Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs

Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy and safety outcomes similar to the originator biologic.1

New REACH nanomaterial requirements: what you need to do

On December 3, 2018, the European Commission (EC) adopted Regulation 2018/1881, amending the existing , amending the existing Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, to directly address nanoparticles. The nanotechnology regulation applies to any substance that might be, or might contain, a nanomaterial (e.g., powder), whether or not it has been manufactured as a nanotechnology. Crucially the revised nanoparticle regulation applies to both new and registered substances and all dossiers will need to be updated with the necessary data.

Oren Cohen, MD, recalls life as an infection disease physician during the HIV epidemic of the 1980’s

Sunday, December 1 is World AIDS Day, an international day dedicated to raising awareness of the AIDS pandemic caused by the spread of HIV infection, and a time to remember those who have died of the disease. It has been observed worldwide since 1988.

Addressing the challenges of data management for pharmaceutical and biotechnology companies: introducing Laboratory FSPx

Data currency management for clinical trial laboratory results can be a point of frustration for today’s pharmaceutical and biotechnology companies. Whether data is coming from a contract research organization (CRO), a central laboratory or third-party laboratories, fulfilling the need for timely availability of clean data based on unique sponsor format/industry requirements has become extremely complex.

Approaches to Accommodate a Wide Range of Asthma Patients

Controlling exposure often helps patients with asthma, a common condition that is often managed with self-care and inhalers.

How to run successful eFate studies for industrial chemicals

Environmental fate (eFate) studies are well established for crop protection chemicals and pharmaceuticals and are becoming commonplace for industrial chemicals, but what are the key considerations for setting up and running them?

Incorporating the patient voice to improve ulcerative colitis recruitment

The exact cause of ulcerative colitis (UC) is still unknown, but approximately 700,000 people in the United States suffer from this chronic, life-long disease that causes inflammation in the large intestine. A wide range of treatment options are available, but drug development sponsors are seeking additional ways to control inflammation, achieve remission and address relapses.

K-REACH: how to register in 12 easy steps

In 2015, South Korea introduced legislation designed to protect human health and the environment from the impact of chemicals. With an estimated 44,000 chemicals in use in South Korea and about 300 new chemicals marketed annually, registrants and regulators will be kept busy assessing the risk posed to humans, animals and the environment by these chemicals. Effective Jan 1, 2019, this legislation has been revised to impose stricter controls on a broader range of substances.

Precision imaging of antibody biodistribution in vivo with Zirconium-89 PET

Zirconium-89 (89Zr) has revolutionized discovery and translation of Ab (and Ab fragment) therapeutics via PET biodistribution imaging.  With standard, straightforward labeling chemistry, 89Zr provides unprecedented specificity and sensitivity of PET Ab detection (to pM levels).  We use 89Zr PET as a platform assay for in vivo quantification of:

Labcorp delivers unmatched COVID-19 diagnostic and therapeutic applications

We’re in this together: How they are delivering unmatched acceleration of COVID-19 diagnostic and therapeutic applications