This week, the European Commission (EC) began a public consultation in relation to a review of the ‘Transparency Directive’ (89/105/EEC), which concerns the transparency of the pricing and reimbursement of medicines in different EU Member States. Considering the fact that the Directive hasn’t been amended for more than 20 years, it’s about time someone took a closer look at its implications on modern healthcare! Read more »

A possible link between cases of the chronic sleep disorder narcolepsy and GlaxoSmithKline’s H1N1 pandemic vaccine, Pandemrix, has led to a call from the World Health Organization (WHO) for further investigation. Narcolepsy is a rare condition with no currently available cure. Read more »

At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »

There was no joy in Paris, at least at sanofi-aventis (Paris) headquarters, on Friday. When the company’s offer to acquire Genzyme (Cambridge, MA) at $69 per share expired that day, fewer than 1% of the biopharmaceutical company’s outstanding shares had been tendered. In response, sanofi extended its deadline to January 21, 2011 without modifying the terms of its offer. Why should the company expect a different result in six weeks’ time? Read more »

Recently, I spoke to R. Arun Kumar about the wider applications of cloud computing. Arun Kumar is Vice President and Head of the Global Life Sciences Business Unit at Infosys, an IT, business consulting and outsourcing services provider. Read more »

Journalists continue to comb through the latest batch of diplomatic cables released by WikiLeaks, seeking to interpret the mass of raw information. Until now, the cables’ significance has seemed to be limited to political circles. But one cable turns out to contain the 2008 version of the Critical Foreign Dependencies Initiative (CFDI) list, which names international facilities that could be considered crucial for American security. Perhaps not surprisingly, the list cites several pharmaceutical and biopharmaceutical facilities. Read more »

The news that Ireland reached an agreement with the European Union and International Monetary Fund for a EUR 85 billion ($110 billion) bailout, which includes EUR 67.5 billion ($88.8 billion) in external assistance and EUR 17.5 billion ($23 billion) from the Irish government raises an important question for the pharmaceutical industry as to how fiscal policy for European Union member states may affect the environment for pharmaceutical manufacturing. Read more »

The European Medicines Agency (EMA) is expected to release shortly for public consultation guidelines for biosimilars for monoclonal antibodies (mAbs). As the regulatory environment for biosimilar mAbs begins to be debated, how strong is their market potential? Read more »

So I’ve just returned from an exhausting but a fantastic week in Paris. The beautiful French capital played host to this year’s CPhI exhibition and whilst I didn’t get to take advantage of the cultural and architectural wonders that the city has to offer, I have to say that I came away with a real feeling of optimism (accompanied by a pair of very sore feet of course). Read more »

The global recession is still prompting a lot of belt tightening. Patients and healthcare payers are looking for ways to cut costs, and drugmakers are trying to boost their manufacturing efficiencies. Developing countries naturally are feeling the squeeze more keenly. Budget constraints in those nations could keep patients from receiving necessary vaccines, which often are produced from recombinant proteins in a multistep process that is complicated and expensive. Read more »