BioCentury | Apr 18, 2020
Regulation

Trio of approvals includes Seattle Genetics’ breast cancer therapy

Just two months after granting Priority Review to Seattle Genetics’ Tukysa tucatinib, FDA approved the drug as part of a triple combo to treat breast cancer, marking one of a trio of approvals Friday. Incyte...
BC Extra | Jan 24, 2020
Preclinical News

Jan. 23 Preclinical Quick Takes: Metastasis-associated cancer-associated fibroblast populations; plus NIH-TeneoBio and Basilea

Cancer-associated fibroblast subsets linked to metastasis In a study published in Nature Communications , a team from Institut Curie and INSERM identified within breast cancer patients’ lymph nodes four subpopulations of cancer-associated fibroblasts (CAFs). Two subsets...
BC Extra | Jan 3, 2020
Clinical News

As itacitinib stumbles in acute GvHD, Incyte turns to chronic setting

Incyte’s discontinuation of itacitinib’s development in acute graft-versus-host disease after a Phase III miss has muddied the outlook for the JAK-1 inhibitor in the larger setting of chronic GvHD and marks a setback as the...
BC Extra | Nov 27, 2019
Company News

Incyte wins Priority Review for cholangiocarcinoma therapy

Two months after presenting Phase II data at ESMO, Incyte Corp. (NASDAQ:INCY) said FDA has accepted and granted Priority Review to an NDA for pemigatinib to treat the rare bile duct cancer cholangiocarcinoma. The candidate's...
BioCentury | Nov 7, 2019
Product Development

AZ replants R&D roots in China, goes all-in on innovation

In a big week for MNCs in China, AstraZeneca defined the latest move in its China strategy with an ‘all-in’ approach to innovation that goes full throttle by fostering R&D, AI and company formation. As...
BC Extra | Sep 27, 2019
Clinical News

Incyte lining up pemigatinib filing on ESMO data

With updated data presented at ESMO, Incyte said it will submit an NDA to FDA this year to seek accelerated approval of its FGFR inhibitor in a niche cancer indication of cholangiocarcinoma. The biotech also...
BC Innovations | Aug 23, 2019
Distillery Therapeutics

KRAS inhibitor combinations for improved therapeutic efficacy

DISEASE CATEGORY: Cancer INDICATION: Lung cancer, pancreatic cancer UCSF’s Kevan Shokat and colleagues have identified two sets of genes for which inhibition could improve the efficacy of KRAS G12C inhibitors. Through a CRISPR-based screen in...
BC Extra | Apr 12, 2019
Company News

J&J's Balversa gets accelerated approval for bladder cancer

FDA granted Janssen's Balversa erdafitinib accelerated approval to treat bladder cancer, making it the first FGFR kinase inhibitor to gain U.S. approval. Balversa is indicated to treat adults with locally advanced or metastatic urothelial carcinoma...
BC Week In Review | Jan 18, 2019
Clinical News

Derazantinib leads to 21% ORR in Phase II intrahepatic cholangiocarcinoma cohort

Basilea Pharmaceutica Ltd. (SIX:SLN) reported interim data from the pivotal Phase II ARQ 087-301 trial to treat intrahepatic cholangiocarcinoma showing derazantinib led to an objective response rate (ORR) of 21% and a disease control rate...
BC Week In Review | Dec 21, 2018
Company News

Innovent diversifies pipeline with China rights to three Incyte compounds

Innovent Biologics Inc. (HKSE:1801) added three targets and a new modality to its pipeline following a deal for Chinese rights to three clinical cancer compounds from Incyte Corp. (NASDAQ:INCY). The biotech will get rights in...
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