BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BC Extra | Aug 27, 2019
Company News

Aug. 27 Company Quick Takes: GSK licenses Ionis HBV program; plus Adaptimmune-Noile, Purdue, Presage-BMS, Kyowa, Alexion, Viela, Kintai, OncoNano

GSK opts into Ionis' HBV program  Positive Phase II data prompted GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to exercise its option to license exclusive, worldwide rights to an antisense chronic HBV program from Ionis Pharmaceuticals Inc. (NASDAQ:IONS)....
BC Extra | Jul 27, 2019
Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
BC Extra | Jun 28, 2019
Company News

June 27 Company Quick Takes: Zogenix soars; plus Gardasil, Darzalex, Soliris and more

Zogenix shares surge after agreement to resubmit Fintepla NDA  Zogenix Inc. (NASDAQ:ZGNX) closed up $8.24 (21%) to $47.65 on Thursday after the company announced it had reached an agreement with FDA to resubmit its NDA...
BC Extra | May 7, 2019
Clinical News

Viela reports detailed Phase II/III data for rare CNS disorder therapy

Viela touted a potential dosing advantage and reiterated its plans to submit mid-year a BLA to FDA for inebilizumab to treat neuromyelitis optica spectrum disorder (NMOSD). The update came during a presentation at AAN on...
BC Week In Review | Jan 4, 2019
Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
BC Extra | Jan 3, 2019
Clinical News

Viela planning BLA submission for inebilizumab in rare CNS disorder

Viela Bio Inc. (Gaithersburg, Md.) said it will submit a BLA to FDA this half for inebilizumab (MEDI-551) to treat neuromyelitis optica spectrum disorder (NMOSD) after the compound met the primary endpoint in the Phase...
BC Week In Review | Dec 21, 2018
Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...
BC Extra | Dec 19, 2018
Clinical News

Chugai's IL-6 receptor mAb meets in Phase III for rare CNS disorder

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said satralizumab (SA237, RG6168) as monotherapy met the primary endpoint in the Phase III SAkuraStar trial to treat neuromyelitis optica spectrum disorder (NMOSD). The company plans to submit regulatory applications...
BC Week In Review | Sep 28, 2018
Clinical News

Alexion eyes submissions for Soliris in rare CNS disease

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) plans to submit regulatory applications in the U.S., EU and Japan for Soliris eculizumab to treat relapsing neuromyelitis optica spectrum disorder (NMOSD) after the drug met the primary endpoint in the...
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