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10:25 AM, Sep 14, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Quantum Leap provides update on I-SPY 2 breast cancer trial

Quantum Leap Healthcare Collaborative provided an update on the overall progress of the Phase II I-SPY 2 trial evaluating neoadjuvant treatments for breast cancer in patients at high risk for early recurrence. Quantum Leap said thus...
12:33 PM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Fosun to start clinical testing in China for Yescarta

China's National Medical Products Administration (NMPA) approved an application from Fosun Pharma Kite Biotechnology Co. Ltd. to begin clinical testing of Yescarta axicabtagene ciloleucel to treat recurrent and refractory large B cell lymphoma. Fosun Kite...
10:59 AM, Sep 07, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Vertex becomes first U.S. company to enter clinic with CRISPR therapy

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) and partner CRISPR Therapeutics AG (NASDAQ:CRSP) have begun enrolling patients in the first U.S. company-sponsored trial using CRISPR/Cas9 editing. The European Phase I/II trial is evaluating CTX001, which comprises autologous CRISPR-modified...
11:13 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Zai discontinuing atopic dermatitis therapy

Zai Lab Ltd. (NASDAQ:ZLAB) said it will discontinue development of fugan (ZL-3101) to treat atopic dermatitis after it failed to meet the primary endpoint in a Phase IIa trial. The double-blind, Chinese study enrolled 295 patients...
11:10 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

TB Alliance starts pivotal trial of four-drug regimen

The Global Alliance for TB Drug Development (TB Alliance) began the pivotal Phase IIc SimpliciTB trial evaluating an oral four-drug regimen called BPaMZ to treat tuberculosis. SimpliciTB will compare BPaMZ, which comprises a once-daily combination of...
11:06 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Pfizer, Astellas speed up Phase III trials of Xtandi in hormone-sensitive prostate cancer

Astellas Pharma Inc. (Tokyo:4503) and Pfizer Inc. (NYSE:PFE) amended the Phase III ARCHES and EMBARK trials of Xtandi enzalutamide to treat hormone-sensitive prostate cancer and now expect to complete both trials sooner than previously guided....
10:58 AM, Aug 31, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Zai starts Chinese Phase III of Zejula for SCLC

Zai Lab Ltd. (NASDAQ:ZLAB) began a double-blind, placebo-controlled, Chinese Phase III trial to evaluate Zejula niraparib in 591 small cell lung cancer (SCLC) patients who have responded to platinum-based chemotherapy. Zejula is approved in the U.S....
12:26 PM, Aug 10, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Gemphire stops NAFLD pediatric trial of gemcabene after liver fat elevations

Gemphire Therapeutics Inc. (NASDAQ:GEMP) will terminate an open-label Phase IIa trial of gemcabene (CI-1027) to treat pediatric patients with non-alcoholic fatty liver disease (NAFLD) after the first three patients to complete the 12-week trial showed...
10:41 AM, Aug 03, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Epizyme falls on DLBCL discontinuations for tazemetostat

Epizyme Inc. (NASDAQ:EPZM) lost $3.10 (24%) to $9.90 on Aug. 2 after discontinuing development of tazemetostat both as monotherapy and in combination with prednisolone to treat diffuse large B cell lymphoma (DLBCL). The news comes...
10:12 AM, Aug 03, 2018  |  BC Week In Review | Clinical News  |  Clinical Status

Sanofi drops two clinical assets; reports rebounding Dupixent sales

Sanofi (Euronext:SAN; NYSE:SNY) disclosed in its 2Q18 earnings that it ended development of antibody-drug conjugate (ADC) SAR566658 to treat triple-negative breast cancer (TNBC), as well as a recombinant subunit vaccine to treat tuberculosis. A Sanofi spokesperson...

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