Japan's fifth-largest drug maker Otsuka Pharmaceutical withdrew its application in Europe for the additional indication of major depressive episodes for its best-selling atypical antipsychotic Abilify (aripiprazole), the European Medicines Agency announced Nov. 19
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
In this week's episode: a look at the likely top drugs in 2030; Lilly CEO advocates US/Europe pricing rebalance; Insmed sees $5bn-plus market for Brinsupri; royalty deals go mainstream; Phase III win sets stage for Epkinly label expansion.
Private Company Edition: Hatteras Venture Partners now has more than $900m under management. Also, in recent $100m-plus VC rounds, Strand Therapeutics raised a $153m series A, ARTBIO revealed a $132m series B and Minghui Pharmaceutical secured a $131m pre-IPO round.
The first new drug for fibromyalgia since 2009, Tonyma is a reformulation of cyclobenzaprine intended for chronic therapy. Tonix said the drug targets non-restorative sleep.
