New Publication Validates Performance of Natera’s Signatera™ MRD Test in Ovarian Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian...
ONWARD Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home
ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), reported topline results from the LIFT Home study, evaluating the safety and...
Connect Biopharma Reports CBP-201 Achieved All Primary and Key Secondary Endpoints in Pivotal Atopic Dermatitis (AD) Trial in China
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced topline results for the primary analysis population of...
PDS Biotech Announces Successful End-of-Phase 2 Meeting With the FDA and Preparation for the Registrational Trial of PDS0101 in Combination With KEYTRUDA®
PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, announced that it has successfully completed an End-of-Phase 2 meeting with the U.S. Food...
Accuray Announces First CyberKnife® Systems in Africa, Providing a New Option and Hope for Potentially Life-Saving Radiation Treatments for More Cancer Patients
Accuray Inc.(NASDAQ: ARAY) announced the company is expanding its global footprint with the introduction of its CyberKnife® platform in Africa, making it possible for more patients to obtain access to the extremely precise stereotactic radiosurgery (SRS) and...
Multilingual Clinical Trial Translations: How Language Access Can Drive Recruitment and Retention of Diverse Participants
As we started to explore in our latest Clinical Trial Corner post, multilingual clinical trial translations are an essential instrument enabling recruitment of racially and ethnically diverse populations as recommended by the US Food and Drug Administration (FDA) in...
Idera Bolsters Rare Disease Portfolio with Aceragen Buyout
Two rare disease companies - Idera Pharmaceuticals and Aceragen - are merging to pursue the common goal of an FDA approval that could come as early as 2024. For Idera, the merger is something of a lifeline after its top drug candidate flopped last year. On the other...
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...
Inside Decentralized Clinical Trials: Multilingual Patient Engagement for DCTs
Why are decentralized clinical trials (DCTs) becoming the go-to model for improving patient-centric medicine? With an increasing number of pharma companies and sponsors conducting clinical trials overseas, DCTs are an evolving solution to the clinical trial landscape,...
Carver Bio Plants Seed to Treat Viral Threats with CRISPR Cas13
With a distinct take on CRISPR technology, Carver Biosciences secured seed financing to support the development of RNA-targeting gene therapies aimed at RNA-based respiratory infectious diseases. The undisclosed financing will further the company’s development of...
Psilera Receives First Patent Allowance for Transdermal Patch Formulations
Psilera Inc., a biopharmaceutical company optimizing next-generation mental health treatments, announces the patent approval of N,N-dimethyltryptamine (DMT) and psilacetin (4-AcO-DMT and psilocybin-like prodrug) transdermal patch formulations. Transdermal application...