Search Results for: COMBINATION PRODUCTS Device Development for
Articles
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges May 2, 2016
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
DRUG DELIVERY - PLEX(TM) Local Drug Delivery Platform Enables Prolonged, Controlled-Release Medications March 29, 2016
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
DISSOLUTION TESTING - Exploring the Link Between Particle Size & Dissolution Behavior for OINDPs March 1, 2016
Paul Kippax, PhD; Deborah Huck-Jones, PhD; et al review current trends in dissolution testing within the context of understanding particle size, which impacts clinical studies and ultimately generic submissions.
SPECIAL FEATURE - Advancements in Drug Delivery Technologies Tackle Solubility & Bioavailability Challenges February 29, 2016
Contributor Cindy H. Dubin speaks with several innovator companies to learn more about the latest advances in drug delivery to address the challenging issues of solubility and bioavailability today
CRO MARKET - CRO Sector: Sales & Margins Remain Healthy January 7, 2016
Adam Dion, MSc, indicates declining R&D productivity and increased development costs have negatively impacted biopharmaceutical companies, and the need for them to maximize productivity and lower costs in their commercial operations will cause them to look to CRO partners as they enter into outsourcing arrangements.
Opsonix is Launched to Develop Pathogen-Extracting Therapy October 16, 2015
Opsonix, Inc. recently announced the company’s launch with an $8-million Series A financing to develop a pathogen-extracting therapy designed to...PRIMARY PACKAGING - Ophthalmic Squeeze Dispenser (OSD): Does One Size Fit All? October 5, 2015
Degenhard Marx, PhD, and Matthias Birkhoff, discuss how the use of preservatives in eye drops is still controversial, but more and more evidence supports the use of unpreserved eye drops for treatment of chronic diseases.
SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies October 5, 2015
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
West Pharmaceutical Services & Healthprize Technologies Announce Self-Reporting & Barcoding Capabilities for Self-Injection Technology September 22, 2015
West Pharmaceutical Services, Inc. and HealthPrize Technologies, LLC, recently announced the completion of the first two phases of their four-phase...Lubrizol CDMO Acquisition Significantly Broadens its Capabilities September 12, 2015
The Lubrizol Corporation recently announced it has acquired Particle Sciences, a leading contract drug development and manufacturing organization with a...Corbion & MedinCell Form Strategic Joint Venture August 18, 2015
The joint venture, CM Biomaterials, will sell the PEG / PLA co-polymers to MedinCell partners who license the MedinCell technology...INDUSTRY PERSPECTIVES - The Future of the Pharma & Biotech Industries: Your Colleague’s Perspectives June 30, 2015
The Global Formulation Report in this issue provided some interesting data on what has been happening in a number of key sectors over the past 18 months. We thought it would be intriguing to hear what some of your colleagues believe will have a significant impact on the Pharma and Biotech industries throughout the next 5 to 10 years.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future May 5, 2015
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
EXECUTIVE INTERVIEW - Gerresheimer: Plastic Perfection May 4, 2015
Niels Düring discusses Gerresheimer’s Plastic Packaging division and the complementary synergies working for a company that also manufactures glass provides.
Teva's Potential $40-Billion Acquisition Could Transform Generics Space April 24, 2015
Teva Pharmaceutical Industries’ recent $40.1-billion offer to purchase Netherlands-based Mylan, which is crucially contingent on Mylan not consummating its offer...New Mechanism for Engineering Genetic Traits Governed by Multiple Genes Paves Way for Various Advances March 18, 2015
When it comes to gene expression, scientists have so far studied one single gene at a time. A new approach...US Asthma Treatment Market Value to Hit $14 Billion March 17, 2015
The US treatment market for asthma will rise in value from $11.7 billion in 2013 to an estimated $14 billion...SPECIAL FEATURE - Bioavailability & Solubility: A Demand for Enhanced Technologies & Materials is Spurring Innovation March 3, 2015
Contributor Cindy H. Dubin spoke with several contract research/manufacturing organizations on how they are successfully overcoming solubility/bioavailability challenges, such as matching APIs to formulations and choosing the best excipients.
STANDARDIZATION TECHNOLOGY - Innovative Temperature Standardization Technology Supports Cell Therapy Clinical Trials March 2, 2015
Rolf O. Ehrhardt, MD, PhD, and Maria Thompson, PhD, discuss a unique proprietary temperature standardization technology that is practical for all stages of cell processing and handling. It is currently supporting a Phase IIb clinical trial investigating the efficacy of an immunotherapy treatment for patients with moderate-to-severe refractory Crohn’s disease.
REGULATORY GUIDANCE - Staying on Top of FDA Guidance for Industry - Training Webinars Foster Transparency & Collaboration March 2, 2015
Frost & Sullivan recently tuned into three webinars that were considered to be particularly relevant to current hot topics and therapy areas, and then reviews the current trends and needs behind each new or revised guidance document and key insights for potential sponsors.
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…..
