Month: September 2022

New Data Published in JNCI Demonstrate Veracyte’s Decipher Prostate Genomic Classifier May Improve Identification of Aggressive Prostate Cancer in African American Men

09/30/2022

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Veracyte, Inc. (Nasdaq: VCYT) announced that data published today in the Journal of the National Cancer Institute demonstrate that the company’s Decipher Prostate Genomic Classifier may help identify African American men with early, localized prostate cancer who are most likely to harbor more aggressive disease. The…

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Revolution Medicines Doses First Patient in Phase 1/1b Clinical Trial of RMC-6291, Company’s First Mutant-Selective RAS(ON) Inhibitor

09/30/2022

KRASG12C(ON) Inhibitor with highly differentiated mechanism of action being evaluated in patients with cancers harboring KRASG12C mutation RMC-6291 is first mutant-selective RAS(ON) Inhibitor to enter clinic, following closely behind company’s RASMULTI(ON) Inhibitor, RMC-6236 Excerpt from the Press Release: REDWOOD CITY, Calif., Sept. 22, 2022 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology…

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Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for Type 2 Diabetes

09/30/2022

Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…

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Iterative Scopes Receives FDA Clearance for AI-Assisted Polyp Detection Device SKOUT™

09/29/2022

SKOUT’s advanced computer vision capabilities enable physicians to detect pre-cancerous lesions in the colon with more accuracy Excerpt from the Press Release: CAMBRIDGE, Mass. & MINNEAPOLIS–(BUSINESS WIRE)–Iterative Scopes, a pioneer in precision medicine technologies for gastroenterology, and Provation, the premier software and SaaS provider of clinical productivity and workflow automation solutions, announced today that SKOUT™…

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TRACON Pharmaceuticals Announces Submission of IND Application for CTLA-4 Antibody YH001 for the Treatment of Front-line Sarcoma Patients in Combination with Envafolimab

09/29/2022

Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the company submitted an Investigational…

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Moximed’s MISHA™ Knee System Achieves Superiority of Primary Endpoint in Pivotal Study

09/29/2022

Implantable shock absorber demonstrates clinically meaningful pain relief and functional improvement in data presented at OSET Excerpt from the Press Release: FREMONT, Calif.–(BUSINESS WIRE)–Moximed, a medical device company on a mission to improve the standard of care for people suffering with chronic knee pain due to osteoarthritis (OA), today announced clinical results presented at the…

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Efemoral Medical Awarded Phase II SBIR Grant from NIH to Advance Treatment for Peripheral Artery Disease

09/28/2022

Excerpt from the Press Release: LOS ALTOS, Calif., Sept. 22, 2022 /PRNewswire/ — Efemoral Medical, developer of advanced interventional bioresorbable therapies, announced today that it has been awarded a Phase II Small Business Innovation Research (SBIR) grant by the National Institutes of Health. SBIR grants are intended to stimulate technological innovation and encourage small United…

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Neurona Therapeutics Presents Clinical Case Study from First Human Trial of Regenerative Cell Therapy, NRTX-1001, in Adults with Drug-Resistant Focal Epilepsy

09/28/2022

Clinical assessments three-months post-treatment report no serious adverse events and reduced seizure frequency to date in first trial participant Data Safety Monitoring Board clears advancement of trial to continue enrollment Pioneering cell therapy approach could provide a disease-modifying treatment for drug-resistant focal epilepsy Data presented at ISSCR-ASGCT Conference: Emerging Therapies at the Intersection of Genetic…

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ABVC BioPharma Provides ADHD Phase II Part 2 Clinical Study Update and Announces UCSF Institutional Review Board Approval

09/28/2022

Excerpt from the Press Release: FREEMONT, CA, Sept. 23, 2022 (GLOBE NEWSWIRE) — via NewMediaWire — ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced enrollment progress in the Phase II Part 2 clinical study of the Company’s ADHD medicine, ABV-1505, currently being conducted at…

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Cardiff Oncology Announces Plans for a Randomized Trial in Metastatic Colorectal Cancer (mCRC), Durability of Responses in Ongoing Phase 1b/2 Trial in mCRC and Additional Business Updates

09/27/2022

Next trial in RAS-mutated mCRC (ONSEMBLE) is a randomized Phase 2 trial to demonstrate onvansertib’s contribution to SoC and position for a possible accelerated approval opportunity; topline data expected in 2H 2024 Data from ongoing Phase 1b/2 trial in KRAS-mutated mCRC show durable responses to treatment, with a median duration of response (mDoR) of 11.7…

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