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FDA OKs breakthrough cholesterol drug for high-risk patients

2015-07-24 21:19:33| Biotech - Topix.net

" The Food and Drug Administration says it has approved a first-of-a-kind drug that lowers artery-clogging cholesterol more than older drugs that have been prescribed for decades. The drug from Sanofi and Regeneron Pharmaceuticals Inc. offers an important new option for millions of patients at high risk of heart disease.

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EU drug regulator recommends 1st license for malaria shot

2015-07-24 14:00:19| Biotech - Topix.net

In this Oct. 30, 2009 file photo, a mother holds her baby as she receives a new malaria vaccine as part of a trial at the Walter Reed Project Research Center in Kombewa in Western Kenya. The European Medicines Agency is recommending that the world's leading malaria vaccine be licensed even though it is only about 30 percent effective and that protection fades over time.

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Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis

2015-07-23 21:20:21| Biotech - Topix.net

Amgen today announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for Kyprolis for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. Kyprolis currently has accelerated approval in the U.S. for the treatment of patients with relapsed multiple myeloma as a monotherapy.

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Surging new drug sales highlight strong Bristol-Myers Q2

2015-07-23 16:20:43| Biotech - Topix.net

Surging sales for new cancer, heart and hepatitis C medicines helped drugmaker Bristol-Myers Squibb Co. beat Wall Street expectations, and it boosted its 2015 profit forecast.

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Investor delighted to support cancer drug project

2015-07-23 14:13:36| Biotech - Topix.net

FUND manager Woodford Investment Management, based in Oxford, is one of several new investors in Immunocure as a result of the biotechnology firm's A 205m private financing round. The company said it would use the proceeds to accelerate its pipeline of biological drugs, which it calls ImmTACs, and which the biotech firm believes have the potential to treat solid cancer tumours.

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