Tech Talk

Pharmaceutical Technology and Patheon are partnering to provide you-our readers-with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world.

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Orphan drugs achieved blockbuster status in 2011, generating over $50 billion, and have the potential to generate as much lifetime revenue as drugs used for more common health conditions, according to a report from Thomson Reuters’ IP & Science division.

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin.

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Be Prepared

As the saying goes, an ounce of prevention is worth a pound of cure. The US Department of Health and Human Services (HHS) has taken that advice to heart.

An upcoming report on India’s pharmaceutical industry in PharmTech (check out the October 2012 issue) discusses India’s strict patent policies and got me thinking about the rights of intellectual property versus patients’ rights to needed medicines.

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A federal appeals court has ruled that the National Institutes of Health (NIH) can continue to fund embryonic stem cell research, upholding a July 2011 ruling that found that such research does not violate the Dickey-Wicker Amendment prohibiting federal funding for research in which a human embryo is destroyed.

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It’s common knowledge in the pharmaceutical industry that medicines regulators do not conduct as many inspections of foreign drug-manufacturing facilities as they might like to.

The International Society of Automation’s (ISA’s) 7th Marketing and Sales Summit, held Aug. 15–17, 2012 in Austin, Texas, was themed “New Rules of Customer Engagement: Riding the Winds of Change”, and emphasized the need to adapt to the changing needs, expectations, and behaviors of marketplace decision makers, according to an Aug. 27, 2012 press release.