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The Pulse of the Pharmaceutical Industry

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FDA staff question utility of Sanofi diabetes drugs

A preliminary FDA review questioned whether Sanofi’s diabetes drug lixisenatide contributed any benefit to a fixed-dose combo product the company hopes to market.

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France faults Bial and Biotrial over fatal drug trial

Portuguese drugmaker Bial and French laboratory Biotrial are at fault “on several counts” for a fatal drug trial that left one person dead and five others hospitalized in January, French Health Minister Marisol Touraine said.

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Sanofi Reshuffles Executive Committee

Sanofi has shuffled around some of its top leaders in support of its 2020 strategic roadmap as three executives have announced their intentions leave the company.

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Arbor Pharma Acquiring Restless Leg Drug Company XenoPort

Atlanta-based Arbor Pharmaceuticals announced that it was acquiring Santa Clara, California-based XenoPort for approximately $467 million.

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Australia watchdog appeals $1.2 million Reckitt Benckiser fine as too light

Australia’s competition watchdog has filed an appeal against a fine of A$1.7 million ($1.2 million) imposed on British consumer goods giant Reckitt Benckiser for misleading consumers on painkiller marketing, arguing that it is too light.

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Marketing in a Digital World

Join the GTO Group for a free webinar exploring how marketing, media, design, and technology are converging in order to effectively reach and empower patients, caregivers, and HCPs.

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World Bank launches $500 million insurance fund to fight pandemics

The World Bank said it was launching a $500 million, fast-disbursing insurance fund to combat deadly pandemics in poor countries, creating the world’s first insurance market for pandemic risk.

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FDA targets sugar in new labeling rules

The U.S. FDA said it would update guidelines for nutritional labels on packaged food and beverages to include info on added sugar and to prominently display calorie count and servings.

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CDC says 157 pregnant women in U.S. test positive for Zika

Some 157 pregnant women in the United States and another 122 in U.S. territories have tested positive for infection with the Zika virus, the U.S. Centers for Disease Control and Prevention said.

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New HIV vaccine trial aims to build on earlier modest success

A late-stage trial will begin later this year in South Africa to test the effectiveness of an HIV vaccine that has shown promise in earlier trials, according to the National Institutes of Health.

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NeuralStem to Cut an Unknown Number of Jobs in Reorganization

Shares of Neuralstem were slightly down after the company announced a reorganization combined with the termination of an unknown number of employees.

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Drugmakers eye volume growth as China cuts prices by up to 67 percent

Chinese health authorities announced price cuts of up to two-thirds for three expensive drugs.

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In Light of Disappointing Trial Results, Acorda Terminates Epilepsy Drug Program

Acorda Therapeutics announced that it is discontinuing development of its Plumiaz (diazepam) Nasal Spray for the treatment of epileptic seizures.

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Roche breast cancer drug Perjeta rejected by UK cost agency

Roche’s breast cancer drug Perjeta (pertuzumab) has been turned down for use on Britain’s state health service.

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Novartis launches new Entresto trials to boost sales

Novartis’s heart failure drug Entresto will be subjected to a battery of new trials as the Swiss drugmaker seeks to boost the medicine after a disappointing introduction.

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Tonix shares soar as PTSD drug shows promise in study

Tonix Pharmaceuticals Holding Corp said a higher dose of its experimental drug for post-traumatic stress disorder (PTSD) helped control symptoms in patients, sending its shares surging 46 percent in premarket trading.

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Cigna plans to cut opioid use among U.S. customers by 25 percent

Health insurer Cigna Corp plans to cut its customers’ prescriptions for opioid treatments by 25 percent over the next three years, putting its weight behind a U.S. government battle against addictive pain killers.

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FDA Approves First New Bladder Cancer Drug in 30 Years

FDA gave Tecentriq accelerated approval to treat specific types of advanced bladder cancer.

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German Merck, Pfizer immunotherapy shows promise in rare skin cancer

Germany’s Merck KGaA reported encouraging interim data against a rare and aggressive form of skin cancer from a mid-stage trial of its experimental drug that helps the immune system attack tumors.

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Landmark deCODE genetics Study Points to a New Mechanism that Affects Cholesterol Levels and the Risk of Heart Disease

deCODE genetics announced the discovery of a rare variation in the sequence of the human genome that confers on carriers a substantial reduction in levels of non-HDL cholesterol, the best measure of the type of cholesterol that causes the build-up of plaques in the arteries that are at the root of most heart disease.

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