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...
00:32 , Mar 2, 2018 |  BC Week In Review  |  Clinical News

CHMP recommends against Puma's Nerlynx

EMA's CHMP recommended against approval of oral neratinib from Puma Biotechnology Inc. (NASDAQ:PBYI) for the extended adjuvant treatment of early stage HER2-positive breast cancer. Puma intends to request a re-examination of the MAA. In January,...
00:15 , Feb 24, 2018 |  BC Extra  |  Company News

CHMP backs approval of Mylotarg, Alpivab, Kineret

EMA's CHMP announced a spate of opinions Friday, including positive recommendations for Mylotarg gemtuzumab ozogamicin, Alpivab peramivir and Kineret anakinra, as well as the expected negative opinion for Nerlynx neratinib. The committee recommended approval of Mylotarg...
19:06 , Feb 21, 2018 |  BC Innovations  |  Distillery Therapeutics

Gastrointestinal

INDICATION: Gastrointestinal Patient sample and mouse studies identified a BBC3 inhibitor that could help treat intestinal injury caused by topoisomerase inhibitors for cancer. In mice receiving the generic topoisomerase inhibitor irinotecan, BBC3 knockout increased survival compared...
20:35 , Feb 2, 2018 |  BC Week In Review  |  Company News

Canbridge licenses Chinsese rights to Puma's Nerlynx

Puma Biotechnology Inc. (NASDAQ:PBYI) granted Canbridge Life Sciences Ltd. (Beijing, China) exclusive rights to develop and commercialize cancer drug Nerlynx neratinib in China, including Hong Kong and Macau, and Taiwan. Puma markets Nerlynx in the U.S....