Noble Launches Human Factors Engineering Services to Support Product Development and US FDA Approval of Medical Devices & Combination Products February 4, 2021

Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, recently announced the launch of Human Factors Plus (HF+), an expanded service to further….

COMBINATION PRODUCTS - Device Development for Pharmaceutical & Biologic Combination Products October 4, 2016

Bill Welch says when developing a combination product, there are many things to be considered – relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding user needs, determining product requirements, as well as device manufacturing variation.

EXECUTIVE INTERVIEW - Petros Pharmaceuticals & Self-Care: Expanding Access to Rx Products Through a Tech-Powered OTC Pathway March 28, 2024

Fady Boctor, President and Chief Commercial Officer at Petros Pharmaceuticals, discusses the process of taking a product from Rx-to-OTC, the benefits and challenges of the process, and the future of the marketplace.

Teva UK & Closed Loop Medicine Announce Strategic Partnership to Advance Development of Personalized Medicines March 26, 2024

Teva UK Limited and Closed Loop Medicine Ltd have announced a strategic partnership to advance the development of personalized medicine. Under the agreement, Closed Loop Medicine and  Teva UK will investigate….

DRUG DELIVERY - EUDRACAP® Select - Examining a Case From Development to Clinical Trial February 29, 2024

Lucas Paulo Cusin, Kamlesh Oza, PhD, and Steven Smith, et al focus on the development of a customized functional coated capsule for the delivery of live biotherapeutics and demonstrate its effectiveness in the oral delivery of a sensitive proprietary microbiome ecosystem while simplifying the drug development process.

Cristalia Products With Nemera’s Reusable Pen Injector Commercialized in Brazil January 30, 2024

Cristalia’s human growth hormone will be administered with CRISPEN. Approved by ANVISA1, CRISPEN is part of Nemera’s state-of-the-art pen injector platform PENDURA AD……..

Recipharm, Medspray & Resyca Enter Exclusive License Agreement to Develop Nasally Delivered Drug Products Using Proprietary Soft Mist Technology January 23, 2024

Recipharm recently announced an exclusive license and collaboration agreement with Medspray and Resyca to develop soft mist nasal delivery devices for single and combination drug products. This collaboration….

Kindeva Drug Delivery Acquires Summit Biosciences, a Specialized Nasal Drug Development & Manufacturing Organization January 18, 2024

Kindeva Drug Delivery recently announced it has acquired Summit Biosciences Inc., an intranasal drug delivery contract development and manufacturing organization, from its founding….

ONK Therapeutics & NAYA Biosciences Announce Research Partnership to Advance Combination Therapy of Optimally Engineered Off-the-Shelf Natural Killer Cell Therapies & FLEX-NK Bispecific Antibodies December 6, 2023

ONK Therapeutics and NAYA Biosciences Inc. announced they have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally engineered natural….

SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023

Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.

PLATFORM DEVICE - Alina: Shining the “Light” on the Benefits of a Platform Approach to Treating Chronic Conditions June 5, 2023

Adam Stops, PhD, says the key to the success of any drug delivery device are factors such as proven technology, low development costs, fast time-to-market, and a strong intellectual property (IP) position for the pharma company, and against this background, platform drug delivery devices have become more important than ever.

FORMULATION FORUM - PLGA – A Versatile Copolymer for Design & Development of Nanoparticles for Drug Delivery June 5, 2023

Jim Huang, PhD, and Shaukat Ali, PhD, focus on the chemistry, properties, applications, and regulatory aspects of PLGA, and the future trends in the industry, especially those requiring the development of long-acting injectables for the treatment of a variety of rare diseases and for life cycle management.

DEVICE DEVELOPMENT - How to Ensure pMDI Drug Products Are Fit for the Future Market Landscape June 5, 2023

Ross Errington explores the latest developments in the pMDI segment and explains the steps pharmaceutical companies need to take to ensure their pMDI drug products are ready to thrive in a very different market environment.

SPECIAL FEATURE - Parenteral Drug Delivery: Could a Dose of AI Improve Development? May 1, 2023

Contributor Cindy H. Dubin speaks with several innovative companies to highlight the strides they are currently making toward improving dose accuracy, integrating design safety, and accelerating time to market.

IMUNON & Break Through Cancer Commence Enrollment in a Phase 1/2 Clinical Study of IMNN-001 in Combination With Avastin in Advanced Ovarian Cancer February 27, 2023

SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022

Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.

2022 Respiratory Drug Development eBook - Demand Accelerates Devices July 8, 2022

This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.

AUTOINJECTOR TECHNOLOGY - De-risking Biosimilar Development With a Clinically Validated & Commercially Proven Disposable Autoinjector June 1, 2022

Victoria Meyer, MBA, explains how for many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.

MEDICAL DEVICE UX DESIGN - Bridging the Divide Between People & Products: How UX Design Can Improve Medical Device Product Development May 2, 2022

Aditya Jagannathan explains how human factors and industrial design can bridge the divide between people and products to maximize the likelihood that new medical devices will be safe and effective for the intended uses, users, and use environments.

Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products March 31, 2022

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…..