BC Extra | Jun 21, 2019
Company News

June 20 Company Quick Takes: Priority Review for Alexion, Melinta therapies; plus Alimera, Denovo and more

Priority Review for Alexion's Ultomiris sBLA  FDA accepted and granted Priority Review to an sBLA from Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) for Ultomiris ravulizumab-cwvz to block complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome....
BC Innovations | Jan 25, 2018

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...
BC Week In Review | Mar 17, 2017
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...
BC Week In Review | Feb 3, 2017
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...
BC Week In Review | Jul 27, 2015
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...
BC Week In Review | May 18, 2015
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...
BC Week In Review | Feb 23, 2015
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...
BC Week In Review | Jan 12, 2015
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...
BC Week In Review | Jun 2, 2014
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 to...
BC Week In Review | Apr 14, 2014
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...
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