Sarah Houlton

It could be the end of the road for the UK's biotech firms if drastic action isn't taken soon.

The new EU directive looks to reduce, refine, and eventually replace animal testing

EU makes plans to police its supply chain

Will the sole-wholesaler approach mean higher costs for NHS?

Pharma defends itself against claims made in charity's report on drug access for the world's poor

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

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.

It's not always obvious just who is reponsible for the various steps of pharmacovigilance.

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.

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

Public revulsion at animal-rights extremists is damaging their cause. The majority of people deem the worst offenders to be terrorists.

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.

Drugs are not directly addressed in Europe's new legislation for chemicals. But they'll be affected, because chemicals are used in drug manufacturing.

In Europe, seven of the top-10 injectible drugs are biologics. Generic versions could be priced 25 to 40 percent lower than prescriptions.

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.

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.

A recently released report claims pharma hides bad clinical trial results and over-promotes drugs. Tougher regs are being called for.

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.

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.

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.

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

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.

Between January and June this year, 45 UK vendors capitulated to the activists and stopped supplying pharma companies.

After saying last year that its treatments for AIDS and malaria were as cheap as they could be, GlaxoSmithKline now claims that improved manufacturing practices and greater economies of scale allow it to reduce prices even more.

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.

Patents help ensure that companies can recoup their development costs-and make profits-by selling their products without competition for a set period of time. The pharma industry has followed that model for decades.

Product development glitches continue to depress share prices at AstraZeneca. Poor trial results for the company's cancer drug Iressa followed hard on the heels of bad news about its cholesterol treatment Crestor (rosuvastatin).

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.

Shares in Danish company Novo Nordisk took a hit after it suspended trials for one of its main pipeline candidates, the dual-acting insulin sensitizer, ragaglitazar.