America may have five times as many biotech firms as Britain, and scores of real products to show for its efforts (only one British firm, Chiroscience, actually has a drug on the market), but Britain has its own powerhouses around Oxford and Cambridge, and in Surrey and central Scotland, to compare with American clusters around Boston and San Francisco.
Once a drug is on the market, physicians are free to prescribe it for other conditions, though drug companies can't promote such off-label uses.
During the first 180 days a generic drug is on the market, the generic company has a virtual market monopoly for its formulation.
And as Genzyme's Mr Tambuyzer notes, rare diseases become less rare once a drug is on the market.
At a showdown meeting next week, an FDA advisory committee will vote on whether the drug should stay on the market, in a culmination of years of controversy over whether the drug causes heart attacks or not.
The FDA does have emergency powers to put a drug or vaccine on the market soon, and Adams said that was a distant possibility if something went awry in the federal supply line for the H1N1 vaccine.
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But small changes can be lost in the fine print of the label, and it may be harder to change habits once a drug has been on the market for several years.
Organon chemist Anton Bom had the radical idea of making a drug that targets another drug, rather than targeting a protein, as just about every other drug on the market does.
Chief executive Ryan Howard plans to mine what he says is a database of 40 million patients by, for example, helping pharmaceutical companies enroll patients in clinical trials, or monitoring a drug following its release on the market.
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They then injected the animals with a drug called amlexanox, which has been on the market for more than 15 years to treat canker sores.
The FDA approved the drug and kept it on the market for a long time, despite a very modest weight loss benefit and obvious problems with the safety of the drug.
There is still a long way to go before millions of patients take 301012 to prevent heart attacks--although the drug could be on the market to help some exceptionally sick people in just a few years.
The U.S. Food and Drug Administration might not be willing to put a vaccine on the market based on such limited data.
Another political intelligence firm, Marwood Group, employs 130 people and was recently subpoenaed by the SEC after one of its clients used Marwood intelligence to short the market on a drug that failed to receive FDA approval.
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Once a drug is approved, other medicines can get on the market by proving they are better.
Being first on the market vastly improves a drug's odds of reaching blockbuster status, as well as securing a place of honor in the annals of scientific breakthroughs.
The agency has taken on new obligations in the past two years in areas like post market drug safety, the creation of a pathway for follow on biologics, and regulation of new advertising channels like the Internet.
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If the amyloid theory is right, anti-amyloid drugs are still highly unlikely to be a cure. (One reassuring possibility is that the bad Eli Lilly result was due to a drug toxicity, not its effect on amyloid.) Only a handful of the drugs that hit the market early will snag most of the sales, if things go the way they usually do.
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Merck is working on a drug that counteracts a major side effect of Niacin, an HDL-raiser that is already on the market.
The two biotech firms have finished their safety review of Tysabri, the multiple sclerosis drug that the companies pulled from the market on Feb. 28 after it was linked to a rare brain disorder.
In the U.S., the first generic drug maker to challenge the patents on a branded drug can be granted a six-month monopoly that prevents other copycats from entering the market.
Studies indicate that Vanlev, a hypertension drug many analysts had once expected to be a blockbuster, may not be much better than inexpensive competition already on the market.
With a 17% stake, a position on ImClone's nine-member board and a partnership to market the company's blockbuster cancer drug Erbitux, Bristol-Myers isn't just any shareholder.
Many doctors were as surprised as investors, because a panel of 32 experts had voted narrowl to keep the drug on the market--yet the agency made the opposite decision.
's controversial diabetes drug, looks likely to stay on the market with just a warning.
In a sign of the increasing hunger among drug giants to get in on the potentially lucrative market for copycats of expensive biotechnology drug, Amgen, the largest standalone biotechnology company, and generic firm Watson Pharmaceuticals will collaborate on developing copycate medicines for cancer.
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The Food and Drug Administration has released the briefing documents for the expert meeting in which it will ask a panel of doctors whether or not the GlaxoSmithKline diabetes drug Avandia should remain on the market, and, if so, what warnings patients should get before they take it.
Zometa is currently on the market, approved by the Food and Drug Administration for a bone-related complication of cancer.
Most chemists in the drug industry go their entire careers without working on a drug that makes it to market.
The drug was expected to be a big driver of growth for Ivax because it had the only copycat version of the drug on the market.
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