Ed Price
Just before the new year 2017, it was reported that new legislation was approved to speed up FDA approvals. This was designed to enable faster and more industry-friendly drug and medical device approvals that could bring innovation and treatments to patients who desperately need them.
Xiaochun Yu, PhD, Derek Wood
Leachables are compounds or elements that migrate from the container/closure system components, manufacturing process components or drug product delivery system components into the drug product formulations or directly to the patients under normal conditions of storage or use.
Denise Basow, MD
One of the most pressing issues facing the U.S. and nearly every country is the trajectory of healthcare costs. Healthcare spending in the U.S. grew 5.8% in 2015, reaching $3.2 trillion, or $9,990 per person.
Gil Y. Roth
“All predictions null-and-void if Trump wins the US Presidential election:" That’s how I closed out last year’s ‘Looking Ahead’ piece. Suffice to say, my crystal ball is C-R-A-C-K-E-D, and my backup Magic 8-Ball’s answer to everything is, “Reply hazy. Try again later."
A common challenge that we see our clients face when developing new products is the lack of drug substance (DS) available for development activities.
Simon Moore
Up until recently, inhaled drugs have been used to deliver medicines that have been specifically targeted at the most prominent of respiratory diseases – these being chronic obstructive pulmonary disease (COPD) and
asthma. At present, it is estimated that around 235 million people across the globe are suffering from asthma and that in excess of 200 million people have COPD - with the startling rates set to increase further in developing countries.
Lan Huang, Richard A. Brand
In the U.S., biopharma companies are tasked with developing experimental cancer drugs and conducting countless clinical trials, all of the while lacking the appropriate numbers when it comes to the amount of patients who are available for testing. In fact, sometimes only four percent of patients enroll in clinical trials, and there are hundreds of trials that compete at any given time, significantly slowing the patient enrollment process.
Gwenaël Servant, Ph.D.
Serialization/aggregation regulations are being implemented or are already in place, in many countries around the world. All members of the pharmaceutical supply chain have a responsibility to comply with these regulations in order to prevent counterfeit medicines from reaching patients.
Nigel Walker
Academic researchers, tech-savvy startups, Big Pharma and biotech, nonprofits, government institutes and public-private partnerships are investigating existing drugs/drug candidates for the treatment of new indications.
The industry has evolved into a digital, patientcentric environment that is producing massive amounts of patient and population data. Research data is no longer limited to clinical trial data.
Sunny Christian, MS, Harshada Sant, MS, Amitkumar Lad, PhD, Hemant N. Joshi, Ph.D., MBA
This column summarizes newly approved drugs and new indications for already approved drugs from February to May 2017. This includes New Drug Applications (NDAs) for small molecules, Biologics Licensing Applications (BLAs), Medical devices and Biosimilar applications. FDA approved 52 applications in these four months.