Concern about pharmaceuticals in our water supply has been in the public consciousness for a few years now. In 2009, the Environmental Protection Agency found traces of various drugs in fish caught in rivers that receive effluent from wastewater-treatment plants. The drugs were believed to come from doses that people had excreted or flushed down the toilet. In response, FDA updated its guidelines for disposing of drugs. New research, however, shows another potential source of drugs in our waterways. Read more »

Partnerships and strategic agreements are common in the pharma industry. Flicking through my inbox of the last few days I see Bristol-Myers Squibb and Ono, Catalent and Toyobo Biologics… both very sensible. But one particular announcement this week gave me cause to raise my eyebrows and smile.

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Mistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…

…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains. Read more »

Botox is a household name when it comes to vanity and related calls for cosmetic surgery. Produced by bacteria (Clostridium botulinum), botulinum is a powerful neurotoxin—it seems strange to me that people have overcome such dangerous sounding words to repeatedly request that it be injected in their face. But then again, fans of tattoos and piercings are not phased by thick needles, pain (or disfigurement), and (off-topic but interesting) a British student recently had her tongue surgically lengthened to help improve her Korean pronunciation. We’re ok with body modification then. And why not? Read more »

Giving goes a long way, and lately, industry and regulators seem to be more open to giving out information. FDA and EMA recently released an update about their joint pilot programs. One pilot, which ran December 2008 to December 2010 and involved FDA, EMA, the European Directorate for the Quality of Medicines, and the Australian Therapeutic Goods Agency, focused on sharing surveillance lists about API manufacturing sites. The shared reports influenced agency decisions about inspections and imports. The second pilot involved FDA and EMA and focused on good clinical practice. The two agencies exchanged more than 250 documents relating to 54 drug products and organized 13 collaborative inspections of clinical trials. Read more »

Free trade, always a subject of concern for business, has been a topic of particular interest for the pharmaceutical and allied industries this past week as individual companies and trade associations weigh in on the debate on several free-trade measures. Read more »

Healthcare reform in Germany has had pharma companies grumbling for months. Among other things, the new system limits the amount that pharma companies can charge for prescription drugs; a law known as AMNOG demands that companies submit a cost–benefit dossier for new drugs, with the outcome being used to set the price, which is a bit of a thorn in pharma’s side. Read more »

Pharmaceutical companies’ interest in furthering their positions in emerging markets is no secret, and this past week, two companies, Novartis and AstraZeneca, offered updates of current projects in one country, Russia. Read more »

Children are not just small adults, which is part of the reason why developing paediatric drugs is not easy. Most medicines are designed for and tested in adults, and then prescribed to children off-label. In particular, there is a lack of medicines for infants aged 0–2 years. There are a variety of reasons for this shortage — mostly relating to the ethical, regulatory and practical issues associated with testing new drugs in infants. Most parents, for instance, would not want new drugs to be tested on their children! Read more »

Biosimilars can be considered a controversial subject because of safety concerns related to immunogenicity. Despite this, the biosimilars industry seems to be booming. Recent research from industry analysts Datamonitor estimated that the value of the global market for biosimilars would jump from $243 million in 2010 to $3.7 billion in 2015, and the biosimilars have now been used safely for 5 years, according to the European Generic Medicines Association (EGA). Read more »