Sarah Houlton

Sarah Houlton, PhD, is Pharmaceutical Executive’s international correspondent.

Articles by Sarah Houlton

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One of industry's main complaints is that delaying the introduction of new medicines is a particularly simple way of saving money

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A landmark court case in the United Kingdom has left Alzheimer's patients with mild to moderate disease unable to receive any of the three drugs that might help them-Aricept (donepezil), Reminyl (galantamine), and Exelon (rivastigmine). Eisai and Pfizer, which make and market Aricept, had challenged the ruling made last year by the National Institute for Clinical Excellence that the drugs should be prescribed only to patients in the later stages of the disease. They were granted a judicial review-the first time one of NICE's decisions had been challenged in this way-and while the judge upheld one part of the challenge, the other two parts were dismissed and NICE's guidance stands.

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If the uk's office of fair trading (OFT) is to be believed, Brits are overpaying for their medicines to the tune of ?500 million a year. That's the conclusion the OFT came to in its long-awaited report on the Pharmaceutical Pricing Regulation Scheme (PPRS), the arcane method by which drug prices are set in the United Kingdom.

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Even when NICE has said that drugs should be available to anyone who needs them, patients still have to convince their Primary Care Trusts.

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Staggering doses in clinical trials may prevent large numbers of people from experiencing serious side effects. But it presents practical and ethical dilemmas, such as determining who is going to be first in line for their dose.

Genentech and Biogen's MabThera has been awaiting NICE appraisal for three years. Merck KGaA's Erbitux has waited two-and-a-half years. A ruling on AstraZeneca's Arimidex isn't expected for more than a year.

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SPCs extend a drug's basic patent protection for up to five years, to take into account the time that may have lapsed between the filing of a patent application and the granting of market authorization.

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Conventional wisdom says that generics businesses are a drain on valuable resources. But these units are much less prone to the disastrous drug safety panics that Big Pharma has recently endured.

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Pharma companies in Europe believe that it already takes too long for new medicines to reach patients. Separate bodies for efficacy and safety will lead to further delays.

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When Is Enough?

The British trade association says the cuts are unnecessary because drug prices have fallen in real terms by 10-15 percent during the last 10 years while the UK government's budget has remained steady.

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If trial results never reach the public, researchers could waste time repeating lines of inquiry that have already proven unsuccessful.

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The fakes likely entered the market through internet commerce, yet the government seems to be encouraging online pharmacies by discussing a shakeup of retail drugstores.

Current lawmakers make frown on cannabis use, but for thousands of years people used it to treat conditions as diverse as rheumatism, convulsions, tumors, and pain. Now the small, private UK company Oxford Natural Products has completed Phase I trials on a cannabis derivative for treating post-operative and cancer pain.

A major consolidation may be underway in the UK biotech sector. According to a report in London's Financial Times, several embattled companies specializing in cancer medicines are talking about a possible merger. Xenova, British Biotech, Antisoma, KS Biomedics, and Oxford GlycoSciences are believed to be in the early stages of discussions about merging to create a much stronger company.

Many more high-risk patients could benefit from statin therapy than currently receive the cholesterol-lowering drugs, according to a major UK study set up by the Medical Research Council and the British Heart Foundation.

Spurred by concerns about rising drug expenditures, the Netherlands' government has introduced a list of "lifestyle" medicines that it intends to stop covering with its basic health insurance.

The number of pharmaceuticals derived from nature is staggering. Many medicine cabinet staples were first isolated from natural sources-penicillin from mold, quinine from the cinchona tree, digitalis (foxglove) for heart ailments, and the list goes on.

Donal Geaney and Tom Lynch, chairman/CEO and vice-chairman, respectively, of the troubled Irish pharma company Elan, resigned following intense pressure from investors.

Croatia's Pliva Pharmaceuticals is the first eastern European pharma company to make a US acquisition. Pliva paid $153 million for New Jersey-based Sobel Holdings,

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