Industry

Seres Therapeutics Announces Confirmatory Results from Investigational Microbiome Therapeutic SER-109 ECOSPOR IV Open-Label Study in Recurrent C. Difficile Infection

– ECOSPOR IV study shows favorable safety profile through 24-week follow-up, consistent with the safety profile observed in ECOSPOR III study – 91.3% sustained clinical response achieved at eight weeks in overall population with consistent results in key subpopulations including first recurrence – – Rolling Biologics License Application (BLA) submission initiated and on track for … [Read more…]

Alzheon to Present ALZ-801 (Valiltramiprosate) Oral Tablet Program Update as Potential Treatment for Alzheimer’s Disease in Adults with Down Syndrome at 4th International Trisomy 21 Research Conference

New Results Position ALZ-801 to Potentially Become the First Oral Agent that Can Slow or Even Stop and Prevent Alzheimer’s Pathology in Patients and Healthy Individuals at Risk for the Disease Significant Effects of ALZ-801 on Beta Amyloid and Tau Biomarkers in Patients with Alzheimer’s Support its Clinical Development in Genetically Determined Disorders of Brain … [Read more…]

Biodesix Obtains Medicare Coverage for the Nodify CDT® Lung Nodule Test

BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, announced that WPS Government Health Administrators, the Medicare Administrative Contractor with jurisdiction for Biodesix’s De Soto, Kansas laboratory, has provided coverage for the Nodify CDT® lung nodule test. The Nodify CDT test is a part of the … [Read more…]

RARE-X Releases New Report that Uncovers Large Number of Previously Uncounted Rare Diseases

–             The “Power of Being Counted” Report reveals previously severely undercounted numbers used for decades to define rare diseases and help shape policies and biomedical discovery –       Study provides critical data to global researchers, clinicians, drug developers and patient advocates in their mission to improve outcomes for patients WASHINGTON–(BUSINESS WIRE)–RARE-X, a nonprofit organization dedicated to … [Read more…]

ECP Pharma’s Path Forward Clearer After FDA’s Response To Pre-IND Submission On Its Neurological, CNS Diseases Drug Products

MIAMI–(BUSINESS WIRE)–ECP Pharma has received a favorable, positive written response from the FDA regarding its Pre-IND submission of novel drugs for targeted indications with no clinically proven treatment options using underutilized APIs (Active Pharmaceutical Ingredients). The FDA provided a clear order of when clinical studies should be conducted by ECP Pharma, which increases the likelihood … [Read more…]

$200+ Billion Cancer Diagnostics Markets by Test, Technology, Application, End User, & By Region – Global Forecast and Analysis 2022-2027 – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Cancer Diagnostics Market, By Test, Technology, Application, End User, & By Region – Forecast and Analysis 2022-2027” report has been added to ResearchAndMarkets.com’s offering. The global cancer diagnostics market was valued at USD 128.30 Billion in 2021, and it is expected to reach a value of USD 203.60 Billion by 2027, at … [Read more…]

Sensorion Announces Approval in France to Initiate Proof of Concept Clinical Trial of SENS-401 for Residual Hearing Preservation During Cochlear Implantation

MONTPELLIER, France–(BUSINESS WIRE)–Regulatory News: Sensorion (FR0012596468 – ALSEN), a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, today announces, that the initiation of a Proof of Concept (POC) clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation … [Read more…]

Genexine reports encouraging top-line results of the Phase 1b/2 clinical trial with GX-I7 (efineptakin alfa) in refractory or recurrent (R/R) metastatic Triple Negative Breast Cancer

SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700) a publicly traded, clinical stage biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, today announced top-line results from the KEYNOTE-899 phase 1b/2 clinical trial of GX-I7 (efineptakin alfa) in combination with pembrolizumab. The results indicated that GX-I7 in combination … [Read more…]

Latest Data of InnoCare’s Robust Oncology Pipelines Presented at the 2022 ASCO Annual Meeting

BEIJING–(BUSINESS WIRE)–Latest data of InnoCare’s robust oncology pipeline were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Poster Presentation 1: Phase I results of gunagratinib (ICP-192), a highly selective irreversible FGFR 1-4 inhibitor in patients with head and neck cancer (HNC) harboring FGF/FGFR gene aberrations Abstract Number: 6039 In the dose-escalation … [Read more…]

New MYLUNG Consortium Research Demonstrates Remote Pharmacist Intervention Significantly Increases Clinical Trial Enrollments in Community Oncology Setting

Average monthly enrollment nearly doubled with pharmacy intervention Remote pharmacist easily adapted into clinic workflows in community practices THE WOODLANDS, Texas–(BUSINESS WIRE)–Results from the second phase of the broad, collaborative MYLUNG ConsortiumTM research study in non-small cell lung cancer (NSCLC) were presented by The US Oncology Network (The Network), US Oncology Research and Ontada® at … [Read more…]