Formulation Development
Mustang Bio Announces First Patient Treated in Its Multicenter Phase 1/2 Clinical Trial of a First-in-Class CD20-targeted, Autologous CAR T Cell Therapy
Mustang Bio, Inc. recently announced the first patient has been treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy…
Monopar Announces Completion of Phase 2b Enrollment & Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis
Monopar Therapeutics Inc. recently announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM)…
MBX Biosciences Advances Phase 1 Clinical Trial of Long-Acting Parathyroid Hormone Peptide Prodrug
MBX Biosciences, Inc. recently announced it has initiated the multiple ascending dose portion of its ongoing Phase 1 clinical trial of MBX 2109. MBX 2109,…
Icosavax Initiates Phase 1 Trial of IVX-A12 Against RSV & hMPV in Older Adults
Icosavax, Inc. recently announced the initiation of a Phase 1 clinical trial of IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in older…
Nutriband & Kindeva Drug Delivery Demonstrate Enhanced Abuse-Deterrent Characteristics for Aversa Fentanyl
Nutriband Inc. and Kindeva Drug Delivery have demonstrated enhanced abuse deterrence kinetics of the company’s patented lead product, Aversa Fentanyl, an abuse-deterrent fentanyl transdermal system….
EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
EXCIPIENT COMPACTION STUDY - Developing a Reliable Controlled-Release Polymer Using a Compaction Simulator
Gopeshkumar Singh, MS, and Ajit Bhagat provide study results showing that through polymer chemistry, it is viable to effectively manufacture matrix tablets via a simple direct compression method; and Hypromellose has impressive compatibility at various compression forces.
Ascendia Pharmaceuticals Named to Inc. 5000 List of America’s Fastest-Growing Private Companies for Third Consecutive Year
Ascendia Pharmaceuticals recently announced it has been named to the prestigious Inc. 5000 rankings of the fastest growing privately-owned companies in the United States for…
DRUG DISCOVERY - Getting the Most From a DNA-Encoded Library Screen
Matthew A. Clark, PhD, says despite this high level of interest, there remains variable understanding of how to maximize the potential of a DEL screen, and shares his company’s approach to DEL screening and how its partners get the most from this powerful technology.
PLATFORM TECHNOLOGY - The Evolution of Cancer Vaccines: Moving Beyond Failure & a New Era for Cancer Treatment
Jeremy R. Graff, PhD, says new studies show promising data with the use of mRNA-based vaccines and the injection of nanoparticles into regional lymph nodes to achieve disease stabilization. This has led to a potentially groundbreaking era of therapeutic cancer vaccines thanks to discoveries in identifying truncal targets, targeting tumor neoantigens and, notably, developing improved delivery technologies that stimulate a robust, targeted, and persistent immune response.
NANOPARTICLE ENGINEERING - Lighting the Way to a Patient-Centric Future
Christopher Worrall, PhD, discusses how nanoparticle engineering technologies could help improve compliance and patient outcomes, for both small-molecule and biological drugs, and how nanotechnology can help facilitate a shift toward more patient-centric medicine.
TOP SPRAY GRANULATION - POLYOX™: Producing Lightweight Metformin Hydrochloride Extended-Release Tablets for Patient Adherence & Cost-Effective Manufacturing
Atul Lohade, PhD, Vinay Muley, and Tejas Gunjikar, PhD, explain how understanding the challenges associated with developing smaller extended-release tablets, and the excipient-based solutions to these challenges, will empower formulators to develop robust, stable drug formulations with high patient adherence while cutting manufacturing costs.
Alexion, AstraZeneca Rare Disease to Acquire LogicBio Therapeutics to Accelerate Growth in Genomic Medicine
LogicBio Therapeutics, Inc. recently announced it has entered into a definitive agreement under which AstraZeneca Rare Disease will acquire LogicBio. The proposed acquisition…
Biogen & Denali Therapeutics Announce Initiation of Phase 3 LIGHTHOUSE Study in Parkinson’s Disease Associated With LRRK2 Pathogenic Mutations
Biogen Inc. and Denali Therapeutics Inc. recently announced dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile…
Zealand Pharma Announces Positive Results from Phase 3 Trial of Glepaglutide in Patients With Short Bowel Syndrome (EASE 1)
Zealand Pharma A/S recently announced positive topline results from the pivotal Phase 3 trial of glepaglutide, a long-acting GLP-2 analogue designed for once or twice…
ON-DEMAND WEBINAR - CMC Strategy to Take Bispecifics From DNA to IND in 13 Months* by Lonza
Lonza has applied it’s 35 years of CMC experience in Biologics to develop an end-to-end comprehensive DS/DP DNA to IND strategy in 13 months. This presentation….
Spectradyne Launches New ARC Particle Analyzer
Spectradyne recently launched its second-generation product, the ARC particle analyzer. Spectradyne’s ARC is a ground-breaking technology for analyzing biological nanoparticles in complex….
NJIT Researchers Unlock a New Method for Testing Protein-Based Drugs
New Jersey Institute of Technology researchers have unveiled a new lab technique they say represents a “paradigm shift” in how pharmaceutical laboratories test and produce…
BD Launches State-of-the-Art Cloud Software Solution to Streamline Flow Cytometry Research
BD (Becton, Dickinson and Company) recently launched BD® Research Cloud, a cloud-based software solution designed to streamline the flow cytometry workflow to enable higher….
