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FDA approves Alexion’s metabolic bone disorder drug

Oct 23 (Reuters) – The U.S. Food and Drug Administration on Friday approved Alexion Pharmaceuticals Inc’s Strensiq, a treatment for a rare kind of metabolic bone disorder. The approval is the first in the United States for a treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). (1.usa.gov/1W9KuRH) HPP is a genetic and potentially fatal disorder […]

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FDA approves J&J’s chemotherapy Yondelis

The U.S. Food and Drug Administration said it approved Johnson & Johnson’s chemotherapy for specific soft-tissue sarcomas that cannot be removed by surgery or have spread to other parts of the body. The drug, Yondelis, is designed to fight cancers that occur in the fat cells and in smooth muscle cells. About 12,000 cases of […]

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Amgen wins EU green light for first virus-based cancer drug

A first-in-class drug from Amgen based on a tumor-killing virus was given a green light by European regulators on Friday, paving the way for its approval within a couple of months.   The decision is a further milestone for a technology that has long fascinated scientists but has previously proved difficult to harness. The European […]

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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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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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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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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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Company Of The Year Gilead: Double The Dose

With not one but two record-shattering product launches that transformed the treatment of hepatitis C, Gilead more than doubled its revenue in a single year, earning its place as Med Ad News’ Company of the Year.

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Gilead Q&A: Paul Carter, Executive VP Of Commercial Operations

Med Ad News spoke with Paul Carter, Gilead’s executive VP of commercial operations, regarding the success of Sovaldi and Harvoni as well as the company’s vision of the future of biopharmaceuticals.

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Amgen: The Next Generation

Amgen has been an independent biotech leader for years with an established array of blockbuster products, and now the company’s next wave of promising medicines is making its mark.

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