Month: January 2022

LANNETT ANNOUNCES FDA COMPLETES REVIEW OF INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR BIOSIMILAR INSULIN GLARGINE

01/26/2022

–FDA States Pivotal Clinical Trial May Proceed, Trial Expected to Commence By March 2022– Excerpt from the Press Release: PHILADELPHIA, Jan. 21, 2022 /PRNewswire/ — Lannett Company, Inc. (NYSE: LCI) today announced that the U.S. Food and Drug Administration (FDA) has notified the company that they have completed the safety review of the Investigational New…

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Circulating Tumor Cell (CTC) Isolation with TellDx Technology Could Inform Personalized Drug Treatment in Prostate Cancer

01/26/2022

— Single-cell proteomics can elucidate kinase activity in prostate cancer models — — Kinase activity in bone metastases and epithelial circulating tumor cells is elevated — Excerpt from the Press Release: BEVERLY, Mass., Jan. 20, 2022 (GLOBE NEWSWIRE) — TellBio, Inc., a development stage biotechnology company focused on revolutionizing the detection of cancer through its…

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Kura Oncology Receives FDA Authorization to Proceed with Phase 1b Study of KO-539 in Acute Myeloid Leukemia

01/26/2022

– FDA lifts partial clinical hold following agreement on mitigation strategy for differentiation syndrome – – KOMET-001 study to resume screening and enrollment of new patients – – Encouraging safety, tolerability and clinical activity observed among patients on study – Excerpt from the Press Release: SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Kura Oncology,…

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Yingli Pharma and MD Anderson Initiate Strategic Collaboration to Advance Development of Multiple Oncology Programs

01/25/2022

Five-year collaboration to provide support for clinical and preclinical efforts as Yingli Pharma expands its U.S. presence with robust oncology pipeline Excerpt from the Press Release: SAN FRANCISCO and HOUSTON, Jan. 20, 2022 (GLOBE NEWSWIRE) — Yingli Pharma US, Inc. (the “Company” or “Yingli”), a biotechnology company developing innovative small molecules, and The University of…

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Meet with Christopher Kata and the TrialStat team (booth # 923), during the SCOPE Summit for Clinical Operations Execs, February 7th – 10th, in Orlando, Florida!

01/25/2022

Meet with Christopher Kata, Director of Sales & Marketing February 7th – 10th, 2022 at the SCOPE Summit for Clinical Operations Executives in Orlando, Florida. Christopher and the TrialStat team are exhibiting in booth # 923. Christopher Kata, Director of Sales & Marketing905 [email protected] Event: SCOPE – Summit for Clinical Operations Executives When: February 7th…

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Cell Publication Highlights Ionpath MIBI Spatial Proteomics Technology in Foundational Study Predicting Breast Cancer Progression

01/25/2022

Innovative study deployed multiplexed ion beam imaging (MIBI™) technology revealing a high-multiplex spatial proteomic signature as a predictive biomarker for breast cancer treatment Excerpt from the Press Release: MENLO PARK, Calif.–(BUSINESS WIRE)–Ionpath, Inc., the leader in high-definition spatial proteomics, today announced that a peer-reviewed research study led by scientists at Stanford University, Washington University, Duke…

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Arch Oncology Receives U.S. FDA Orphan Drug Designation for AO-176, a Next-Generation Anti-CD47 IgG2 Antibody, for the Treatment of Multiple Myeloma

01/25/2022

Excerpt from the Press Release: BRISBANE, Calif. and ST. LOUIS, Jan. 21, 2022 (GLOBE NEWSWIRE) — Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 biologic therapies, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to AO-176 on January 3rd, 2022, for the…

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Frontiers in Immunology Publishes New Study Data from IncellDx Supporting a Model for Understanding Long COVID’s Cause

01/24/2022

Excerpt from the Press Release: SAN CARLOS, Calif.–(BUSINESS WIRE)–IncellDx, a precision medicine company, today announced the journal Frontiers in Immunology has published a study detailing a framework for understanding the potential mechanism of, and potential treatment for, Post-Acute Sequelae of COVID-19 (PASC), also known as long COVID or long haul COVID. “Recent analysis confirms long…

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BostonGene and WellDyne Announce Strategic Partnership to Predict Immunotherapy Response and Reduce Overall Cost of Care in Cancer

01/24/2022

Excerpt from the Press Release: WALTHAM, Mass. & LAKELAND, Fla.–(BUSINESS WIRE)–BostonGene Corporation and WellDyne today announced a strategic partnership to improve therapeutic decision-making for cancer patients. With BostonGene Tumor Portrait™ Tests, WellDyne will increase efficiency and therapy selection for patients who are candidates for immunotherapy in melanoma, non-small cell lung cancer, gastric, bladder and kidney…

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Panavance Therapeutics Inc. Created to Transform Cancer Treatment

01/24/2022

The new company is focused on developing GP-2250, a novel cancer therapeutic with a unique mechanism of action Excerpt from the Press Release: Panavance Therapeutics Inc. (“Panavance”) is a new clinical-stage pharmaceutical company created to advance and develop GP-2250, a patented, novel therapeutic for the treatment of cancer and other therapeutic indications. GP-2250 is a…

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