In two weeks the results of the Arbiter 6 study of Merck's cholesterol pill Vytorin v. Abbott Labs' Niaspan will be unveiled at the American Heart Association meeting in Orlando. A different study out today found that Niaspan was effective in reducing artery thickness . BNET previously noted that no one expects Vytorin to win the Arbiter 6 study . If Arbiter 6 becomes the third study in which Zetia and Vytorin fail to demonstrate superiority on a primary endpoint, that could wipe 20 percent off those drugs' sales , according to Bernstein analyst Tim Anderson.  
Share:  In two weeks the results of the Arbiter 6 study of <span class="company">Merck</span>'s cholesterol pill Vytorin v. Abbott Labs' Niaspan will be unveiled at the American Heart Association meeting in Orlando. A different study out today found that Niaspan was effective in reducing artery thickness . BNET previously noted that no one expects Vytorin to win the Arbiter 6 study . <span class="sent"> If Arbiter 6 becomes the third study in which Zetia and Vytorin fail to demonstrate superiority on a primary endpoint, that could wipe 20 percent off those drugs' sales , according to Bernstein analyst <span class="analyst">Tim Anderson</span>. </span>...In two weeks the results of the Arbiter 6 study of <span class="company">Merck</span>'s cholesterol pill Vytorin v. Abbott Labs' Niaspan will be unveiled at the American Heart Association meeting in Orlando. A different study out today found that Niaspan was effective in reducing artery thickness . BNET previously noted that no one expects Vytorin to win the Arbiter 6 study . <span class="sent"> If Arbiter 6 becomes the third study in which Zetia and Vytorin fail to demonstrate superiority on a primary endpoint, that could wipe 20 percent off those drugs' sales , according to Bernstein analyst <span class="analyst">Tim Anderson</span>. </span> Tweet this 

Leerink's Seamus Fernandez and Kathryn C. Alexander say that Merck could prevail in the fight — on a technicality! .  
Share:  <span class="sent">Leerink's <span class="analyst">Seamus Fernandez</span> and Kathryn C. Alexander say that <span class="company">Merck</span> could prevail in the fight — on a technicality! . </span>...<span class="sent">Leerink's <span class="analyst">Seamus Fernandez</span> and Kathryn C. Alexander say that <span class="company">Merck</span> could prevail in the fight — on a technicality! . </span> Tweet this 

The $41 billion Merck merger wrapped up yesterday, and the sun rose today on a combined company that's the world's second biggest drugmaker. Celebratory executives predicted high single digit earnings growth over the next several years and pledged to scout for more licensing deals armed as they are with $8 billion in cash and investments. . That earnings growth won't come without a price, of course. 
Share:  <span class="sent">The $41 billion <span class="company">Merck</span> merger wrapped up yesterday, and the sun rose today on a combined company that's the world's second biggest drugmaker. </span> Celebratory executives predicted high single digit earnings growth over the next several years and pledged to scout for more licensing deals armed as they are with $8 billion in cash and investments. . That earnings growth won't come without a price, of course. Tweet this 

Not according to the FDA. This sort of thing doesn't happen to Merck every day, but the agency refused to accept its application to turn Pfizer's Lipitor and Zetia, the cholesterol pill it sells with Schering Plough, into a combination medicine, according to a filing with the US Securities and Exchange Commission ( see page 46 ). "The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA's response in order to determine a new timetable for filing," Merck disclosed in a terse two line statement in the filing, which calls the drug MK 0653C. The drugmaker submitted its filing to the FDA only last September, an unusually speedy rejection by the agency. "For a company this size, this is not the norm," Steve Brozak, an analyst with WBB Securities, tells the Associated Press.  
Share:  Not according to the FDA. This sort of thing doesn't happen to <span class="company">Merck</span> every day, but the agency refused to accept its application to turn Pfizer's Lipitor and Zetia, the cholesterol pill it sells with Schering Plough, into a combination medicine, according to a filing with the US Securities and Exchange Commission ( see page 46 ). "The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA's response in order to determine a new timetable for filing," <span class="company">Merck</span> disclosed in a terse two line statement in the filing, which calls the drug MK 0653C. The drugmaker submitted its filing to the FDA only last September, an unusually speedy rejection by the agency. <span class="sent"> "For a company this size, this is not the norm," <span class="analyst">Steve Brozak</span>, an analyst with WBB Securities, tells the Associated Press. </span>...Not according to the FDA. This sort of thing doesn't happen to <span class="company">Merck</span> every day, but the agency refused to accept its application to turn Pfizer's Lipitor and Zetia, the cholesterol pill it sells with Schering Plough, into a combination medicine, according to a filing with the US Securities and Exchange Commission ( see page 46 ). "The FDA has identified additional manufacturing and stability data that are needed and the Company is assessing the FDA's response in order to determine a new timetable for filing," <span class="company">Merck</s Tweet this 

