PharmTech Talk

Earlier this year in June, Roche’s name hit the headlines after a pharmacovigilance inspection discovered around 80000 safety reports that had not been evaluated by the company to determine whether they should be reported as adverse drug reactions.

Dr. Lei Zhang of CDER’s Office of Translational Sciences gave an update at the AAPS Annual Meeting in Chicago yesterday regarding the agency’s regulatory science initiative.

The recent presidential and vice-presidential debates have highlighted the need for strategies for economic growth in the US, including the roles innovation and trade play in stimulating the US economy.

The CPhI Innovation Awards, this year rebranded as the CPhI Pharma Awards, took place last week at CPhI Worldwide in Madrid.

Yesterday, I reported the news that the US Pharmacopeial Convention (USP) released new standards for labels on prescription containers dispensed by pharmacists in the US.

In an op-ed in the New York Times, a trio of physicians from the Memorial Sloan Kettering Cancer Center in New York announced their decision to remove an expensive new cancer treatment from the hospital formulary.

Recent years of low approvals of new blockbuster products have given rise to the perception that pharmaceutical drug development.

At this week’s AAPS 2012 Annual Meeting in Chicago, graduate students across the country are being honored for their research and work in bio/pharmaceutical innovation.

The best approach to deal with an observation with which a company does not agree is to prevent an FDA-483 observation in the first place.

Last week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product.

I’ll be in Chicago next week for the 2012 annual AAPS meeting and hope to see you there.

The perception of buyers of pharmaceutical ingredients and contract services in how they see market conditions and their own individual business prospects is an important barometer in assessing the market for pharmaceutical outsourcing and ingredients.

he Nobel Prize for Physiology and Medicine was shared by two researchers: Sir John B. Gurdon of the Gurdon Institute, Cambridge, United Kingdom; and Shinya Yamanaka of Kyoto University, Kyoto, Japan and the Gladstone Institutes, San Francisco, CA, “for the discovery that mature cells can be reprogrammed to become pluripotent.”

Research into hot melt extrusion (HME) as a solution to improve solubility continues to expand with a partnership between Encap Drug Delivery, a contract development and manufacturing organization in the UK, and the School of Pharmacy at the Queen’s University Belfast (QUB), announced in a press release this week.

As fine-chemical producers, contract manufacturers, and pharmaceutical/biopharmaceutical companies meet this week in Madrid at CPhI Worldwide, what are the key issues on the minds of industry players?

A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities.

Innovation is the cornerstone of the pharmaceutical industry. That innovation is not only seen in new drug development but also in approaches to extend the lifecycle of a given product through improved formulations and drug-delivery systems.

Biologic-based drugs are increasingly important in the drug pipelines of pharmaceutical companies.

Earlier this year, the concept of solar-powered aviation was further propelled from its proverbial runway, testing many limits that had not been previously realized in the realm of energy-efficient transportation.

Laboratories that offer stem-cell treatments have come under close scrutiny by FDA. A recent court ruling clarified that stem-cell products that have been more than minimally manipulated can be regulated as drugs, and FDA can require both an IND and manufacture under GMP for such products. Texas-based Celltex Therapeutics, a company that isolates and expands adipose-derived mesenchymal stem cells, ran into trouble with FDA earlier this year over its stem-cell products.

The heavy buzz at the recent fall technical conference sponsored by the Generic Pharmaceutical Association (GPhA) involved proposals for reorganizing the Office of Pharmaceutical Science (OPS) in the Center for Drug Evaluation and Research (CDER).

A new report has forecast that the global biopharmaceutical market will be worth more than $320 billion by 2020, up from just $138 billion in 2011.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry.

At the inaugural joint FDA/ISPE conference on CGMP earlier this year, the FDA’s Dr. Janet Woodcock delivered a strong message to the pharmaceutical industry: the efforts to adopt Quality by Design (QbD) principles within pharmaceutical manufacturing must be a top priority for the industry.

What’s the best way to reach first-in-man studies when you have little to no information? Bioavailability issues, financial constraints.

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question.

In a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable.

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.

Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015”.