23:32 , Oct 19, 2018 |  BC Extra  |  Company News

FDA, EMA delay review of Opdivo/Yervoy for first-line NSCLC

Bristol-Myers Squibb Co. (NYSE:BMY) said Friday that FDA and EMA have both pushed back their reviews of anti-PD-1 mAb Opdivo nivolumab plus anti-CTLA-4 mAb Yervoy ipilimumab for first-line non-small cell lung cancer. The company also...
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...
19:47 , Oct 5, 2018 |  BC Week In Review  |  Clinical News

FDA approves Pfizer's dacomitinib for first-line NSCLC

FDA approved Vizimpro dacomitinib from Pfizer Inc. (NYSE:PFE) as first-line treatment of EGFR-mutated metastatic non-small cell lung cancer. Pfizer spokesperson Jessica Smith told BioCentury the pharma will launch the drug in mid-October at a monthly...
23:37 , Sep 27, 2018 |  BC Extra  |  Company News

FDA approves Pfizer's dacomitinib for first-line NSCLC

FDA approved Vizimpro dacomitinib from Pfizer Inc. (NYSE:PFE) as first-line treatment of EGFR-mutated metastatic non-small cell lung cancer. Pfizer spokesperson Jessica Smith told BioCentury the pharma will launch the drug in mid-October at a monthly...
01:21 , Sep 21, 2018 |  BC Innovations  |  Tools & Techniques

Precision for pancreatic cancer

Real-time sequencing and organoid-based screens in pancreatic cancer could place new targets and biomarkers in the hands of drug developers looking for ways to side-step KRAS, a gene mutated in 90% of patients. Because KRAS...
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...
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...