Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Read more »

FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »

Economically motivated adulteration became a major concern after heparin manufactured by Baxter Healthcare was contaminated with oversulfated chondroitin sulfate. FDA told the Government Accountability Office (GAO) that getting information from industry about potential instances of economic adulteration is crucial to addressing the problem. Companies have been reluctant to share this information, but a GAO report suggests a possible solution. Read more »

In attending CPhI this week in Frankfurt, one theme that repeatedly emerged was the increasing importance of CROs, CDMOs, and CMOs to build more strategic, deeper, and collaborative relationships with pharmaceutical companies as a way to meet the evolving needs of the industry and as a a mutual tool in value creation. Read more »

The Pharma ChemOutsourcing conference, an annual event that brings together pharmaceutical companies, CROs, and CMOs to discuss industry trends and perspectives, was held in Long Branch, New Jersey, last week. The central question at the heart of many of the discussions was a fundamental but important one: where is the opportunity in pharmaceutical outsourcing, specifically in pharmaceutical chemical development and manufacturing? Read more »

There’s a lot of activity between the EMA and the FDA at the moment. Recently, reports have been published following two international pilot programmes regarding API inspections and good clinical practices (GCP). The outcome of the pilots? Success! Read more »

Good news on the drug-approval front. Through the end of July, FDA’s Center for Drug Evaluation and Research had approved 21 new drugs (new molecular entities and new biologics license applications), which equals the total number of new drugs approved in all of 2010. Although not enough to claim a reversal of the recent downward trend in drug R&D productivity, the numbers are a good sign for the industry. Read more »

The pharmaceutical industry has sometimes been slow to embrace ideas that promise great practical benefits. The industry’s ingrained aversion to risk is partly to blame, but it’s usually not the whole story. Take the quality-by-design (QbD) initiative, which posits that the better a company understands a product’s quality attributes, the more likely that product will be safe and efficacious. The industry has generally supported this initiative, and Pfizer has brought it into the spotlight. Read more »

In 2008, a shortage of pig intestines, used in the manufacture of the blood anticoagulant heparin, was associated with the drug product’s contamination in China and led to many deaths around the globe. This event demonstrated the significance of a shortage of supplies needed to manufacture a particular drug and its effect on public health. Read more »