Formulation Development
Shape(TX) Collaborates With Otsuka to Develop Novel AAV Gene Therapies for Ocular Diseases
Shape(TX) and Otsuka Pharmaceutical Co., Ltd. recently announced a multi-target collaboration to develop intravitreally delivered adeno-associated viruses (AAVs) for ocular….
WEBINAR - Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
The Evolving Role of a Contract Development & Manufacturing Organization
The meaning of a Contract Development and Manufacturing Organization (CDMO) is not the same as it was a decade ago. Customers today are seeking….
Valneva & Pfizer Report Positive Pediatric & Adolescent Phase 2 Booster Results for Lyme Disease Vaccine Candidate
Valneva SE and Pfizer Inc. recently announced positive pediatric and adolescent immunogenicity and safety data for their Lyme disease vaccine candidate, VLA15, when given….
Myricx Enters Antibody License Agreement With Biocytogen
Myricx Bio recently announced an antibody license agreement with Biocytogen Pharmaceuticals (Beijing) Co., Ltd, a global biotech company focusing on the….
Avextra Signs Distribution Agreements With Pharmaceutical Partners & Commences Exports of Cannabis-Based Medicines to Switzerland & Austria
Avextra AG recently announced the signing of three long-term supply and distribution agreements. Avextra has signed distribution agreements with two leading Swiss pharmaceutical partners and…
Artelo Biosciences Completes Positive Pre-IND Meeting With FDA
Artelo Biosciences, Inc. recently announced it has completed a pre-IND meeting with the US FDA regarding the manufacturing, preclinical, and clinical development plan for ART26.12.…
Antion Announces Granting of Key Technology Patent in the United States
Novel patent solidifies Antion’s position as an industry leader in multiplex engineering of cell and gene therapies….
Eledon Pharmaceuticals Announces Publication of Data Showing Treatment With Tegoprubart Promotes Kidney & Islet Allograft Survival & Function in Nonhuman Primates
Eledon Pharmaceuticals, Inc. recently announced the publication of a study evaluating tegoprubart as an immunomodulatory monotherapy in nonhuman primate kidney and islet allotransplants. The study,…
Palisade Bio Transforms GI-Focused Pipeline Through Exclusive Worldwide Licensing Agreement With Giiant Pharma for Multiple Oral Drug Candidates Targeting Inflammatory Bowel Disease
Palisade Bio, Inc. recently announced it has entered into a licensing agreement with Giiant Pharma, Inc., providing the company with the exclusive worldwide rights to develop, manufacture, and commercialize….
Lisata Therapeutics Announces Outcome of Interim Futility Analysis for its Phase 2b ASCEND Trial in Metastatic Pancreatic Ductal Adenocarcinoma
Lisata Therapeutics, Inc. recently announced a positive outcome of the prespecified interim futility analysis for the ASCEND trial, a Phase 2b study evaluating LSTA1, Lisata’s…
Recipharm Partners With Ahead Therapeutics to Develop Rare Autoimmune Disease Therapy
Recipharm is partnering with Ahead Therapeutics to develop a ground-breaking treatment for a rare autoimmune disease, myasthenia gravis. Ahead Therapeutics is a Spanish start-up biotech…
WHITEPAPER - Streamline Early-Stage Development to Reach the Clinic Faster
It can be easy to overlook the importance of early-stage pharmaceutical product development, viewing it as a series of checklist tasks slowing progression toward clinical trials. Rather, early-stage development is critical to establish a solid foundation for those trials…..
CELL & GENE THERAPY - Cell & Gene Therapy’s Everest – The Challenges & Opportunities That Will Shape Success
Samir Acharya, PhD, Rajiv Vaidya, PhD, Laura Kerepesi, PhD, and Cyrill Kellerhals, MBA, provide their unique insights as they explore the challenges cell and gene therapy developers and manufacturers are currently facing, those they can expect to see in the future, and more critically, how to overcome them.
EXECUTIVE INTERVIEW - Sever Pharma Solutions: Development & Manufacturing of High Potent Polymer-Based Dosage Forms
Tony Listro, Vice President of Technology and Site Lead for SPS’s North American site in Putnam, CT, discusses the company’s recent focus areas as well as current plans for expansion.
THERAPEUTIC FOCUS - Effect of NE3107 on the Pharmacokinetics Profile of Carbidopa/Levodopa in Patients With Parkinson’s Disease
Joseph M. Palumbo, MD, says addressing Parkinson’s via the inflammatory pathway offers a unique perspective that was virtually unheard of only 10 years ago.
MEDICAL DEVICE TESTING - Breathing Component Biocompatibility: The Practical Application of ISO 18562
Luminita Moraru, MSc, explains how the medical devices industry has grown and is expanding daily and presents the key steps that need consideration when assessing breathing devices.
EXECUTIVE INTERVIEW - Tarsus Pharmaceuticals: A Journey to Establishing a New Disease Category in Eyecare & Transforming Treatment for Patients With Serious Diseases
Sesha Neervannan, PhD, Chief Operating Officer of Tarsus, discusses the company’s innovative approach to creating a new treatment category for eyelid disease and their strategic focus on advancing other treatments in their pipeline.
Nykode Therapeutics Announces FDA Approval of IND for VB-C-04, a Trial of VB10.16 in HPV16-Positive Cervical Cancer
Nykode Therapeutics ASA recently announced FDA approval of its investigational new drug (IND) application for the Phase 2 clinical trial. The trial is designed to…
Zenas BioPharma Announces Strategic License & Collaboration Agreement With Bristol Myers Squibb
Collaboration furthers Zenas’ vision to bring innovative immunology-based medicines to patients around the world by leveraging Bristol Myers Squibb’s long-standing expertise in immune-mediated diseases….
