Kenox Pharmaceuticals Announces Successful Completion of a Pre-IND Meeting With US-FDA for Novel Inhaled Drug-Device Combination Product  December 20, 2021

Kenox Pharmaceuticals Inc. has submitted Type B Pre-Investigational New Drug (IND) meeting request with the US FDA for its lead program KNX018, a novel inhaled drug-device combination product as an….

INHALATION THERAPY - An Overview to Drug-Nebulizer Combination Development With Biologics November 30, 2021

Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.

DEVICE DEVELOPMENT - Selecting Drug Delivery Systems for Higher Doses, Higher Viscosities & Lower Risk October 4, 2021

Nicolas Bralet and Megan Lan, MBA, MA, discuss how companies can de-risk their device selection as they bring this new generation of high-volume, high-viscosity biologics to market.

DRUG DEVELOPMENT - Simplifying the Drug Development Journey October 4, 2021

Fran DeGrazio explains how experienced and focused collaborators can provide guidance, support services, manpower, and intellect to make it easier to achieve all the goals needed in delivering a drug to a patient.

SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021

Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.

DELIVERY DEVICE - Aerosol Deposition Characterization of Innovative PureHale® Technology Targeting the Upper Airways August 26, 2021

Degenhard Marx, PhD, Fotos Stylianou, PhD, and Stavros Kassinos, PhD, explain how PureHale provides a modern device option for the delivery of a fine mist for a variety of solutions to only the upper respiratory tract without significant deposition in the lungs and lower airways.

2021 Respiratory Drug Development eBook – The Three Cs Driving Respiratory Drug Delivery June 29, 2021

In this third annual Drug Development & Delivery Respiratory eBook, several companies discuss what they are currently working on to propel the respiratory sector.

Vectura Signs Preclinical Development Agreement With Incannex  June 23, 2021

Vectura Group plc recently announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide preclinical development services for….

WEARABLE PLATFORM - Next-Generation Wearable Drug Delivery: Prefilled Devices Provide a Truly Patient-Centric Solution June 2, 2021

Mindy Katz says with increasingly positive expectations for the wearable device market to provide an intuitive and user-friendly drug delivery experience, her company continues to optimize its wearable platform solution, investigating new technologies and processes to improve the offerings for patients and providers.

BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices March 29, 2021

Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.

FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies March 1, 2021

Jim Huang, PhD, explains how a niche CDMO, which has specialized  technologies in complex  injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.

Aerogen Collaborates on Development of More Than 15 Potential COVID-19 Inhaled Therapies November 5, 2020

Scientific Management of Pharmaceutical Container Closure & Delivery Device Compatibility October 13, 2020

Diane Paskiet says the relationship between pharmaceutical products and CC/DD is best managed through a rich science-based approach that factors in potential risk and is adapted early in the development process.

Vectura Partners With Monash University to Support Development of Inhaled Oxytocin to Prevent Postpartum Haemorrhage September 15, 2020

Vectura Group plc recently announced it has signed an agreement with Monash University’s Institute of Pharmaceutical Sciences (MIPS) to develop inhaled oxytocin delivered via a….

Evonik Qualifies Advanced Aseptic Filling Line for Complex Parenteral Drug Products September 9, 2020

Evonik recently announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its FDA-inspected Birmingham….

SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market? September 1, 2020

Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.

COMBINATION PRODUCTS - Development Challenges & Solutions August 31, 2020

Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.

2020 Analytical Testing in Drug Development e-Book: A Critical Role in End-to-End Drug Development August 24, 2020

This second annual Drug Development & Delivery Analytical Testing eBook shines a light on analytical outsourcing providers that are optimizing testing solutions to ensure more robust results, speed time to market, and characterize methods earlier in development.

Sorrel Medical Opens New Manufacturing Facility, Increasing Clinical & Commercial Supply Capabilities of Wearable Drug Delivery Devices July 7, 2020

2020 Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases June 30, 2020

This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.

WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products

Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..