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...
17:49 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

FDA OKs U.S. trial for Alphamab Oncology's HER2 bispecific antibody

Alphamab Oncology (Suzhou, China) said it received clearance from FDA to begin a U.S. Phase I trial of KN026, a HER2 bispecific antibody. Alphamab Oncology Chairman and CEO Ting Xu said in a statement that...
17:12 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

Genentech's Kadcyla meets in Phase III as breast cancer adjuvant

Genentech Inc. said adjuvant treatment with Kadcyla ado-trastuzumab emtansine met the primary endpoint of improving invasive disease-free survival (DFS) vs. Herceptin trastuzumab in the Phase III KATHERINE trial to treat breast cancer. The open-label, international...
18:08 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Checkpoint's CK-101 leads to 75% ORR in NSCLC subgroup of Phase I/II

Checkpoint Therapeutics Inc. (NASDAQ:CKPT) said twice-daily 400 mg oral CK-101 (RX518) led to an objective response rate (ORR) of 75% in eight treatment-naïve patients with EGFR mutation-positive non-small cell lung cancer (NSCLC) in a dose-expansion...
22:56 , Oct 11, 2018 |  BC Week In Review  |  Clinical News

Reata's CKD candidate improves kidney function in IgA nephropathy, diabetes cohorts

Reata Pharmaceuticals Inc. (NASDAQ:RETA) reported data from the IgA nephropathy and chronic kidney disease (CKD) associated with Type I diabetes cohorts of the open-label, U.S. Phase II PHOENIX trial of bardoxolone methyl to treat rare...
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...
20:33 , Oct 5, 2018 |  BC Week In Review  |  Company News

Janssen terminates licenses to Aduro cancer therapies

Aduro BioTech Inc. (NASDAQ:ADRO) revealed in an SEC filing that the Janssen Biotech Inc. subsidiary of Johnson & Johnson (NYSE:JNJ) will terminate its licenses for three cancer therapies, effective Dec. 24. A Janssen spokesperson told...
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...
16:19 , Oct 4, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Brain cancer Mouse studies suggest CAR T cells targeting ALCAM and HER2 could help treat brain cancer. The cells are generated by conjugating T cells expressing HER2-targeting CARs to a construct consisting of pentamers...