Health
CSOFT’s health blog aims to provide insight into complex diseases, treatment options and regulatory developments, and other prevalent health issues people face today.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...
Thermo Fisher Scientific Partners with Pennsylvania Biotechnology Center to Support Life Sciences Growth in Philadelphia
The Pennsylvania Biotechnology Center (PABC) announced that Thermo Fisher Scientific has become a founding sponsor supporting the PABC campus in Doylestown, Pa., and their new B+Labs incubator in Philadelphia, where emerging life science companies can accelerate their...
Alzheon Biomarker Trial Brings Insight to Stalled Treatment Space
Alzheon unveiled promising data Tuesday from a Phase II biomarker trial of its investigational drug ALZ-801 to treat early Alzheimer’s disease. The trial, made up of 75 Alzheimer’s patients with an average age of 69, experienced significant plasma biomarker reduction,...
Neogen® Launches Quantitative Cashew ELISA Assay
Neogen Corporation (NASDAQ: NEOG) announced that it has released its innovative Veratox® VIP assay for the detection of cashew, the second assay in Neogen's new Veratox VIP line of enhanced quantitative ELISA products. The new Veratox VIP for Cashew allergen test...
ORYZON to Present Preliminary Blinded Aggregate Safety Data From Vafidemstat’s Ongoing Phase IIb PORTICO Trial in Borderline Personality Disorder
ORYZON Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company leveraging epigenetics to develop therapies in diseases with strong unmet medical need, presents initial preliminary blinded aggregate safety data from its ongoing Phase...
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