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  • Jan 12- The U.S. Food and Drug Administration approved AbbVie Inc's treatment for Parkinson's disease, three months ahead of the scheduled review date. Last week, the FDA approved Impax Laboratories Inc's Parkinson's drug, Rytary, after rejecting it twice. Other companies developing drugs for the disease include NeuroDerm Ltd, Acorda Therapeutics Inc and...

  • AbbVie wins U.S. approval for Parkinson's treatment Monday, 12 Jan 2015 | 8:25 AM ET

    Jan 12- The U.S. Food and Drug Administration approved AbbVie Inc's treatment for Parkinson's disease, three months ahead of the scheduled review date. The treatment, Duopa, is administered using a small portable infusion pump that delivers the drug directly to the small intestine. The combination treatment, comprising carbidopa and levodopa, is the first to be...

  • Jan 12- Drug developer Arrowhead Research Corp said the U.S. Food and Drug Administration asked the company to reduce the dosage of its experimental Hepatitis B treatment and requested additional data from the drug's mid-stage trial. The company's shares fell 19 pct premarket on Monday. Arrowhead said its ongoing mid-stage trial would continue as planned...

  • Jan 7- A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, setting the stage for the regulator's first approval of a biosimilar. The biosimilar could be priced at the same level as Neupogen, but cost to insurers and consumers would be lower, Novartis executives...

  • Jan 7- A panel to the U.S. Food and Drug Administration unanimously backed the approval of Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen, paving the way for the regulator's first approval for a biosimilar. The injectable biologic, Neupogen, prevents infections in breast cancer patients undergoing chemotherapy, which reduces their white...

  • Jan 7- Zafgen Inc said a mid-stage study showed its experimental drug reduced weight in patients obese due to damage to a part of the brain. Vivus Inc's Qsymia, Arena Pharmaceuticals Inc's Belviq and Orexigen Therapeutics Inc's Contrave appear to work by signaling the brain, but their exact mechanism of action is unknown. The U.S. Food and Drug Administration...

  • Jan 6- CytRx Corp said interim data showed its experimental brain cancer drug was effective in a mid-stage study and a partial clinical hold on enrollment could be lifted this month. The company has provided the FDA with a package of information and expects to hear back from the agency later this month, CytRx Chief Executive Steven Kriegsman told Reuters.

  • Jan 6- The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people. Bellafill, developed by privately held Suneva Medical Inc, is made primarily of bovine collagen. Ava Shamban, an assistant clinical professor of dermatology at UCLA, who...

  • Jan 6- The U.S. Food and Drug Administration approved the first dermal filler to treat scarring caused by acne, the most common skin disorder in the United States afflicting 40-50 million people. Bellafill, developed by privately held Suneva Medical Inc, has been developed to treat moderate to severe acne scars on the cheeks of patients over the age of 21..

  • Cytrx cancer drug shows promise in mid-stage study Tuesday, 6 Jan 2015 | 6:31 AM ET

    Jan 6- Cytrx Corp said interim data showed its experimental cancer drug was effective in a mid-stage study to treat patients with a deadly form of brain cancer. The drug, aldoxorubicin, prevented the disease from progressing and shrank tumors, the company said. The U.S. Food and Drug Administration had placed a hold on enrolling new patients in clinical trials of...

  • Jan 5- Staff reviewers at the U.S. Food and Drug Administration recommended approval for Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen. Novartis's drug is the first to be reviewed in the United States under the so-called biosimilar pathway. The reviewers recommended that Novartis's copy should be approved for all the five indications...

  • Jan 5- Staff reviewers at the U.S. Food and Drug Administration recommended approval for Novartis AG's copy of Amgen Inc's blockbuster cancer drug Neupogen. Novartis's drug is the first to be reviewed in the United States under the so-called biosimilar pathway. The reviewers recommended that Novartis's copy should be approved for all the five indications...

  • Jan 2- Aethlon Medical Inc said the U.S. Food and Drug Administration had approved the testing in Ebola patients of its bio-filtration device, which was used against the deadly virus in a critically ill patient in Germany who later recovered. Aethlon said on Friday that the FDA's approval allows for an Ebola study to be conducted in up to 20 infected subjects in...

  • Jan 2- Aethlon Medical Inc said the U.S. Food and Drug Administration approved testing of the company's experimental device in Ebola patients. Patients will be administered for six to eight hours daily with the company's device, Hemopurifier, until the Ebola viral load drops below 1000 copies/ml, Aethlon said on Friday. The approved protocol allows for a study...

  • Ebola crisis back in focus as UK case confirmed Tuesday, 30 Dec 2014 | 8:30 AM ET
    A volunteer nurse who contracted Ebola while working in Sierra Leone was airlifted from Scotland to a specialist clinic in London on December 30, 2014.

    Ebola made headlines again on Tuesday after the U.K. announced its first in-country case of the deadly virus and two other patients underwent tests.

  • Dec 24- The U.S. Food and Drug Administration approved a drug to treat dementia in Alzheimer's patients that was developed by Actavis Plc and Adamas Pharmaceuticals Inc.. Memantine is the active ingredient in Actavis' Namenda, while donepezil is the active ingredient in Pfizer Inc's Aricept. Dublin, Ireland- based Actavis said it expects to launch Namzaric in...

  • Actavis, Adamas win FDA approval for Alzheimer's drug Wednesday, 24 Dec 2014 | 8:20 AM ET

    Dec 24- The U.S. Food and Drug Administration approved a drug to treat dementia in Alzheimer's patients that was developed by Actavis Plc and Adamas Pharmaceuticals Inc.. The drug, Namzaric, is designed to treat moderate-to-severe dementia in Alzheimer's patients who are stabilized with other drugs. Namzaric combines two ingredients in drugs often...

  • FDA approves Novo Nordisk's injection for obesity Tuesday, 23 Dec 2014 | 5:14 PM ET

    Dec 23- The U.S. health regulator approved a formulation of Novo Nordisk's diabetes drug, liraglutide, for treating patients of obesity, a disease that affects one in three Americans. Saxenda's rivals include Vivus Inc's Qsymia and Arena Pharmaceuticals Inc's Belviq, which are taken orally. A study showed that half the patients given Saxenda lost at least 5...

  • "The FDA has carefully examined and considered the available scientific evidence relevant to its blood donor deferral policy for men who have sex with men, including the results of several recently completed scientific studies and recent epidemiologic data," FDA Commissioner Margaret Hamburg said in a statement. The FDA said the move aligns the policy for...

  • Scientific evidence shows the move will not create risks for the nation's blood supply, the FDA said. The FDA said the move aligns the policy for gay men with that for other men and women who are at increased risk for HIV infection. The FDA said it will issue draft guidance on the policy, hopefully early in 2015. It would then review the comments and issue final...