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Bristol-Myers says HIV drug gets FDA incentives

2015-07-21 20:30:52| Biotech - Topix.net

The Food and Drug Administration designated the drug BMS-663068 as a breakthrough treatment, so Bristol-Myers Squibb Co. will get extra meetings with the FDA and earlier communication with scientists as it studies the drug.

Tags: drug hiv incentives fda

 

Sanofi Cholesterol Drug, GSK Malaria Shot May Get EU Okay Friday

2015-07-21 16:29:02| Biotech - Topix.net

Sanofi and Regeneron's new cholesterol drug Praluent could be recommended for approval in Europe as early as this week, along with the world's first malaria vaccine from GlaxoSmithKline.

Tags: friday drug shot okay

 
 

Why Genzyme isn't worried about a threat by Amicus to its next Fabry drug

2015-07-20 20:46:31| Biotech - Topix.net

It's been less than a year since Genzyme started offering the first-ever pill to treat the very rare disease known as Gaucher. Now it's one of two big drug companies in the world aiming to do the same thing with a related rare disease, called Fabry.

Tags: its next drug threat

 

Amgen reports positive preliminary results on leukemia drug

2015-07-17 19:38:55| Biotech - Topix.net

Amgen Inc on Thursday said some patients with a deadly form of leukemia experienced complete remission after being treated with its Blincyto drug in a midstage clinical trial, results that could eventually lead to an expanded approval of the pricy cancer medicine. While providing few details, the world's largest biotechnology company said the drug, which helps the immune system to fight cancer, induced complete remission or complete remission with partial hematological recovery in a "clinically meaningful number of patients" with relapsed or refractory Philadelphia chromosome-positive B-cell precursor acute lymphoblastic leukemia .

Tags: results reports positive drug

 

Takeda Oncology files for approval of first drug since name change

2015-07-15 23:08:27| Biotech - Topix.net

Takeda Oncology is seeking U.S. approval of what could be its first new drug since it officially changed it's name from Millennium Pharmaceuticals last fall.

Tags: name since change files

 

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