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  • 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: FDA blocks hepatitis C drug for now Wednesday, 26 Nov 2014 | 1:37 PM ET

    U.S. regulators have declined to approve Bristol-Myers Squibb's daclatasvir as part of a combination hepatitis C treatment with another antiviral drug called asunaprevir. The FDA then requested more data on the effects of daclatasvir in combination with other drugs for treating hepatitis C, currently one of the hottest areas in drug research.

  • 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.

  • Calorie count to appear with many prepared foods Tuesday, 25 Nov 2014 | 12:01 AM ET

    WASHINGTON— Whether they want to or not, consumers will soon know how many calories they are eating when ordering off the menu at chain restaurants, picking up prepared foods at supermarkets and even eating a tub of popcorn at the movie theater. The Food and Drug Administration announced long-delayed calorie labeling rules Tuesday, requiring establishments...

  • What's covered in new menu labeling rules Tuesday, 25 Nov 2014 | 12:01 AM ET

    The Food and Drug Administration on Tuesday is announcing new rules requiring chain restaurants, movie theaters and other retailers that sell prepared foods to put calorie labels on menus and menu boards. —Displays of food, such as pastries, at coffee chains like Starbucks. —Food prepared on site at large retail outlets, such as Target and Costco.

  • What's covered in new menu labeling rules Monday, 24 Nov 2014 | 8:01 PM ET

    WASHINGTON— The Food and Drug Administration plans new rules requiring chain restaurants, movie theaters and other retailers that sell prepared foods to put calorie labels on menus and menu boards. The rules will only apply to establishments that have 20 or more locations. —Displays of food, such as pastries, at coffee chains like Starbucks.

  • New FDA rules will put calorie counts on menus Monday, 24 Nov 2014 | 7:59 PM ET

    WASHINGTON— Counting your calories will become easier under new government rules requiring chain restaurants, supermarkets, convenience stores— and even movie theaters, amusement parks and vending machines— to post the calorie content of food "clearly and conspicuously" on their menus. The Food and Drug Administration plans to announce the long-delayed...

  • Bayer: FDA will speed review of 2 respiratory meds Monday, 24 Nov 2014 | 5:51 PM ET

    WHIPPANY, N.J.— Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics. Bayer HealthCare, based in Whippany, New Jersey, said Monday the Food and Drug Administration has designated two of its...

  • FDA strengthens warning on device linked to cancer Monday, 24 Nov 2014 | 11:34 AM ET

    The Food and Drug Administration updated its April safety warning, saying doctors should not use the devices, called laparoscopic power morcellators, for performing a hysterectomy or removing uterine fibroids "in the vast majority of women." Maisel said the FDA is recommending that makers of laparoscopic power morcellators immediately include in the...

  • 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.

  • Study lifts cloud over heart drugs Zetia, Vytorin Monday, 17 Nov 2014 | 8:53 AM ET

    CHICAGO— A major study lifts a cloud around Zetia and Vytorin, blockbuster drugs for lowering cholesterol. Merck& Co.' s ezetimibe, which went on sale in 2002, lowers cholesterol in a different way. The drug won Food and Drug Administration approval for lowering LDL, but some studies suggested that might not translate to fewer heart attacks and strokes.

  • Heart stents may require longer blood thinner use Sunday, 16 Nov 2014 | 4:47 PM ET

    Patrick O'Gara, clinical cardiology chief at Brigham and Women's Hospital in Boston and president of the American College of Cardiology. Laura Mauri, at the request of the federal Food and Drug Administration. Results were discussed Sunday at an American Heart Association conference in Chicago and published online by the New England Journal of Medicine.

  • FDA approves Lemtrada for multiple sclerosis Saturday, 15 Nov 2014 | 1:00 PM ET

    NEW YORK— The Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. Sanofi, the parent company of Genzyme, wants to market Lemtrada as a treatment for relapsing multiple sclerosis, a disease in which the immune system attacks healthy nerves. Sanofi estimates that the disease affects...