The new drug certainly has scientists who study HDL excited.
Phase 1 is the very first step in the study of a new drug in people.
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The FDA warning comes after the agency reviewed a study on the drug that was published last May in the New England Journal of Medicine, as well as another study by a manufacturer of the antibiotic.
The stock dropped after Cephalon announced that a new study had shown that its main drug, a compound called modafinil sold under the brand name Provigil, was not effective in treating Attention Deficit Hyperactivity Disorder (ADHD).
On Monday, Novartis said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
On Monday, Novartis (nyse: NVS - news - people ) said the U.S. Food and Drug Administration wants it to run a new safety study of Galvus.
Recently Diovan's marketers added a new weapon: a big study showing that adding the drug to standard medications reduces complications from heart failure.
In results from a 12-patient study of that drug published in the New England Journal of Medicine last year, there was a small improvement in six-minute walk time.
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To that end he is changing the structure of the research labs, from monoliths to smaller units that are either entrepreneurial (racing to develop a drug) or exploratory (looking for new biology to study).
The National Institute of Alcohol Abuse and Alcoholism is watching new human trials of the antiseizure drug topiramate (Topamax) to study the effectiveness of dual treatment for alcohol and cocaine addiction.
The U.S. approved 33% more new cancer drugs than European nations including the United Kingdom, France, and Germany between 2000 and 2011, and approved them much faster as well, according to new research released today by the Tufts Center for the Study of Drug Development.
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This time the agency asked for a new study to test the effect of a high dose of the drug on heart rhythm.
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The blockbuster cholesterol drug Vytorin failed to improve a rare heart valve condition called aortic stenosis and seemed to increase rates of cancer, a new study says, dealing another blow to the top-selling drug and its makers, Merck and Schering-Plough .
In 2005 Chatenoud and fellow researchers showed that the Tolerx drug had similar benefits in an 80-patient New England Journal of Medicine study.
In June 2011, the U.S. Food and Drug Administration issued new regulations on sunscreen, updates that took 34 years of study and deliberation to develop.
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The New York-based drug giant says last night it received news that in a study, sponsored by the National Cancer Institute, on using Celebrex to prevent cancerous colon polyps, the drug more than doubled the risk of heart attacks and strokes. (The risk showed up with the highest dose of Celebrex.) That study, called the APC trial, has been halted.
But doctors like Sussman and Casey hope data from the new study will make it easier to match patients like Harrell with the right drug for them.
This year, the company has faced controversy over its drug Trasylol, used in heart surgery, which a study in The New England Journal of Medicine said may pose significant risks to patients.
When China released its first nationwide survey this year, it found 5.7% of that country's newly diagnosed TB patients were multi-drug-resistant, according to a study published this year in the New England Journal of Medicine.
WSJ: Tuberculosis Strain in Mumbai Doesn't Respond to Main Treatment
Overall, 6.6% of 4, 400 newly diagnosed TB patients in the study, conducted at 18 clinics nationwide, were found to be drug resistant, an officer of the Foundation for Innovative New Diagnostics, a nonprofit conducting the study for the Indian government, said at a private presentation last week.
WSJ: Tuberculosis Strain in Mumbai Doesn't Respond to Main Treatment
According to a study published in tomorrow's New England Journal of Medicine (NEJM), a drug called pamidronate can prevent such bone weakening in prostate cancer patients.
The new drug is by no means ready for the clinic, but it is about to undergo a preliminary safety study in healthy male volunteers.
All I was noting is that they are possible, and if the FDA continues to be concerned about a remote possibility that the Arena drug could cause cause cancer in women years down the road, it can always order up a giant new study.
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