December 16, 2008 |
DaVita Inc., the operator of dialysis centers, received a subpoena from U.S. authorities in Georgia investigating the administration of anemia drugs and vitamin D to kidney patients. DaVita, based in El Segundo, will produce "a wide range of documents" concerning Abbott Laboratories' Zemplar, Amgen Inc.'s Epogen, Daiichi Sankyo Co.'s Venofer, Genzyme Inc.'s Hectorol and Watson Pharmaceuticals Inc.'s Ferrlecit, according to a statement. DaVita said it was working with officials from the U.S. attorney's office for the northern district of Georgia and the Health and Human Services Department's Office of Inspector General.
December 16, 2008 |
Abbott Laboratories has won U.S. approval to sell a new pill to lower cholesterol alone or in combination with other medicines. The Food and Drug Administration cleared the product, called TriLipix, the Abbott Park, Ill., company said Monday. The medicine has been shown in studies to reduce artery-clogging cholesterol and fat in patients' blood when used with blood-thinning drugs called statins, such as Pfizer Inc.'s Lipitor and Merck & Co.'s Zocor.
December 13, 2008 |
Bristol-Myers Squibb Co. and Sanofi-Aventis won an appeals court ruling Friday that will help them block generic competition to the blood thinner Plavix, the world's No. 2 selling-drug, in the U.S. until 2011. Bristol-Myers and Sanofi said that as a result of the ruling by a three-judge panel of the U.S. Court of Appeals for the Federal Circuit in Washington, they will seek reimbursement from Canadian drug maker Apotex Inc.
October 30, 2008 |
The top staff regulators who oversaw the approval of new drugs in this country objected to the Bush administration's drive to shield drug makers from being sued, according to internal documents released Wednesday by Rep. Henry A. Waxman (D-Beverly Hills), chairman of the House Oversight and Government Reform Committee. The regulators said the White House and top administration officials were operating under the "false assumption" that warning labels on new drugs were adequate and up-to-date.
October 4, 2008 |
A prominent Emory University psychiatrist received at least $2.8 million in consulting fees from companies whose drugs he was evaluating and failed to report a third of it, congressional investigators studying medical conflicts of interest said Friday. The allegations against Dr. Charles B. Nemeroff, the latest in a series of such charges, are the most striking to emerge from the probe, which seems likely to alter the cozy relationships between prominent academics and the drug industry.
October 1, 2008 |
Pfizer Inc. is shifting its drug research focus to diseases that have high potential for big profits and for treatment improvements in such fields as cancer and Alzheimer's disease. The world's biggest drug maker also is ending new research on conditions including obesity and heart disease, but research on drugs already in late-stage human testing will continue, spokeswoman Liz Power said Tuesday.
September 27, 2008 |
Federal health regulators said Friday that they were reviewing an experimental use of blockbuster anemia drugs made by Amgen Inc. and Johnson & Johnson that have been associated with higher death rates in a study involving stroke patients. This month J&J reported results from a German trial in which more stroke patients treated with its drug Eprex died than those taking a placebo.
September 7, 2008 |
Bridget Robb was awakened last December by a powerful electric shock to her chest. "It was a jolt of electricity. It felt like being shot in the chest or being hit by lightning," said the 34-year-old mother from a Philadelphia suburb. She knew the cause of her agony. A device implanted in her chest was supposed to shock her, but only if her heart had quit. Instead, because of frayed wires, it misfired 31 times in 13 minutes. She underwent two operations to replace the defective device, requiring months of recovery.
August 29, 2008 |
GlaxoSmithKline will pay Valeant Pharmaceuticals International as much as $820 million and a share of profit from the experimental epilepsy drug retigabine. Glaxo, based in London, and Valeant, based in Aliso Viejo, next year will seek U.S. and European approval to begin selling the drug, the companies said in a statement Thursday. Glaxo will pay $125 million now and as much as $695 million later as Valeant reaches development and regulatory goals. The companies also will split profit in the U.S., Canada, Australia, New Zealand and Puerto Rico, and Valeant will receive a 20% royalty on sales in the rest of the world.
August 7, 2008 |
Watson Pharmaceuticals Inc. reported a 66% gain in second-quarter profit on lower expenses as it struggled to expand sales in the increasingly competitive U.S. market for generic drugs. Net income rose to $60.3 million, or 53 cents a share, from $36.4 million, or 33 cents a share, a year earlier, the Corona-based company said. Revenue rose 3% to $622.6 million, trailing the $627.7-million average estimate of analysts surveyed by Bloomberg. Watson has been focusing on U.S. sales as rivals Mylan Inc. and Barr Pharmaceuticals Inc. fund growth with acquisitions in other countries.