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Valeant to set up panel to review link with specialty pharmacy

Valeant Pharmaceuticals International Inc (VRX.TO) (VRX.N) said on Monday it would set up an ad hoc committee to look into allegations related to the company’s association with specialty pharmacy distributor Philidor.   Valeant, whose U.S.-listed shares were down 14 percent in premarket trading, also said a board review had found that the company was in […]

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BioDelivery’s opioid treatment wins FDA approval

BioDelivery Sciences International Inc said the U.S. Food and Drug Administration had approved its opioid treatment for chronic pain, sending the drugmaker’s shares up 19 percent in premarket trading on Monday. Endo International Plc licensed the worldwide manufacturing and marketing rights to the treatment, Belbuca, from BioDelivery in 2012. Belbuca is an opioid film patch […]

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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 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 panel votes in favor of approving AstraZeneca’s gout drug

An independent panel of advisers to the U.S. Food and Drug Administration on Friday voted 10-4 in favor of approving AstraZeneca Plc’s gout drug. All 10 who backed the drug, lesinurad, qualified their vote by urging the FDA to ask AstraZeneca for studies after the drug’s launch to gauge its long-term effectiveness and safety. Gout […]

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WHO experts signal victory over one of three polio strains

The world should stop vaccinating children against one of the three strains of the crippling polio virus as part of a drive to eradicate the disease once and for all, a group of health experts has advised the World Health Organization. There is no cure for polio, which attacks the nervous system and can cause […]

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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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Cholesterol levels and tendon pain may be related

(Reuters Health) – People with unhealthy blood cholesterol levels are more likely to have tendon pain or altered tendon structure, according to a new review. Cholesterol is essential for life, but too much in the blood increases the risk for cardiovascular disease and may also be linked to musculoskeletal problems, such as tendon injuries, said […]

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World’s first malaria vaccine delayed as WHO experts urge caution

The world’s first malaria vaccine is promising but should be used on a pilot basis before any wide-scale use, given its limited efficacy, World Health Organization (WHO) experts said on Friday. The decision is likely to delay a possible broad roll-out of the shot for between three and five years. GlaxoSmithKline’s Mosquirix could, in theory, […]

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EU drugs agency recommends suspension of Medtronic implant

Europe’s medicines regulator recommended the suspension of Medtronic Plc’s Inductos, an implant used to help bone development, pending the resolution of issues at a U.S. site where a component is made. The European Medicines Agency (EMA) began a review of Inductos following an inspection by Dutch and Spanish authorities of a site that makes an […]

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