Tech Talk

Cargo theft, for many years, was a problem that largely plagued the electronics industry, but criminals have recently shifted more attention to the far more lucrative pharmaceutical trade.

In the September PharmTech issue, researchers from MIT’s Center for Biomedical Innovation (CBI) describe the interim results from recent research into 34 commercial-scale biopharmaceutical products at 11 international sites.

Deviations happen. FDA recognizes this and requires deviations to be investigated and documented, say Peter Smith and David Elder. The former senior FDA officials are both in strategic compliance consulting at Parexel. When performing a deviation investigation, FDA expects certain things.

On Sept. 12, 2012, the Pharmaceutical Research and Manufacturers of America (PhRMA) is cohosting a brand new national awards program at the Newseum in Washington, DC, to honor individuals and organizations who have contributed significantly to the advancement of patient care and medical innovation in the United States.

Federal Judge Jose L. Linares of the District Court of New Jersey has ruled to move forward to hear an antitrust suit filed by a group of doctors against Sanofi in December 2011.

Tufts University research shows that silk protein can be used to stabilize and maintain the potency of vaccines and other drugs that would otherwise need refrigeration.

Change Management: How to Deal Published by Angie Drakulich on August 14, 2012 02:19 pm under Regulation Finding an effective and fully compliant change management system that works is not easy.

On the heels of last week’s study showing that generic pharmaceuticals saved US consumers around a trillion dollars over 10 years, the Generic Pharmaceutical Association (GPhA) took the opportunity to advocate for the strategy known as pay-to-delay.

PhRMA Senior Vice-President Matthew Bennett released a statement today on the state of the biopharmaceutical industry, in response to an analysis in the British Medical Journal.

Improving lives for less-that’s the tagline from the press release from the Generic Pharmaceutical Association (GPhA) describing the results of an IMS study of the savings produced by generic medicines.

Emerging markets continue to attract the attention of pharmaceutical companies thanks to their high growth and large patient populations.

Just about a year ago, in July 2011, FDA published a roadmap for addressing the challenges of globalization

An important third party is struggling to make its voice heard in European pharma discussions.

No matter the upside or downside to the Affordable Care Act, there's work to be done.

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes

The news that the London 2012 Olympic Games aims to be the first Olympics to be “zero waste to landfill” is an indication of the growing importance of finding new ways to fulfill the old mantra of “reduce, reuse, and recycle”.

The US District Court for the District of Columbia has ruled that FDA has the authority to regulate stem-cell treatments as drugs.

Prominent scientists and political leaders at the International AIDS Conference in Washington, D.C., in late July were optimistic for the first time about bringing an end to the global AIDS pandemic.

If your company has ever received a 483 from FDA, you likely had a ton of questions about how to respond, how to make things right, and fast.

Athletics and drugs do not share the spotlight often, but when the two combine, it usually turns heads.

This week, industry members and experts gathered in Philadelphia for two days of informal presentations and discussion regarding biopharmaceutical manufacturing partnerships.

What will be the future of pharmaceutical outsourcing? What factors will influence the relationships between sponsor companies and contract service providers and what practical solutions are both seeking?

New drug approvals sometimes come in class-specific clusters, as drug makers competing for the same indication race to get to market first. In the US, the year 2011 was notable for approvals of drugs to treat hepatitis C. Merck’s protease inhibitor, Victrelis (boceprevir), was the first in its class to be approved in May 2011, followed later that month by Incivek (telaprevir) from Vertex Pharmaceuticals.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials

Tomorrow opens the Biopharmaceutical Manufacturing Partnerships conference in Philadelphia, in coordination with CBI and Pharmaceutical Technology magazine.

It’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients.

The pharmerging nations are expected to nearly double their spending on medicine by 2016, according to an IMS Institute for Healthcare Informatics report, The Global Use of Medicines:

There are many ways in which pharmaceutical companies can make a contribution to society beyond developing and manufacturing medicines.