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Novavax Initiates Pivotal Phase 3 Clinical Trial October 17, 2019
Novavax, Inc. recently announced the initiation of a pivotal Phase 3 clinical trial for NanoFlu, its recombinant quadrivalent seasonal influenza...Credence MedSystems Awarded Gates Foundation Grant to Develop Dual Chamber Drug Delivery Device October 15, 2019
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…..
AGTC & Otonomy Announce Strategic Collaboration to Develop & Commercialize Gene Therapy October 3, 2019
Applied Genetic Technologies Corporation and Otonomy, Inc. recently announced they have entered into a strategic collaboration to co-develop and co-commercialize...WEARABLE DEVICES - Wearable Drug Delivery Applications: Considerations for Adhesive Material Selection & Wear Testing October 1, 2019
Neal Carty, PhD, MBA, and Deepak Prakash, MS, MBA, discuss the broader healthcare and digital health landscape behind wearable device developments and provide a brief overview of two types of wearable applications — insulin pump therapy/continuous glucose monitoring (CGM) systems and wearable drug injectors.
Dance Biopharm Presents Phase 2 Clinical Data Highlighting Rapid Effects of Inhaled Human Insulin September 24, 2019
Dance Biopharm Holdings, Inc., recently presented data from its Phase 2 clinical study of Dance 501, a novel gentle mist formulation of human insulin administered with its….
SPECIAL FEATURE - Injection Devices: Wearables, Connectivity & Patient-Centric Designs Empower Self-Administration September 3, 2019
Contributor Cindy H. Dubin highlights the innovation in injection devices – from wearables to connectivity to varied dose administration – that have occurred in the past year.
Cara Therapeutics Enters Commercial License Agreement With Enteris BioPharma August 21, 2019
Cara Therapeutics, Inc. recently announced it has entered into a non-exclusive commercial license agreement with Enteris BioPharma, Inc. for oral formulation rights to…..
DRGT Completes a Pivotal Phase I Trial; Results Confirm 6X Faster Attainment of Maximum Plasma Levels June 13, 2019
Druggability Technologies Holdings (DRGT) recently announced results from a pharmacokinetic study of their novel formulation of celecoxib (DRGT-46), which achieves faster time to maximum plasma concentration (Tmax) compared to traditional celecoxib capsules.
Foamix Announces Publication of Phase 3 FMX101 Study June 6, 2019
Foamix Pharmaceuticals Ltd. recently announced the peer review publication of the Phase 3 study FX2017-22 (Study 22) in the Journal...DRUG DELIVERY – ENHANZE (®): An Efficient Way to Optimize Biologic Therapies for Subcutaneous Administration April 30, 2019
Michael J. LaBarre, PhD, discusses how the ENHANZE drug delivery technology has the potential to improve the pharmacokinetic profiles of co-administered drugs through increased dispersion, absorption, and bioavailability.
Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial April 18, 2019
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).
CURE Pharmaceutical to Acquire Chemistry Holdings Inc. April 3, 2019
CURE Pharmaceutical, an innovative drug delivery and development company, recently announced that it has agreed to acquire Chemistry Holdings Inc., a formulation technology company that is developing innovative delivery systems for a variety of industries, in an all-stock transaction.
SPECIAL FEATURE - Excipients: Formulators Want Excipients for Solubility & Beyond April 1, 2019
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
argenx & Halozyme Enter Global Collaboration & License Agreement February 7, 2019
argenx and Halozyme Therapeutics, Inc. recently announced a global collaboration and license agreement that enables use by argenx of Halozyme’s...SPECIAL FEATURE - Outsourcing Analytical Testing: The Gateway to Drug Manufacturing January 10, 2019
Contributor Cindy H. Dubin speaks with several leading analytical labs and CDMOs to review their technologies, services, and new strategies to operate in this ever-changing environment.
Quotient Sciences & Druggability Technologies Announce Collaboration December 11, 2018
Quotient Sciences and Druggability Technologies recently announced a collaboration to utilize Quotient’s integrated Translational Pharmaceutics platform to advance the development of DRGT-46, a novel, fast-acting formulation of celecoxib using proprietary super-API compositions developed by DRGT.
EXECUTIVE INTERVIEW - BD Integrated Systems: From Innovation to Integration November 12, 2018
Theresa Bankston, PhD, Director of the Technical Services group for BD Medical – Pharmaceutical Systems, discusses the advantages of using an integrated system for complex drug-device combination products.
Enable Injections Enters Strategic Partnerships With UCB & Apellis November 12, 2018
Enable Injections, Inc., a patient-centric drug delivery combination product company developing advanced wearable devices for subcutaneous delivery of high-volume therapeutics, recently announced it has entered into development agreements with Apellis Pharmaceuticals, and most recently, UCB.
Intensity Therapeutics Highlights Data in Advanced Solid Tumors November 12, 2018
Intensity Therapeutics, Inc. recently announced additional data from a Phase 1/2 clinical study of INT230-6, the company’s novel lead product candidate...WEARABLE INJECTORS - BD Wearable Drug Delivery Devices: An Attractive Proposal October 2, 2018
Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome, and describes how the design and development of the BD Libertas(TM) is an attractive proposal for pharma companies.