakthrough Designation for Blood Test to Help Diagnose Inaccessible Brain Tumors

The FDA has granted 'Breakthrough Device Designation' for its 'TriNetra™-Glio', a blood test to help in the diagnosis of brain tumors.

Seagen Announces U.S. FDA Approval of New Indication for ADCETRIS® (brentuximab vedotin) for Children with Previously Untreated High Risk Hodgkin Lymphoma

“ADCETRIS is a groundbreaking medicine approved for adults with certain types of lymphomas. Today’s FDA approval extends its availability to younger patients with high-risk classical HL,” said Marjorie Green, M.D., Senior Vice President and Head of Late-Stage Development, Seagen. “We want to acknowledge and thank the patients, families and care providers who participated in the Children’s Oncology Group clinical trial that supported this approval.”

ProciseDx Announces FDA Clearance of ProciseDx instrument and C Reactive Protein (CRP) Assay

ProciseDx has a menu of 5-minute gastroenterology and Therapeutic Drug Monitoring (TDM) tests available in Europe.