Changes announced to two big clinical trials aimed at getting the drug on the market in the U.S. and other companies probably mean that it probably does add some bleeding risk.
The two firms will co-market the drug in Brazil, Australia, New Zealand and Russia with Glenmark retaining the rights for the Indian 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.
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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In 2005, the company pulled its multiple sclerosis drug, Tysabri, from the market after a patient who was taking the drug in conjunction with another medication died of a rare brain disorder.
But it still said the rising costs of drug development and the increase in time in takes from to bring a new drug to the market remains an ongoing problem for the pharmaceutical industry.
Earlier in January, Merck Chief Executive RichardClarkRichard Clark said he expected Vytorin to keep a secure position in the cholesterol drug market and cited several other ongoing studies in addition to this one.
Earlier in January, Merck Chief Executive Richard Clark said he expected Vytorin to keep a secure position in the cholesterol drug market and cited several other ongoing studies in addition to this one.
It is unclear whether the drug will remain on the market in these places.
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Because while the drug was taken off the market in the early 1960s as a cure for nausea, it was not long before researchers found it was remarkably effective in treating other conditions.
The approval opens a market of 40, 000 or so such women to London-based pharmaceutical company AstraZeneca azn (nyse: azn - news - people), which has the exclusive right to market the drug in the U.S. AstraZeneca already sells the drug to hundreds of thousands of women at risk of developing breast cancer.
The Pfizer drug was pulled from the market in 2000 because it caused liver problems.
Nor has it changed an already announced delay in Crestor's launch--the drug is still expected to go on the market in the fourth quarter, and not before.
Perhaps the rationale for the continued use of diclofenac is rooted in the fact this drug has been on the market for 40 years and that physicians feel comfortable with it, despite the warnings.
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It was used in the 1940s for allergic rhinitis, but apparently taken off the market in the 1970s as an approved drug after concerns developed regarding safety of the product.
That and the expense of distributing a drug in this manner keeps generic copycats off the market.
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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Regeneron has said it expects file with the U.S. Food and Drug Administration to market Arcalyst for gout in the middle of this year.
Owing to these factors, the global diabetes drug market has seen rapid growth rate in the last couple of years.
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But the drug will lose its patent protection in 2002, opening the market to copycat generic drugs sold at far lower prices.
On June 5 and 6, the FDA will convene an advisory committee meeting on the diabetes drug Avandia, which was removed from the market in 2010 in most countries and placed under severe restrictions in the United States.
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The trial in Texas highlighted the efforts drug companies will go to in order to boost their profits and market share.
The situation here reminds me a little bit of the biotech stocks: everyone is all excited about the unlimited prospects when a promising new drug is in trials, but once it hits the market, the company turns into a mundane pharmaceutical company that has to actually sell something.
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The FDA and the device makers, in the four years drug-coated stents have been on the market, should have collected more information about them so that safety questions could be answered.
In March an analyst for the hedge fund Great Point Partners started market chatter that the drug harms the liver, Isis alleged in an April internal memo.
Kevin Abar, assistant special agent in charge of Homeland Security Investigations in New Mexico, said there's evidence that Mexican drug cartels are getting involved in the counterfeit NFL black market trade because they can make quick money.
The new discipline could change the drug market by reducing the rate of product failure in clinical trials.
Pfizer' s blockbuster Celebrex will get the most serious type of warning the FDA can level, and Bextra, another Pfizer arthritis drug, will be removed from the market in the U.S. and in Europe.
Where UBS sees value is in the drug pipelines, which the market is pricing for free.
However, in recent years, the company has battled its way back to prominence with new product introductions, and has also taken the lead in the race to bring the next generation drug-coated stent to market.
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