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Stevanato Group Announces Product Development Collaboration With Cambridge Design Partnership on Pen-Injector Technology April 29, 2020
Stevanato Group, a leading producer of glass primary packaging and provider of integrated capabilities for combination products and Cambridge Design Partnership (CDP), a UK- and US-based leading technology and product design partner, recently….
Haselmeier Receives Medical Device Master File Number for Product Platform March 19, 2020
Haselmeier officially announced it has received Master File Number MAF3202 from the US FDA for its D-Flex product platform, a...Copley Scientific Introduces Simple Device for Inhaled Dose Dissolution Testing February 14, 2020
The new Inhaled Dissolution Dose Collector (IDDC) from Copley Scientific is a flexible, easy-to-use system for collecting the respirable fraction...AUTOINJECTOR PLATFORM - Identifying New, Enhanced Device Delivery Solutions for Chronic Diseases January 14, 2020
Karima Yadi, MSc, and Lionel Maritan, MSc, believe identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.
CPI Accelerates Gene Therapy Development With Robust Purification System October 23, 2019
CPI recently announced the success of its CRD IUK project to develop a scalable, cost-effective purification process for adeno-associated viruses...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…..
Streamlining Drug Development Processes Through the Accenture INTIENT Clinical Platform October 9, 2019
To facilitate the demand for this new world order, we’ve unveiled the Accenture INTIENT Clinical platform. It helps companies run faster clinical trials with better transparency and….
COMBINATION PRODUCT DEVELOPMENT - New Horizons in Development to Meet Emerging Demands October 1, 2019
Ed Trappler and John A. Merhige, MEM, believe it is no longer sufficient to put a product in a vial, and the future of healthcare products places increasing demands on the industry to provide innovations for delivering combination products.
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.
FUJIFILM Irvine Scientific Launches BalanCD Gal Supplement for Biotherapeutic Development September 5, 2019
The new formula has been developed to increase galactosylation in biotherapeutic development, to help achieve….
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.
2019 Respiratory Drug Development eBook - Increased Focus on Respiratory Drug & Device Development Makes Treatment More Personal June 26, 2019
This e-Book highlights some of the innovators and innovations in the respiratory sector, addresses the importance of end users in the device development process, and presents recent advancements in improving patient adherence.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: CDMOs Shift to Offer More Specialized Services June 5, 2019
Contributor Cindy H. Dubin speaks with several innovative CDMOs to discuss their formulation development and manufacturing capabilities (as well as shifting strategies) for bio/pharma companies of all sizes.
Caris Life Sciences Receives FDA Breakthrough Device Designation May 13, 2019
Caris Life Sciences recently announced the US FDA has granted Breakthrough Device designation for the company’s MI Transcriptome companion diagnostic...SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Flexibility for Faster Development April 30, 2019
Contributor Cindy H. Dubin interviews several contract manufacturers and device developers who are responsible for creating next-generation parenteral drug delivery.
MULTIPARTICULATE FORMULATIONS - Using Multiparticulate Technology to Develop Pediatric Drug Products February 28, 2019
Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.
DEVICE REGULATIONS - The New Medical Device Regulation & the Applicability of Article 117 to Medicinal Products January 8, 2019
Louise Place focuses on the impact of Article 117 in Europe on the combination of a drug and a device, where the primary mode of action is performed by the drug and the two products are combined in a single, integral product that is exclusively for use in the given combination and not reusable.
Cartridge Filling: Combination of Features That Can Help Gain a Competitive Edge December 5, 2018
By 2050, it is projected that the proportion of people aged 65 and older will be more than double that of children aged 5. This global phenomenon is also leading to an increasing number of people suffering from chronic diseases, such as diabetes and osteoporosis.
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.
SPECIAL FEATURE - Injection Devices: As Self-Injection Grows, Drug Delivery Gets Smarter August 28, 2018
Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
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…..