Regulatory rejection flurry does not make a storm
Fears of heightened scrutiny by the FDA will be calmed by a look at historic rates of complete response letters.
Go or no go? UCB bids to make a mark in psoriasis
Chemocentryx and Avadel will also see important FDA regulatory action this month, while Omeros gets another delay.
Upcoming events – Avadel takes on Jazz and Axovant awaits early results
Data will soon show whether Avadel’s FT218 is more convenient than Jazz’s Xyrem, while Axovant will be looking for a dose response with its Parkinson’s gene therapy.
Go or no go? Vascepa’s finale and Allergan's pain relief
Amarin’s Vascepa and Allergan’s migraine project ubrogepant are the high-profile pending FDA approval decisions as the sector heads into the last month of the year.
