Rare diseases are not so rare

Some rare diseases have famous fundraising events attached to them, like the Ice Bucket Challenge for ALS or the many walks, runs, and telethons for diseases ranging from cystic fibrosis to muscular dystrophy. Other conditions, like Wilson’s Disease, a rare condition in which excess copper builds up in the body, …

How to renew plant protection products – EU regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing …

Expediting SEND datasets for an international regulatory submission

A case study with Peg Biomedical Co., Ltd Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.   While business between Peg Bio and Covance first started in 2014, the strength and …

Honoring African American History Month: recognizing contributions from one of our own community-builders

National African American/Black History Month recognizes the accomplishments of African Americans who have made a difference in our society. Many notable African American physicians, engineers, scientists, and nurses have contributed to medical and scientific breakthroughs and continue to serve as role models for students of color interested in pursuing careers …

RA Biosimilar Recruitment

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

Introduction 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 …

New REACH nanomaterial requirements: what you need to do

The new EU nanotechnology regulation 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 …

Closing the knowledge gap with Real-World Evidence (RWE) studies: the importance of starting early

Successfully demonstrating product safety and efficacy in a randomized clinical trial is a monumental event, but it doesn’t always translate to market access and uptake one it’s launched. Since clinical trials are limited to a controlled sub-set of patients, observations recorded in the clinical trial setting can vary from what …

The 7 secrets to success in field trials for crop residue analysis

Residues of plant protection products (PPPs) are inevitably present in or on food, even when they are applied in line with good agricultural practice. The upper limit of residue permitted on food or feed is the ‘maximum residue level’ (MRL), which, in Europe, is legislated by the European Commission based …