FDA

SEC warns pharma companies to be honest about FDA correspondence

The U.S. Securities and Exchange Commission's top enforcement chief warned on Tuesday that too many pharmaceutical companies are failing to accurately portray their dealings with federal drug regulators - a problem that could get them in trouble.

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FDA approves Eisai's thyroid cancer drug

The U.S. Food and Drug Administration said it approved Japan's Eisai Co Ltd's drug to treat the most common form of thyroid cancer more than two months ahead of the review date.

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Liberia Ebola vaccine trial 'challenging' as cases tumble

A steep fall in Ebola cases in Liberia will make it hard to prove whether experimental vaccines work in a major clinical trial about to start in the country, the head of the U.S. National Institutes of Health (NIH) said on Saturday.

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FDA approves NPS drug, in move validating Shire takeover deal

The U.S. Food and Drug Administration has approved NPS Pharmaceuticals Inc's drug Natpara to treat a rare hormone disorder, validating a bet by Shire Plc, which recently agreed to acquire NPS for $5.2 billion.

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Shire to buy NPS for $5.2 billion to boost rare disease drugs

Shire Plc has agreed to buy NPS Pharmaceuticals Inc for $5.2 billion in its biggest acquisition yet, as the Dublin-based drugmaker strengthens its position in the lucrative field of medicines for rare diseases.

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NeuroDerm shares double as Parkinson's drug shows promise

NeuroDerm Ltd's shares more than doubled in value on Tuesday, after the company said data from a mid-stage study suggested that a higher dose of its Parkinson's drug could provide an alternative to treatments that require surgery.

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FDA approves Roche Ebola test for emergency use

Roche Holding AG said U.S. health regulators have approved its Ebola test for emergency use in response to the world's worst outbreak of the disease in West Africa

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AstraZeneca's ovarian cancer drug gets U.S. approval

AstraZeneca Plc's ovarian cancer drug has been granted an accelerated approval by the U.S. health regulator, a day after the treatment was approved by the European Commission.

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FDA says expects China to OK staff visas after two-year delay

The U.S. Food and Drug Administration said on Friday it expects China, after almost two years of delays, to soon approve visas that will allow the agency to more than double its staff in China.

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NutraSweet to exit artificial sweetener aspartame business

Artificial sweetener maker NutraSweet Co said on Wednesday it would exit its aspartame business by the end of the year, citing increasing foreign competition.

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23andMe lands $1.4 million grant from NIH to detect genetic roots for disease

Home genetics startup 23andMe has secured a $1.4 million two-year grant from the National Institutes of Health (NIH) to build survey tools and expand its gene database.

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India-based Ranbaxy Laboratories Ltd recalls 64,000 bottles of generic Lipitor in US due to dosage packing error

Ranbaxy Laboratories has recalled 64,000 bottles of its generic version of Lipitor in the US after a 20-milligram tablet was found in a bottle for 10-milligrams, Reuters reported.

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Silicon Valley's Glooko bags $7M funding for global expansion for its predictive diabetes care

California, US-based innovative diabetes management startup Glooko landed $7 million in a funding round led by Samsung Venture Investment Company and Lifeforce Ventures to expand its predictive diabetes care service.

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23andMe defends genetic testing product

23andMe Chief Executive Officer Anne Wojcicki defended her company's genetic testing product and stands by the data on the accuracy of their results after the public warning letter issued by the US Food and Drug Administration.

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What to watch in the day ahead

Friday is the first day of sales for Sony's PlayStation 4 interactive gaming console. GE holds an meeting for investors and analysts focused on its GE Capital business. The Federal Reserve releases its report on U.S. industrial production.

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