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News Breaks
March 25, 2013
06:57 EDTVNDAVanda reports successful completion of pre-NDA meeting with FDA on tasimelteon
Vanda Pharmaceuticals announced that the company held a pre-NDA meeting with the Division of Neurology Products of the FDA to discuss the regulatory path for filing a New Drug Application, or NDA, for tasimelteon, a circadian regulator, for the treatment of Non-24-Hour Disorder. Non-24 is a serious, rare circadian rhythm disorder that affects a majority of totally blind individuals. Currently there is no FDA approved treatment for Non-24. At the pre-NDA meeting, the FDA confirmed that the efficacy and safety data proposed by Vanda to be submitted in the tasimelteon NDA for Non-24 is adequate to support filing. The NDA supporting package that includes data from clinical pharmacology, pre-clinical pharmacology program, chemistry and manufacturing was also deemed adequate to support filing.
News For VNDA From The Last 14 Days
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April 24, 2015
07:47 EDTVNDAVanda receives positive CHMP opinion for Hetlioz for sleeping disorder in the EU
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April 20, 2015
08:12 EDTVNDAVanda names Tom Gibbs as SVP and Chief Commercial OfficerBristol-Myers
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April 13, 2015
17:48 EDTVNDAVanda announces Feb. 29, 2016 trial date for Fanapt patent cases
Vanda Pharmaceuticals announced a February 29, 2016 trial date for two pending cases against Roxane Laboratories regarding Roxane's submission of an ANDA to obtain approval to make and sell generic Fanapt. The two cases have been consolidated by agreement of the parties and are scheduled to be tried together in a four-day bench trial beginning on February 29, 2016. In C.A. No. 14-757-GMS, Vanda is asserting U.S. Patent No. 8,586,610 ('610 patent), covering methods of treating schizophrenia by administering Fanapt to certain patients, while in C.A. No. 13-1973-GMS, Vanda is asserting the U.S. composition of matter patent for Fanapt, U.S. Patent No. RE39,198. Both patents are listed in the FDA publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book. The '610 patent expires November 2027 and the RE'198 patent expires November 2016.

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