A Call for Clarity about Vaccines

Erik Greb PharmTech editorAs I wrote last week, the market for vaccines is expanding, and the newswires have stories about these products almost daily. Sanofi and GlaxoSmithKline, to name just two major players, are increasing investments in research and manufacturing capacity for these therapies. Kalorama Information predicts that sales of pediatric vaccines will grow even more quickly than sales for adult vaccines. Yet drugmakers have surely noticed that not all publicity about vaccines has been positive. Read more »

Narcolepsy Prompts GSK Vaccine Investigation

Stephanie Sutton Pharm Tech EuropeA 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 »

Echoes of Avandia

Erik Greb PharmTech editorBig Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »

Big Pharma Gets Caught in the WikiLeaks Spotlight

Erik Greb PharmTech editorJournalists 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 »

Avandia Banned In Europe

Stephanie Sutton Pharm Tech EuropeTwo weeks ago I wrote about GlaxoSmithKline’s Avandia (rosiglitazone) being under the magnifying lens of regulators because of cardiovascular safety concerns and the verdict is now in: the treatment is being pulled completely from the EU market and will face severe restrictions in the US.

Controversy has surrounded Avandia ever since it was first approved but in recent months there has been increasing pressure — including published articles and a UK television documentary highlighting the risks associated with Avandia — on the FDA and the European Medicines Agency (EMA) to take action. Read more »

Avandia’s Fate Debated In Europe

Stephanie Sutton Pharm Tech EuropeUK headlines this week have been in uproar about the safety of GlaxoSmithKline’s  (GSK) Avandia (rosiglitazone) diabetes drug, following an article in the British Medical Journal (BMJ), which claimed that the drug should never have been approved in the first place, as well as a television programme aired in the UK that highlighted cardiovascular safety concerns associated with the drug. Read more »

Will Sanofi Bag Genzyme?

Stephanie Sutton Pharm Tech EuropeThe past two weeks have seen dozens of third-party headlines speculating about sanofi aventis possibly making a move to acquire Genzyme. Officially, there has been no word with both companies remaining extremely cagey about any of the details. However, Reuters, Bloomberg and a few other sources claim to have squeezed out a few dribbles of information from “people familiar with the situation” and anonymous staff members. So let’s take a look at what may (or may not be) the current situation. Read more »

Actos Cashes In On Avandia Safety Concerns

Jacky LawCommunicating the risks of pharmaceuticals has never been easy. Say too much and no-one wants to take your drug; say too little and politicians, competitors and soon, the entire social media, will fill in the gaps for you. Read more »

UK welcomes patent box

Stephanie Sutton Pharm Tech EuropeThere has been a lot of talk in the media recently about a tax proposal in the UK that should offer companies more incentive to invest in innovative industries, such as pharma and biotech. The proposal, dubbed the ‘patent box’ was announced in the UK HM Treasury’s Pre-Budget Report 2009. Read more »

GSK Wants to Get under Your Skin

Erik Greb PharmTech editorDespite, or because of, economic difficulties and meager pipelines, the recent past has seen many drug companies investigate alternative delivery methods for new and established products. A new deal between GlaxoSmithKline (GSK, London) and Intercell (Vienna) reflects this trend and raises hopes for the development of innovative routes of administration. Read more »

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