FDA extends review period for Novartis' oral MS drug; Start-up gets rights to QLT programs;

 @FierceBiotech: GE brings $3B life sciences project to light. Report | Follow @FierceBiotech

 @JohnCFierce: Biosimilars, in many ways, will be even harder to test, often demanding comparative effectiveness studies with the branded biologic.| Follow @JohnCFierce

> The FDA has extended its review period for Novartis' oral MS program Gilenia (fingolimod), previously known as FTY720, by three months. Novartis is engaged in a closely-watched race to gain an approval for the first oral MS therapy, a likely blockbuster. Story

> Shares of Canada's Theratechnologies slid this morning after FDA staffers noted that its experimental therapy reduced abdominal fat in patients but noted that some people taking the drug developed diabetes. Staffers also noted that the drug's effect ended once treatment stopped. Story

> A newly formed biotech dubbed Valocor Therapeutics has in-licensed some of QLT's dermatology therapeutic programs. Valocor Therapeutics was founded by Daniel Wattier, president and CEO, David Hunt, Ph.D., V.P. of research and Agnes Chan, Ph.D., V.P. project direction and operations. The company also announced that Julia Levy, Ph.D., former CEO of QLT, has joined the Valocor Board as chairman. Release

> Alkermes shares were boosted a bit after the FDA provided priority review status for its opioid dependence therapy Vivitrol. Report

> The FDA has designated Repligen's experimental treatment of an inherited neurodegenerative disease an orphan drug. Report

And Finally... Tim Bruckner, assistant professor of public health at UC Irvine, and colleagues at UC Berkeley found that the fetal death rate for males spiked in September 2001 and that significantly fewer boys were born than expected in December of that year. Report

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