FDA Accepts Biogen Biologics License Application for Biosimilar Candidate Referencing ACTEMRA (tocilizumab) December 12, 2022

Incannex Expands Intellectual Property Position Over IHL-42X December 6, 2022

Incannex Healthcare Limited recently announced the filing of a provisional patent application directed to the use of IHL-42X for the treatment of Obstructive Sleep Apnoea….

SPECIAL FEATURE - Injection Devices: Three Trends Influencing Development & Delivery September 1, 2022

Contributor Cindy H. Dubin showcases in this annual feature how various innovative device manufacturers are addressing the current trends in their injection designs.

GENE THERAPY - Developing Affordable Point of Care CAR-T Therapies: Expanding Efficacy & Impact August 31, 2022

Rimas Orentas, PhD, and Boro Dropulić, PhD, MBA, believe the future belongs to those who will be able to innovate rapidly, maintain regulatory confidence, and drive down costs to make CAR-T cell and other engineered cell therapies available to all who would benefit.

SYRINGE PLUNGER - Exploring How the Functional Properties of the PremiumCoat® 1-3-mL Plunger Facilitate its Implementation on Filling Lines & Enable the Delivery of Sensitive Vaccines & Biotech Drugs October 4, 2021

Sebastien Cordier, Laure-Hélène Guillemot, PhD, and Audrey Chardonnet explain how the PremiumCoat 1-3-mL syringe plunger combines a pure Bromobutyl formulation with a market-proven ETFE film that acts as a barrier to limit the transfer of rubber leachables into the drug product.

SPECIAL FEATURE - Injection Devices: Designing Simplicity, Safety & Adherence Into One Delivery System August 26, 2021

Contributor Cindy Dubin, in this annual report, speaks with industry innovators and takes a deep dive into the myriad injectables that are currently in development or recently introduced to the market.

PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 4 – Building Playgrounds & Fences June 1, 2021

Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.

BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications January 13, 2021

Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.

Arcutis Announces Enrollment of First Patient in Phase 1/2b Study  April 23, 2020

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.

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.

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.

BIOLOGICS DELIVERY - Enabling Biologic Drug Delivery of Volumes Beyond 1 mL August 29, 2019

Megan Lan, MBA, MA, and Patrick Le Gal say delivery system manufacturers need to use methodologies and tools to manage conflicting requirements and to offer delivery solutions that balance performance, robustness, and usability while delivering higher volume or viscosity biologics.

AbbVie’s Immunology Pipeline Will Protect it From Biosimilar Erosion February 1, 2019

Although AbbVie is feeling the impact of Humira biosimilar launch in Europe, its strong immunology pipeline is likely to protect its hold on the plaque psoriasis (PsO) and rheumatoid arthritis (RA) markets, according to GlobalData, a leading data and analytics company.

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.

iBio Establishes Strategic Commercial Relationship with CC-Pharming Ltd. July 10, 2018

Novel First-In-Class Immunotherapeutic APVO210 Features Unique Mechanism of Action Delivering IL-10 June 6, 2018

TxCell Names Lonza as its CAR-Treg Cellular Product Manufacturer June 6, 2018

TxCell SA and Lonza Pharma & Biotech recently announced entering into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation. 

ANTIBODY DISCOVERY - Why Understanding Immune Dysregulation is the Key to Drug Development June 4, 2018

David S. Johnson, PhD, provides a unique insight into immune dysregulation through a proprietary technology known as Surge – a platform that quickly characterizes every cell in complex immune systems so that natural immune repertoires can be translated into medical treatments.