Neuroendocrine Tumors

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

Reuters

U.S. FDA declines to approve two more China-tested drugs

Business, China, Complete Response Letter, FDA, FDA Statements, Gastroenteropancreatic neuroendocrine tumors, Gastroenteropancreatic Neuroendocrine Tumors, Gastrointestinal Tumors, Lung Neuroendocrine Tumors, Nasopharyngeal Carcinoma (NPC), Neuroendocrine Tumors, Oncology, R&D, Shares, Therapeutics, Throat Cancer

The U.S. Food & Drug Administration declined to approve two China-tested cancer treatments on Monday, saying one of the companies – Hutchmed Ltd. – needs to test its drug for the U.S. population in a diverse multi-regional trial.

May 2, 2022/by Christiane Truelove

Global Roundup: Genfit Launches NASH Diagnostic Kit

Business, Cell Therapy, Diagnostic Tests, Fast Track Designation, Launches, Neuroendocrine Tumors, New Drug Applications, Non-alcoholic steatohepatitis (NASH), Orphan Drug Designation, R&D, The Lancet Gastroenterology & Hepatology

France-based Genfit launched NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH) powered by the company’s proprietary diagnostic technology, NIS4. The test is offered in the United States through Labcorp.

May 6, 2021/by Andrew Humphreys

A Glimpse into the Pancreatic Cancer Pipeline

Adenocarcinomas, Clinical Trials, Deaths, Immunotherapies, Mutations, Neuroendocrine Tumors, Pancreatic Cancer, Product Pipelines, R&D, Stem Cells

The passing of singing great Aretha Franklin has focused attention on pancreatic cancer. Franklin, 76, succumbed to a neuroendocrine tumor of the pancreas. According to the National Cancer Institute, pancreatic cancer is relatively rare with about 55,440 cases diagnosed annually, representing about 3.2 percent of new cancer cases.

August 23, 2018/by BioSpace

Crinetics Pharmaceuticals Snags $63.5 Million in Series B Funding

Acromegaly, Cushing's disease, Financing, Hyperinsulinism, Investors, Neuroendocrine Tumors, Product Pipelines, Series B

Five months after the company’s lead drug began Phase I testing, San Diego-based Crinetics Pharmaceuticals Inc. secured $63.5 million in Series B financing.

March 14, 2018/by BioSpace