And while we're on the subject of supplements . . .
Last time, I mentioned that lots of people take calcium supplements for "bone health." Well, you might want to think again. The linked article presents very complex statistical analysis, but to make a long story short the authors have done everything they can to control for potential confounding in an epidemiological cohort study. (They took advantage of a cohort of Swedish women recruited originally for a study of the benefits [or lack thereof] of screening mammography.)The bottom line is that the body regulates the level of calcium in the blood very closely. Unless you have a real calcium deficiency, more calcium won't m...
Source: Stayin' Alive - February 15, 2013 Category: Health Medicine and Bioethics Commentators Source Type: blogs
Merck Finally Settles Over Vytorin
You may remember that Merck and Schering-Plough took a lot of fire for the way that they released the clinical data for one of the key Vytorin trials (ENHANCE). The numbers were delayed for months, and when they were finally released, they were. . .problematic for the drug. And for the companies' stocks.
The institutional shareholders did not take that one well; and a number of them filed suit. This week it was announced that Merck has settled for $688 million, while admitting no wrongdoing. This settles the suit, but it isn't going to settle anyone's nerves, as Matthew Herper rightly observes:
Merck admitted no liabilit...
Source: In the Pipeline - February 15, 2013 Category: Chemists Tags: Cardiovascular Disease Source Type: blogs
Merck Pays $688M To Settle Suits Over Enhance Trial
On the eve of a widely anticipated courtroom battle, Merck has agreed to settle shareholder lawsuits over the highly controversial Enhance clinical trial for the Vytorin cholesterol pill. The latest deal actually resolves two separate lawsuits in which the drugmaker has agreed to make a total payment of $688 million, which was described as one of the 25 largest securities class action settlements ever by the lawyers who represented Merck shareholders.
For those who may not recall, the Enhance clinical trial was designed to boost sales of Vytorin, which combines Zetia and Zocor, but ended in failure. And a ruckus erupted w...
Source: Pharmalot - February 14, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Carrie Cox Fred Hassan Merck Schering Plough Vytorin Zetia Zocor Source Type: blogs
More on Merck
Merck settles lawsuits over cholesterol drug for $688 million
Merck & Co. has agreed to pay $688 million to settle two long-running lawsuits brought by investors who alleged the drugmaker delayed releasing bad news on its blockbuster cholesterol drugs to prevent a drop in sales.
Merck, the world’s third biggest drugmaker by revenue, said yesterday that it agreed to the settlement because it’s in the best interest of the company and current shareholders. It is taking a charge of nearly a half-billion dollars against 2012 earnings.
The delay in releasing results of a study that was meant to bolster sales of pricey chol...
Source: PharmaGossip - February 14, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Merck Pays $688M To Settle Suits Over Enhance Trial
On the eve of a widely anticipated courtroom battle, Merck has agreed to settle shareholder lawsuits over the highly controversial Enhance clinical trial for the Vytorin cholesterol pill. The latest deal actually resolves two separate lawsuits in which the drugmaker has agreed to make a total payment of $688 million, which was described as one of the 25 largest securities class action settlements ever by the lawyers who represented Merck shareholders.
More here
http://www.pharmalot.com/2013/02/merck-pays-688m-to-settle-suits-over-enhance-trial/ (Source: PharmaGossip)
Source: PharmaGossip - February 14, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Pharmalot… Pharmalittle… The Weekend Nears
And so, we have officially returned from a speaking engagement in San Diego, although you may have noticed that we worked from the road when possible. Of course, we are back just in time for a blizzard. Oh boy. Nonetheless, being snowed in gives us more time to daydream about weekend plans. Our agenda is obvious – lots of shoveling, hot coffee and naps. But what about you? Some of you may also need to dig your way out, but this is also a chance to tidy up around the mansion, watch a movie or read a book (remember those?). For those of you in nicer climates, well, consider yourselves lucky. Whatever you do this weeken...
Source: Pharmalot - February 8, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Amgen AstraZeneca Belviq Diet Pills Donut Hole Eli Lilly Express Scripts FDA. Alzheimer's JJ Johnson & Johnson Medicaid Fraud Medicare Merck Pfizer Rheumatoid Arthritis Sanofi Seroquel Teva Pharmaceuticals Source Type: blogs
Not Working Out So Well at Merck?
Here's a rather grim analysis from the AP of Merck's current status. The company's stock was recently downgraded by two analysts after last Friday's earnings call didn't go very well (links added by me below):
Future sales of Vytorin, a controversial combination drug on sale since 2004 that includes Zocor, and prospects for a crucial experimental osteoporosis drug called odanacatib were thrown into question Friday as Merck announced its fourth-quarter results. Company executives made some cryptic comments, suggesting significant problems with both drugs. . .
Merck said Friday that it won't apply for approval of odanacati...
Source: In the Pipeline - February 5, 2013 Category: Chemists Tags: Business and Markets Source Type: blogs
Merck’s Combination Of Ezetimibe And Atorvastatin Back On NDA Path
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year. Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
Merck’s Combination Of Ezetimibe And Atorvastatin Combo Back On NDA Path
A combination tablet containing the cholesterol-lowering drugs ezetimibe and atorvastatin is back on the path to possible FDA approval, according to Merck, which already markets Zetia (ezetimibe) and Vytorin, the combination of ezetimibe and simvastatin. Merck has repeatedly stumbled in its efforts to gain FDA approval of the proposed new drug, which has been dubbed “Son of Vytorin.” The new drug application (NDA) submission was first rejected by the FDA in 2009 and, again, last year. Merck said yesterday that the FDA had accepted Merck’s resubmission of its NDA, which included additional data provided ...
Source: CardioBrief - January 3, 2013 Category: Cardiology Authors: Larry Husten Tags: Prevention, Epidemiology & Outcomes cholesterol ezetimibe FDA food and drug administration LDL cholesterol lovastatin Merck New Drug Application vytorin Source Type: blogs
