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  • 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...

  • UPDATE 1-FDA panel backs Daiichi's blood thinner Thursday, 30 Oct 2014 | 6:57 PM ET

    Oct 30- A panel of advisers to the U.S. Food and Drug Administration voted 9-1 in favor of approving Japanese drugmaker Daiichi Sankyo Co's blood thinner for use in some patients with atrial fibrillation. According to late-stage trial data submitted by Daiichi, the drug is as effective- and safer than- warfarin, an anticoagulant that has been on the market for more...

  • FDA panel backs Daiichi's blood thinner Thursday, 30 Oct 2014 | 4:36 PM ET

    Oct 30- A panel of advisers to the U.S. Food and Drug Administration voted 9-1 in favor of approving Japanese drugmaker Daiichi Sankyo Co's blood clot and stroke preventer for use in some patients with atrial fibrillation. The drug, edoxaban, is a once-daily anticoagulant that inhibits Factor Xa, a protein that plays a central role in blood-clotting.

  • UPDATE 1-Pfizer meningitis vaccine wins U.S. approval Wednesday, 29 Oct 2014 | 3:06 PM ET

    Oct 29- Pfizer Inc has won U.S. approval for its Trumenba vaccine against meningitis, a potentially deadly bacterial disease that has recently caused outbreaks on college campuses, the U.S. Food and Drug Administration said on Wednesday. It is the first approved U.S. vaccine that prevents invasive disease caused by the bacterium Neisseria meningitidis B, a...

  • Oct 28- U.S. Food and Drug Administration staff reviewers recommended approval of a 60 mg dose of Daiichi Sankyo Co's blood thinner for some atrial fibrillation patients, but suggested limiting its use to those with abnormal kidney function. The drug, edoxaban, is a once-daily anticoagulant that inhibits Factor Xa, a protein that plays a central role in...

  • Oct 28- U.S. Food and Drug Administration staff reviewers recommended approval of a 60 mg dose of Daiichi Sankyo Co's blood thinner for certain atrial fibrillation patients, but suggested limiting its use in those with abnormal kidney function. The drug, edoxaban, is a once-daily anticoagulant that inhibits Factor Xa, a protein playing a central role in...

  • Ebola vaccine candidate  Monday, 27 Oct 2014 | 2:02 PM ET

    Discussing the development of an Ebola vaccine, with Stanley Erck, Novavax CEO.

  • Oct 24- Drugmaker Baxter International Inc said the U.S. Food and Drug Administration had approved its drug for treating bleeding episodes in adults with a rare bleeding disorder. Other approved hemophilia B treatments include Baxter's Rixubis, Pfizer Inc's Benefix and CSL Behring Ltd's Mononine. Baxter's shares were up about 1 percent at $69.66 in early...