The two drugmakers have been partners on cholesterol medicines since 2000 and are about to merge. Merck, of Whitehouse Station, N.J., applied to the FDA in September for approval of the combo pill. But Merck said the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug. "For a company this size, this is not the norm," said analyst Steve Brozak, president of WBB Securities. Normally, when companies seek approval of an experimental drug, the FDA accepts the application and spends months reviewing it. 
Share:  The two drugmakers have been partners on cholesterol medicines since 2000 and are about to merge. <span class="company">Merck</span>, of Whitehouse Station, N.J., applied to the FDA in September for approval of the combo pill. <span class="sent"> But <span class="company">Merck</span> said the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug. "For a company this size, this is not the norm," said analyst <span class="analyst">Steve Brozak</span>, president of WBB Securities. </span> Normally, when companies seek approval of an experimental drug, the FDA accepts the application and spends months reviewing it. ...The two drugmakers have been partners on cholesterol medicines since 2000 and are about to merge. <span class="company">Merck</span>, of Whitehouse Station, N.J., applied to the FDA in September for approval of the combo pill. <span class="sent"> But <span class="company">Merck</span> said the FDA refused to file the application and instead is requiring more data on the manufacturing and stability of the drug. "For a company this size, this is not the norm," said analyst <span class="analyst">Steve Brozak</span>, president of WBB Securities. </span> Normally, when companies seek approval of an experimental drug, the FDA accepts the application and spends months reviewing it. ...<span class="company">Merck</span>, of Whitehouse Station, N.J., applied to the FDA in September for approval of the combo pill. <span class="s Tweet this 

Merck and Schering Plough said Thursday they have won merger approval from the Federal Trade Commission and antitrust regulators in Switzerland and Canada. Merck hopes to close its $41.1 billion acquisition of Schering Plough before the end of the year. The companies said that the F.T.C and Canadian Competition Bureau ended their waiting periods to review the transaction. 
Share:  <span class="sent"><span class="company">Merck</span> and Schering Plough said Thursday they have won merger approval from the Federal Trade Commission and antitrust regulators in Switzerland and Canada. </span> <span class="company">Merck</span> hopes to close its $41.1 billion acquisition of Schering Plough before the end of the year. The companies said that the F.T.C and Canadian Competition Bureau ended their waiting periods to review the transaction. Tweet this 

Recently, Merck ( MRK , Analyst Report ) and Schering Plough ( SGP , Analyst Report ) received approval from the US Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger. However, the transaction has yet to receive approval from other regulators, including China and Mexico. The deal was approved by the European Union antitrust regulators last week. 
Share:  <span class="sent">Recently, <span class="company">Merck</span> ( MRK , Analyst Report ) and Schering Plough ( SGP , Analyst Report ) received approval from the US Federal Trade Commission (FTC), the Swiss Competition Commission and the Canadian Competition Bureau for their proposed merger. </span> However, the transaction has yet to receive approval from other regulators, including China and Mexico. The deal was approved by the European Union antitrust regulators last week. Tweet this 

Investors suing Merck over Vioxx got a boost from the White House yesterday. In an amicus curiae brief filed with the Supreme Court, the Obama administration backed the investors' right to sue the drugmaker. You'll remember that Merck contended the shareholders should have sued earlier; information about Vioxx risks had been public for awhile by the time they filed suit in 2003. Vioxx wasn't withdrawn from the market until 2004. 
Share:  <span class="sent">Investors suing <span class="company">Merck</span> over Vioxx got a boost from the White House yesterday. In an amicus curiae brief filed with the Supreme Court, the Obama administration backed the investors' right to sue the drugmaker. </span> You'll remember that <span class="company">Merck</span> contended the shareholders should have sued earlier; information about Vioxx risks had been public for awhile by the time they filed suit in 2003. Vioxx wasn't withdrawn from the market until 2004. Tweet this