Now it’s official. Rumors about sanofi-aventis’s (Paris) desire to purchase Genzyme (Cambridge, MA) have stirred speculation for weeks. The French drugmaker laid its cards on the table on Sunday by publishing its offer letter to Henri Termeer, Genzyme’s CEO. Sanofi proposed to pay $69 in cash per Genzyme share, or a total of about $18.5 billion, to acquire the biologics manufacturer. On Friday, Genzyme shares closed at $67.62.

Termeer’s response came this morning. It can be summed up in two words: nothing doing. Read more »

Pharmaceutical companies sometimes explain their unimpressive pipelines by saying that it’s become harder to discover and develop new drugs. Believing that the low-hanging fruit has been picked already, manufacturers are focusing on serving small patient populations. But a new paper suggests that the industry may be overlooking the potential of a particular class of drugs to treat tens of millions of patients. Read more »

They may be well-meaning, but sometimes the EU’s decisions can have harmful effects, as is the case with its much criticized clinical trials directive. Read more »

In the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

Companies always want the longest patent protection possible for their products — and with good reason considering the immense costs of R&D. However, some companies go a little too far in seeking patent protection to the point that they may even try to mislead the regulators in order to extend the life of patents. Read more »

The calamitous and ongoing Deepwater Horizon oil spill has brought pollution to the center of the public consciousness again. The environmental effects of the petroleum industry’s operations have been the subject of public scrutiny for years. The current spill has understandably focused regulators’ attention on oil pollution, but we should remember that other sectors, including the pharmaceutical industry, can sometimes release pollutants into our waterways, too. Read more »

Late last month, MEPs on the European Parliament committee responsible for health voted to include sales of pharmaceuticals over the internet in the European Commission’s draft directive on falsified medicines. With some surveys suggesting that more than 60% of drugs purchased online are fake, bringing internet sales under new mandatory safety rules for pharmaceuticals is aimed at reducing the supply of ‘potentially lethal’ fake medicines in the European Union. Read more »

A committee of the European Parliament voted yesterday to regulate online pharmacies to prevent falsified medicines from entering the legal supply chain. The committee agreed that the provision should be included in new draft EU legislation regarding falsified medicines and pharmacovigilance. Read more »

The European Medicines Agency (EMA) has recently undergone a year-long evaluation by Ernst & Young assessing its effectiveness and efficiency, and the results are largely positive for the agency. Read more »

Patent expiries and the imminent threat of competition from generics is the bane of many pharmaceutical companies’ lives and I’m frequently reading and writing about the doom and gloom pharma is facing because of these issues. This is of course a serious issue for the industry, but there are many beneficiaries, including healthcare providers. Read more »