Market News & Trends
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…
BD Launches Two-Step Disposable Autoinjector
BD (Becton, Dickinson and Company) recently announced the launch of the BD Intevia 1 mL two-step disposable autoinjector, a robust platform device combining autoinjector and…
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…
Yourway Mitigates Uncertainty of Brexit for Clinical Trials In Europe
Yourway, the only truly integrated premium courier and clinical packager in the industry, announced its establishment of a new location within the European Union providing…
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.
White Paper: High Purity Low Endotoxin Arginine: Applications in Biopharmaceutical Processing & Biotherapeutic Stabilization
This white paper discusses arginine, also known as L-arginine (symbol Arg or R), a basic amino acid widely used in biopharmaceutical processing and stabilization of biotherapeutics.
Credence MedSystems Awarded Gates Foundation Grant to Develop Dual Chamber Drug Delivery Device
Credence MedSystems, an innovator in injectable drug delivery technology for the biopharmaceutical industry, recently announced it has been awarded a grant from the Bill & Melinda Gates Foundation to support the…..
Pfenex Receives US FDA Approval for PF708 to Treat Osteoporosis
Pfenex Inc. recently announced the US FDA has approved the new drug application (NDA) for PF708 submitted under the 505(b)(2) regulatory pathway, with…
Increased Security for Connected Medical Devices to Drive Cybersecurity Market to $143 Billion
The Food and Drug Administration (FDA) recently released a safety communication regarding a set of 11 cybersecurity vulnerabilities, referred to as the URGENT/11, which could…
Sienna Biopharmaceuticals Files 510(k) Submission With FDA
Sienna Biopharmaceuticals, Inc. recently announced the company has filed a Premarket Notification 510(k) submission to the US FDA for SNA-001, a topical pre-treatment to standard…
Stevanato Group Signs License Exclusive Agreement With Haselmeier
Stevanato Group, an Italy-based producer of glass primary packaging and global leader in providing integrated capabilities and solutions for combination products, and Haselmeier, a Switzerland…
MilliporeSigma Becomes the First to Use Acoustic Technology for Cell Therapy Manufacturing
MilliporeSigma recently announced it has acquired FloDesign Sonics, of Wilbraham, MA, developer of a unique acoustic cell processing platform for the industrialization of cell and…
Akcea & Pfizer Announce $250-Million Licensing Agreement for Investigative Therapy
Akcea Therapeutics, Inc., a majority-owned affiliate of Ionis Pharmaceuticals, Inc., and Pfizer Inc. recently announced the companies have entered into a worldwide exclusive licensing agreement…
