17:53 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Priority review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting. AbbVie said the...
14:44 , Oct 17, 2018 |  BC Extra  |  Company News

Priority Review for Imbruvica-Gazyva combo to treat CLL, SLL

AbbVie Inc. (NYSE:ABBV) said FDA accepted and granted Priority Review to an sNDA for Imbruvica ibrutinib plus Gazyva obinutuzumab to treat chronic lymphocytic leukemia or small lymphocytic leukemia in the first-line setting. AbbVie said the...
18:36 , Sep 28, 2018 |  BC Week In Review  |  Clinical News

TG won't seek accelerated approval of CLL combo

TG Therapeutics Inc. (NASDAQ:TGTX) shed $4.10 (44%) to $5.15 on Sept. 25 after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202) to treat chronic lymphocytic leukemia. The company...
15:16 , Sep 25, 2018 |  BC Extra  |  Clinical News

TG won't seek accelerated approval of CLL combo; shares sink

TG Therapeutics Inc. (NASDAQ:TGTX) shed $4.10 (44%) to $5.15 on Tuesday after the company said it will not seek accelerated approval of ublituximab (TG-1101) plus umbralisib (TGR-1202) to treat chronic lymphocytic leukemia. The company said...
19:16 , Sep 14, 2018 |  BC Week In Review  |  Company News

MS Society protests NICE rejection of Ocrevus for primary progressive MS

The U.K.'s NICE issued a final appraisal determination (FAD) on Sept. 10 recommending against the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat primary progressive multiple sclerosis with imaging features characteristic of inflammatory...
01:48 , Sep 10, 2018 |  BC Extra  |  Company News

MS Society protests NICE rejection of Ocrevus for primary progressive MS

The U.K.'s NICE issued a final appraisal determination (FAD) Sunday recommending against the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat primary progressive multiple sclerosis with imaging features characteristic of inflammatory activity in...
18:40 , Aug 8, 2018 |  BC Innovations  |  Emerging Company Profile

Catching antibodies with polymers

Polyneuron Pharmaceuticals AG's glycopolymers act as decoys for the autoantibodies that drive autoimmune diseases, such as anti-MAG neuropathy, and are designed to be more effective and safer than other therapies. Polyneuron's Antibody-Catch platform generates glycopolymers that...
00:46 , Aug 4, 2018 |  BioCentury  |  Finance

Functions of formulation

Halozyme Therapeutics Inc. is quickly expanding the reach of its Enhanze platform on the back of regulatory approvals for products that are now gaining market share, plus a playbook for streamlined early development it can...
18:58 , Jul 13, 2018 |  BC Week In Review  |  Company News

NICE does not recommend Roche's ocrelizumab for primary progressive MS

The U.K.'s NICE said in an appraisal consultation it does not recommend the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat primary progressive multiple sclerosis (MS) with imaging features characteristic of inflammatory activity...
17:56 , Jun 22, 2018 |  BC Week In Review  |  Company News

NICE recommends Roche's Ocrevus for relapse-remitting multiple sclerosis

The U.K.'s NICE issued a final appraisal determination (FAD) recommending the use of Ocrevus ocrelizumab from Roche (SIX:ROG; OTCQX:RHHBY) to treat relapse-remitting multiple sclerosis. In January, the European Commission approved the second-generation humanized mAb against CD20...