Tag Archives: IND

July, 2017

7 July
Shire Submits IND for its Gene Therapy for the Treatment of Hemophilia A

Lexington, Mass. – July 6, 2017 – Shire plc (LSE: SHP, NASDAQ: SHPG), the leading biotechnology company focused on serving people with rare diseases, today announced the submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for SHP654, also designated as BAX 888, an investigational factor VIII …
Share

12 June
FDA Accepts Bioverativ’s IND Application for its Hemophilia A Drug BIVV001

WALTHAM, Mass.–(BUSINESS WIRE)–Bioverativ (NASDAQ: BIVV), a global biotechnology company focused on the discovery, development and commercialization of innovative therapies for hemophilia and other rare blood disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for BIVV001 (also known as …
Share

10 April
FDA Accepts Syros’ IND to Advances its CDK7 Inhibitor SY-1365 into Phase 1 Clinical Trial in Advanced Solid Tumors

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of disease-driving genes, announced today that the U.S. Food and Drug Administration (FDA) accepted the Company’s Investigational New Drug (IND) application to advance SY-1365, its first-in-class selective cyclin-dependent kinase 7 …
Share

7 March
FDA Accepts Advaxis’ IND for Amgen-Partnered Personalized Cancer Immunotherapy

PRINCETON, N.J., March 06, 2017 (GLOBE NEWSWIRE) — Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has indicated the Investigational New Drug (IND) application for ADXS-NEO, a personalized neoantigen-targeted approach to cancer immunotherapy that is being developed in …
Share

6 February
FDA Clears Aura Biosciences’ IND Application for Light-Activated AU-011 for Treatment of Ocular Melanoma

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Aura Biosciences, a biotechnology company developing a new class of therapies to target and selectively destroy cancer cells using viral nanoparticle conjugates, announced today that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug application (IND) for the company’s lead program, light-activated AU-011 in …
Share

20 June
FDA Clears Sangamo Biosciences’ IND for ZFN-Mediate Genome Editing Treatment of MPS II

RICHMOND, Calif., June 20, 2016 /PRNewswire/ — Sangamo BioSciences, Inc. (NASDAQ: SGMO), the leader in therapeutic genome editing, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug application (IND) for SB-913, a zinc finger nuclease (ZFN)-mediated approach designed as a single treatment with …
Share

24 February
Regen BioPharma Completes Preclinical Experimentation of its Novel siRNA NR2F6 Checkpoint Inhibitor

SAN DIEGO, February 24, 2016 /PRNewswire/ — Regen BioPharma, Inc., (OTCBB: RGBP) and (PINK: RGBP) announced today completion of experiments, in collaboration with Dr.Santosh Kesari, demonstrating immunological mechanisms of its novel NR2F6 gene silencing approach. Subsequent to these experiments, the Company has begun the process of compiling an Investigational New Drug …
Share

16 December
FDA Lifts IND Clinical Hold for Three of Advaxis’ Product Candidates

PRINCETON, N.J., Dec. 16, 2015 (GLOBE NEWSWIRE) — Advaxis, Inc. (NASDAQ:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on all of the company’s Investigational New Drug (IND) applications for its three product candidates: axalimogene filolisbac …
Share