Tech Talk

Sales of traditional drugs fell for the first time according to Express Scripts’ annual Drug Trend Report.

Biopharmaceutical production is an often discussed application for single-use technologies, but single-use technologies also have application for small-scale finished drug-product manufacturing for producing clinical-trial materials.

In January, 2011, FDA released its guidance, Process Validation, General Principles and Practices, describing process validation practices based on quality-by-design principles.

The US Orphan Drug Act of 1983 defines a rare disease as one that affects fewer than 200,000.

As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace.

Are equipment innovations keeping up with manufacturers’ needs? What do industry members think about quality by design and process analytical technology? The editors at Pharmaceutical Technology and Pharmaceutical Technology Europe are currently running a survey of trends in finished drug product manufacturing and innovation in pharmaceutical equipment and manufacturing to gain feedback on these and other questions.

Researchers from Heriot-Watt University in Edinbugh and Roslin Cellab in the UK describe a method for producing uniformly sized spheroids composed of human embryonic stem cells in the Feb. 4, 2013 issue of the journal Biofabrication.

The growing dangers from substandard and falsified medicines around the world has prompted a blue-ribbon panel formed by the Institute of Medicine (IOM) to call for clear international standards for higher quality medical products, plus an electronic tracking system in the US to uncover bogus products in the supply chain.

Janssen is partnering with the UK National Health Service (NHS) on a new programme that seeks to inspire innovative ideas that will help reshape and improve the way dementia care is delivered.

President Obama’s State of the Union Address on Feb. 12, 2013 touched on some issues that may directly impact the pharmaceutical industry: healthcare reform, innovation, and job creation.

According to FDA, 75% of the products in shortage are generic sterile injectables; low-margin products that must be manufactured in specialized facilities and that must meet stringent quality metrics.

I’ve written frequently about the problem of counterfeit medicines in the United Kingdom and how the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is working to prevent these, but counterfeits are not the only potentially dangerous medicines that are becoming increasingly prevalent.

In an article called “Beyond magic bullets: true innovation in health care,” published in the February 2013 issue of Nature Reviews Drug Discovery, scientists from Janssen encouraged the healthcare industry to think outside of the drug product-focused box and look at an integrated approach to care, said a Janssen press release.

Developing and maintaining the right labor pool is an ongoing challenge for any industry, and it is one that the pharmaceutical industry also is facing. Recent attention in the pharmaceutical industry has focused on the restructuring that has occurred and that is still occurring among the large pharmaceutical companies.

Consultancy firm IDEA Pharma has released what it calls a ‘Productive Innovation Index’, which ranks pharmaceutical companies based on their ability to successfully commercialise new innovations.

San Francisco and Boston sit on opposite coasts and each has a rich history and character that make them distinct. However, they share some similarities: both cities are centers of top biotechnology hubs in the US.

Revisions to the United States Pharmacopeia (USP) General ChapterHeavy Metals have been much discussed over the past decade.

Federal law enforcers are looking hard at pharmaceutical manufacturers that put consumers at risk by cutting corners on product quality and safety and violating current good manufacturing practices (cGMPs).

At the end of February, sunny southern California will be the site for a week-long conference devoted to the development and production of biopharmaceuticals.

There are growing concerns regarding the safety of third- and fourth-generation combined oral contraceptives following media reports on blood clots (venous thromboembolism) associated with the use of more recently-introduced contraceptive products containing newer progestins such as drospirenone, gestodene and desogestrel.

In the dog-eat-dog world of federal deficit reduction in the US, there seems to be one health-related spending cut with broad bi-partisan support:

Biosimilars. They bring cheap prices to patients and healthcare payers, but for biopharmaceutical companies, such products impact the sales of innovative biopharmaceuticals.

A new international agreement to reduce mercury contamination of air and water was recently adopted by 140 countries, without a proposal that threatened to limit access to vaccines in much of the world.

Biopharmaceutical companies are touting their huge investment in R&D, which has filled the drug pipeline with more potential first-in-class medicines, including orphan drugs, personalized medicines and new therapies based on novel scientific strategies.

Six of the world’s leading health research centres have joined forces to form a global alliance that seeks to strengthen international academic and not-for-profit drug development.

Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October.

PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry.