Formulation Development
Lonza & Genetix Biotherapeutics Extend Commercial Manufacturing Agreement for ZYNTEGLO
-Extended agreement will expand manufacturing capacity at Lonza Houston (US) to support growing demand for Genetix’s ZYNTEGLO (betibeglogene autotemcel), the only FDA-approved gene therapy for…
Centauri Therapeutics Granted FDA QIDP Status for CTX-187 Treatment of Gram-Negative Bacterial Infections
Centauri Therapeutics Limited recently announced the its lead clinical candidate in the ABX-01 program, CTX-187, has received Qualified Infectious Disease Product (QIDP) designation from the…
WHITE PAPER - Stop Guessing. Start Predicting: Rethinking Early Oral Drug Development
This article explores how AI-driven predictive insights reduce uncertainty in early oral drug development, enabling smarter decisions on solubility, dosing, stability, and scale-up while preserving API, accelerating timelines, and de-risking clinical success .
Medicus Pharma Reports Positive Phase 2 Topline Data Observing 73% Clinical Clearance & 40% Histological Clearance
Medicus Pharma Ltd. recently announced topline results from its Phase 2 clinical study (SKNJCT-003) evaluating safety and efficacy of Doxorubicin Microneedle Array (D-MNA) to non-invasively…
Codexis Signs Agreement to Manufacture 50 g siRNA Using its ECO Synthesis Manufacturing Platform
Codexis, Inc. recently announced it has entered into an agreement with an innovator pharmaceutical company to manufacture 50 grams of small interfering RNA (siRNA) using…
FUJIFILM Biotechnologies Unveils ShunzymeX Precision Purification Technology
FUJIFILM Biotechnologies recently unveiled ShunzymeX precision purification technology, which simplifies downstream processing for complex biologics. The technology will be presented this week at the Festival…
BioDuro & Cenra Launch Joint Venture to Expand Resilient Global API Manufacturing Capacity
BioDuro recently announced it has established a joint venture with Cenra API Solutions, also as known as Chunghwa Chemical Synthesis & Biotech Co., Ltd. (CCSB),…
NorthSea Therapeutics Announces Achievement of Key Regulatory Milestones for Orziloben
NorthSea Therapeutics B.V. recently announced the US FDA and the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have granted Orphan Drug Designations…
ESTEVE CDMO Commences $15.5 Million Expansion of Chicago Small Molecule API Facility
ESTEVE CDMO recently announced it had commenced a $15.5-million investment to enhance production capabilities and associated space at its newly acquired North American facility in…
WHITE PAPER - Small Molecules: Choosing the Right Development Path
This white paper outlines a structured, risk-minimized approach to early CMC (Chemistry, Manufacturing, and Controls) development for small-molecule drugs—particularly for startups and virtual pharma companies with limited resources.
Bioxytran Reports Positive Study Results for a Broad-Range Antiviral Drug in Mild-to-Moderate COVID-19
Bioxytran, Inc. recently announced results from a randomized, double-blind, placebo-controlled Phase 1b/2a clinical study evaluating oral ProLectin-M in hospitalized patients with mild to moderate COVID-19 caused…
Quotient Sciences Extends Commercial Manufacturing Partnership for Ultra-Rare Disease Treatment
Quotient Sciences recently announced an extended commercial supply partnership with Ipsen, a global biopharmaceutical company, to manufacture a treatment for Fibrodysplasia Ossificans Progressiva (FOP), an…
Neurizon Initiates Dosing of NUZ-001 in HEALEY ALS Platform Trial
Neurizon Therapeutics Limited recently announced the first participant has been dosed in Regimen I of the HEALEY ALS Platform Trial evaluating Neurizon’s lead candidate, NUZ-001,…
WHITE PAPER - How Advanced Containment Technology Is Reshaping High-Potency API Micronization
Harry Wade, Technical Associate, and Rosie Bird, EHS Lead, Catalent Dartford, review how for many high-potency APIs, micronization is not a downstream convenience but a critical performance step. Particle size distribution directly influences dissolution behavior, bioavailability, blend uniformity, and dose accuracy, particularly when therapeutic doses are measured in micrograms.
TARA-002 Demonstrates 68% Complete Response Rate at 6 Months in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer
Protara Therapeutics, Inc. recently announced updated interim results from its ongoing Phase 2 open-label ADVANCED-2 trial assessing intravesical TARA-002, the Company’s investigational cell-based therapy, in…
etherna´s Intratumoral mRNA/LNP Platform Advances to Clinical Testing in Nonmelanoma Skin Cancer Led by Almirall
etherna recently announced one of its key collaborators, Almirall, a leading medical dermatology company, nominated LAD116 as a novel therapy targeting non-melanoma skin cancer for…
SolasCure Completes Phase 2 Clinical Trial Demonstrating Accelerated Healing With Aurase Wound Gel
SOLASCURE Ltd recently announced the successful completion of its second Phase 2 clinical trial, CLEANVLU2. The study demonstrated that its investigational product, Aurase Wound Gel…
AC Immune Initiates Phase 1 Clinical Trial of NLRP3 Inhibitor
AC Immune SA recently announced that the first participant has been dosed in a Phase 1 clinical trial of ACI-19764, an orally administered small molecule…
Lonza Strengthens Advanced Synthesis Capabilities to Lead Bioconjugates Innovation & Development
Lonza recently announced that it has strengthened its Advanced Synthesis offering to increase phase-appropriate support for the discovery and development of antibody-drug conjugates (ADCs) and…
Proveris Laboratories Launches Redesigned Website Focused on Analytical Clarity in OINDP Development
Proveris Laboratories recently announced the launch of a redesigned website centered on its analytical and regulatory expertise in orally inhaled and nasal drug product (OINDP)…
