23:13 , Jan 25, 2018 |  BC Innovations  |  Strategy

Takeda rides Denali’s ATV

In its deal with Denali, Takeda has not only boosted its CNS pipeline, but also gained access to a delivery technology that could open the door to a host of CNS targets only druggable with...
13:01 , Mar 17, 2017 |  BC Week In Review  |  Clinical News

Latuda: Ph III Illuminate data

Top-line data from the double-blind, international Phase III Illuminate trial in about 471 patients ages 10-17 with depression associated with bipolar I disorder showed that flexible dosing with once-daily 20-80 mg Latuda met the primary...
00:01 , Feb 3, 2017 |  BC Week In Review  |  Clinical News

Latuda regulatory update

FDA approved an sNDA from Sumitomo Dainippon’s Sunovion Pharmaceuticals Inc. subsidiary for Latuda lurasidone to treat schizophrenia in patients ages 13-17. Latuda is approved in the U.S. to treat adults with schizophrenia and depressive episodes...
07:00 , Jul 27, 2015 |  BC Week In Review  |  Clinical News

Latuda lurasidone: Phase III data

The double-blind, international Phase III RESOLVE 1 trial in 211 MDD patients who presented with a limited number of manic symptoms showed that flexibly-dosed, once-daily 20-60 mg Latuda met the primary endpoint of reducing MADRS...
07:00 , May 18, 2015 |  BC Week In Review  |  Clinical News

Latuda lurasidone: Updated Phase III data

Sumitomo said updated data from the double-blind, Asian Phase III PASTEL trial of lurasidone no longer support approval of the product to treat schizophrenia in Japan. In 439 patients in the modified intent-to-treat (mITT) population...
08:00 , Feb 23, 2015 |  BC Week In Review  |  Company News

Sumitomo Dainippon Pharma Co. Ltd, DKSH deal

The companies added commercialization rights to a deal under which DKSH was responsible for obtaining regulatory approval for lurasidone in Thailand, Singapore and Hong Kong. Under the original deal, subsidiaries of DKSH submitted regulatory applications...
08:00 , Jan 12, 2015 |  BC Week In Review  |  Clinical News

Latuda lurasidone: Preliminary Phase III data

Preliminary data from 430 patients in the modified intent-to-treat (mITT) population of the double-blind, Asian Phase III PASTEL trial showed that once-daily 40 mg lurasidone met the primary endpoint of reducing PANSS total score from...
07:00 , Jun 2, 2014 |  BC Week In Review  |  Company News

Daiichi Sankyo, Dainippon Sumitomo deal

Dainippon granted Daiichi exclusive rights in Brazil and Venezuela to commercialize antipsychotic Latuda lurasidone ( SM-13496). Daiichi is responsible for submitting regulatory applications in the territories. Dainippon declined to disclose when it expects Daiichi...
07:00 , Apr 14, 2014 |  BC Week In Review  |  Clinical News

Latuda lurasidone regulatory update

Health Canada approved Latuda lurasidone to treat depressive episodes associated with bipolar I disorder as monotherapy or as adjunctive therapy to lithium or valproate. FDA approved Latuda for the indication last July. The product is...
07:00 , Mar 31, 2014 |  BC Week In Review  |  Clinical News

Latuda lurasidone regulatory update

The European Commission and Australia's Therapeutic Goods Administration ( TGA) separately approved Latuda lurasidone to treat schizophrenia in adults. Latuda is a small molecule antagonist of dopamine D2 receptor, serotonin (5-HT2A) and (5-HT7) receptors...