Here are some highlights from current pharma and clinical research news, views and data-
FDA warns against using four asthma drugs as stand-alones or for extended periods.
The Los Angeles Times reported that the FDA "on Thursday called for putting new limits on powerful and long-lasting bronchial drugs" containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids, in "a move designed to lower the risk of complications leading to hospitalization or even death." The agency "said patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible." Meanwhile, "patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said."
FDA Clears Drug To Treat Respiratory Symptoms Of Cystic Fibrosis.
The Food and Drug Administration has approved for marketing Gilead Sciences, Inc.'s "drug Cayston [aztreonam for inhalation solution] as a treatment for respiratory symptoms of cystic fibrosis, the company said Tuesday." The company "said it plans to make the drug available by the end of next week." The San Francisco Business Times reported that "Cayston, administered three times a day over a 28-day period, treats the bacteria Pseudomonas aeruginosa, which causes mucus to build up in the lungs and digestive tract of cystic fibrosis patients," and which is also "the single greatest cause of death for CF patients."
FDA Panel Recommends Approval Of Xifaxan To Treat Hepatic Encephalopathy.
A Food and Drug Administration panel "recommended Salix Pharmaceutical's drug Xifaxan [rifaximin] be approved to treat" hepatic encephalopathy, which is "brain damage caused by liver failure." In a 14-to-4 vote, the panel found that "the drug's benefits warrant its approval. In a separate vote, the panel also voted 14-4 in favor of the drug's safety." The agency will consider its panel's vote when it makes a final decision anticipated by Mar. 24. Reuters also noted that the FDA has already approved Xifaxan to treat travel-related diarrhea.
Three Major US Drugmakers Create Asian Cancer Research Group.
Three major US drugmakers, Eli Lilly and Co., Merck & Co., and Pfizer Inc., said Tuesday they have formed a not-for-profit company in Asia to focus on cancer research and treatments." The Asian Cancer Research Group will "focus on the most commonly diagnosed cancers in Asia, including lung and gastric cancers." The companies aim to "create an extensive database that will be made available to researchers."
FDA warns against using four asthma drugs as stand-alones or for extended periods.
The Los Angeles Times reported that the FDA "on Thursday called for putting new limits on powerful and long-lasting bronchial drugs" containing both long-acting beta agonists, commonly called LABAs, and inhaled corticosteroids, in "a move designed to lower the risk of complications leading to hospitalization or even death." The agency "said patients should use products containing only the corticosteroids or other asthma-relieving medication whenever possible." Meanwhile, "patients who cannot control asthma symptoms any other way should use LABAs for the shortest possible time, but the drugs should never be used alone in treating asthma in adults or children, the agency said."
FDA Clears Drug To Treat Respiratory Symptoms Of Cystic Fibrosis.
The Food and Drug Administration has approved for marketing Gilead Sciences, Inc.'s "drug Cayston [aztreonam for inhalation solution] as a treatment for respiratory symptoms of cystic fibrosis, the company said Tuesday." The company "said it plans to make the drug available by the end of next week." The San Francisco Business Times reported that "Cayston, administered three times a day over a 28-day period, treats the bacteria Pseudomonas aeruginosa, which causes mucus to build up in the lungs and digestive tract of cystic fibrosis patients," and which is also "the single greatest cause of death for CF patients."
FDA Panel Recommends Approval Of Xifaxan To Treat Hepatic Encephalopathy.
A Food and Drug Administration panel "recommended Salix Pharmaceutical's drug Xifaxan [rifaximin] be approved to treat" hepatic encephalopathy, which is "brain damage caused by liver failure." In a 14-to-4 vote, the panel found that "the drug's benefits warrant its approval. In a separate vote, the panel also voted 14-4 in favor of the drug's safety." The agency will consider its panel's vote when it makes a final decision anticipated by Mar. 24. Reuters also noted that the FDA has already approved Xifaxan to treat travel-related diarrhea.
Three Major US Drugmakers Create Asian Cancer Research Group.
Three major US drugmakers, Eli Lilly and Co., Merck & Co., and Pfizer Inc., said Tuesday they have formed a not-for-profit company in Asia to focus on cancer research and treatments." The Asian Cancer Research Group will "focus on the most commonly diagnosed cancers in Asia, including lung and gastric cancers." The companies aim to "create an extensive database that will be made available to researchers."
