Tech Talk

With around 80% of APIs manufactured outside the US, many in developing nations without strong regulatory oversight.

The confluence of science, technology, and regulation can provide path forward.

Historically, the pharmaceutical industry had the luxury of accepting lower manufacturing utilization rates compared to other manufacturing industries given the higher margins for their products.

The 2009 swine flu pandemic (and panic) has been forgotten by most, but regulators, global health organisations and pharmaceutical companies are continuing post-pandemic activities.

Amid one of the most divisive eras in our nation’s political history, one thing we can all pretty much agree on is the fact that our stalled economic engine needs a jumpstart.

Personalized medicine is gaining traction as scientists gain greater understanding of disease processes.

GlaxoSmithKline this week gave the UK government and several trade organisations reason to celebrate after announcing that it will build a new manufacturing facility in the country.

“One of the most daunting challenges facing pharmaceutical companies is securing the long and complex supply chains that are typical in today’s global industry.

A critical drug that has experienced shortages is Genzyme’s, Fabrazyme (agalsidase beta), the only enzyme replacement therapy approved in the US for Fabry disease.

Is it a mark of desperation? UK-based pharma company AstraZeneca has resorted to suing the US Food and Drug Administration in a bid to stop it from approving generic competition to Seroquel, the company’s blockbuster anti-depressant, before December 2012.

This week, the Drug, Chemicals, and Associated Technologies Association (DCAT) is holding its annual week-long meeting in New York City.

Medicine regulatory agencies in the EU, US and Australia have been successfully collaborating for some time now in the area of GMP inspections of API manufacturers.

A short time ago, I wrote about the Transforming the Regulatory Environment to Accelerate Access to Treatments Act, (TREAT).

Gartner has developed a body of research around the convergence of IT and Operational Technology (OT) and the implications for organizations (1).

FDA's treatment of whistleblowers lacks internal consistency.

This week an interesting report was released about the use of gelatine in medicines. Most of us are comfortable with the use of animal products as ingredients.

Rare disease day is an annual awareness-raising event coordinated at the international level by EURORDIS, a non-governmental patient-driven alliance of patient organizations representing more than 502 rare diseases patient organizations in over 46 countries.

Last week, counterfeits of the anti-cancer drug Avastin were discovered in the US and this week fake pharmaceuticals continue to occupy headlines.

Senator Kay R. Hagan (NC) introduced a piece of legislation called the Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) Act.

In an article published in Nature last June, FDA’s Darrell Abernethy, Lawrence Lesko and Janet Woodcock outlined the agency’s desire to incorporate “mechanism-based drug safety assessment and prediction” into the regulatory approval process.

Much negative criticism has been directed at the pharmaceutical industry’s perceived lack of innovation in recent years, but one area that has received a lot of attention is neglected diseases.

FDA and Genentech, a member of the Roche Group, have issued warnings about counterfeit versions of the injectable cancer drug, Avastin, circulating in the US. According to the FDA safety alert, the counterfeit version of Avastin does not contain the medicine’s active ingredient, bevacizumab, which may have resulted in patients not receiving needed therapy.

After its high profile acquisition of Genentech in 2009, Roche is back in the M&A spotlight again.

After months of anticipation, the Food and Drug Administration issued guidances last month that outlines its recommendations for developing and approving biosimilar therapies.

A report released on Feb. 8, 2012 from the California Healthcare Institute, BayBio and PwC shows that the shrinking economy, changes in investment strategies, and pressures on the pharmaceutical market have put the brakes on one of the US’s most robust biotechnology centers.

Textbooks and journal articles treat common cause variation as if it is an inevitable fact of nature and beyond our control: “In any production process, regardless of how well-designed or carefully maintained it is, a certain amount of inherent or natural variability will always exist.

Pfizer has proactively recalled 28 lots of birth control pills. An investigation by the company discovered that some blister packs may have mixed up the inert and active ingredient tablets. Watch the PharmaFaceoff video blog on YouTube to see what happened and why.

Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V.

Rachel Sherman, MD, Associate Director for Medical Policy, within FDA’s Center for Drug Evaluation and Research, gave a press briefing today. Below is a summary.

Rumors of change at AstraZeneca have been rumbling through newspapers all week and yesterday the company finally revealed the details by releasing a statement about its restructuring initiatives “to drive productivity and support innovation”.