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...
Sermonix Pharmaceuticals Announces Results of Phase 2 Study of Lasofoxifene vs. Fulvestrant in Postmenopausal Women With Locally Advanced or Metastatic ER+/HER2- Breast Cancer and an ESR1 Mutation
Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical company developing innovative therapeutics to specifically treat ESR1-mutated metastatic breast and gynecological cancers, announced results of its signal-seeking Evaluation of Lasofoxifene in ESR1...
Horizon Therapeutics plc Announces Phase 2 Trial Evaluating Dazodalibep for the Treatment of Sjögren’s Syndrome Meets Primary Endpoint
Horizon Therapeutics plc (Nasdaq: HZNP) announced that its Phase 2 trial evaluating dazodalibep for the treatment of Sjögren’s syndrome met the primary endpoint in patients with moderate-to-high systemic disease activity as defined by the European Alliance of...
Alnylam Presents Positive Results from the APOLLO-B Phase 3 Study of Patisiran in Patients with ATTR Amyloidosis with Cardiomyopathy
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive results from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment of transthyretin-mediated (ATTR)...
Clinical Trial Corner: The Russia-Ukraine War’s Impact on Global Industry Clinical Trials
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT's VP of Global Clinical Strategy. As I wrote in my introduction to this blog series, my aim here is to introduce and dissect one of the pertinent topics in the area of...
BIDMC and Deerfield Management Announce Research Collaboration to Accelerate the Creation and Development of Therapeutics
Beth Israel Deaconess Medical Center (BIDMC) and Deerfield Management, a healthcare investment firm, announce a research collaboration to accelerate discovery of novel therapeutics. Deerfield will provide up to $130 million along with additional scientific and...
Ionis presents positive results from Phase 3 NEURO-TTRansform study at International Symposium on Amyloidosis
Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) presented positive results from a planned 35-week interim analysis of the Phase 3 NEURO-TTRansform study of Ionis and AstraZeneca's eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy...
Bertis Announces Proteomic Based Research Results of New Biomarker for Ovarian Cancer Diagnosis
Bertis, a proteomics-based precision medicine technology development company (CEOs Dong-young Noh, Seung-man Han), announced that the research results of their search for protein biomarkers for early diagnosis of high-grade serous ovarian cancer (HGSOC) were published...