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U.S. drug prices should reflect value to patients: expert panel

A panel of medical experts said on Friday the prices of prescription medicines in the United States need to be brought in line with the value they bring to patients instead of continuing to let drugmakers set any price they choose.   “Americans at the same time are getting tremendously ripped off with drugs and […]

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FDA clears Merrimack’s pancreatic cancer drug with warning

The U.S. Food and Drug Administration on Thursday approved Merrimack Pharmaceutical Inc’s pancreatic cancer drug, Onivyde, with a severe safety warning. The company’s shares fell as much as 28 percent to a 13-month low of $7.27 in afternoon trade before halving the losses. Onivyde, in combination with chemotherapy treatments 5-fluorouracil and leucovorin, aims to treat […]

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Gilead’s new HIV drug shows lower side-effects over longer term

Drugmaker Gilead Sciences Inc said data from a late-stage study showed that its experimental drug, Genvoya, showed reduced side-effects compared with an older version of the drug in treating HIV-infected patients over a longer term. The company said Genvoya was as good as Stribild, which is the older version, after 96 weeks of treatment and […]

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FDA approves Relypsa’s drug to treat high potassium levels

The U.S. Food and Drug Administration approved Relypsa Inc’s drug to treat potentially fatal levels of potassium in patients with chronic kidney disease or heart problems. The drug, Veltassa, is designed to treat hyperkalemia, a chronic condition characterized by excessive potassium levels in the blood that could lead to dangerous changes in heart rhythm. Relypsa’s […]

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Exclusive: Clinton urges U.S. regulators to examine Daraprim price hike

Democratic presidential candidate Hillary Clinton on Monday urged U.S. regulators to determine how to bring lower-cost generic drugs to market more swiftly and combat anticompetitive practices in the pharmaceutical industry. Clinton’s requests to the Food and Drug Administration and the Federal Trade Commission were prompted by what she called the “egregious actions of Turing Pharmaceuticals,” […]

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Strong dermatology product sales help Valeant top estimates

Valeant Pharmaceuticals International Inc, which is under fire for massive price hikes of its two heart drugs, reported a better-than-expected quarterly profit, boosted mainly by strong performance in its U.S. dermatology business. Net income attributable to the company fell to $49.5 million, or 14 cents per share, for the third quarter ended Sept. 30, from […]

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TARSA Therapeutics’ NDA For TBRIA, The First Oral Calcitonin For The Treatment Of Postmenopausal Osteoporosis, Accepted For Filing

PHILADELPHIA, Oct. 19, 2015 /PRNewswire/ — TARSA Therapeutics, Inc. today announced that its New Drug Application (NDA) for TBRIATM (calcitonin-salmon [rDNA origin] delayed release tablets) submitted to the U.S. Food and Drug Administration (FDA) in July 2015, has been accepted for review, with a PDUFA date of May 30, 2016. Calcitonin has been available as […]

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Eye drug setback hits Shire shares amid Baxalta pursuit

Shares in Shire Plc fell 2 percent on Monday after the U.S. Food and Drug Administration (FDA) decided not to approve its most important pipeline medicine for dry eye disease and asked for more information.   The news is a blow for Shire, which is to trying to buy Baxalta Inc to forge the leading […]

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FDA Approves Praxbind (idarucizumab), Specific Reversal Agent for Pradaxa (dabigatran etexilate mesylate)

RIDGEFIELD, Conn., Oct. 16, 2015 /PRNewswire/ — Boehringer Ingelheim Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) granted approval of Praxbind® (idarucizumab). PRAXBIND is indicated for patients treated with Pradaxa® (dabigatran etexilate mesylate), when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. […]

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PTC says DMD drug data supports U.S. approval despite trial failure

PTC Therapeutics Inc’s experimental muscle disorder drug failed to meet the main goal in a keenly watched late-stage study, but the company said data from all trials on the drug supported a U.S. marketing application. The company’s stock fell about 16 percent in extended trading on Thursday, before reversing course to notch marginally gains. PTC […]

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