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Archive for the ‘ filed for approval ’ Category

Dual-filing feat a rarity for little guy

Wednesday, February 17th, 2010

You may have read recently about a small biotech outfit in New Jersey having successfully submitted simultaneous regulatory filings in the United States and Europe for Luveniq, a new oral treatment for non-infectious uveitis, an inflammatory condition of the eye that can lead to blindness (see the release here). You ...

Big stage for diabetes hopeful

Friday, August 28th, 2009

Recent regulatory setbacks aside, Takeda Pharmaceutical Co. is plowing full steam ahead on its quest to win approval for the company’s key type 2 diabetes drug alogliptin, another potential entrant into the suddenly competitive field of DPP-4 inhibitors. The Japanese drug giant said today that it received the “all-clear” from FDA ...

Clumps key in Huntington’s disease breakthrough

Friday, June 5th, 2009

Scientists have figured out the cause of brain damage and death in Huntington’s disease patients that may lead to treatments to stop the disease. There is currently only one treatment that eases the symptoms of Huntington’s, Xenazine, marketed and developed by H. Lundbeck. Although there are a handful of drugs ...

Prasugrel not pleasing

Wednesday, June 3rd, 2009

Since January 2008, FDA has been discussing the benefits over the risks of Eli Lilly’s prasugrel. The drug prevents more heart attacks than Plavix, but causes more internal bleeding, according to a study conducted by Lilly. Consumer health advocates and Dr. Victor Serebruany, who worked on the early development of ...

   
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