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FDA expands use of Bristol-Myers’ cancer drug Yervoy

The U.S. Food and Drug Administration expanded the use of Bristol-Myers Squibb Co’s skin cancer drug, Yervoy, as an additional therapy for patients with late-stage melanoma. This approval extends Yervoy’s use to patients with stage III melanoma, who have a high risk of recurrence after surgery, the agency said on Wednesday. Due to the potential […]

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Gilead hepatitis C drug sales trend flattens, shares dip

Gilead Sciences Inc on Tuesday said its quarterly profit rose 70 percent, but sales growth for its hepatitis C drugs flattened as health insurers limited access to the expensive treatments. Shares of the biotechnology company fell slightly. Gilead’s quarterly product sales rose 37 percent to $8.2 billion. Sales of hepatitis C drugs Sovaldi and Harvoni […]

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Arena Pharmaceuticals Announces New Strategic Focus and Cost Reduction Plan

– Strategic priorities include clinical-stage pipeline and core research function –   SAN DIEGO, Oct. 27, 2015 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced plans to improve efficiencies and reduce costs as it focuses on the advancement of its research and development priorities. Arena intends to focus on its key strengths by concentrating […]

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Shire to resubmit dry-eye disease drug to FDA with new study data

London-listed pharma firm Shire said its dry-eye disease drug lifitegrast significantly improved patient symptoms in a new study, supporting a re-submission of the potentially block-busting medicine to U.S. regulators early next year. Shares in Shire jumped more than 6 percent after it announced the positive results of the study on Tuesday. They were trading up […]

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Novartis AG to Cough Up $390 Million to Settle U.S. Kickback Case

Novartis AG agreed to pay $390 million to resolve a lawsuit claiming the company paid kickbacks to increase sales of several prescription drugs. The agreement is preliminary. The payment covers all claims related to the medicines Myfortic, Exjade, Tasigna, Gleevec and TOBI, the company said. The U.S. had sought as much as $3.3 billion from […]

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FDA sees no heart risks from Novartis’ Parkinson’s drug

U.S. health regulators said on Monday that there was no evidence of increased cardiovascular risks related to Novartis AG’s treatment, Stalevo, for Parkinson’s disease. Recommendations for using the drug, which won U.S. approval in 2003, will remain the same on the labels, the U.S. Food and Drug Administration said, after examining data from a required […]

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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 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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