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New Drugs

October 4, 2010
The Medicare "doughnut hole" is not something to have with your morning coffee. The term refers to the coverage gap in some drug plans offered as part of Medicare Part D. Basically, Medicare enrollees pay the cost of their drugs after they've reached the plan's spending limit but before they hit the out-of-pocket-expenses limit. Some plans cover the gap, often with generic drugs, but those may charge higher premiums. The Orlando Sentinel's Vital Signs blog reports on a new plan aimed at trimming drug costs that's being rolled out nationwide Monday: "Walmart, Humana join to create inexpensive Medicare drug plan.
September 14, 2010
The Food and Drug Administration said Tuesday that it has approved a new drug to treat gout in patients who do not respond to existing therapy. The drug is called Krystexxa and is manufactured by Savient Pharmaceuticals Inc. of East Brunswick, N.J. The FDA had rejected the drug in August of 2009 because of manufacturing problems. In a letter to the company then, the agency said that the potential commercial supplies of the drug were not identical to the product used in clinical trials.
March 10, 2010 | By Michael Hochman and Danny McCormick
Some doctors treat patients with early-stage prostate cancer with radiation. Others favor surgery, while some advocate only close monitoring. Which approach is most successful? No one knows. When it comes to diabetes management, doctors don't have answers to key questions: At what point should insulin be started? Is it safe to lower the blood sugar to normal levels? What is the best way to monitor blood sugar control? Similarly, endocrinologists don't know what is the best way to treat patients with hyperactive thyroids.
March 1, 2010
Doctors may not agree on the need to screen children for high cholesterol, but those who do will likely want to treat kids with abnormal results. Lifestyle interventions, especially dietary changes, form the foundation of any lipid treatment plan. Fat consumption should be reduced, with less than 10% of daily caloric intake coming from saturated fats and with trans fats eliminated completely if possible. Exercise is also important. Even modest amounts of exercise, if performed regularly, can improve lipid levels.
January 26, 2010 | By Nathan Olivarez-Giles
Biotech giant Amgen Inc. reported a 1% profit increase for the fourth quarter of 2009, with stable sales for many of its popular drugs. The Thousand Oaks company said its drug sales in the quarter were mixed, with its colon cancer drug Vectibix showing growth. But sales of its anemia drug, Aranesp, dropped 20% in the U.S. and 8% worldwide after a study linked the medicine to increased risk of stroke, the company said. In a conference call with analysts, the company said fourth-quarter sales for Vectibix were $66 million worldwide, up 44% from $46 million a year earlier.
December 26, 2009 | By Yuriko Nagano
At a time when major biotech companies in California are eager for investors, Japanese pharmaceutical companies are increasingly becoming a go-to place for money to develop and sell new drugs. Japan's largest drug maker teamed up with Amylin Pharmaceuticals Inc. in San Diego last month to develop and sell an obesity drug that the companies think could eventually be worth $1 billion. In October, Japan's second-largest drug firm announced a $110-million payment to Medivation Inc. of San Francisco to develop and market a potential prostate cancer drug together in a deal that they hope could reach $655 million.
August 12, 2009 | Thomas H. Maugh II
The first member of a new class of osteoporosis drugs reduced spinal fractures by about two-thirds in post-menopausal women and in men undergoing hormone-deprivation therapy for prostate cancer, according to two studies released online today by the New England Journal of Medicine. The drug, called denosumab, is the first to block production of cells called osteoclasts that break down bones, and physicians have high hopes for it because of its efficacy, ease of administration and apparent lack of severe side effects.
July 21, 2009 | Thomas H. Maugh II
After a 50-year drought of new drugs and a string of disappointing failures of potential treatments for lupus, researchers said Monday that they have found an experimental drug that can ameliorate the symptoms of the life-threatening autoimmune disorder that afflicts as many as 1.5 million Americans.
July 14, 2009 | DAN NEIL
Big Pharma experienced acute dizziness and irritability last month when House Ways and Means Chairman Charles B. Rangel (D-N.Y.) proposed rescinding the tax deduction for direct-to-consumer prescription drug advertising. This is the ad segment that brought you "Viva Viagra," the Ambien CR rooster and the Cialis couple-in-the-tubs, who I sincerely hope are soon struck by lightning. The segment accounts for about $5 billion in advertising per year. This is your IRS on drugs.
January 10, 2009 | Karen Kaplan
They have four legs, fuzzy faces and udders full of milk. To the uninitiated, they look like dairy goats. To GTC Biotherapeutics Inc., they're cutting-edge drug-making machines. The goats being raised on a farm in central Massachusetts are genetically engineered to make a human protein in their milk that prevents dangerous blood clots from forming. The company extracts the protein and turns it into a medicine that fights strokes, pulmonary embolisms and other life-threatening conditions.
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