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  • The news sent shares of J&J, whose annual Remicade sales of $6.5 billion are mostly in the United States, down more than 3 percent. FDA scientists released their favorable report ahead of a scheduled meeting on Tuesday of an independent medical advisory panel to the agency. "In considering the totality of the evidence, the data submitted by Celltrion show that is...

  • FDA scientists released their supportive findings ahead of a scheduled meeting on Tuesday of an independent medical advisory panel to the agency. "In considering the totality of the evidence, the data submitted by Celltrion show that is highly similar to U.S.-licensed Remicade" in treatment of rheumatoid arthritis and a related condition called...

  • Feb 5- The U.S. Food and Drug Administration has denied the expanded use of Vertex Pharmaceutical Inc's bestseller, Kalydeco, in certain cystic fibrosis patients, the company said on Friday. Kalydeco, which brought in revenue of $632 million in 2015, is already approved to treat CF patients aged 2 and older with 10 different mutations in the CFTR gene.

  • FDA scientists early on Friday released their supportive findings ahead of a scheduled meeting on Tuesday of an independent medical advisory panel to the agency. South Korea's Celltrion and partner Pfizer Inc want to sell Remsima in the United States as a cut-price copy of Johnson& Johnson and Merck& Co's Remicade, or infliximab, which had global 2014 sales of...

  • Feb 5- The U.S. Food and Drug Administration has denied the expanded use of Vertex Pharmaceutical Inc's bestseller, Kalydeco, in certain cystic fibrosis patients, the company said on Friday. The regulator rejected the company's application for using the drug in cystic fibrosis patients aged 2 or older, who have one of 23 residual function mutations. 1/ 8.

  • Feb 4- U.S. Food and Drug Administration staff members on Friday said clinical data from Celltrion Inc's biosimilar form of blockbuster arthritis drug Remicade indicated it is "highly similar" to the branded product in terms of safety, purity and potency. FDA scientists released their supportive findings ahead of a scheduled meeting on Tuesday of an...

  • Robert Califf, President Barack Obama's nominee to lead the Food and Drug Administration, said on Thursday the agency would reform its process for approving opioid painkillers. The FDA said it has agreed to convene a committee before approving any new opioid that does not have abuse-deterrent properties. Califf, who joined the FDA a year ago as a deputy...

  • Privately owned, Connecticut- based Purdue had sued Teva, Amneal Pharmaceuticals and Epic Pharma after they sought approval from the U.S. Food and Drug Administration to make generic OxyContin. Purdue said in a statement that it was reviewing the decision and considering what to do next. "Despite the court's ruling, Purdue has several other patents protecting...

  • Jan 28- The U.S. Food and Drug Administration approved Eisai Co Ltd's drug derived from sea sponge for a rare type of soft tissue cancer. The drug, Halaven, was approved for use in patients who have undergone chemotherapy with drugs derived from a type of bacteria, the FDA said on Thursday. Halaven, derived from a marine sponge called Halichondria okadai, was approved...

  • TRENTON, N.J.— Patients with hepatitis C have yet another advanced treatment option, as the Food and Drug Administration on Thursday approved a new once-a-day pill developed by drugmaker Merck. The FDA said Merck can begin marketing Zepatier for patients with two of the subtypes the liver-destroying virus, types 1 and 4. Merck& Co. said the price will be $54,600...

  • Jan 28- The U.S. Food and Drug Administration approved Eisai Co Ltd's drug derived from sea sponge for a rare type of soft tissue cancer which has no approved treatment so far. The drug, Halaven, was approved for use in patients who have undergone chemotherapy with drugs derived from a type of bacteria, the FDA said on Thursday. Halaven, derived from a marine sponge...

  • FDA approves Neos Therapeutics' long-acting ADHD drug Wednesday, 27 Jan 2016 | 11:58 PM ET

    Jan 28- Neos Therapeutics Inc's drug to treat a common type of childhood behavioral disorder was approved by the U.S. Food and Drug Administration, making it the first of its kind to win U.S. approval. The disorder affects about 4.1 percent of American adults aged 18 years and older in a given year and 9 percent of children aged 13-18 years, according to the National...

  • Shoppers want 'natural' food: What does that mean? Wednesday, 27 Jan 2016 | 11:02 AM ET
    A woman shops at Whole Foods in New York.

    Study shows that many people don't know what they're paying for with natural labels, but are consuming more, The USAToday reports.

  • Robert Califf, is a cardiologist and researcher who joined the FDA a year ago as a deputy commissioner. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies, "Sanders said in a statement. Peter Pitts, a former associate...

  • Robert Califf, is a cardiologist and researcher who joined the FDA a year ago as a deputy commissioner. Califf's extensive ties to the pharmaceutical industry give me no reason to believe that he would make the FDA work for ordinary Americans, rather than just the CEOs of pharmaceutical companies, "Sanders said in a statement. The Senate Committee on Health,...

  • Sanders opposes nominee for FDA head Tuesday, 26 Jan 2016 | 10:39 AM ET
    Sanders opposes nominee for FDA head

    Presidential candidate Bernie Sanders is blocking President Obama's nominee for head of the FDA. CNBC's Meg Tirrell explains.

  • Senator and Democratic presidential candidate Bernie Sanders on Tuesday blocked President Barack Obama's nominee to oversee the U.S. Food and Drug Administration, citing the presidential pick's ties to drug companies. Sanders said in a statement he was placing a hold on the nominee for FDA commissioner, Dr. Robert Califf, "because of his close ties to the...

  • Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee should consider the risk of addiction and abuse during the approval process. "Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate...

  • Democratic senator blocks Obama's pick to head FDA Monday, 25 Jan 2016 | 1:17 PM ET

    Robert Califf, the No. 2 official at the agency, who was a prominent cardiologist and medical researcher at Duke University for more than 30 years. "The FDA needs to commit to shift the way it approaches and evaluates addiction before I can support Dr. At the vote, she said she wanted reassurances that FDA will write rules for labeling genetically modified salmon.

  • Markey wants future opioid-approval matters to be reviewed by an FDA advisory committee, and believes the committee should consider the risk of addiction and abuse during the approval process. "Last year, the FDA approved a new pediatric use for OxyContin without convening an advisory committee even though its guidelines note that FDA decisions that relate...