The US FDA has issued Actelion with a complete response letter for its drug Zavesca (miglustat), for the treatment of progressive neurological manifestations in adults and children with Niemann-Pick type C (NP-C) disease – a rare, fatal ...
PTC Therapeutics and Genzyme 's ataluren, an experimental nonsense mutation suppressor, has failed in nonsense mutation Duchenne/Becker Muscular Dystrophy (nmDBMD), show top-line Phase IIb results. Around 10-15% of DBMD cases are due to nonsense ...
The US FDA has accepted for standard review Dainippon Sumitomo Pharma 's (DSP) NDA for the atypical antipsychotic lurasidone, for the treatment of acute schizophrenia.
The filing was made ahead of the company's original schedule on December 30th, ...
XenoPort is shedding 50% of its workforce and shelving its discovery research efforts following the "unexpected setback" in the approval of Horizant (XP13512; gabapentin enacarbil extended release tablets), which is under development with ...
Lilly expects its Japanese business to grow by double digits this year and has assured that it is on track to virtually double its sales in the country to more than $2 billion in 2014.
"We have full confidence that we will meet our targets, which ...
