Then, as another bellwether, watch for approval of the economically obvious XL oil pipeline from Canada.
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It expects to apply to the FDA for approval of GLYX-13 in early 2016, says Ronald M.
Genentech is expected to complete its rolling application for approval of Avastin by the end of September.
Roche filed for approval of its anemia drug Cera this year, and several analysts expect approval in the U.S. in 2007.
In due course, Bill Clinton accepted this formulation, as well, when it became a non-negotiable Senate precondition for approval of the CWC.
That trend is destined to continue because in 2010 the number of applications for approval of new drugs was the lowest in decades.
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ImClone Systems' (nasdaq: IMCL - news - people ) application for approval of its colon cancer drug, Erbitux , was so inadequate that regulators refused to consider it.
Some key background: In May 2003, Paddock filed an Abbreviated New Drug Application (ANDA) with FDA for approval of a generic version of AndroGel, as did another generic producer, Watson Pharmaceutical.
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Genta's melanoma, leukemia and myeloma trials are all nearing completion, and the company along with partner Aventis (nyse: AVE - news - people ) hope to file for approval of Genasense in the summer of next year.
Today, Bristol-Myers (nyse: BMY - news - people ) and ImClone (nasdaq: IMCL - news - people ) submitted a new application for approval of the drug, far sooner than many skeptics had predicted.
He was characterized by a brash style, and chose to file with the Food and Drug Administration for approval of Provenge on studies that had failed their main goal of preventing tumors from growing, but seemed to make patients live longer.
This despite the fact the Senate demanded, as a condition for approval of the CWC, and received assurances that certain applications of RCAs by the military were permissible, an understanding that until now was upheld by Republican and Democratic administrations alike.
's U.K. newspaper unit, much of the session was devoted to a dissection of whether the media company improperly used its political muscle and connections as it lobbied the U.K. government for regulatory approval of its multibillion-dollar bid, launched in June 2010, for BSkyB.
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Roche said it plans to file for FDA approval of T-DM1 by the end of this year.
Based on these studies alone, AstraZeneca asked the FDA for accelerated approval of Iressa on Dec. 28, 2001.
We should lower the barriers at the Nuclear Regulatory Commission for the approval of new nuclear reactors, especially the new small ones.
Across the country, politicians are responding accordingly, and that is clouding prospects for congressional approval of pending free-trade pacts with South Korea and Colombia.
He may even call an election before 2000 to ask the voters for their approval of the terms on which he might negotiate a final settlement.
The merits of these are that they allow any airline to fly where and when it wants between two countries, with no limits on capacity or need for official approval of fares.
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Boston Scientific (nyse: BSX - news - people ), another rival, said yesterday that it plans to file soon for FDA approval of its own drug-coated stent, leaving Guidant a distant third.
The next day ImClone announced that the U.S. Food and Drug Administration had rejected its application for the approval of its Erbitux cancer drug, the one product in its pipeline, causing a steep decline in the share price.
The Technical Secretariat of ICHAD has planned to submit the Revised Draft of Curriculum to Education Material Approval for Printing Committee (EMAP) of the Ministry for final approval in July 2012.
And the SEC could slam EY for, what looks like to me, papering over misleading disclosures with their quarterly review stamp of approval and for their bungling of the Matthew Lee investigation.
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Monsanto has received U.S. Department of Agriculture approval for commercial sale of Bt strains of corn, potatoes and cotton.
In forums that look like Twitter feeds or Facebook pages, sales teams can share leads and information about clients (some of it gleaned from profiles on public networks), ask for and get speedy approval of discounts and slap one another virtually on the back for clinching a deal.
Due to the lack of evidence of efficacy in early clinical trials, the drug (a combination of two proven cardiac medicines) had been rejected by the Food and Drug Administration nine years previously for approval for patients of all races.
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The AWC alleged that Knieriem prepared a number of Verbal Forms for approval and signed the names of the relevant MSSB employee who had received the verbal instruction.
Since the Coalition now needs a seal of approval for the revised standard version of their bill from those who had qualms about the original, her public support would be a valuable prize.
Indeed, they even submitted lists of the managers they proposed to hire for approval by the Board of the Fund.
FORBES: The Politics of Minority or Emerging Manager Programs (August 2, 2004 )
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