GLOBAL FORMULATION REPORT – Notable Technologies, Approvals, Transactions, Pipelines & Inflection Points
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.
Robert Lins, MD, PhD, believes classical primary respiratory endpoints are far from successful in exploratory and confirmatory studies, and new techniques being developed have most potential in early phase, exploratory, clinical trials, but there may be the opportunity to apply at least some of them in the later stages of development.
SPECIAL FEATURE – Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
Joseph S. Dillon, PhD, MBA, and Lainie Mulvanny discuss the transformation of CNTs into a unique composition of matter, marking a complete departure from the dirty, tangled micron bundles of CNTs that frustrated medical researchers for years.
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
THERAPEUTIC FOCUS – Direct Effects™ Cannabinoid Therapy: Medical Cannabis Without Psychoactive & Systemic Effects
Ronald Aung-Din, MD, reports topical CBD is beneficial in treating symptoms of a number of neuropathic and psychiatric conditions. Individual clinical response varied depending on condition treated and on severity and longevity of symptoms, and overall, topical CBD therapy was well tolerated.
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
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.
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
EXCLUSIVE ONLINE CONTENT
CURE Pharmaceutical recently announced it entered into a multi-year licensing agreement for the first time with a leading international cannabis company.
Sol-Gel Technologies Ltd. recently announced it has entered into a collaborative agreement with Perrigo Israel, an affiliate of Perrigo Company plc, for the development, manufacturing, and commercialization of a generic product candidate.
Nevakar Inc. recently announced it entered into an exclusive licensing agreement with Endo International plc’s subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the US and Canada.
Credence MedSystems Closes $12.8-Million Financing to Support Ongoing Development & Scaling of Innovative Delivery Products
Credence MedSystems, Inc., an innovator in injectable drug delivery devices, recently announced the closing of a Series B financing resulting in gross proceeds to the company of $12.8 million.
Croda International Plc and SiSaf Ltd recently announced an exciting new strategic partnership. Croda, the name behind high-performance ingredients and technologies that are relied on by industries and consumers everywhere, has agreed a commercial arrangement with SiSaf, a pioneering UK-based biopharmaceutical company.