Formulation Development
Evonik Launches New Oral Drug Delivery Technology for Enteric Protection & Rapid Release in the Upper Small Intestine
Evonik has recently launched an advanced oral drug delivery technology that provides enteric protection followed by rapid, homogeneous release for effective….
PLATFORM TECHNOLOGY - Morphomer(TM) & SupraAntigen(TM) Platforms: Targeting Misfolded Proteins in Neurodegenerative Disorders
Andrea Pfeifer, PhD, details the efforts to develop the therapeutic and diagnostic tools necessary to enable precision medicine approaches targeting the right protein, at the right time, in the right patient.
FORMULATION FORUM - Parenteral Sustained Delivery of ASD-005 Liposomal Formulation: A Case Study in Applications of Lipid-Based Nanoparticle Carriers
Jim Huang, PhD, presents an investigation aimed at studying the administration of a liposomal form of a third-generation β-blocker, ASD-005, by injectable route of administration to efficiently manage emergency hypertension and congestive heart failure.
ASSAY DEVELOPMENT - Case Study: How Custom Assay Development Helped Spur Precision Medicine Research in Multiple Myeloma
Steven Gross, MS, provides a behind-the-scenes look at the CMMC assay development process (from 2010 through today) to show how pharmaceutical companies can effectively partner with a laboratory to design customized assays that complement their drug discovery and development programs.
PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
CDMO CASE STUDY - AJILITY: Streamlining Drug Product Manufacturing
Dustin Campbell says the AJILITY platform takes the burden off clients and allows his company to drive, manage, and support their drug product manufacturing, maximizing speed and success, while prioritizing these programs are driven to completion.
DRUG DELIVERY - Recognizing the Patient Potential for Transdermal Drug Delivery
Sally Waterman, PhD, and Vasiliki Nikolaou, PhD, explain how transdermal drug delivery patches have the potential to significantly improve not only the outcome of treatments, but also the quality of life for those patients using them.
EXECUTIVE INTERVIEW - Immunic Therapeutics: Developing Next-Generation Oral Drugs in Chronic Inflammatory, Autoimmune & Infectious Diseases
Daniel Vitt, PhD, Immunic’s Chief Executive Officer and President, discusses his company’s pipeline of selective, small molecule therapies aimed at treating chronic inflammatory and autoimmune diseases, and its recent progress.
DEVICE DEVELOPMENT - Designing Devices for Inhaled Drugs
Andreas Meliniotis explains how there is plenty of opportunity for the development of new, improved devices to ensure inhaled drugs can be accessible for a wide range of patients and can treat various diseases and conditions effectively.
OVER-ENCAPSULATION CAPSULES - Double-Blind, Zero Bias: Over-Encapsulation — The Right Tool for Blinding Studies?
Julien Lamps believes that while many blinding options are available to drug sponsors and external clinical research partners, over-encapsulation remains a popular choice for its dosing simplicity, trial efficacy, patient accessibility, and cost-effectiveness.
EXECUTIVE INTERVIEW - Enteris BioPharma: Pioneers in Oral Formulation Development
Dr. Rajiv Khosla, CEO of Enteris BioPharma, discusses how his company’s innovative oral formulation technology is helping the pharmaceutical industry overcome the hurdle of low bioavailability to reshape treatment categories and expand market opportunities with minimal financial and regulatory risks.
OSD FORMULATIONS - Dissolving Bioavailability & Solubility Challenges in Formulation & Development
Vinod Patil, PhD, says many of the innovative and novel formulations introduced throughout the past decade have had to cope with poorly water-soluble APIs. Considering the pace of development, overcoming solubility issues will remain problematic, and this is especially true for important new classes of pharmaceuticals entering the market.
Mott's Controlled Release Drug Diffusion Studies Reduce In Vitro Test Time by Over 90% & Narrow Scope of Animal Trials
Device diffusion testing is a critical step that can delay the time for an implantable drug delivery device to get through clinical trials, regulatory hurdles and ultimately, to market. Mott conducts controlled release studies for….
Veru Completes Enrollment of Phase 2 Clinical Trial of Novel Oral Drug
Veru Inc. recently announced it has fully enrolled its Phase 2 clinical study of VERU-111, its novel, oral, alpha and beta tubulin targeting drug for…
Orgenesis Announces Agreement to Acquire Koligo Therapeutics
Orgenesis Inc. and Koligo Therapeutics, Inc. recently announced the two companies have entered into a definitive merger agreement, subject to final closing conditions, with expected completion….
Mereo BioPharma Receives FDA Rare Pediatric Disease Designation
Mereo BioPharma Group plc recently announced that the US FDA has granted Rare Pediatric Disease designation to setrusumab for the treatment of osteogenesis imperfecta (OI).…
FSD Pharma Begins Phase 2 Clinical Trial to Evaluate FSD201 for the Treatment of Hospitalized COVID-19 Patients
FSD Pharma Inc. recently announced the US FDA has authorized the initiation of a Phase 2 study for the use of FSD201 (ultramicronized palmitoylethanolamide, or…
Celyad Oncology Announces Clinical Trial Collaboration With MSD
Celyad Oncology SA recently announced it has entered into a clinical trial collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, through…
Catalent Acquires New Biologics Facility to Create North American Clinical Manufacturing Center of Excellence
Catalent recently announced it has acquired a new manufacturing facility in Bloomington, IN, to create a North American center of excellence for early phase clinical…
Ajinomoto Bio-Pharma Services & DNDi Partner to Develop Critical Immunomodulator for Cutaneous Leishmaniasis Therapeutic
Ajinomoto Bio-Pharma Services recently announced a strategic supply partnership with the Drugs for Neglected Disease Initiative (DNDi), a collaborative, patients’ needs-driven, non-profit drug research and…
