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Statement by FDA Commissioner Scott Gottlieb, M.D., Director of FDA’s Center for Drug Evaluation and Research Janet Woodcock, M.D. and Director of FDA’s Center for Biologics Evaluation and Research Peter Marks, M.D. on Expanded Access –Looking Forward

05/26/2019

In March of 2019 the FDA released this statement regarding the value of Expanded Access Programs and the FDA’s encouragement of Sponsors to consider providing them as options for Patient Populations. A few interesting statements worth highlighting in the statement: “Since 2010, drug sponsors and manufacturers have given the opportunity of such access to more…

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Atara Biotherapeutics Announces Preliminary Results for ATA2271, a Next-Generation Autologous Mesothelin-targeted CAR T-cell Therapy for Solid Tumors, at ESMO Immuno-Oncology Congress 2021

12/13/2021

ATA2271 targets difficult-to-treat solid tumors using proprietary 1XX CAR signaling and intrinsic PD-1 checkpoint inhibition technology Ongoing Phase 1 dose-escalation trial in advanced mesothelioma shows promising early safety and persistence of armored CAR T cells in patients Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)– Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy,…

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Accuray TomoTherapy® Helical Radiotherapy System Helps Preserve Breast Cancer Patients’ Long-term Heart and Lung Functionality

02/17/2022

– Phase III, randomized controlled trial results highlight patient reported outcomes at 10 years’follow-up– TomoTherapy delivered hypofractionated radiotherapy was superior to conventional radiotherapy in maintaining patients’ heart and lung functioning, enabling them to more easily perform daily and leisure time activities, and/or work Excerpt from the Press Release: SUNNYVALE, Calif., Feb. 10, 2022 /PRNewswire/ — Accuray Incorporated (NASDAQ: ARAY)…

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Blue Earth Therapeutics Announces Promising Results of Preclinical Biodistribution and Efficacy Evaluation of 177Lu-rhPSMA-10.1 in Treatment of Prostate Cancer

06/23/2022

− 177Lutetium-labelled radiohybrid Prostate-Specific Membrane Antigen (177Lu-rhPSMA-10.1) is in development as a highly optimized, next generation therapeutic radiopharmaceutical – − 177Lu‑rhPSMA-10.1 demonstrated favorable tumor:kidney ratio and statistically significant tumor growth suppression in preclinical studies − − Phase 1/2 clinical trial of 177Lu-rhPSMA-10.1 in men with metastatic castrate‑resistant prostate cancer recently cleared to proceed in United…

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Allogene Therapeutics Initiates Industry’s First Allogeneic CAR T Phase 2 Trial

10/19/2022

ALPHA2 Trial, Evaluating ALLO-501A in Relapsed/Refractory Large B Cell Lymphoma Patients, is Designed to Leverage the Ease and Convenience of a Single Dose of ALLO-501A Protocol Supported by Clinical and Translational Data from Phase 1 Trial Indicating Deep Responses are Achievable with a Single Dose of ALLO-501A When Used with a Lymphodepletion Regimen That Includes…

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Peptilogics and Cerebras Systems Partner on AI Solutions to Advance the Future of Peptide Therapeutics

08/24/2021

Excerpt from the Press Release: SUNNYVALE, Calif. & PITTSBURGH, Pa.–(BUSINESS WIRE)–Cerebras Systems, the pioneer in high performance artificial intelligence (AI) compute, and Peptilogics, a biotechnology platform company and an emerging leader in leveraging computation to design novel therapeutics, today announced a collaboration to accelerate the development cycle of peptide therapeutics through AI. Leveraging the revolutionary Cerebras…

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Innovent Announces the First Patient Dosed in the Phase 1 Study of IBI319 (Anti-PD-1/CD137 Bispecific Antibody) in Patients with Advanced Malignant Tumors

07/19/2021

Excerpt from the Press Release: SAN FRANCISCO and SUZHOU, China, July 15, 2021 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced that the first patient has been dosed in a Phase 1a/1b study of IBI319, an anti-PD-1/CD137 bispecific…

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Mayo validates COVID-19 plasma treatment as public seeks vaccine

01/15/2021

Excerpt from the Article: Donor plasma from patients who have recovered from COVID-19 can reduce deaths in others if given early and at high enough doses, Mayo Clinic researchers found. The discovery validates one of COVID-19’s only known treatments, which will be relied on until an increase in vaccinations snuffs out the global pandemic, said…

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Naveris’ New Saliva Test Detects Head and Neck Cancer

06/07/2021

Excerpt from the Press Release: WALTHAM, Mass.–(BUSINESS WIRE)–A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result. Researchers at Washington University School of Medicine in St. Louis used the Naveris, Inc. test to analyze saliva for sequences of the human papilloma virus (HPV)…

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Valitor Announces Presentation on Novel Anti-VEGF Antibody Conjugate and Multivalent Polymer Technology Platform at Upcoming Ophthalmology Innovation Source (OIS) Summit

12/05/2022

– Preclinical data support twice-yearly dosing in wet AMD – Excerpt from the Press Release: BERKELEY, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) — Valitor, a biotechnology company engineering better medicines to conquer drug limitations, today announced that its president and chief scientific officer, Wesley Jackson, Ph.D., will present at the Ophthalmology Innovation Source (OIS) XII…

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