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Bellafill dermal filler effective five years after treatment: study

A study of the injectable dermal filler Bellafill showed that more than 80 percent of patients were satisfied with the results five years after finishing treatment, maker Suneva Medical said. The dermal filler, made primarily of bovine collagen, has been approved by the U.S. Food and Drug Administration for smoothening “laugh lines” since 2006 and […]

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FDA staff flags possible dosing risk with Collegium painkiller

The U.S. Food and Drug Administration’s staff expressed concerns over the risk of incorrectly administering Collegium Pharmaceuticals Inc’s long-acting opioid painkiller. The experimental pill, to be called Xtampza, is designed to be taken after eating as data has shown the absorption of the opioid increases in the presence of food. ( Inadequate pain control caused […]

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Biogen Forges $544M Deal to Take on Celgene With a Rival Autoimmune Drug

Biogen, Inc., headquartered in Cambridge, Mass., announced today that it licensed MT-1303 from Mitsubishi Tanabe Pharma Corporation, located in Osaka, Japan. MT-1303 is being investigated in a number of autoimmune disorders, including multiple sclerosis (MS), ulcerative colitis, Crohn’s disease and others.   Biogen will obtain worldwide rights to MT-1303, excluding Asia. It will oversee global […]

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GlaxoSmithKline lung drug fails to extend life in huge study

GlaxoSmithKline’s inhaled medicine Breo failed to prolong life in patients with chronic respiratory disease in a high-stakes clinical trial of 16,500 people, torpedoing hopes of a sales boost for the drug. Shares in Britain’s biggest drugmaker fell 1.5 percent on Wednesday, lagging a strong London market, in reaction to the news announced by the company […]

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Pacira sues FDA over pain drug marketing restrictions

Pacira Pharmaceuticals Inc on Tuesday filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel, for a wide range of surgeries, which the U.S. Food and Drug Administration opposes. The lawsuit, filed in federal court in Manhattan, cites another New York judge’s recent decision allowing Irish drugmaker Amarin Plc […]

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Independent group finds new cholesterol drugs far too costly

An independent non-profit organization that evaluates clinical and cost effectiveness of new medicines said announced prices for a just-approved class of potent cholesterol lowering drugs were far too high, according to a draft report released on Tuesday. The Boston-based Institute for Clinical and Economic Review (ICER) said its analyses indicated “that the price that best […]

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FDA staff flag likely dosing errors with Purdue’s opioid painkiller

U.S. Food and Drug Administration staff have expressed concerns over likely errors in administering Purdue Pharma’s fast-acting oxycodone painkiller that could result in inadequate relief. The drug is designed to be taken every 4-6 hours on an empty stomach as the absorption of oxycodone from the drug can be substantially delayed in the presence of […]

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Roche CEO attacks Britain’s ‘stupid’ cancer drug system

Roche Chief Executive Severin Schwan criticized Britain’s health system on Tuesday after two of the company’s cancer drugs were dropped from use, calling it a “stupid” way to control costs that could jeopardize research in the country. He also criticized India, an emerging economic powerhouse, for not doing more to increase its spending on healthcare. […]

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Concordia Healthcare Snaps Up Rare Disease Drugmaker in $3.5 Billion Deal

Canadian company Concordia Healthcare[2] (CXR.TO[3]), headquartered in Oakville, Ontario, announced[4] today that it is buying Amdipharm Mercury Limited[5] (AMCo) from Cinven[6] for $3.5 billion. Cinven is a European private equity firm. The deal will be a combination of cash, common shares of Concordia, and a performance-based earn-out payable in cash. “This acquisition is a key […]

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Bristol pairs Yervoy safely with Opdivo vs lung cancer

An early-stage study shows Bristol-Myers Squibb Co’s Opdivo treatment can be safely and effectively paired with relatively low and infrequent dosages of the company’s other immunotherapy, Yervoy, for patients with previously untreated lung cancer, researchers said on Monday. Opdivo, whose chemical name is nivolumab, is approved to treat advanced melanoma and the less-common squamous type […]

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