02:33 , Jul 13, 2019 |  BioCentury  |  Finance

How crossover, insider support and big money correlated with performance across 1H19 IPOs

The performance of 1H19 IPOs point toward a continuation of a dual-class system where biotechs backed by deep-pocketed VCs and crossover investors can tap the public market at will and generate stronger after-market performance than...
01:30 , Jul 13, 2019 |  BioCentury  |  Tools & Techniques

Broadening role for external control arms in clinical trials

External control arms are moving from theory to practice as drug developers begin to use them to make internal go/no-go decisions for clinical programs and to support regulatory applications. The field is largely split between...
01:58 , Jun 29, 2019 |  BioCentury  |  Finance

Biotech backs down in 2Q19

In a reversal from 1Q19, biotech stocks across all market cap tiers fell in the second quarter, leading to a total loss of $22.3 billion. However, the year-to-date change in market cap remains well in...
00:27 , Jun 22, 2019 |  BC Extra  |  Clinical News

June 21 Clinical Quick Takes: Melanoma miss for Exelixis/Genentech combo; plus Progenics, Turning Point, Gracell

Cotellic/Tecentriq combo misses in melanoma  Exelixis Inc. (NASDAQ:EXEL) revealed in a Thursday SEC filing that Cotellic cobimetinib plus Tecentriq atezolizumab from partner Genentech Inc. missed the primary endpoint of improving progression-free survival vs. Keytruda pembrolizumab...
22:28 , Jun 18, 2019 |  BC Extra  |  Company News

Japanese approvals include a global first for Roche's tissue-agnostic cancer drug

Among the four Japanese drug approvals announced on Tuesday was the global first for tissue-agnostic cancer therapy Rozlytrek entrectinib from Roche. Japan's Ministry of Health, Labour and Welfare (MHLW) approved the inhibitor of ROS1, TrkA,...
02:43 , Jun 1, 2019 |  BioCentury  |  Product Development

ASCO 2019 abstracts show solid tumor race heating up among bispecifics and CAR Ts

While strong progress in CAR T therapies will again feature at this year’s ASCO meeting, bispecific antibodies are having a moment -- making more inroads into solid tumors than CAR Ts and branching out via...
22:07 , May 31, 2019 |  BC Extra  |  Clinical News

Turning Point sinks on ASCO update for repotrectinib

Updated data showing a lower response rate in a cohort of ROS1-positive NSCLC patients treated with repotrectinib than a previous analysis sent shares of Turning Point tumbling on the first day of the American Society...
22:20 , May 29, 2019 |  BC Extra  |  Company News

Bayer taps a second partner to develop Vitrakvi's companion diagnostic

Six months into Vitrakvi larotrectinib's approval as a tissue-agnostic therapy, Bayer has added a second co-development partnership for the NTRK inhibitor's still-needed companion diagnostic, this time with Roche's Foundation Medicine unit. In April 2018, Vitrakvi's...
23:10 , May 16, 2019 |  BC Extra  |  Clinical News

Roche, Bayer unveil brain tumor data for NTRK inhibitors ahead of ASCO

Efficacy data for two tissue-agnostic NTRK inhibitors from Roche and Bayer to treat primary and metastatic brain tumors were released in abstracts ahead of the American Society of Clinical Oncology meeting in Chicago. Data from...
22:06 , May 7, 2019 |  BC Extra  |  Company News

May 7 Company Quick Takes: Akcea, Bicycle/DDF, Arbutus, Celgene/Sutro, MDGH, Pfizer, Sanofi/Regeneron

Akcea's Waylivra approved in EU  The European Commission granted conditional approval to Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) and Ionis Pharmaceuticals Inc. (NASDAQ:IONS) as an adjunct to diet in adult patients with familial chylomicronemia...