Saturday, February 10, 2018
Each year industry leaders prognosticate about the year ahead and its challenges and opportunities. However, this year may be a bit different.
Thursday, December 07, 2017
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 ...
Monday, September 25, 2017
Process chemists developing Active Pharmaceutical Ingredients (APIs) for clinical trials today face a challenging array of business and regulatory hurdles.
Documentation – and loads of it – is essential in API manufacturing if a company wants to comply with current Good Manufacturing Practice (cGMP), and eventually seek and obtain FDA approval.
Wednesday, February 01, 2017
While manufacturing Active Pharmaceutical Ingredients (APIs) is a costly and time-consuming process, there currently is enormous market demand for APIs to address the challenges of an aging population, and an increasing amount of chronic diseases ...
Sunday, November 20, 2016
The 400 percent increase in the cost of the life-saving allergy treatment EpiPen has gotten its manufacturer, Mylan, into some deep scrutiny – and rightly so. Maybe it’s a combination of greed, market dominance, regulatory requirements and clearly ...
Friday, September 30, 2016
The roles of Contract Manufacturing Organizations (CMOs) and Contract Research Organizations (CROs) are growing at light speed as pharma, life sciences and biotech firms of all shapes and sizes discover the benefit of outsourcing key functions in the...
The price of ensuring quality in chemical manufacturing goes far beyond
cost. Hopefully, quality problems are caught before they can affect patients
but even then, such problems can make or break a manufacturing
organization. In the U.S., while it...
Judging by a resurgence of IPO activities since the new year and increasing
product commercialization news in the pharma and biopharma industries,
the future of these industries is clearly on the rise. And as the market for
generics continues to ...