Formulation Development
Flexion Announces Clearance of NDA for Gene Therapy Candidate
Flexion Therapeutics, Inc. recently announced clearance of the company’s Investigational New Drug (IND) application for FX201 in knee osteoarthritis.
Cycle Pharmaceuticals & Catalent Partner to Develop Treatments for Rare Diseases
Cycle Pharmaceuticals Ltd. has recently signed an agreement with Catalent, Inc. to develop innovative formulations targeting rare disease patients.
Ashland Launches New Excipient Solutions for Improved Drug Delivery
Ashland recently announced the launch of three new pharmaceutical solutions, Plasdone S630 Ultra, Benecel XR and XRF, and Viatel bioresorbable polymers. Ashland is expanding its portfolio to meet formulators’ growing needs….
Menlo Therapeutics Announces Completion of Enrollment in Two Phase 3 Trials
Menlo Therapeutics Inc. recently announced it has completed enrollment of patients in its two Phase 3 clinical trials evaluating the safety and efficacy of once-daily…
Artelo Biosciences Announces Selection of Clinical Research Organization
Artelo Biosciences, Inc. recently announced it has selected Aptus Clinical Ltd. (Aptus) as its contract research organization (CRO) for the company’s planned Phase 1b/2a randomized,…
Disc Medicine Completes $50-Million Series A Financing, Enters Exclusive License Agreement With AbbVie
Disc Medicine recently announced the completion of a $50-million Series A financing. The company’s novel approach focuses on targeting hepcidin, a key regulator of iron…
Femtogenix Presents Novel Data on Antibody Drug Conjugates
Femtogenix Ltd recently announced data demonstrating the potent efficacy and favorable toxicity profile of a reduced potency analogue from its Pyridinobenzodiazepine (PDD) ADC payload platform…
Octapharma Adopts Genedata Bioprocess to Develop Next-Generation Bio-Manufacturing Processes
Genedata recently announced that Octapharma has adopted the Genedata Bioprocess platform to support the development and manufacturing of therapeutic proteins addressing severe diseases in the…
Amarantus Enters Into Agreement to License Diverse Therapeutics Portfolio to CBD-Focused Emerald Organic Products
Amarantus will receive Emerald Preferred Stock to be valued at a minimum of $100 million in 2022, and up to double digit royalties (in addition to pass-through royalties and milestones) in exchange for worldwide, exclusive development and commercial rights to….
CPI Accelerates Gene Therapy Development With Robust Purification System
CPI recently announced the success of its CRD IUK project to develop a scalable, cost-effective purification process for adeno-associated viruses (AAVs), in partnership with Cobra…
Foamix Receives FDA Approval for Topical Treatment
Foamix Pharmaceuticals Ltd. recently announced the US FDA has approved its novel AMZEEQ (minocycline) topical foam, 4%. AMZEEQ, formerly known as FMX101, is indicated for…
Theralase Granted European Patent for Anti-Cancer Photo Dynamic Compounds
Theralase Technologies Inc. recently announced the company has been granted a European Patent for their anti-cancer PDCs, which will issue in due course. The patent,…
Genedata & Merck Co-Develop Digital Platform
Genedata recently announced the successful completion of a multi-year software development project in close collaboration with Merck, a leading science and technology company. Fulfilling Merck’s…
CombiGene Signs Agreement With Cobra Biologics
CombiGene AB recently signed an agreement with the Anglo-Swedish Contract Development and Manufacturing Organisation (CDMO) Cobra Biologics (Cobra) for production of candidate drug CG01. The…
Adaptate Biotherapeutics Formed to Develop Antibody-Based Therapies That Modulate Gamma Delta T-Cells
GammaDelta Therapeutics, a company focussed on harnessing the unique properties of gamma delta T-cells to develop transformational immunotherapies, recently announced the formation of a spin-out…
Novavax Initiates Pivotal Phase 3 Clinical Trial
Novavax, Inc. recently announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza vaccine candidate, in adults aged…
Orgenesis Announces Co-Development Agreement With Accellix
Orgenesis Inc recently announced it has entered into a co-development agreement with Accellix, Inc. The agreement will enable Orgenesis to integrate Accellix’s proprietary optic system, cartridges, reagents,…
An End to Alzheimer’s? New Drugs Fight Memory Loss
Researchers in Toronto have developed an experimental drug that appears to renew the underlying brain impairments causing memory loss, fuelling hopes that a treatment for…
Patient-Derived Tumor Organoid Drug Development Platform Launched
Crown Bioscience recently announced the launch of a new tumor organoid drug development platform with the potential to significantly improve the……
White Paper: Control of Beta-Glucans & Endotoxin in High Purity Sucrose for Biopharmaceutical Applications
This white paper discusses a Quality by Design (QbD) scenario that allows end users to rationally select the well characterized excipients during biopharmaceutical development and develop a control strategy for biologic drug products.
