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  • 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. Obizur will compete with Biogen Idec Inc's Eloctate, which was approved in June. Other approved hemophilia B treatments include Baxter's Rixubis, Pfizer Inc's Benefix and CSL...

  • Baxter's blood disorder drug gets FDA approval Friday, 24 Oct 2014 | 9:35 AM ET

    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. The drug, Obizur, has been approved for use in patients with acquired hemophilia A, which usually affects older adults, Baxter said in a statement. The drug will be launched in the United...

  • The FDA also asked the company to submit a Risk Evaluation and Mitigation Strategy for the drug, Natpara. The FDA extension follows an 8-5 vote in favor of the drug's approval by an FDA advisory panel in September. The FDA set Jan. 24 as the review date for the drug.

  • NPS Pharma says FDA extends review of Natpara Thursday, 23 Oct 2014 | 5:13 PM ET

    NEW YORK— NPS Pharmaceuticals says the Food and Drug Administration won't make a decision on its drug Natpara on Friday and will extend its review by three months. The company said Thursday that the FDA is now scheduled to make a decision on Natpara by Jan. 24. Shares of NPS Pharmaceuticals Inc. shed $1.08, or 3.7 percent, to $28 in aftermarket trading.

  • Oct 21- Omeros Corp said it suspended enrolment in a mid-stage study testing its experimental Huntington's drug as the company evaluates data from a concurrent trial in rats, sending its shares down 10 percent before the bell. The drug has been well tolerated in all human trials, Omeros said. The U.S. Food and Drug Administration has asked the company to further...

  • Since 1997, FDA has operated under a proposed rule that allows food manufacturers to get new food additives onto the market by notifying FDA that they are generally recognized as safe. In February, the non-profit Center for Food Safety sued FDA, alleging that the agency failed to follow legal rulemaking requirements. "For more than 17 years, FDA has imposed a lax...

  • Oct 20- BioMerieux SA is working with U.S. health regulators to determine if its test to screen for bio threats could be used to detect the Ebola virus, spokeswoman Suzanne Jones said. Since the system was solely developed for environmental surveillance, it is necessary for BioMerieux to show the U.S. Food and Drug Administration evidence that the test could be...

  • FDA panel unanimously backs Novartis' psoriasis drug Monday, 20 Oct 2014 | 2:28 PM ET

    Oct 20- An advisory panel to the U.S. Food and Drug Administration unanimously recommended the use of Novartis AG's anti-inflammation drug in patients with a type of psoriasis, paving the way for its approval. FDA staff reviewers last week had said the drug's benefits outweighed its risk. The FDA is not obligated to accept the panel's recommendations, but...

  • Chimerix gets FDA OK to test drug for Ebola Friday, 17 Oct 2014 | 10:54 AM ET

    Chimerix Inc. said Thursday that it has received FDA clearance to proceed with a trial examining the safety and effectiveness of its brincidofovir tablets in patients who have the virus. Chimerix did not immediately return requests for comment. Chimerix is working with the U.S. Department of Defense on developing the drug as a treatment against smallpox.

  • Oct 16- Pfizer Inc failed to convince the U.S. Food and Drug Administration to remove a black box warning on its controversial quit-smoking drug Chantix, with an advisory panel to the agency voting against the removal on Thursday. The panel agreed to revisit its stance on the warning label once data from Pfizer's post-marketing study of Chantix is available.

  • FDA panel votes to keep boxed warning on Chantix Thursday, 16 Oct 2014 | 4:10 PM ET

    WASHINGTON— Federal health advisers say a bold-letter warning about suicide risks with Pfizer's Chantix should remain on the anti-smoking drug until it can reevaluated based on new, rigorous study information. Eleven advisers to the Food and Drug Administration voted to retain the so-called black box warning about reports of suicide, hostility and...

  • Oct 16- The benefits of Novartis AG's anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. There were no major safety issues associated with secukinumab, according to the review posted on the FDA website on Thursday- four days before a panel of outside advisers is...

  • Oct 16- The benefits of Novartis AG's anti-inflammation drug outweighed the risks in using it to treat a type of psoriasis, staff reviewers at the U.S. Food and Drug Administration said. While the FDA is not obligated to accept the recommendations of the panel, it typically does so. The FDA staff based its recommendation on the review of the data from this study,...

  • FDA approves first drugs for deadly lung disease Wednesday, 15 Oct 2014 | 6:05 PM ET

    WASHINGTON— The Food and Drug Administration has approved the first drug treatments for a deadly disease that causes severe lung damage. The agency on Wednesday approved two novel treatments from Boehringer Ingelheim and Roche for idiopathic pulmonary fibrosis. Patients with the disease experience lung damage over time that makes it difficult to breathe...

  • The first, Esbriet, was developed by InterMune Inc, which Switzerland- based Roche Holding AG agreed to buy for $8.3 billion in August, banking largely on the treatment's potential. The agency's decision marks a crucial milestone in the management of the disease, which affects about 100,000 people in the United States. Roche's drug, known generically as...

  • Oct 15- The U.S. Food and Drug Administration approved two drugs to treat idiopathic pulmonary fibrosis, marking its first-ever approvals for the fatal lung disease with no clear etiology and no cure. Roche Holding AG's Esbriet, which is already in use in Europe and Canada, and privately held German drugmaker Boehringer Ingelheim's Ofev both received the...

  • Oct 14- Pfizer Inc's quit-smoking drug Chantix received its latest setback on Tuesday after U.S. Food and Drug Administration staff recommended that the drugmaker keep a severe warning on the treatment's label. Chantix is one of Pfizer's most controversial drugs and has a number of severe side effects, including suicidal thoughts, erratic behavior and...

  • J&J hikes 2014 forecast for a third time Tuesday, 14 Oct 2014 | 8:18 AM ET

    Johnson& Johnson lifted its 2014 earnings forecast for a third time on Tuesday, fueled in part by revenue gains from its new blockbuster hepatitis C treatment Olysio. J&J's higher forecast came a couple days after the Food and Drug Administration approved Harvoni, a pill from Gilead Sciences Inc. that can cure the most common form of hepatitis C without the...

  • Oct 7- Bristol-Myers Squibb said it withdrew its U.S. marketing application for a drug combination to treat hepatitis C. Bristol-Myers said the combination treatment of daclatasvir and asunaprevir was approved in July for use in Japan. The company plans to submit additional data on daclatasvir from an ongoing study to the U.S. Food and Drug Administration.

  • Battling Ebola     Tuesday, 7 Oct 2014 | 8:01 AM ET

    CNBC's Meg Tirrell, and Dr. Moncef Slaoui, GlaxoSmithKline, discuss the latest efforts to develop an Ebola vaccine.