The end of the year is just around the corner so I thought I’d spend some time today looking at how marketing authorisation applications are progressing at the European Medicines Agency. The past few years have witnessed some dreary numbers in both Europe and the US when it comes to new products, but the figures for 2011 could be early indicators for a 2012 upturn. Read more »
Archive for the 'Europe News' Category
The Court of Justice of the EU ruled on Oct. 18, 2011 that “A process which involves removal of a stem cell from a human embryo at the blastocyst stage, entailing the destruction of that embryo, cannot be patented.” The ruling was not unexpected, following as it did a preliminary ruling in March 2011 by the Court that prohibited patents on embryonic stem cells, declaring such patents to be “contrary to ethics and public policy.” Read more »
Earlier this week, the European Commission (EC) at last clarified what information pharma companies are allowed to disseminate to the European public about prescription-only medicines. Although direct-to-consumer advertising (DTCA) of such medicines is part of everyday life in the US, it is banned in Europe. Historically, there has been no way for companies to convey the benefits of their products, and in recent years this has become problematic as patients take an increased interest in their own health and treatment programmes
The move by the EC this week will somewhat relax the stringent control, but it’s important to differentiate between providing information and full-blown DTCA. For a start, television, radio and general print media will not be allowed and the information will be factual rather than promotional. Read more »
Immunology was the focus of the 2011 Nobel Prize for Physiology or Medicine with the October 3 announcement that the award will be shared by three whose work has been seminal in the understanding of immune system function. Half the award will go to Drs. Jules A. Hoffmann and Bruce A. Beutler for their discoveries concerning the activation of innate immunity, and the other half will go to the estate of Dr. Ralph M. Steinman for his discovery of the dendritic cell and its role in adaptive immunity. Read more »
The European pharma industry has been very quiet in the summer months, but September has seen a flurry of action (and press releases to my inbox) as companies start gearing up for one of the most important European events for the pharma industry: CPhI Worldwide. The show starts on 25 October, and I hope you’ve made your travel arrangements to Frankfurt (Germany) because some flights and hotels are fully booked! This show is one of the most important in many European companies’ calendars.
I’ve been reading a lot about CPhI this week as companies prepare their media campaigns and with the start of October looming, I thought I’d take a brief look at where the behemoth event started and where it’s going. Read more »
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.
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 »