BC Week In Review | Mar 22, 2019
Clinical News

FDA places hold on Venclexta for multiple myeloma

FDA issued a safety warning after it placed a partial clinical hold on all trials evaluating Venclexta venetoclax to treat multiple myeloma after an interim analysis showed that the drug led to a higher proportion...
BC Extra | Jan 7, 2019
Politics & Policy

Bipartisan bill to streamline U.S. response to foreign theft of IP may hasten clarity on biotech impact

As the biopharma industry awaits guidance from the government on the scope and potential impact of proposed technology export controls, a new congressional bill could help speed the process. Members of the Senate Select Committee...
BioCentury | Dec 8, 2018
Product Development

Intermittent move beyond Blincyto

A swath of data at ASH shows that companies have been able to move beyond the 28-day continuous dosing of Amgen Inc.’s first-generation BiTE, Blincyto, to build next-generation antibodies with more convenient, intermittent dosing and...
BC Week In Review | Nov 30, 2018
Clinical News

FDA approves two drugs for first-line AML

FDA approved on Nov. 28 two drugs for first-line treatment of acute myelogenous leukemia, setting off a race in a setting that's been void of new approvals for patients who do not harbor an FMS-like...
BC Innovations | Nov 30, 2018
Targets & Mechanisms

Adhesion targets emerge at ASH 2018

The next wave of targets in blood cancers and hematology will come from adhesion molecules, innate immune cells and regulators of gene expression, according to BioCentury’s analysis of emerging targets at ASH 2018. BioCentury’s analysis...
BC Extra | Nov 21, 2018
Company News

FDA approves two drugs for first-line AML

FDA approved on Wednesday two drugs for first-line treatment of acute myelogenous leukemia, setting off a race in a setting that's been void of new approvals for patients who do not harbor an FMS-like tyrosine...
BC Week In Review | Nov 16, 2018
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...
BC Week In Review | Nov 2, 2018
Clinical News

EC approves AbbVie's Venclexta in combination with Rituxan for CLL

The European Commission approved Venclyxto venetoclax in combination with Rituxan rituximab to treat relapsed/refractory chronic lymphocytic leukemia in patients who have received at least one prior therapy. Venclyxto is already approved for the indication as...
BioCentury | Jul 13, 2018
Strategy

Roche’s partnering priority

As James Sabry gets set to lead partnering for all of Roche pharma, his first order of business might be to build out the company’s late-stage pipeline ahead of an impending patent cliff that puts...
BC Week In Review | Jun 15, 2018
Clinical News

Imbruvica, Venclexta combo leads to responses with no detectable MRD in Phase II for CLL

AbbVie Inc. (NYSE:ABBV) said 23 of the first 30 evaluable patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in the Phase II CAPTIVATE (PCYC-1142) trial achieved a response with no...
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