Formulation Development
NASAL SPRAY BIOEQUIVALENCE - Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product
Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).
DRUG DEVELOPMENT EXECUTIVE - Poseida Therapeutics: Creating the Next Wave of Cell & Gene Therapies With the Capacity to Cure
Eric M. Ostertag, MD, PhD, CEO of Poseida Therapeutics, discusses the company’s innovative approach to develop safer, more effective, accessible and affordable cell and gene therapies for patients.
DIGITAL CUSTOM PLATFORM - PCI Pharma’s Digital Transformation: Reaching New Levels of Customer Experience
Wayne Hull and Rebecca Coutts, PhD, explain how incorporating digital transformation as core to their company’s business strategy was a decision based on increasing evidence that investment in digital solutions provides real and measurable returns.
HOT MELT EXTRUSION - API Bioavailability: Suspending Hydrophobic Drugs in a Solid Solution
Ameya Deshpande, MS, says for APIs that are compatible with HME, careful attention to the formulation quality attributes that include excipient selection, dosage form design, analytical testing, and stability are required to maximize the efficacy and quality of the final product.
Aptamer Group & Bio-Works Technologies Partner to Enable Improved Solutions for Gene Therapy Manufacturing
Aptamer Group Ltd and Bio-Works Technologies AB recently announced they have entered into an agreement to co-develop a new affinity resin for improved purification and scale up of….
Noxopharm Phase 1 Clinical Trial Shows Anti-Inflammatory Response in COVID-19 Patients
Noxopharm has released preliminary top-line data from its NOXCOVID Phase I clinical trial testing the suitability of idronoxil (Veyonda®), a TBK1 (TANK-binding kinase 1) inhibitor,…
BioPlx Announces Focus on Developing Cure for Antibiotic-Resistant Bacteria
Antimicrobial Resistance (AMR) is one of the greatest threats to society, human and animal health, and economic prosperity. Those are the unequivocal words regarding the…
Recipharm Launches New Laboratory to Expand Analytical Services Offering
Global contract development and manufacturing organisation (CDMO), Recipharm, has announced the completion of a new analytical laboratory at its facility in Bengaluru, India. The new…
Shape Therapeutics Enters Strategic Research Collaboration With Roche to Advance Breakthrough AAV-Based RNA Editing Technology for Neuroscience & Rare Disease Indications
Through this partnership Shape will apply its proprietary RNA editing platform RNAfix and potentially leverage its AAVid technology platform for next-generation tissue-specific adeno-associated viruses (AAVs) for the development of gene therapy for….
Vifor Pharma & Cara Therapeutics Announce US FDA Approval of Injection for Treating Moderate-to-Severe Pruritus in Hemodialysis Patients
Cara Therapeutics and Vifor Pharma recently announced the US FDA has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with….
SomaLogic & Twist Bioscience Corporation Announce Partnership to Discover Novel Therapeutic Targets & Antibodies
CM Life Sciences II and SomaLogic, Inc., and Twist Bioscience Corporation recently announced a collaboration aimed at creating novel antibodies and enabling innovative drug discovery based on….
Vyant Bio & Cyclica Announce a Strategic Collaboration to Identify Compounds to Treat CDKL5 Deficiency Disorder
Vyant Bio, Inc. and Cyclica, Inc. recently announced a non-exclusive strategic collaboration combining Vyant Bio’s patient-derived complex organoid biology alongside Cyclica’s….
Junshi & Coherus Biosciences Announce Positive Interim Results of CHOICE-01 Phase 3 Clinical Trial
Shanghai Junshi Biosciences Co., Ltd. and Coherus BioSciences, Inc. recently announced positive interim results from the pivotal study CHOICE-01 (NCT03856411), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating….
Persica Pharmaceuticals Has Completed the First Stage of its Clinical Trial on Unique Injectable to Treat Chronic Lower Back Pain
Persica Pharmaceuticals Ltd recently announced it has successfully completed the first stage of a Phase Ib clinical trial to evaluate the safety, tolerability, and pharmacokinetics…
AzurRx BioPharma Announces Positive Topline Data For Phase 2 MS1819 Combination Therapy Trial in Cystic Fibrosis Patients With Severe Exocrine Pancreatic Insufficiency
AzurRx BioPharma recently announced positive topline results from its Phase 2 Combination Trial evaluating MS1819 in combination with the current standard of care, porcine-derived pancreatic enzyme…
Solaris Pharma Receives Approval for First Generic Version of Clindagel
Solaris Pharma Corporation recently announced the company has received an abbreviated new drug application (ANDA) approval from the US FDA for the first generic version…
NGM Bio Discloses Fourth Oncology Development Candidate, NGM831, an ILT3 Antagonist Antibody
NGM Biopharmaceuticals, Inc. recently disclosed its fourth oncology development candidate, NGM831, an antagonist antibody designed to block the interaction of ILT3 with fibronectin, as well…
Zealand Pharma Announces First Patient Dosed in EASE-SBS 4 Phase 3b Trial Assessing Glepaglutide in Patients with Short Bowel Syndrome
Zealand Pharma A/S recently announced dose administration for the first subject in the Phase 3b trial, EASE-SBS 4, evaluating glepaglutide, the company’s long-acting GLP-2 analog,…
Assembly Bio Selects Fourth HBV Core Inhibitor Candidate for Advancement Into Clinical Development
Assembly Biosciences, Inc. recently announced it has selected a fourth core inhibitor candidate, ABI-4334 (4334), that has been optimized for potency, to advance into clinical…
Adial Pharmaceuticals Reaches Full Enrollment Target for ONWARD Phase 3 Trial of AD04 for the Treatment of Patients With Alcohol Use Disorder
Adial Pharmaceuticals, Inc. recently announced it has reached its full enrollment target of 290 subjects in the company’s ONWARD Phase 3 trial evaluating AD04 as…
