21:50 , Aug 16, 2019 |  BC Extra  |  Company News

Genentech prices tissue-agnostic therapy at almost half the cost of Bayer's

After scoring FDA approval for its tissue-agnostic therapy Thursday, Genentech Inc. priced Rozlytrek entrectinib Friday at a wholesale acquisition cost of up to $17,050 per month, nearly half that of its only competitor. Rozlytrek is...
22:33 , Aug 15, 2019 |  BC Extra  |  Company News

Genentech gains its first U.S. tissue-agnostic approval with Rozlytrek

Following a Japanese approval in June, Roche’s Genentech unit scored accelerated approval in the U.S. Thursday for its Rozlytrek entrectinib to treat NTRK fusion-positive solid tumors. FDA also approved the inhibitor of ROS1, TrkA, TrkB,...
00:05 , Jul 27, 2019 |  BC Extra  |  Company News

Vitrakvi set to become EU’s first tissue-agnostic cancer drug

EMA's CHMP delivered its first positive recommendation for a tissue-agnostic cancer therapy to Vitrakvi in its monthly basket of positive opinions, which also included one for GW’s Epidyolex. CHMP backed approval of an MAA from...
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...
01:37 , Jun 28, 2019 |  BC Innovations  |  Product Development

How Array stayed alive long enough to grow up

Array’s 21-year journey as an independent platform company, culminating in an $11.4 billion buyout, required shifting focus from research to development and back again. The acquisition sends a message that developing focused expertise and sticking...
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...