Formulation Development
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….
Recursion Announces Completion of Phase 1 Study for REC-3964 for Clostridioides Difficile Infection
Recursion recently announced it has completed the Phase 1 study for REC-3964 in healthy volunteers. The study achieved its primary objectives of assessing the safety,…
SomaLogic Expands Agreement With Novo Nordisk to 2025
Novo Nordisk will extend its use of SomaLogic’s innovative proteomics technologies for research in cardiometabolic and other diseases….
WHITEPAPER - Accelerate Preclinical Developments & Improve Oral Bioavailability With Lipid-Based Formulation & Encapsulation Technology Combination
This paper covers the benefits of the LBF and capsules combination in dosage form developments, an efficient technology platform to bring efficient and differentiated products to the market.
WHITEPAPER - Improving API Solubility by Salt & Cocrystal Formation
Ensuring sufficient solubility is critical to the success of small molecule drugs. An active pharmaceutical ingredient (API) must be absorbed by the body and enter the systemic circulation to deliver the desired therapeutic effect. Many APIs,….
Optibrium Acquires BioPharmics, Expanding its 3D Drug Design & Visualization Offering
Optibrium recently announced the acquisition of BioPharmics LLC, expanding its 3D drug design and modelling offering. Bringing decades of experience in computational chemistry and biology…..
Zevra Therapeutics to Acquire Acer Therapeutics, Expanding its Rare Disease Portfolio & Adding Commercial Product
Proposed acquisition of Acer for $15M in Zevra stock plus Contingent Value Rights (CVRs) and Zevra’s purchase of Acer’s secured debt in capital efficient structure….
Zealand Pharma Announces Designation of Priority Review by the US FDA for Dasiglucagon in Congenital Hyperinsulinism
Zealand Pharma A/S recently announced that the US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric…
OKYO Pharma Achieves 90% Enrollment in 240-Patient Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
OKYO Pharma Limited recently announced it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of…
Denali Therapeutics Announces New Interim Data From Phase 1/2 Study of DNL310 in MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced new interim data from the ongoing open-label, single-arm Phase 1/2 study of DNL310 (ETV:IDS) in children with MPS II (Hunter…
Bio-Rad Launches First StarBright Red Dye & Extends Range of Antibody Markers Conjugated to StarBright Dyes to Enhance Multiplex Flow Cytometry & Research Capabilities
With 29 additional targets the range also includes dog, cow, and pig targets to support translational models in veterinary immunology research….
