6 More Firms Cleared to Sell Generic Zocor
Six more companies have been approved to begin selling generic versions of Merck's cholesterol-lowering statin drug Zocor.
The authorizations, posted Wednesday on the U.S. Food and Drug Administration's Web site, bring to eight the number of companies granted sanction to sell the generics since Merck's patent on Zocor expired in June.
The move promises to be a boon to consumers, since the newer versions of the pill are expected to drive down prices of the drug by as much as 70 percent, Bloomberg News reported on Thursday.
Teva Pharmaceutical and Ranbaxy Laboratories, the first companies to file for approval of generic versions of Zocor, also known as simvastatin, had earlier won six months of exclusivity to sell a generic version of the formula. Other companies now receiving F.D.A. approval to sell the medication are Cobalt Pharmaceuticals of Canada; Aurobindo Pharma, Zydus Pharmaceuticals and Dr. Reddy's Laboratories of India; the Sandoz unit of Swiss drug maker Novartis; and the Perrigo Company of Allegan, Mich.
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Statins Pose Low Risk of Acute Pancreatitis: Study
While cholesterol-lowering statin drugs such as Lipitor and Pravachol may increase the risk of painful inflammation of the pancreas, the side effect is relatively rare, a new study says.
Researchers from Wake Forest University School of Medicine in Winston-Salem, N.C., found that while the drugs increased the risk of pancreatitis by 40 percent, the occurrence is rare -- only one of every 300,000 people taking the drugs for a year would be expected to develop the condition.
"Nevertheless, there are likely to be many millions of people on long-term statins, which means that scores of patients will face the serious complications of acute pancreatitis," cautioned Dr. Sonal Singh, chief researcher and an instructor in the university's Section of General Internal Medicine.
The study reviewed 33 spontaneous reports of statin-induced pancreatitis from the Canadian Adverse Drug Event Monitoring System and 20 published case reports. The researchers also pooled results from two observational studies on the association between statins and pancreatitis.
"We found that all statins can cause pancreatitis, so switching from one to another will not help," said Singh. "The data also suggest that pancreatitis can occur after several months of statin use, suggesting that this is usually not an immediate reaction. We also found that patients on both low and high doses developed pancreatitis. Hence, starting at a low dose of statin may not be sufficient to prevent the side effect of pancreatitis."
The findings were published in the current issue of Drug Safety.
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Herpes Treatment Fails in Animal Tests
Quigley Corp. announced Thursday that tests to determine the efficacy of its herpes treatment for infections of the eye in an animal model proved ineffective.
The company said that tests of QR-435 against herpes keratitis, in which the herpes simplex virus infects the eye, showed that the treatment did not stay in the eye long enough to penetrate the cells to get to the virus. The treatment had eliminated the virus on direct contact in other studies, the Associated Press reported.
The drug maker's Quigley Pharma unit will seek other uses for the treatment, including developing the compound to treat respiratory viruses. The compound has been shown to have an effect against influenza viruses, such as the H5N1 strain of the bird flu, AP said.
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10th Death From Bird Flu in Egypt
A 26-year-old Egyptian man has died of bird flu, the third member of his extended family to die of the virus and the 10th in the country since an outbreak of the virus started in February, a World Health Organization (WHO) official said Wednesday.
Rida Farid Abdel Halim, a brick factory worker from the Nile Delta province of Gharbia, had been in a hospital for 10 days, according to Hassan el-Bushra, WHO's regional adviser for communicable diseases surveillance. A 15-year-old girl from the worker's family died on Monday, and a female relative died the day before, raising concerns about the possibility of human-to-human transmission.
Before the latest three deaths, only one person had died of the disease in Egypt since May.
The family had raised ducks at home, and the brother and sister had slaughtered the flock after ducks fell sick and died. The flu outbreak did extensive damage to the Egyptian poultry industry this year but preventive measures appear to have contained the disease.
Bird flu has killed at least 156 people worldwide since 2003, according to WHO. People can contract the virus by coming into contact with infected poultry but experts fear the virus could mutate into a form that passes from human to human, sparking a pandemic that could kill millions.
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Cancer Drug Telcyta Fails Late-Stage Trials
A new cancer drug, Telcyta, did not prolong survival in patients with advanced non-small cell lung cancer and platinum-resistant ovarian cancer and has failed three late-stage trials, Palo Alto, California-based Telik Inc. said in a statement Tuesday. The trials were conducted in the third of three testing stages needed for U.S. regulatory approval.
Telik's studies for lung cancer and advanced ovarian cancer, called ASSIST I and ASSIST II, did not achieve a "statistically significant improvement'" in overall survival, the company said. The third study, ASSIST III, failed to demonstrate its effectiveness in tumor response for ovarian cancer, Bloomberg News reported.
While all three trials showed some tumor response, two of the trials, ASSIST II and ASSIST III, contained "inconsistencies" that need to be investigated, the company added.
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