
With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class.

With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class.

The pharmaceutical industry does not have a good reputation among patients and consumers.

In its new study on pharma market growth in Africa, IMS Health highlights three ‘rising star’ countries from the continent’s sub-Saharan region.

PharmTech’s March issue will feature an update on process analytical technologies that will include a focus on validation.

Over the last two years, the gap between analysts’ estimates of big pharma sales and the global drug market forecast by IMS Health has widened significantly.


In about 20 years and with a cost of around $10 billion. That’s the estimate given by researchers at the Beth Israel Deaconess Medical Center in the US who used quantitative modelling to forecast how much time and money would be required before pharmacogenomics could be expected to be used in clinical care.

A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation.

Continuous manufacturing is now becoming a trend as its advantages are being increasingly recognized.

Shortages of certain sterile injectables pushed some practices to source these products from unapproved distributers.

On the second day of the PDA/EMA joint conference, we had a choice of three different topics, all running simultaneously:

How to optimize continuous processing and make it work in pharmaceutical manufacturing is a crucial issue.

Once upon a time in the world of healthcare, the only competition for a pharmaceutical company was other pharmaceutical companies.

Last week, I attended the PDA/EMA joint conference in Cascais, Portugal.

Endo Pharmaceuticals, maker of the opioid medication Opana ER (oxymorphone HCl), is suing FDA to prevent generic manufacturers from entering the market with formulations of oxymorphone that are not abuse-resistant.

The second half of 2012 has not been kind to FDA. Last month, Secretary Hamburg was grilled by the House of Representatives for failing to follow-up on warning letters to the New England Compounding Center (NECC), now comes word that a U.S. District Court has ruled that a sales representative’s off-label promotion of a drug was protected speech.

Passengers travelling via Air France this December will see an in-cabin movie made by Sanofi to raise awareness about the dangers of counterfeit drugs.

Want to know what the future of pharma science looks like? AAPS knows.

Recent change likely to boost drug coverage by plans, but with variation in formularies.

The Polymer Processing Institute (PPI), an independent, not-for-profit, research and development organization that is headquartered at the New Jersey Institute of Technology (NJIT), has expanded its mission of working with industry and government to advance the field of polymer processing to include generating and using fundamental knowledge related to incorporating APIs into polymer excipients through hot-melt extrusion.

A golden era of productivity awaits the pharmaceutical industry in 2020, according to a report from PricewaterhouseCoopers (PwC).

No one likes needles, so imagine the benefits of needle-free delivery systems, especially for chronic conditions where lifetime therapy is required, for example rheumatoid arthritis (RA).

As an industry that is constantly being scrutinised, pharma is now under pressure to openly publish all data from clinical trials, including negative results such as failures of medicines during phase I–III evaluation.

Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak.

The editorial offices of PharmTech are based in New Jersey, so when Hurricane Sandy hit last month, we were all affected.

Rollprint Packaging Products’ new, patent-pending, color-changing sealant technology is appropriately named Chameleon; it enhances product security with a color change indicating that a pouch or tray lid has been opened.

The head of the Association of the British Pharmaceutical Industry has issued a stark warning about the state of the UK’s pharmaceutical industry.

In the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC).

Laboratory best practices for meeting regulatory and compendial requirements are changing. FDA’s emerging expectations on data integrity.

Last week, Merck agreed to settle a Missouri consumer class-action suit, which claimed the company violated the Missouri Merchandising Practices.