17:33 , Nov 16, 2018 |  BC Week In Review  |  Clinical News

Venclexta/Gazyva combo meets PFS endpoint in Phase III for first-line CLL

Genentech Inc. and AbbVie Inc. (NYSE:ABBV) said first-line treatment with Venclexta venetoclax plus Gazyva obinutuzumab met the primary endpoint of improving investigator-assessed progression-free survival (PFS) compared with Gazyva plus chlorambucil in the Phase III CLL14...
18:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS;...
20:18 , Nov 5, 2018 |  BC Extra  |  Company News

Sandoz gives up on Rituxan biosimilar in U.S.

With two competing biosimilars under FDA review, Sandoz will no longer seek U.S. approval of GP2013, its biosimilar of cancer and autoimmune drug Rituxan/MabThera rituximab from Roche (SIX:ROG; OTCQX:RHHBY). The unit of Novartis AG (NYSE:NVS;...
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...