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 »

With 2011 sales of approximately $54.1 billion, Pfizer currently holds the crown as the world’s largest drugmaker, but next year may see the pharma giant usurped from its throne by Sanofi and Novartis, who will claim pole and second position respectively in the global pharmaceutical rankings. Pfizer, meanwhile, will drop to third place, and is likely to remain there for the foreseeable future, according to analysis firm EvaluatePharma. Read more »

The pharma industry has been scratching its head for some time about how best to exploit social media and efforts in this area have been tentative with uncertainty over regulations. Pharmaceutical spammers, on the other hand, have little reason to hold back. Already, spammers are taking advantage of Twitter to promote cheap pharmaceutical products such as Viagra and Levitra. Indeed, a recent study by the University of Akron in the US explained that Twitter “presents a new forum for spammers to facilitate illegal pharmaceutical scams”. 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 »

Bribery and corruption are not supposed to happen, but of course they do happen and no industry is immune. In 2009, the World Health Organisation estimated that healthcare fraud and abuse can cost individual governments as much as $23 billion a year.

Fortunately, there are many rules and watchdog organisation keeping a close eye on businesses to make sure everything is honest and above board. In the UK, bribery rules have recently been strengthened by the long-awaited (or long-dreaded depending on how you look at it) Bribery Act 2010. Although it’s UK legislation, it has a long reach. It will impact any corporate entity that conducts business in the UK and applies to business interactions both inside and outside the UK. 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 »

Every now and then, media headlines become excited by a new potential ‘cure’ for cancer. Usually, this excitement stems from the results of very early research, which often involves a vegetable. Tomatoes, broccoli, cabbage, sprouts and beetroot have all had their turn in the spotlight over the years. Read more »

The other day I was editing an interesting piece about e-prescribing in Europe. A lot of processes in both healthcare and the pharma industry, as well as in every other aspect of our lives, are moving to electronic systems and, of course, such systems offer many benefits. Being sceptical, however, I turned to my colleague and asked, “what happens when the system goes wrong?” Because, let’s face it, all electronic systems seem to suffer serious issues at some point. Read more »

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 »

There’s a lot of activity between the EMA and the FDA at the moment. Recently, reports have been published following two international pilot programmes regarding API inspections and good clinical practices (GCP). The outcome of the pilots? Success! Read more »