Kinase Inhibitors Archives

US Bridging Study Not Enough as FDA Denies Hutchmed’s Pancreatic Cancer Drug

Angio-immuno kinase inhibitors, Bridging Studies, China, Clinical Trials, Complete Response Letter, Fast Track Designation, FDA, Neuroendocrine Tumors, New Drug Applications, Orphan Drug Designation, Pancreatic Cancer, R&D

China-based Hutchmed failed to get the U.S. Food and Drug Administration’s approval for the company’s proposed drug for pancreatic cancer.

May 2, 2022/by BioSpace

FDA Action Alert: Immunocore, Reata, CTI, Gilead and Legend/Janssen

Biologics License Application (BLA), Chronic Kidney Disease, Clinical Trials, FDA/Regulatory, Genetic Mutations, Gilead, Kinase Inhibitors, Multi-drug resistant HIV-1 infection, Multiple Myeloma, Myelofibrosis, PDUFA, Priority Review Status, R&D, Uveal Melanoma

Legend Biotech has a target action date of February 28 for the company’s BLA for ciltacabtagene autoleucel (cilta-cel) for adults with relapsed and/or refractory multiple myeloma. The BLA was submitted by Legend’s collaboration partner, Janssen Biotech Inc., a Johnson & Johnson company.

February 21, 2022/by Andrew Humphreys

FDA Approves Truseltiq for Cholangiocarcinoma

Accelerated Approval, Cholangiocarcinoma, FDA, FGFR tyrosine kinase inhibitors, New Drug Approvals, Overall Response Rate (ORR), Therapeutics

The U.S. Food and Drug Administration approved Truseltiq (infigratinib) under the accelerated approval program for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement.

May 28, 2021/by Andrew Humphreys

Companies Land Funds to Advance Pipelines

Biotech, Business, Financing, Kinase Inhibitors, Preclinical Data, Product Pipelines, Series B, Tumors

2021 is shaping up to be another banner year for biotech companies. According to BioSpace, funds appear to be in near-endless supply as companies advance next-gen technologies and therapeutics for the health of all. BioSpace reviews a few raking in cash for their programs.

May 11, 2021/by Andrew Humphreys

Merck KGaA’s ATR Inhibitor Shows Promise in Cancer and Covid-19

ATR inhibitors, ATR protein, Biopharma, Cancer, Coronavirus Disease 2019 (COVID-19), DNA, DNA Repair, Kinase Inhibitors, Los Angeles (UCLA), R&D, SARS-CoV-1, Small Molecules

According to a research collaboration among UCLA investigators and Merck KGaA, berzosertib has shown promise for Covid-19 and is also being touted for the drug’s unusually broad effect in treating a range of cancers.

March 30, 2021/by Andrew Humphreys

FDA Grants Full Approval of Deciphera Pharmaceuticals’ Qinlock for Treatment of Fourth-Line Gastrointestinal Stromal Tumor

Approvals, Breakthrough Therapy Designation, Clinical Studies, Fast Track Designation, FDA, FDA Oncology Center of Excellence, FDA/Regulatory, Gastrointestinal Stromal Tumors, Kinase Inhibitors, New Drug Approvals

The U.S. Food and Drug Administration approved Deciphera Pharmaceuticals Inc.’s Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with 3 or more kinase inhibitors, including imatinib.

May 15, 2020/by Business Wire

Koselugo Approved In U.S. For Pediatric Patients With Neurofibromatosis Type 1 Plexiform Neurofibromas

Approvals, FDA, FDA/Regulatory, Genetic Conditions, Kinase Inhibitors, Neurofibromatosis Type 1 (NF1), Pediatric, Priority Review Voucher, Tumors

AstraZeneca and Merck & Co. announced that the U.S. Food and Drug Administration approved the kinase inhibitor Koselugo (selumetinib) for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.

April 13, 2020/by Business Wire

Merck acquires ArQule for $2.7 billion

Acquisitions, Analysts, Blockbusters, Blood Cancers, Business, Cancer, Chemotherapy, Genetic Mutations, Kinase Inhibitors, Shares, Targeted Cancer Therapies, Targeted Therapies

Merck & Co. Inc. is buying ArQule Inc. for $2.7 billion, seeking to tap into the drug developer’s experimental blood cancer therapy that targets genetic mutations.

December 9, 2019/by Reuters Health

AstraZeneca Backs $1 Billion Fund to Support China’s Growing Pharma Market

Artificial Intelligence, Business, Cancer, China, Fibroblast Growth Factor Receptor (FGFR) Inhibitors, Gastrointestinal Stromal Tumors, Innovation, IQVIA, Kinase Inhibitors, KIT Inhibitors, Launches, Oncology, R&D

AstraZeneca is significantly expanding the company’s footprint in China with the establishment of a global R&D center and launch of a $1 billion fund aimed at supporting that nation’s healthcare sector.

November 6, 2019/by BioSpace

Bayer, Bristol-Myers, Ono Partner for Colorectal Cancer Study

Business, Clinical Studies, Colorectal Cancer, Data Analysis, Immuno-oncology, Kinase Inhibitors, Metastatic Colorectal Cancer (mCRC), Microsatellite stable tumors, Partnerships

Bayer, Bristol-Myers Squibb and Ono Pharmaceutical teamed up to study the most common type of metastatic colorectal cancer.

July 18, 2019/by BioSpace