BioCentury | Sep 9, 2020
Product Development

Intra-Cellular eyes broad label for bipolar depression after Phase III hit

...as an adjunctive therapy to lithium or valproate...
BioCentury | Feb 22, 2020
Product Development

Regenerative medicine for hearing loss makes quiet progress

...of FX-322 in 2H20. The small molecule combination therapy pairs the approved HDAC inhibitor sodium valproate...
BioCentury | Dec 23, 2019
Company News

Caplyta’s unanticipated schizophrenia approval lifts Intra-Cellular shares

...in another. A third trial assessing the Caplyta as an adjunctive treatment with lithium or valproate...
BioCentury | Jul 8, 2019
Clinical News

Intra-Cellular optimistic on lumateperone's future in bipolar despite mixed Phase III results

...of lumateperone. Study 402 is assessing the molecule as an adjunctive treatment with lithium or valproate...
BioCentury | Nov 18, 2017
Regulation

Measuring regulatory outcomes

...whole -- which sought patient and healthcare professional testimonies on the safety of epilepsy drug valproate...
BioCentury | Jul 13, 2017
Clinical News

EMA to hold first public hearing in valproate safety review

...public hearing on Sept. 26 at which citizens are invited to share their experiences using valproate...
...part of a review begun in March by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concerning valproate's...
...25. European Medicines Agency (EMA) , London, U.K. Product: Valproate Business: Neurology Meghan Sullivan European Medicines Agency (EMA) valproate...
BioCentury | Jul 11, 2017
Politics & Policy

EMA to hold first public hearing in valproate safety review

...public hearing on Sept. 26 at which citizens are invited to share their experiences using valproate...
...part of a review begun in March by EMA's Pharmacovigilance Risk Assessment Committee (PRAC) concerning valproate's...
...a PRAC safety review. A 2014 EMA review led to stronger warnings and restrictions on valproate...
BioCentury | Mar 17, 2017
Clinical News

Latuda: Ph III Illuminate data

...6 vs. placebo. Latuda is approved in the U.S. as monotherapy or with lithium or valproate...
BioCentury | Mar 16, 2017
Clinical News

Intracerebroventricular valproate: Ph I/II ADDRESS started

...Cerebral Therapeutics began the Australian Phase I/II ADDRESS trial to evaluate intracerebroventricular valproate delivered via the...
...pump system in 12 patients. The double-blind, dose-escalation Phase I portion will evaluate 3-60 mg valproate...
...Mt. Olive, N.J. Product: Intracerebroventricular valproate Business: Neurology Molecular target: Histone deacetylase (HDAC) Description: Intracerebroventricular valproate...
BioCentury | Apr 14, 2016
Emerging Company Profile

Thinking about HDAC2

...much better safety margins as well." Several companies market valproic acid-based generics, or are developing valproate...
Items per page:
1 - 10 of 91