Search Results for: BIOTHERAPEUTICS DEVELOPMENT The Role of
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GENE THERAPY - Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact August 31, 2022
Rimas Orentas, PhD, and Boro Dropulić, PhD, MBA, believe the future belongs to those who will be able to innovate rapidly, maintain regulatory confidence, and drive down costs to make CAR-T cell and other engineered cell therapies available to all who would benefit.
LIVE BIOTHERAPEUTIC PRODUCTS - Not All Microbiome Approaches Are Created Equal August 31, 2022
Duncan Peyton says in comparison with other therapeutic classes, such as antibodies or gene therapy, the progress that has been made with LBPs to date has been rapid, and for the field to maintain this rate of progress and to establish LBPs as a mainstay in the treatment of patients across a variety of diseases, a number of key questions need to be addressed.
Soligenix Receives FDA IND Clearance for Phase 2 Clinical Trial of Synthetic Hypericin in the Treatment of Psoriasis June 28, 2022
Soligenix, Inc. recently announced the US FDA has cleared the Investigational New Drug (IND) application for a Phase 2a clinical...Apellis Expands R&D Collaboration With Affilogic to Develop Targeted Complement Therapies for Delivery into the Brain June 22, 2022
Apellis Pharmaceuticals, Inc. and Affilogic recently announced the companies have expanded their research and development (R&D) collaboration, which was initially formed in 2018, to include the development of Nanofitins….
Agenus Advances Portfolio With 6 Clinical Collaborations May 31, 2022
Agenus Inc. recently announced it has entered into three new clinical collaborations with Targovax, Oxford BioTherapeutics, and Immunogenesis, doubling its current number of….
Artax Biopharma Closes Financing to Advance Clinical-Stage, First-in-Class Oral Immunomodulator to Treat T Cell-Mediated Diseases May 11, 2022
Artax Biopharma, Inc. recently announced the close of a $26-million financing round to develop AX-158, the company’s first oral small molecule immunomodulating agent…..
Univercells Acquires SynHelix, Entering Into Synthetic Biology & the Race to Next-Generation DNA Synthesis January 6, 2022
Univercells S.A. (Univercells) recently announced its acquisition of SynHelix, a biotechnology company that aims to debottleneck biotherapeutics development through an unprecedented robust, scalable, and….
Catalent Opens New Full-Service Clinical Supply Facility in Shiga, Japan October 5, 2021
Catalent recently announced the opening of its new clinical supply facility, strategically located in the Shiga prefecture of Japan, in...EXECUTIVE INTERVIEW - Croda: Solutions for Your High Value Drug Products October 4, 2021
Dr. Stephen Rumbelow, Life Sciences Research Fellow for Croda Inc., discusses polysorbates, a key excipient used for stabilizing drug molecules in injectable dosage forms.
Passage Bio Teams With Catalent to Start cGMP Manufacturing for Lead Gene Therapy Products December 9, 2020
Passage Bio, Inc. and Catalent recently announced that manufacturing operations have commenced to support adeno-associated virus (AAV) production for Passage Bio’s lead….
4D Pharma Presents New Data From Two MRx0518 Clinical Trials November 11, 2020
4D pharma plc recently announced new positive clinical data from two clinical trials of MRx0518, its lead immuno-oncology single strain...NapaJen Pharma Reports Positive Results From Phase 1 Clinical Trial of Novel RNAi Therapeutic October 14, 2020
NapaJen Pharma, Inc. recently announced positive results from the company’s Phase 1 first-in-human clinical trial of NJA-730. NJA-730 is a...Arcutis Announces Enrollment of First Patient in Phase 1/2b Study April 23, 2020
Arcutis Biotherapeutics, Inc. recently announced it has enrolled the first patient in Phase 1/2b study of ARQ-252, a potent and...MARKET BRIEF - Tumor-Infiltrating Lymphocytes: A New Frontier in Cancer Immunotherapy January 13, 2020
Cheryl L. Barton, PhD, and Bianca Piachaud-Moustakis, PhD, believe the role of TIL therapy as an anticancer therapy in melanoma and possibly other solid tumors holds great promise and could become a viable course of treatment in the future.
Flexion Announces Clearance of NDA for Gene Therapy Candidate October 31, 2019
Flexion Therapeutics, Inc. recently announced clearance of the company’s Investigational New Drug (IND) application for FX201 in knee osteoarthritis.
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications October 16, 2019
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
White Paper: High Purity Low Endotoxin Arginine: Applications in Biopharmaceutical Processing & Biotherapeutic Stabilization October 16, 2019
This white paper discusses arginine, also known as L-arginine (symbol Arg or R), a basic amino acid widely used in biopharmaceutical processing and stabilization of biotherapeutics.
DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration April 30, 2019
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
HUMAN MICROBIOME - Advancing New Frontiers in a Rapidly Emerging Market November 12, 2018
Flo Orim, MD, PhD, focuses on biomedical aspects of research, development, and commercial endeavors in the human microbiome space, including essential background information, evolution of the field, and advances in basic research.
Bellerophon Reaches Agreement With FDA on Study Design of Phase 2b Trial June 6, 2018
Bellerophon Therapeutics, Inc. recently announced that, following the receipt of minutes from a recent meeting with the US FDA, the company has reached agreement with the FDA on all key aspects of its planned Phase 2b study of INOpulse for the treatment of Pulmonary Hypertension Associated with Chronic Obstructive Pulmonary Disease (PH-COPD).
