01:55 , Oct 13, 2018 |  BioCentury  |  Product Development

Bourla’s breadcrumbs to value

Incoming CEO Albert Bourla has spent only a few of his 25 years at Pfizer Inc. in the pharma’s innovative drugs business, but there are signs he already has laid the groundwork for innovating how...
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...
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...
16:37 , Sep 21, 2018 |  BC Week In Review  |  Clinical News

Mersana gets green light to resume ADC trial, but new dosing may slow progress

Mersana Therapeutics Inc. (NASDAQ:MRSN) said it will resume a Phase I trial of antibody-drug conjugate XMT-1522 after FDA lifted a partial clinical hold on the trial. However, Mersana fell $3.24 (23%) to $11.14 on Sept....
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...
22:34 , Sep 17, 2018 |  BC Extra  |  Clinical News

Mersana gets green light to resume ADC trial, but new dosing may slow progress

Mersana Therapeutics Inc. (NASDAQ:MRSN) said it will resume a Phase I trial of antibody-drug conjugate XMT-1522 after FDA lifted a partial clinical hold on the trial. However, Mersana fell $3.24 (23%) to $11.14 seemingly in...
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....
17:52 , Sep 7, 2018 |  BC Week In Review  |  Company News

How an ex-GSK employee funneled trade secrets to Chinese company

Former GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) employee Yu Xue pleaded guilty on Aug. 31 to theft of GSK trade secrets, which included information about antibody-based programs against at least five targets and step-by-step instructions for developing,...