October 2010





PHARMACEUTICAL

GSK settles $750 million whistleblower suit

GlaxoSmithKline (GSK) has agreed to pay $750 million (£471 million) to settle the criminal and civil charges relating to the manufacture of adulterated drugs at the company’s now closed plant at Cidra, Puerto Rico. Under the provisions of the US False Claims Act, the whistleblowing former staff member who initiated the suit will receive approximately $96 million.

The case involves drugs manufactured by GSK’s Puerto Rican subsidiary, SB Pharmaco, between 2001 and 2005. SB Pharmaco has pleaded guilty to releasing adulterated forms of its antiemetic Kytril (granisetron); the antibiotic Bactroban (mupirocin), the antidepressant Paxil (paroxetine); and its diabetes drug Avandamet (rosiglitazone with metformin), for which the company will pay a criminal fine of $150 million. GSK will pay an additional $600 million to the federal and state governments to resolve allegations that it caused false claims to be submitted to Medicaid and other federal healthcare programs for the adulterated drugs. (more…)

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Companies have started delivering their financial results for the third quarter of 2010. Here’s a look at some of the stats in so far. (All percentage changes are based on the same period last year.)

PHARMACEUTICAL

Abbott made sales of $8.7 billion (£5.5 billion), a 12 per cent increase. Operating income decreased 28 per cent to $1.2 billion.

Eli Lilly made sales of $5.7 billion, a 2 per cent increase. Operating income increased 49 per cent to $1.7 billion. (more…)

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What’s the connection between pregnant horses’ urine and the contraceptive pill? Find out with Hayley Birch in this week’s Chemistry in its element podcast

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PHARMACEUTICAL

Lorcaserin refused entry

The US decision on obesity candidate Lorqess (lorcaserin), developed by Arena, has been made – and it’s a thumbs down. According to the company, the Food and Drug Administration (FDA) said in its ‘complete response’ letter that ‘it cannot approve the application in its present form’.

The decision won’t be a surprise for most people. In September, the drug received a negative opinion from the FDA advisory committee. But it’s led to much speculation about how quickly Arena might be able to turn things around. The main issues flagged by the FDA seem to relate to tumours in animal studies and the overall efficacy of the drug – its capacity to reduce weight – which is described as ‘marginal’. 

(more…)

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Graphene cut by Nickel

Ni nanoparticles absorb carbon from graphene edges which then reacts with H2 to create methane © Nano Letters

New Scientist has published the second half of it’s 50 ideas to change science forever list, and it’s no surprise chemistry featured heavily again. So see the rest for yourself:

  1. Graphene: Although the Nobel prize went to physicists who found a new and convenient way of making this wonder material, no one can doubt the chemistry that  makes it so interesting. (See Chemistry World articles here, here, here)

    (more…)

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25 October 2010: Have something to say about an article you’ve read on Chemistry World this week? Leave your comments below…

(more…)

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PHARMACEUTICAL

Polished performance from Pradaxa

The US Food and Drug Administration (FDA) has approved Pradaxa (dabigatran), made by Boehringer Ingelheim, for the prevention of stroke and blood clots in patients with abnormal heart rhythm, known as atrial fibrillation.

The approval isn’t a huge surprise. In September, Boehringer got a unanimous 9-0 positive decision from the FDA advisory committee tasked with giving an opinion on the risk versus the benefit. But it will still be a very welcome bit of good news for Boehringer, which recently dropped development of flibanserin for the treatment of the hypoactive sexual desire disorder (HSDD) – a controversial condition characterised by low sexual desire in women.

Pradaxa is an anticoagulant that inhibits thrombin, an enzyme involved in blood clotting. In the most recent trial, called RE-LY, patients taking Pradaxa had fewer strokes than those who took warfarin. Interestingly, the drug will be available in 75mg and 150mg capsules, but RE-LY used on the 110mg and 150mg capsules.

Trials of apixaban, an oral anticoagulant developed by Bristol-Myers Squibb, have revealed good performance compared with aspirin. Results from the head-to-head study with warfarin are expected in April 2011. (more…)

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saltAre you the salt of the earth or below the salt? Find out the origin of these phrases and how humble salt has pervaded our everyday lives in this week’s Chemistry in its element podcast with author Brian Clegg.

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PHARMACEUTICAL

FDA approves Botox for migraine

The US Food and Drug Administration (FDA) has approved Botox (onabotulinumtoxin A), marketed by US biotech Allergan, for the treatment of chronic migraine.

The move comes just weeks after Allergan agreed to pay $600 million (£380 million) to settle claims that it illegally marketed Botox, best known as a cosmetic product for the reduction of wrinkles. It is likely to aid Botox sales, which flattened out in 2009 at $1.3 billion, the same as in 2008.

The approval only covers patients with chronic migraine: those that have headaches on 15 days per month or more. During a treatment session, medical staff make 31 Botox injections at seven sites around the head and neck in order to dull future headaches. The effects can last for up to three months, the company says. (more…)

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Is it possible that the UK government is only just waking up to the Registration, Evaluation, Authorisation & Restriction of Chemicals (Reach) regulation? It came into force way back in June 2007 – three years ago. But, with the first registration deadline only weeks away, UK cabinet ministers have written to European officials to ask for special conditions for some downstream users, the Financial Times has reported. (more…)

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