Formulation Development
Alzheon Reports Plasma Biomarker Results From Phase 3 & 2 Studies, Validating First-in-Class Mechanism of Action & Underscoring Benefits in Cognition, Function & Brain Volume Protection in Alzheimer’s Patients
Alzheon, Inc. recently announced plasma biomarker analyses from its APOLLOE4 Phase 3 and Phase 2 clinical studies of valiltramiprosate/ALZ-801. New results offer robust evidence supporting the…
SPECIAL FEATURE - Artificial Intelligence in Drug Discovery, Development & Delivery
Contributor Cindy H. Dubin speaks with leading drug makers, device manufacturers, and contract organizations who dispel the myths around AI and Machine Learning in the pharma industry and share how they are using AI to streamline clinical trials, automate lab tests, optimize resource allocation, enhance development timelines, and improve patient-friendly dosage forms.
FORMULATION FORUM - Solid Oral Dosages: Controlled Release of Drugs
Shaukat Ali, PhD, and Jim Huang, PhD, review a few examples of controlled release excipients and their attributes from monolithic matrix tablets and polymeric coated tablets.
LEADERSHIP PANEL - Trends to Watch for in 2026
Contributor Cindy H. Dubin interviews life science leaders to discuss the role of AI in drug repurposing, the future of personalized medicine, the importance of sustainability, and how to keep pace with innovation amid real-time FDA reviews.
Sanofi’s Venglustat Met All Primary Endpoints in Phase 3 Study of Type 3 Gaucher Disease
Positive results from the LEAP2MONO Phase 3 study (clinical study identifier: NCT05222906) demonstrated that venglustat met the primary and three out of four key secondary…
Piramal Pharma Solutions Introduces Tablet-in-Capsule Capabilities
Piramal Pharma Solutions recently announce the successful development, scale-up, and commercialization of a tablet-in-capsule drug delivery system at its drug product facilities in Pithampur and Ahmedabad,…
CONTROLLED RELEASE - Challenges in Consistent & Predictable Delivery of Drugs Using Oral Controlled Release Technologies
True Rogers, RPh, PhD, Matthias Knarr, PhD, and Mark Dreibelbis, PhD, say excipient selection is a key consideration within the QbD framework, particularly for CR technologies. Excipients must be chosen carefully to ensure they deliver the needed processability, quality, stability, and performance during and following the manufacture of dosage forms.
EXECUTIVE INTERVIEW - Incannex Healthcare: Pioneering the Future of Cannabinoid & Psychedelic Therapies
Joel Latham, CEO of Incannex Healthcare, shares how the company navigates complex global regulatory pathways, building strategic collaborations, and forging a path toward commercial success.
CELL & GENE THERAPY - What the Industry Can Learn From Baby KJ About Optimizing CRISPR Development
Venkata Indurthi, PhD, believes the success of Baby KJ provides a model that could be replicated many times over to treat people with ultra-rare genetic diseases.
PLATFORM TECHNOLOGY - How PolyPid’s PLEX Unlocks the Potential of Local & Prolonged Release
Dikla Czaczkes Akselbrad asks what if, instead of relying on systemic delivery, a platform could be created that anchors drugs directly at the site of need and controls its release over weeks or months?
MAB FORMULATION & FILL-FINISH - Obstacles in Monoclonal Antibody Formulation & Fill-Finish
Nandkumar Deorkar, PhD, explores some of the key challenges in mAb formulation and fill-finish, offering practical insights to help developers navigate complexity and ensure success.
EXECUTIVE INTERVIEW - CERo Therapeutics: A Novel Approach to Treating Cancer
Chris Ehrlich, CEO of CERo Therapeutics, discusses the company’s science, clinical program, the treatment landscape, and more.
MRNA THERAPEUTICS - Strategies for Enhanced Stability, Targeted Delivery & Safe Translation
Carsten Rudolph, PhD, explores many challenges and the solutions offered by novel technology platforms, providing insight into the evolving landscape of mRNA drug development and its potential as a future transformative modality.
PhaseV Launches AI-Powered Enrollment Lab: Eliminating Guesswork & Grounding Study Design in Clinical Reality
PhaseV recently announced the launch of its new Enrollment Lab solution at the 17th Annual SCOPE Summit. A high-impact addition to the PhaseV ClinOps platform, this…
Ardena Completes Divestment of its Södertälje Drug Substance Site in Sweden to Nanologica
Ardena recently announced it has completed the divestment of its drug substance (API) site in Södertälje, Sweden, to Nanologica AB. The business will operate as…
Vetter Pharma to Build New Manufacturing Site in Germany
Vetter Pharma has confirmed its plans to build a state-of-the-art production facility in the Saarland region of southwest Germany. This strategic investment marks a significant…
ENA Respiratory Announces Dosing of First Participants in Phase II Study of Nasal Spray Designed to Protect Against Symptomatic Viral Respiratory Infections
ENA Respiratory recently announced it has dosed the first participants in its Phase II community study of INNA-051, (with the first participant dosing now completed).…
Boehringer Ingelheim’s Investigational Asset Delivers Proteinuria Reduction in Phase II Kidney Trial
Boehringer Ingelheim today announced results from a 12-week Phase II clinical trial evaluating apecotrep (BI 764198), an oral, potential first-in-class, non-immunosuppressive TRPC6 inhibitor for people…
Halo Pharma to Become a Stand-Alone Drug Product Contract Development & Manufacturing Organization
Halo Pharma, a leading CDMO specializing in drug product pharmaceutical development and manufacturing services, will become a stand-alone business as a result of the sale…
Argo Biopharma Announces First Patient Dosed in Phase 2b Trial of siRNA Therapeutic in Patients with Elevated Lp(a)
Argo Biopharmaceutical Co., Ltd. recently announced the first patient has been dosed in a global Phase 2b clinical trial sponsored by Novartis evaluating DII235, also…
