News & Updates

Decisions, Decisions! 3 good questions to ask when considering new eClinical Technology.

03/08/2023

For 2023, we’re taking our blog in a new direction with more content directly from our team, more detailed information for our readers answering common questions we get, and helpful expert information and ideas you can use. We hope you enjoy this new approach. For this week, we’re covering an introduction (or refresher) to TrialStat…

Pyxis Oncology Announces Dosing of First Subject in Phase 1 Trial of PYX-201, a Novel ADC for Solid Tumors

03/23/2023

Milestone marks transition of Pyxis Oncology to a clinical-stage company Preliminary data anticipated in early 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) — Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing next-generation therapeutics to target difficult-to-treat cancers, today announced dosing of the first subject in a…

Jounce Therapeutics Announces Results from Pre-Planned Data Review of INNATE Phase 2 Trial of JTX-8064 and Pimivalimab Demonstrating Deep and Durable Responses in Platinum Resistant Ovarian Cancer

03/22/2023

Excerpt from the Press Release: CAMBRIDGE, Mass., March 16, 2023 (GLOBE NEWSWIRE) — Jounce Therapeutics, Inc. (Nasdaq: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced that patients from the INNATE Phase 2 trial in the ovarian cancer combination cohort with platinum resistant ovarian cancer…

Long-Term Data from CANbridge Pharmaceuticals CAN008 Phase 1/2 Trial in Glioblastoma Multiforme Shows 67% Five-Year Overall Survival Rate Compared to 8.2% in Institutional Database

03/21/2023

Data to be Presented at the ESMO Sarcoma and Rare Cancers Annual Congress Excerpt from the Press Release: BEIJING & BURLINGTON, Mass.–(BUSINESS WIRE)–CANbridge Pharmaceuticals, Inc. (1228.HK), a global biopharmaceutical company, with a foundation in China, committed to the research, development and commercialization of transformative therapies to treat rare diseases and oncology, announced that long-term follow…

Palvella Therapeutics Announces Positive Topline Results from Phase 2 Study of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Microcystic Lymphatic Malformations, a Serious, Rare Genetic Skin Disease with No FDA-approved Therapies

03/20/2023

QTORIN™ rapamycin generally well-tolerated; no drug related severe adverse events and no observed rapamycin in systemic circulation 100% of participants were either “Much Improved” or “Very Much Improved” as rated by the Clinician Global Impression of Change following 12-weeks of QTORIN™ rapamycin End of Phase 2 meeting completed with U.S. Food and Drug Administration in…

Galera Announces Presentation of Supplemental Analysis of Phase 3 ROMAN Trial at European Congress on Head and Neck Oncology

03/17/2023

Excerpt from the Press Release: MALVERN, Pa., March 10, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of a net treatment benefit analysis of Phase 3…

InVivo Therapeutics Announces Topline Data from Pivotal INSPIRE 2.0 Study in Acute Spinal Cord Injury

03/16/2023

Study did not achieve primary endpoint of defined improvement on standard impairment scale InVivo to evaluate full data set and strategic options for the company Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (Nasdaq: NVIV), a research and clinical-stage biomaterials and biotechnology company with a focus on the treatment of spinal cord…

Sermonix Pharmaceuticals Announces Initiation of Phase 3 ELAINE-3 Study of Lasofoxifene Plus Abemaciclib in Pre- and Post-Menopausal Patients with Locally Advanced or Metastatic ER+/HER2- Breast Cancer with an ESR1 Mutation as Detected by Guardant Health’s Guardant360 CDx Liquid Biopsy

03/15/2023

Excerpt from the Press Release: COLUMBUS, Ohio and PALO ALTO, Calif., March 09, 2023 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast and gynecological cancers harboring ESR1 mutations, and Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the initiation of…

AusperBio Announces First-in-Human Dosing of AHB-137, an Antisense Oligonucleotide Drug Candidate for the Treatment of Chronic Hepatitis B

03/14/2023

Excerpt from the Press Release: SAN FRANCISCO, March 9, 2023 /PRNewswire/ — Ausper Biopharma Co., Ltd. and AusperBio Therapeutic, Inc. (Together AusperBio) today announced the completion of the first cohort dosing in a Phase 1 clinical trial evaluating AHB–137 in adult healthy volunteers and chronic hepatitis B (CHB) patients in New Zealand. AHB-137 is a…

Praxis Precision Medicines Announces Topline Results from the Essential1 Study of Ulixacaltamide for the Treatment of Essential Tremor and Continued Advancement of Program to Phase 3

03/13/2023

Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…

IgGenix Demonstrated Potential for Single-Cell RNA-Sequencing to Address Shellfish Allergies at the 2023 AAAAI Annual Meeting

03/10/2023

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–IgGenix, Inc., a pre-clinical antibody discovery and development company taking a revolutionary approach to directly address allergic disease, recently presented insights into the potential for IgE antibody re-engineering in shellfish allergy. These data, generated using IgGenix’s novel patented SEQ SIFTER™ single-cell RNA-sequencing discovery platform, were presented…

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