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. Included in the reports were approximately 15161 deaths, although the European Medicines Agency explained at the time that the actual number of reports could be lower once verified. EMA also added that the deaths may not have a casual link to the medicine. Either way, it’s still a huge number of reports that should have been assessed.

Today, the case accelerated as the European Medicines Agency launched an infringement procedure against Roche to investigate the alleged pharmacovigilance deficiencies. Read more »

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. However, as is the case with virtually every achievement since the dawn of civilization, the question remains the same: Where do we go from here?

From May–July 2012, Solar Impulse—with the help of several sponsors, including Bayer MaterialScience, the subsidiary of the pharmaceutical manufacturer Bayer—successfully completed a series of flights (known as Crossing Frontiers) as part of a round-trip journey from Switzerland to Morocco, setting several world records, according to the World Air Sports Federation, in the solar-powered subcategory (including for free distance along a course, and for straight distance with predeclared waypoints). In addition, the mission included the first solar-powered intercontinental flight linking Europe to Africa when Solar Impulse’s HB-SIA plane crossed the Strait of Gibraltar.

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In a bit of good news for pharma, Moody’s Investors Service has upgraded its outlook for the global pharmaceutical industry to stable. The Moody’s rating reflects expectations for fundamental business conditions in the industry over the next 12 to 18 months, and until now, the industry had been limping along under a negative outlook assigned back in October 2007. According to a statement from Moody’s, the change in status reflects the fact that worst of the revenue drops caused by blockbuster drugs falling off patent are over, and so earnings are expected to stabilize. Read more »

Yesterday, Sanofi issued a press statement titled “Sanofi provides information on the adaption of its activities in France through 2015.” Read past the headline and you quickly realise that the ‘adaption of activities’ involves eliminating around 900 jobs at the company’s sites France by 2015. You can read the statement here.

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An important third party is struggling to make its voice heard in European pharma discussions. Drug pricing is not just a matter of manufacturers battling with health ministries, insist groups representing the end-users of medicines — that is, the patients. Over and above the questions of costs and bureaucracy, the more important issues of equity and patients’ rights are at stake. And these, according to patient groups, are critically threatened by delays in access to treatment. Read more »

The European Medicines Agency announced on July 30, 2012, that its efforts to increase interaction and cooperation with regulatory authorities in Japan have paid off. In 2007, confidentiality agreements between the EU and Japan were established for a five-year period to allow for an exchange of information to enhance regulatory and scientific processes. According to EMA, the areas of orphan drugs, pediatrics, advanced therapies, pharmacogenomics, and nanomedicines have especially benefited from the collaboration. Read more »

Last week, I looked at a consultation in the UK concerning access to unlicensed medicines. The 12-week consultation, launched by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), seeks opinions on giving physicians the option to prescribe seriously ill patients certain medicines that are still progressing through Phase II and Phase III clinical trials. The blog is available here.

The scheme forms a key part of the UK government’s Strategy for UK Life Sciences, which aims to support innovation and give the UK a leading role in life sciences globally. Included in this is a provision to provide patients with better access to innovative medicines. Read more »

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recently launched a 12-week public consultation for a national scheme that will look at the possibility of providing seriously ill patients with access to unlicensed medicines still in Phase III, or possibly even Phase II, clinical trials. Similar initiatives, mainly through extensions of clinical trials or managed-access programmes, are already in place in certain parts of the UK, as well as in the US and other countries, but these are often ad-hoc in nature and locally based. The proposed scheme would provide a national approach to providing early access to certain medicines in the UK.

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There are many ways in which pharmaceutical companies can make a contribution to society beyond developing and manufacturing medicines. GlaxoSmithKline, based in the UK, has always been keen to position itself as a supporter of the British economy so it’s no surprise to see the pharma giant being patriotic once again as it touts its involvement in the Olympic Games, which will start in London in just under two-weeks time. Read more »

Germany used to be a golden market for the pharma industry in Europe because the country allowed global pharmaceutical companies to set their own prices for new medicines. However, all good things must come to an end…

In Germany, healthcare reform (known as AMNOG – Arzneimittelmarkt-Neuordnungsgesetz) that came into effect in January 2011 introduced stringent new pricing measures that linked the price of a medicine to its perceived therapeutic benefit. Eighteen months from the reform and the full effects have been realised. Although successful in cutting costs (a primary goal of the legislation), the change has resulted in a number of global companies delaying or refusing to market their drugs in Germany. It’s a testament to the fact that Germany has historically been one of the first markets in Europe to receive innovative new drugs. Read more »