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  • FDA panel says newer HIV tests effective Tuesday, 2 Dec 2014 | 5:00 PM ET

    Dec 2- Newer methods to test donated blood samples for HIV infections are effective, a panel of experts at the U.S. Food and Drug Administration concluded, in a move that could limit the ban on donations by men who have had sex with other men. The FDA's ban, in place for about three decades, disallows donations from men who have had sex with even one man since 1977, as they...

  • Dec 1- The U.S. Food and Drug Administration lifted a clinical hold on Flexion Therapeutics Inc's lead experimental drug to relieve osteoarthritis-related pain, allowing the company to resume its mid-stage trial. Osteoarthritis is one of the most common forms of arthritis in the United States and affects about 27 million Americans. Up to Monday's close,...

  • FDA lifts hold on Flexion's lead drug Monday, 1 Dec 2014 | 5:12 PM ET

    Dec 1- The U.S. Food and Drug Administration lifted a clinical hold on Flexion Therapeutics Inc's lead experimental drug to relieve osteoarthritis-related pain, allowing the company to resume mid-stage trials. The agency had halted trials of the injectable drug, FX006, in September after one patient's knee was infected. Flexion said it also plans to initiate a...

  • FDA rejects Avanir's migraine drug-device Wednesday, 26 Nov 2014 | 5:30 PM ET

    Nov 26- The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions regarding some data submitted as part of the marketing application. Earlier this month the FDA had asked Avanir to assess the root cause of errors observed in the data from the drugmaker's human factors...

  • Bristol-Myers said it had initially sought permission from the U.S. Food and Drug Administration to market the drug, a so-called NS5A inhibitor, in combination with asunaprevir, one of the New York- based company's experimental medicines. But Bristol-Myers abandoned its U.S. marketing application for asunaprevir in October because of potential...

  • FDA declines to approve Bristol-Myers hepatitis drug Wednesday, 26 Nov 2014 | 11:56 AM ET

    Nov 26- Bristol-Myers Squibb Co on Wednesday said U.S. regulators had declined to approve use of its experimental daclatasvir drug for hepatitis C, in combination with other antiviral drugs.

  • FDA approves Purdue's painkiller that can reduce abuse Thursday, 20 Nov 2014 | 1:46 PM ET

    Nov 20- The U.S. Food and Drug Administration has approved a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P., the agency said on Thursday. The FDA approved the once-daily drug, Hysingla ER, with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting.

  • Nov 20- A U.S. court has denied a request by Indian drugmaker Ranbaxy Laboratories Ltd to stop competitors from launching copies of AstraZeneca Plc's heartburn pill Nexium and Roche's antiviral, a court filing showed. Ranbaxy had filed a lawsuit against the U.S. Food and Drug Administration last week for revoking tentative approvals it gave the company to make...

  • Nov 19- Pharmaceutical investment firm Royalty Pharma said it would buy royalties on Vertex Pharmaceuticals Inc's cystic fibrosis treatments from Cystic Fibrosis Foundation for $3.3 billion in cash. Vertex's cystic fibrosis drug, Kalydeco, was approved by the U.S. Food and Drug Administration in January 2012. Vertex co-developed the drug with an affiliate...

  • Nov 19- Pharmaceutical investment firm Royalty Pharma said it would buy royalties on Vertex Pharmaceuticals Inc's cystic fibrosis treatments from Cystic Fibrosis Foundation for $3.3 billion in cash. Vertex's cystic fibrosis drug, Kalydeco, was approved by the U.S. Food and Drug Administration in January 2012. Vertex co-developed the drug with an affiliate...

  • Nov 18- CytRx Corp said the U.S. Food and Drug Administration placed a hold on enrolling new patients in clinical trials of its experimental cancer drug after a patient died, sending the company's shares down 11 percent in premarket trading. Patients already enrolled in the trials, currently in mid stage, will continue receiving the treatment, CytRx said.

  • FDA puts partial hold on CytRx cancer drug trials Tuesday, 18 Nov 2014 | 6:36 AM ET

    Nov 18- CytRx Corp said the United States Food And Drug Administration has placed a partial hold on clinical trials of its experimental cancer drug after a patient died. CytRx shares were down 10 percent in premarket trading. The patient received the drug, aldoxorubicin, under the company's expanded access program that makes promising drugs and devices...

  • Unilever, suing rival over ‘mayo,’ changes website Monday, 17 Nov 2014 | 10:14 AM ET
    Just Mayo by Hampton Creek

    The changes came after Unilever sued Hampton Creek over a mayonnaise spread, The New York Times reports.

  • Nov 14- The U.S. Food and Drug Administration said on Friday it expects China, after almost two years of delays, to soon approve visas that will allow the agency to more than double its staff in China. "We're heading into the homestretch," Margaret Hamburg told reporters on a conference call, when asked how soon China might approve the visas, which would more than triple...

  • Things you can sue over: The word 'mayonnaise' Tuesday, 11 Nov 2014 | 11:47 AM ET
    Just Mayo by Hampton Creek

    Food giant Unilever is suing Hampton Creek, maker of eggless spread Just Mayo, accusing it of false advertising and fraud, the New York Times reports.

  • Nov 7- Avanir Pharmaceuticals Inc said it was unlikely that its experimental migraine drug-device would win U.S. Food and Drug Administration approval by the scheduled timeline. The FDA has raised questions regarding some data submitted as part of the marketing application, the company said on Friday. Over 37 million Americans suffer from migraines,...

  • Nov 7- Avanir Pharmaceuticals Inc said it was unlikely that its experimental migraine drug-device would win U.S. Food and Drug Administration approval by the scheduled timeline, sending its shares down 5 percent in premarket trading. The FDA has raised questions on the data submitted in its marketing application, the company said on Friday.

  • *FDA says not enough "verifiable" data, asks for fresh trial. *FDA says drug could have led to a cardiac event in trial. Nov 6- Canada's Aeterna Zentaris Inc said the U.S. Food and Drug Administration rejected macimorelin, which the drugmaker had hoped would be the first orally administered drug to determine if adults had growth hormone deficiency.

  • Nov 6- Aeterna Zentaris Inc said the U.S. Food and Drug Administration rejected macimorelin, which the company had hoped would be the first orally administered drug to determine if adults had growth hormone deficiency. An analysis showed the company's key trial did not meet its main efficacy goal, the FDA said, noting the lack of "complete and verifiable" data used...

  • FDA rejects Aeterna's growth hormone diagnostic test Thursday, 6 Nov 2014 | 7:34 AM ET

    Nov 6- Aeterna Zentaris Inc said the U.S. Food and Drug Administration rejected macimorelin, an experimental test designed to determine if adults' pituitary glands are secreting enough growth hormone. The company's trial did not meet its main goal, the FDA said, also noting the lack of "complete and verifiable" source data used to determine if adult patients were...