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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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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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Spectrum says FDA declines to approve Evomela for injection

Biotechnology company Spectrum Pharmaceuticals Inc said the U.S. Food and Drug Administration declined to approve its Evomela injection to treat patients with multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow. Spectrum Pharmaceuticals said it received a complete response letter, which the FDA sends to let a drug […]

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Lack of sleep linked to risk factors for diabetes and heart disease

(Reuters Health) – People who get less than six hours of sleep a night may be more likely to have risk factors that increase their odds of diabetes, heart disease and strokes, a Korean study suggests. This combination of risk factors – including high blood sugar, high cholesterol, extra fat around the midsection, high blood […]

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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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Aurobindo Receives FDA Approval for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg

Dayton, N.J., October 22, 2015 – Aurobindo Pharma Limited has received final approval from the U.S. Food and Drug Administration for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. The Division of Bioequivalence has determined Aurobindo Pharma Limited’s Memantine Hydrochloride Tablets USP, 5 mg and 10 mg to be bioequivalent and, therefore, therapeutically equivalent […]

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Orchestrated customer engagement: Going beyond multichannel marketing

IMS Health has released its report Orchestrated Customer Engagement, which looks at what pharma companies need to do beyond multichannel and omnichannel marketing in order to deliver a full customer engagement experience. Med Ad News spoke with Richie Etwaru, chief digital officer of IMS Health and primary author of the report, to expand on some […]

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Perrigo to Chop 800 Jobs, Buy Back Shares to Fend Off Mylan

Dublin, Ireland-based Perrigo Company plc (PRGO) announced today that it will take a number of actions, including layoffs, to increase profitability and help fend off a hostile takeover by Canonsburg, Penn. and UK-based Mylan N.V.   The company plans to consolidate its global supply chain, operations and procurement management activities into a single global center […]

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British PM Cameron against imposing sugar tax to fight child obesity

British Prime Minister David Cameron is against imposing a tax on sugar as a means to tackle childhood obesity, his spokesman said on Thursday, rejecting the arguments of a high-profile campaign for a levy on sugary food and drinks.   Childhood obesity is described as one of the most serious public health challenges of the […]

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ImmunoGen, Roche gastric cancer drug fails study

ImmunoGen Inc said the gastric cancer drug it is developing with Roche Holding AG did not meet the main goal in a large study. ImmunoGen entered into a royalty purchase agreement with Roche for Kadcyla this year. Kadcyla, approved in 2013 for the treatment of late-stage breast cancer, was being tested as a second-line treatment […]

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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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