Formulation Development
Tenaya Therapeutics Announces FDA Clearance of IND & Initiation of Phase 1 Safety Study for an HDAC6 Inhibitor for Heart Failure With Preserved Ejection Fraction
Tenaya Therapeutics, Inc. recently announced clearance of its Investigational New Drug (IND) application to begin clinical testing of TN-301 by the US FDA. TN-301 is…
Synlogic Achieves Research Milestone in Collaboration With Roche for Development of Novel Synthetic Biotic to Treat Inflammatory Bowel Disease
Synlogic, Inc. recently announced it has received a milestone payment for the achievement of prespecified success criteria under the research collaboration agreement with Roche for….
Hovione Expands Drug Product Offering With New Manufacturing Line Dedicated to Continuous Tableting
Hovione recently announced it has expanded its continuous manufacturing offering and services. A new state-of-the-art continuous manufacturing facility is….
Novo Nordisk to Acquire Forma Therapeutics & Expand Presence in Sickle Cell Disease & Rare Blood Disorders
Novo Nordisk and Forma Therapeutics, Holdings Inc. recently announced they have entered into a definitive agreement under which Novo Nordisk will acquire Forma Therapeutics for….
Qureight Announces World’s First Digital Biomarker for Lung Fibrosis
For the first time, artificial intelligence (AI) using convolutional neural networks has been used to analyse trial data involving the lung disease idiopathic pulmonary fibrosis (IPF). The technology picked up….
Vaxart Announces Positive Top-line Phase 2 Clinical Study Data Demonstrating Safety & Immunogenicity of Its Wuhan S-Only COVID-19 Pill Vaccine Candidate
Vaxart, Inc. recently reported positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19…
SOLUBILITY ENHANCEMENT - How Microparticles are Opening Doors to New Solutions for Oral Drug Delivery
Jessica Mueller-Albers, PhD, Yiming Ma, PhD, Alexander Bernhardt, PhD, and Michael Damm review the use of microparticles for solubility enhancement of oral small molecules and how this approach can address the challenges in pharmaceutical formulations.
GENERATIVE AI TECHNOLOGY - Generative Machine Learning Can Construct Smooth Chemical Search Spaces for Efficient Drug Discovery
Jason Rolfe, PhD, and Ali Saberali, PhD, and Mehran Khodabandeh, MSc, explain how Generative ML promises to efficiently optimize more accurate estimates of binding affinity and other pharmacological properties over the entirety of drug-like chemical space.
GENE THERAPY - Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact
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.
EXECUTIVE INTERVIEW - Emergent CDMO: A Molecule-to-Market Partner for Complex Biologics
Bill Hartzel, Senior Vice President and Head of CDMO Business, discusses the company’s plans for current and future CDMO operations and client partnership opportunities.
DRUG DEVELOPMENT STRATEGIES - Marrying Target Product Profile, Regulatory & Partnering Strategies for Long-Term Product Success
Chris Rojewski believes given the costs, time, and risks associated with contemporary drug development, it’s time this fundamental aspect of successful development be brought as close to the program as possible — the CDMO tasked with executing drug strategy in the first place.
LIVE BIOTHERAPEUTIC PRODUCTS - Not All Microbiome Approaches Are Created Equal
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.
Laverock Therapeutics Founded to Develop the Next Generation of Programmable Cell Therapies
Laverock Therapeutics Ltd was founded to develop a unique gene silencing platform for the creation of programmable, allogeneic cell therapies. Having recently completed a….
Hepion Pharmaceuticals Announces Initiation of Phase 2b ASCEND-NASH Trial
Hepion Pharmaceuticals, Inc. recently announced it has screened the first subject in the ASCEND-NASH clinical trial. The trial is being conducted at up to 121…
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 results from a Phase 1/2 trial of DNL310 (ETV:IDS) in MPS II (Hunter syndrome). DNL310 is an investigational,…
FDA Grants Fast Track Designation for Longeveron’s Treatment for Hypoplastic Left Heart Syndrome in Infants
Longeveron Inc. recently announced the US FDA has granted Fast Track Designation to Lomecel-B for the treatment of Hypoplastic Left Heart Syndrome (HLHS), a rare…
WHITEPAPER - Key Considerations in Oral Delivery of Peptides – Factors to Consider While Evaluating Oral Administration
Peptide therapeutics are a hot topic in pharmaceutical R&D. While most peptides are administered parenterally, oral delivery of peptide therapeutics offers several advantages. Enteris BioPharma’s…
Aria Pharmaceuticals Advances Pipeline With Six Provisional US Patents Filed Across Three Diseases
Aria Pharmaceuticals recently announced the company has successfully filed a total of six provisional patents with the United States Patent and Trademark Office (USPTO) for lead candidates in its lupus, idiopathic pulmonary fibrosis (IPF), and….
Immutep Granted Japanese Patent for Eftilagimod Alpha, a Soluble Lag-3 Protein, in Combination With a PD-1 Pathway Inhibitor
Immutep Limited recently announced the grant of a new patent (No. 7116547) titled Combined Preparations for the Treatment of Cancer or Infection by the Japanese…
Outlook Therapeutics Re-Submits BLA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has re-submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational ophthalmic therapy which, if…
