PharmTech Talk

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.

My daughter has been learning how to ride a bike for the past year. She’s actually become quite adept at it, and for someone who loves to cycle, I am certainly proud. But there were certain obstacles to overcome to get to this point. We started simply with the tricycle – learning to pedal.

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.

It’s been a few months since the Obama administration launched the Big Data Research and Development Initiative, aimed at pooling large collections of data to gain knowledge and insight into everything from national security to the environment to biomedical research.

This week, KV Pharmaceuticals filed a lawsuit against FDA to force the agency to stop compounded versions of their synthetic progesterone drug, Makena (hydroxyprogesterone caproate), from being produced.

Continuous manufacturing is the way of the future for solid-dosage pharmaceuticals, but one of the challenges for implementation is how to define a batch for quality assurance testing.

The recent announcement that GlaxoSmithKline will pay a record $3 billion in civil and criminal penalties marks the largest settlement ever incurred by a drug company,

Developments in hot-melt extrusion using twin-screw extruders to make solid-dosage drug forms.

Last week, I looked at a consultation in the UK concerning access to unlicensed medicines.