Month: September 2022

IMFINZI® (durvalumab) plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up

09/19/2022

HIMALAYA Phase III trial exploratory results support the benefit of tremelimumab added to IMFINZI in unresectable liver cancer regardless of etiology Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit…

Read More

Atea to Advance Global Phase 3 Registrational Study of Bemnifosbuvir in High-Risk Non-Hospitalized Patients with COVID-19

09/16/2022

Novel Phase 3 Trial Design to Evaluate Bemnifosbuvir as Monotherapy and Combination Antiviral Therapy for COVID-19 Trial to Focus on High-Risk Patients at Greatest Risk for Disease Progression Trial Expected to Initiate in Fourth Quarter 2022 Conference Call at 8:30 a.m. ET Today Excerpt from the Press Release: BOSTON, Sept. 13, 2022 (GLOBE NEWSWIRE) —…

Read More

Amylyx Pharmaceuticals Announces Publication of Preclinical Data Showing Potential Synergistic Effect of AMX0035 Compared to Individual Compounds

09/16/2022

Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) today announced the publication of preclinical data showing the effect of sodium phenylbutyrate (PB) and taurursodiol (TURSO, also known as ursodoxicoltaurine) on the transcriptomic and metabolomic profiles of primary skin fibroblasts from adults with sporadic amyotrophic lateral sclerosis (ALS)…

Read More

Amolyt Pharma Announces Positive Efficacy and Safety Data from First Cohort of Phase 2a Study of AZP-3601 in Patients with Hypoparathyroidism at the American Society for Bone and Mineral Research 2022 Annual Meeting

09/16/2022

– Company to host Key Opinion Leader webinar today, September 12, at 1:30 pm CT/2:30 pm ET – Excerpt from the Press Release: LYON, France and CAMBRIDGE, Mass., Sept. 12, 2022 (GLOBE NEWSWIRE) — Amolyt Pharma, a global company specialized in developing therapeutic peptides for rare endocrine and related diseases, today announced positive efficacy and…

Read More

TumorGen and PhenoVista Capture the Seeds that Drive Cancer Metastasis

09/15/2022

TumorGen’s microfluidic platform traps metastatic cancer cell clusters from lung cancer patients, creating new opportunities for anti-metastatic drug development. Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–TumorGen Inc., and PhenoVista Biosciences LLC have successfully isolated and characterized metastatic cancer cell clusters (MCCCs) from the blood of lung cancer patients’, validating TumorGen’s novel MCCC capture technology.…

Read More

The New England Journal of Medicine Publishes Second Manuscript Reporting Positive Phase 2 Results for Biogen’s Litifilimab (BIIB059) in Lupus

09/15/2022

Part A results from the two-part Phase 2 LILAC study show litifilimab significantly reduced disease activity based on active joint count in people with systemic lupus erythematosus (SLE) compared to placebo Biogen is currently enrolling people with active SLE into two Phase 3 studies in 31 countries worldwide and plans to initiate a pivotal study…

Read More

Xevinapant Five-Year Data Show Survival Rate Nearly Doubled in Patients with Unresected LA SCCHN, When Added to Standard of Care

09/15/2022

Not intended for UK-based media First randomized trial in decades to show significant improvement in overall survival in patients with LA SCCHN, reinforcing the transformative potential of xevinapant over standard of care in the curative setting Patients treated with xevinapant plus CRT almost twice as likely to be alive at five years (53% vs 28%)…

Read More

OncXerna Therapeutics Doses First Patient in Phase 2 Trial Evaluating Navicixizumab Alone or in Combination with Chemotherapy in Patients with Select Advanced Solid Tumors

09/14/2022

Multicenter basket trial includes cohorts enrolling patients with colorectal and triple negative breast cancer Trial designed to assess efficacy, safety, and evaluate the relationship between tumor Xerna™ TME Panel biomarker subtype and treatment response Excerpt from the Press Release: WALTHAM, Mass., Sept. 08, 2022 (GLOBE NEWSWIRE) — OncXerna Therapeutics, Inc. (“OncXerna”), a precision medicine company…

Read More

First Patient Enrolled in AMIHOT III Trial Investigating ZOLL’s Supersaturated Oxygen Therapy in Heart Attack Patients

09/14/2022

Study Evaluates the Effectiveness of TherOx Supersaturated Oxygen (SSO2) Therapy in Patients Presenting with Acute Anterior Myocardial Infarction with Successful Reperfusion Compared to Standard Therapy Excerpt from the Press Release: CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, announced today that the first patient has enrolled…

Read More

Ashvattha Therapeutics Announces First Patient Enrolled in a Phase 2 Study of D-4517.2 for the Treatment of Wet AMD and DME

09/14/2022

– First patient was enrolled as part of a two-stage Phase 2 study evaluating Ashvattha’s subcutaneous (SC) anti-VEGF wet AMD and DME candidate, D-4517.2 – – The first stage of the study will evaluate the safety and relative pharmacodynamic effect of different doses of subcutaneously (SC) administered D-4517.2 compared to intravitreal (IVT) injection of aflibercept,…

Read More