CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas (CTCL)
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation...
CRISPR Therapeutics Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to CTX130™ for the Treatment of Cutaneous T-Cell Lymphomas (CTCL)
CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation...
Foresight Diagnostics Patent Issued for Minimal Residual Disease Detection Technology
Foresight Diagnostics, Inc, a leader in cancer diagnostics and cancer relapse testing, announced that the U.S. Patent and Trademark Office (USPTO) has granted the company patent No.11,447,833 for the detection of minimal residual disease (MRD) using its personalized...
Sorrento Therapeutics Completes Enrollment of Phase 2 Clinical Trial of Resiniferatoxin (RTX) for Treatment of Knee Pain in Moderate to Severe Osteoarthritis of the Knee (OAK) Patients
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced that the company has completed enrollment of its latest Phase 2 clinical study of RTX for treating moderate-to-severe osteoarthritis of the knee pain (OAK). This Phase 2 study follows the analysis of the...
Biogen Strives for Tofersen Approval in ALS Based on Neurofilament
An in-depth review of pivotal one-year data indicates Biogen’s tofersen, being developed for a rare form of amyotrophic lateral sclerosis (ALS), slows the decline of the disease through the lowering of SOD1 protein and neurofilament levels. The most significant...
Clinical Trial Corner: Patient Diversity In Clinical Trials, Why It Matters, Who Should Be Concerned, and What Can Be Done
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. The US FDA is rightfully concerned about patient diversity in industry-sponsored clinical trials (iCTs). (1) In its recent guidance to...
Novo’s Once-Weekly Insulin Treatment Part of a Transforming T2D Space
New data from Novo Nordisk's Phase IIIa ONWARDS 2 trial studying insulin icodec shows it is effective as a once-weekly treatment for Type 2 diabetes. Insulin icodec differs from other basal insulin products currently on the market, as they require once-daily...
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