Formulation Development
PDS Biotechnology Announces Achievement of Efficacy Threshold in Stage 2 of the VERSATILE-002 Trial Evaluating PDS0101 & KEYTRUDA in Head & Neck Cancer
PDS Biotechnology Corporation recently announced it achieved the threshold for efficacy as per investigator assessment in Stage 2 of the VERSATILE-002 (NCT04260126) Phase 2 clinical…
PaxMedica Submits Clinical Trial Request in Autism Spectrum Disorder
PaxMedica, Inc. recently announced it has submitted a request to the South African Health Products Regulatory Authority (SAHPRA), seeking approval to conduct a double-blind, placebo-controlled…
Valo Therapeutics & Texcell Announce Research Collaboration to Evaluate Immune Responses to PeptiCRAd-1 in Phase 1 Clinical Study
Valo Therapeutics Oy recently announced a collaboration with global contract research organization, Texcell, to investigate immune responses to PeptiCRAd-1 in its Phase 1 clinical study.…
Salipro Biotech Expands Global Intellectual Property Portfolio With Granted Patent in Japan
Salipro Biotech AB recently announce the issuance of a new patent in Japan for its Salipro platform technology. The patent, titled Saposin lipoprotein particles and…
Mustang Bio Announces Updated Results From Waldenstrom Macroglobulinemia Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted Autologous CAR T Therapy
Mustang Bio, Inc. recently announced that updated data from the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, show…
Phathom Pharmaceuticals Announces FDA Acceptance of NDA Resubmission for Erosive GERD
Phathom Pharmaceuticals, Inc. recently announced the US FDA has acknowledged that its New Drug Application (NDA) resubmission for vonoprazan, a novel first-in-class potassium-competitive acid blocker…
ABVC BioPharma ADHD Phase 2 Part 2 Clinical Study First Subject Enrolled at UCSF
ABVC BioPharma, Inc. recently announced the first subject was enrolled at University of California San Francisco (UCSF) Medical Center on June 9, 2023. The UCSF…
WHITEPAPER - Enhancing the Solubility of Active Pharmaceutical Ingredients Using Hot Melt Extrusion & Polyvinyl Alcohol
This white paper describes how hot melt extrusion (HME) and a specially-engineered grade of polyvinyl alcohol can be used to increase the solubility of DCS IIb molecules.
Quell Therapeutics Signs Collaboration, Exclusive Option & License Agreement With AstraZeneca to Develop, Manufacture & Commercialize Engineered Treg Cell Therapies for Autoimmune Diseases
Collaboration brings together Quell’s proprietary multi-modular T-regulatory (Treg) cell engineering and manufacturing expertise with AstraZeneca’s proven development and commercial capabilities as well as its deep therapeutic area knowledge….
Daré Bioscience Announces Publication of Phase 1/2 Pharmacokinetic, Safety & Pharmacodynamic Data for a Potential New Hormone-Free Treatment for Vulvovaginal Atrophy
Daré Bioscience, Inc. recently announced the publication of results of its Phase 1/2 clinical study of DARE-VVA1, a proprietary, investigational formulation of tamoxifen for intravaginal…
Ventyx Biosciences Announces Completion of Enrollment of Phase 2 Trial of VTX002 in Ulcerative Colitis & Phase 2 Trial of VTX958 in Plaque Psoriasis
Ventyx Biosciences, Inc. recently announced it has completed patient enrollment in the Phase 2 trial of VTX002 in ulcerative colitis and the Phase 2 SERENITY…
Axol Bioscience Collaborates With StrataStem to Deliver Stem Cell-Based ‘Clinical Trial in a Dish’ for Alzheimer’s Disease
Axol Bioscience Ltd. has signed an exclusive agreement with StrataStem to access and commercialize its extensive collection of Alzheimer’s Disease (AD) patient samples…..
Ocular Therapeuti Completes Enrollment of the HELIOS Clinical Trial of OTX-TKI for the Treatment of Diabetic Retinopathy
Ocular Therapeutix, Inc. recently announced completion of enrollment in the HELIOS clinical trial of OTX-TKI. Using Elutyx technology, OTX-TKI is the company’s axitinib intravitreal implant…
European Patent Office to Grant ZyVersa Therapeutics’ Patent Application for Cholesterol Transport Mediator for Use in Patients With Diabetic Nephropathy/Diabetic Kidney Disease
ZyVersa Therapeutics, Inc. recently announces the European Patent Office has issued a “Notice of Intention to Grant” ZyVersa’s patent application covering the company’s Phase 2a-ready…
Anavex Life Sciences Announces Completion of Phase 2/3 Rett Syndrome Clinical Trial
Anavex Life Sciences Corp. recently announced the completion of dosing of all participants of the placebo-controlled EXCELLENCE Phase 2/3 study ANAVEX2-73-RS-003 in pediatric patients with…
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Putting Customers First
Contributor Cindy H. Dubin speaks with several leading CDMOs from around the globe on their unique development and manufacturing capabilities and technologies, and presents real-world examples of how they have put these to use to produce innovative compounds, lower development costs, and shorten time to market.
FORMULATION FORUM - PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery
Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.
DRUG DEVELOPMENT - Overcoming Challenges on the Path From Candidate Selection to First-in-Human Clinical Testing
Eleanor Row, PhD, explores the current challenges drug developers face in transitioning their candidate molecules to first-in-human (FIH) clinical trials, including what the different drug development functions should be considering at this stage, and how an integrated approach can help to accelerate your molecule’s pathway to trial and beyond.
DEVICE DEVELOPMENT - How to Ensure pMDI Drug Products Are Fit for the Future Market Landscape
Ross Errington explores the latest developments in the pMDI segment and explains the steps pharmaceutical companies need to take to ensure their pMDI drug products are ready to thrive in a very different market environment.
Catalent Expands OneBio® Suite for Integrated Development, Manufacturing & Supply Across Biologic Modalities
Catalent recently announced it has expanded its integrated development, manufacturing and supply solution, OneBio® Suite, across a range of biologic modalities, including antibody and recombinant…
