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Rapid Acceleration of Diagnostics (RADx)

05/09/2020

Excerpt from the announcement: “The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is urgently soliciting proposals and can provide up to $500M across multiple projects to rapidly produce innovative SARS-CoV-2 diagnostic tests that will assist the public’s safe return to normal activities. Rapid Acceleration of Diagnostics (RADx), is a fast-track technology development program that…

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Partner Therapeutics Announces Publication of Two Studies Demonstrating Leukine® Improves Survival in Acute Radiation Syndrome (ARS)

02/25/2021

Excerpt from the Press Release: LEXINGTON, Mass., Feb. 18, 2021 /PRNewswire/ — Partner Therapeutics, Inc. (PTx), a commercial biotech company, announces publication of two pivotal studies that provided the basis for approval of Leukine (sargramostim, yeast-derived rhu GM-CSF) to improve survival in patients exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome…

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LAPIX Therapeutics Inc. Announces a Successful Conclusion of its Pre-IND Meeting Request with the U.S. FDA

02/01/2023

Excerpt from the Press Release: BOSTON, Jan. 26, 2023 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA). The meeting’s objective…

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Puma Biotechnology Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer

12/20/2023

Excerpt from the Press Release: LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201). Based on the Company’s interactions with the U.S. Food and Drug Administration (FDA), the Company…

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SkylineDx and NeraCare enter a strategic partnership to advance precision medicine for early-stage melanoma

04/28/2023

Excerpt from the Press Release: ROTTERDAM, Netherlands and SAN DIEGO, April 20, 2023 /PRNewswire/ — SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics for oncology and inflammatory diseases, today announced its first non-academic strategic partnership with NeraCare GmbH from Frankfurt, Germany to co-develop a test to help life science companies…

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Immune-Onc Therapeutics Announces First Patient Dosed in Phase 1 Clinical Trial Evaluating IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients With Advanced Solid Tumors

10/22/2021

– Multicenter Phase 1 study to evaluate IO-108 as monotherapy and in combination with an anti-PD-1 – – IO-108 is Company’s second program to advance to clinic – Excerpt from the Press Release: PALO ALTO, Calif.–(BUSINESS WIRE)–Immune-Onc Therapeutics, Inc. (“Immune-Onc”), a clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting immunosuppressive myeloid checkpoints, today announced that…

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BOA™ Biomedical’s GARNET™ therapeutic product begins First in Human clinical trial

03/23/2021

Excerpt from the Press Release: CAMBRIDGE, Mass., March 18, 2021 /PRNewswire/ –BOA Biomedical, a Miraki™ Innovation company, focused on rapidly diagnosing and treating some of the world’s deadliest infectious diseases has announced that the company will begin its First in Human clinical trial for GARNET. GARNET is an extracorporeal blood cleansing therapeutic capable of removing…

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TransCode Therapeutics Announces FDA Authorization to Proceed with First-In-Human Clinical Trial

01/10/2023

Excerpt from the Press Release: BOSTON, Dec. 29, 2022 (GLOBE NEWSWIRE) — TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, announced today that it has received written authorization from the U.S. Food and Drug Administration (FDA) that it may proceed with its First-in-Human (FIH) Phase…

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Marinus Pharmaceuticals Announces Resumption of Phase 3 RAISE Trial in Status Epilepticus

05/11/2022

Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced that it has resumed screening and recruitment for the Phase 3 RAISE (Randomized Therapy in Status Epilepticus) trial in refractory status epilepticus (RSE). The company continues to…

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New Talk About It Resources Aim to Accelerate Integration of Mental Health into Quality Cancer Care

02/08/2023

BeiGene Releases Report and Launches CancerandMentalHealth.com in Conjunction with World Cancer Day to Help Patients and Caregivers Overcome Barriers to Access Excerpt from the Press Release: BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass.–(BUSINESS WIRE)–BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, has released a report highlighting the challenges cancer patients and caregivers…

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