Search Results for: COMBINATION PRODUCTS Device Development for
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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.
SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure June 4, 2025
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
NASAL DRUG DELIVERY - Overcoming the Challenges of Formulation Development May 7, 2025
Eric Kaneps explores the nasal drug delivery landscape, including the benefits of nasal administration compared with other routes and the unique formulation challenges associated with this delivery method.
Nemera Awarded EcoVadis Gold Medal: A Recognition of its Commitment to Sustainable Development January 28, 2025
Having been awarded the silver medal since 2020, Nemera has reached a significant milestone in 2024 by obtaining the EcoVadis...EXECUTIVE INTERVIEW - Respiratory Drug Development: Lonza Experts Share Trends & Key Takeaways October 1, 2024
Beatriz Fernandes, Principal Scientist for R&D, and Kim Shepard, Director, Technology Head Respiratory Delivery, at Lonza, discuss their presentations at RDD 2024, current trends, and the future of the inhalation space.
Sanner Group Acquires Gilero to Expand Global Medical Device Offering September 25, 2024
Sanner Group has acquired Gilero LLC, a world class medical device design, development, and contract manufacturer headquartered in Durham, NC....PCI Pharma Services Invests Over $365 Million in EU, US Facilities for Clinical & Commercial Supply of Advanced Drug Delivery & Drug-Device Combination Products September 24, 2024
PCI Pharma Services is investing more than $365 million in infrastructure supporting the clinical and commercial-scale final assembly and packaging of...Enable Injections Announces Agreement with Sobi to Develop & Distribute Aspaveli in Combination With enFuse September 12, 2024
Enable Injections, Inc. and Swedish Orphan Biovitrum AB (Sobi) recently announced an international development and distribution agreement for the enFuse...SPECIAL FEATURE - Injection Devices: From Pens & Autoinjectors to Pills, Sprays & Capsules, Injections Become More Efficient September 6, 2024
Contributor Cindy H. Dubin reports on innovative and promising injection technologies that are ever more user friendly, versatile, precise, and life-saving.
2024 Respiratory Drug Development eBook – CDMOs Will Become More Essential to Inhalation Device Programs July 12, 2024
In this fifth annual Respiratory e-book, learn more about several companies and their contributions to inhalation drug delivery and device design.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Going Beyond the Science to Become True Partners June 3, 2024
Contributor Cindy H. Dubin speaks with leading CDMOs about how they are adapting to bio/pharma client needs, their capabilities in handling complex molecules, and how they are transforming from specialist contractors to true partners.
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.
DRUG-DEVICE DEVELOPMENT - Exploring the Complexities of Drug-Device Combination Products
Jeremy Guo, Senior Vice President at WuXi Biologics, and colleagues explain that many factors need to be taken into account when producing a Drug-Device Combination Product from development testing to fill/finish and assembly.
CPHI Annual Report 2024: Drug Delivery Trends & Insights From a Device Perspective
Significant growth in the drug delivery sector is predicted for many areas, with headliners including cell and gene therapies and the GLP-1 blockbusters. Small molecule-based formulations still dominate innovator pipelines, but advanced biologics are also….