22:39 , Feb 19, 2019 |  BC Extra  |  Company News

FDA issues handful of new PDUFA dates

With the government shutdown resolved, FDA has accepted a handful of applications for review, according to company announcements early this week. FDA granted Priority Review to two applications from Genentech Inc. for entrectinib and polatuzumab...
23:51 , Feb 15, 2019 |  BC Extra  |  Company News

Bayer claims full rights to Vitrakvi from Lilly’s Loxo

Eli Lilly and Co. (NYSE:LLY) gained two fewer assets from its acquisition of Loxo Oncology Inc. than planned, as Loxo partner Bayer AG (Xetra:BAYN) said Friday it will exercise a change-of-control option to acquire full...
17:38 , Jan 11, 2019 |  BC Week In Review  |  Company News

Second big M&A deal of 2019: Lilly to acquire Loxo

Eli Lilly and Co. (NYSE:LLY) said on Jan. 7 it reached an $8 billion agreement to acquire Loxo Oncology Inc. (NASDAQ:LOXO), the pharma's third cancer-focused acquisition in the past year. The deal also comes in...
15:12 , Jan 7, 2019 |  BC Extra  |  Company News

Second big M&A deal of 2019: Lilly to acquire Loxo

Eli Lilly and Co. (NYSE:LLY) has reached an $8 billion agreement to acquire Loxo Oncology Inc. (NASDAQ:LOXO), the pharma's third cancer-focused acquisition in the past year. The deal also comes in the wake of the...
18:24 , Nov 30, 2018 |  BC Week In Review  |  Clinical News

FDA approves Loxo's larotrectinib, second tissue-agnostic approval from agency

FDA granted accelerated approval to Vitrakvi larotrectinib from Loxo Oncology Inc. (NASDAQ:LOXO), making the drug the second tissue-agnostic cancer treatment approved by FDA. Vitrakvi is a small molecule inhibitor of neurotrophic tyrosine kinase receptor 1...
00:13 , Nov 27, 2018 |  BC Extra  |  Company News

FDA approves Loxo's larotrectinib, second tissue-agnostic approval from agency

FDA granted accelerated approval to Vitrakvi larotrectinib from Loxo Oncology Inc. (NASDAQ:LOXO), making the drug the second tissue-agnostic cancer treatment approved by FDA. Vitrakvi is a small molecule inhibitor of neurotrophic tyrosine kinase receptor 1...
19:06 , Oct 26, 2018 |  BC Week In Review  |  Financial News

Ahead of Phase II, TP raises $80M mezzanine round

Oncology company TP Therapeutics Inc. (San Diego, Calif.) raised $80 million in a mezzanine round on Oct. 19 and promoted Athena Countouriotis to CEO from CMO as the company readies to begin a potentially registrational...
12:26 , Oct 19, 2018 |  BC Extra  |  Financial News

Ahead of Phase II, TP raises $80M mezzanine round

Oncology company TP Therapeutics Inc. (San Diego, Calif.) raised $80 million in a mezzanine round and promoted Athena Countouriotis to CEO from CMO as the company readies to begin a potentially registrational Phase II study...
20:32 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Genentech reports ORR of 77.4% for entrectinib in pooled analysis of ROS1-positive NSCLC patients

The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) reported data from an integrated analysis of 53 patients with locally advanced or metastatic c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1)-positive non-small cell lung cancer (NSCLC) in...
17:06 , Aug 23, 2018 |  BC Innovations  |  Distillery Techniques

Biomarkers

TECHNOLOGY: Gene profiling TrkB fusion oncogenes and mutations could help predict sensitivity to the TrkA/TrkB/TrkC inhibitor larotrectinib in patients with blood cancers. Genomic sequencing of 7,311 patients with hematologic malignancies identified one TrkA, one TrkB...