Featured Articles
THERAPEUTIC PEPTIDES - Continuous Manufacturing of Peptides Could Speed Up Development, Reduce Costs & Improve Quality
Jens Bukrinski, PhD, MSc, says the high-quality, high-process consistency between manufacturing runs and the in-line PAT analytics of the μLOT platform will enable unprecedented robustness of the manufacturing process, significantly retiring the risk of failure to supply due to non-scalability of the manufacturing process.
CANNABINOID THERAPY - NeuroDirect Effects(TM) CBD: Non-Systemic Cannabidiol for Autism Spectrum Disorder
Ronald Aung-Din, MD, says NeuroDirect Effects Technology CBD is particularly attractive in this population as it utilizes the body’s own ECS, and in utilizing a non-systemic therapeutic mechanism, there is less likelihood for long-term negative effects in developing brains of children.
ORAL THIN FILMS - Misconceptions, Advantages & Limitations About an Emerging Drug Delivery System
Srinivasan Shanmugam, PhD, says due to advancements in the science behind OTF design, as well as the predicted increase in OTF market valuation, this drug delivery system is becoming increasingly popular.
EXECUTIVE INTERVIEW - Tedor Pharma, Inc.: A Strategy Shift to Serve Both Generic & Branded Companies
Doug Drysdale, President & CEO of Tedor Pharma, Inc., discusses the FLEXITAB technology, his strategy for managing a shift in business model, and how Tedor is addressing the needs of small- and medium-size companies developing innovative and repurposed small molecules for unmet medical needs.
NATURAL LANGUAGE PROCESSING - How Life Sciences Companies Are Leveraging NLP From Molecule to Market
Jane Z. Reed, PhD, MA, discusses some of the challenges facing pharma researchers and executives; the benefit NLP can bring; and some specific customer-use cases (covering patent landscaping, gene disease associations, access to safety silos, and more).
DEVELOPMENT TIMELINES - Drug Development Times, What it Takes - Part 3
Josef Bossart, PhD, analyzes the development and review times of the US FDA’s new drug approvals (NDA and BLA) for the period of 2010 through 2018.
MARKET BRIEF - Allergic Rhinitis Immunotherapy: Opportunity Analysis & Forecasts to 2028
Rose Joachim, PhD, indicates that while a wide variety of OTC therapies exist for the temporary abatement of AR symptoms, allergen-specific immunotherapy is the only truly disease-modifying therapy available for AR.
STANDARD OPERATING PROCEDURES - How Writing an Effective SOP Can Influence Compliance & Build a Better Organization
Heidi Stuttz provides a common outline used in many companies and explores the essential elements of a well-written SOP that can be effective whether developing one from scratch or remediating a current system of SOPs that will foster success in every area of your company in which it is implemented.
CLINICAL STUDY REPORTING - Assessing the Value of Interim Analyses in Clinical Trials
Paul Stark, MS, ScD, reviews how and when an interim analysis would be valuable and how, with examples and outcomes, it can be applied in a clinical trial setting.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 2, Notable Drug Delivery & Formulation Product Approvals of 2019
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on notable drug delivery and formulation product approvals.
EXCLUSIVE ONLINE CONTENT
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
2019 Analytical Testing in Drug Development eBook - Regulations Help Propel Testing Market
This e-Book showcases the various types of services that leading testing companies offer and how they are helping industry comply with regulations to get their products approved and commercialized.
EXECUTIVE INTERVIEW - Oasmia Pharmaceutical: Commercializing Technologies While Pursuing the US Market
Julian Aleksov, Executive Chairman of Oasmia Pharmaceutical, discusses his company’s efforts to enter the US market, its strategy to increase commercial adoption, and why it believes its underlying drug delivery system technology is significant not only within the oncology sector, but the entire pharmaceutical industry.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.