01:14 , Oct 6, 2018 |  BioCentury  |  Finance

Large cap comeback

The biotech sector continued to be a stock pickers’ market for investors through 3Q18 as there was a near even split between global biotech stocks that gained and lost value in the quarter. While 1H18...
19:57 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

Canbridge submits NDA in China for breast cancer drug Nerlynx

Canbridge Life Sciences Ltd. (Beijing, China) said China's National Medical Products Administration (NMPA) accepted an NDA for Nerlynx neratinib as an extended adjuvant treatment for adult patients with early stage HER2-positive breast cancer following adjuvant...
18:44 , Sep 7, 2018 |  BC Week In Review  |  Clinical News

EC approves Puma's Nerlynx as adjuvant for breast cancer

The European Commission approved Nerlynx neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for extended adjuvant treatment of adults with early hormone receptor-positive, HER2-overexpressed/amplified breast cancer within one year of completion of prior adjuvant Herceptin trastuzumab-based therapy....
18:04 , Sep 4, 2018 |  BC Extra  |  Company News

EC approves Puma's Nerlynx as adjuvant for breast cancer

The European Commission approved Nerlynx neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for extended adjuvant treatment of adults with early hormone receptor-positive, HER2-overexpressed/amplified breast cancer within one year of completion of prior adjuvant Herceptin trastuzumab-based therapy....
20:07 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

EMA's CHMP recommends CAR Ts, rare disease therapies

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a key...
20:20 , Jun 29, 2018 |  BC Extra  |  Company News

CHMP backs CAR Ts, Orphan candidates

EMA's CHMP recommended for approval Kymriah tisagenlecleucel and Yescarta axicabtagene ciloleucel, the first two CAR T therapies backed by the committee. CHMP also recommended a handful of other Orphan drug candidates, including Cablivi caplicizumab, a...
18:35 , Jun 26, 2018 |  BC Extra  |  Company News

Puma: CHMP reversing course to favor neratinib's approval

Puma Biotechnology Inc. (NASDAQ:PBYI) said EMA's CHMP is likely to recommend approval of oral neratinib as extended adjuvant treatment of early stage, hormone receptor-positive, HER2-positive breast cancer. The company's shares were up $12.45 (24%) to...
22:54 , Jun 20, 2018 |  BC Extra  |  Preclinical News

Broad ErbB inhibition arrests KRAS mutant cancer

Multi-ErbB inhibitors may provide a treatment option for K-Ras (KRAS)-driven lung cancer where ErbB family member EGFR1-specific therapies have failed, according to two studies published in Science Translational Medicine on Wednesday. The findings suggest a way...
20:18 , May 10, 2018 |  BC Extra  |  Company News

Puma sinks on delayed Ph III readout

Puma Biotechnology Inc. (NASDAQ:PBYI) said Thursday in its 1Q18 earnings report that data from the Phase III NALA trial are not expected until 4Q18 due to a slower than expected event rate. On March 1,...
23:09 , Apr 6, 2018 |  BioCentury  |  Finance

Fundamentally driven

Continued struggles by the mega-cap bellwethers and the resurgence of volatility in global equity markets were the major themes of 1Q18, whipsawing biotech stocks throughout the quarter but leaving index values little changed on the...