BC Week In Review | Mar 16, 2015
Company News

Chugai sales and marketing update

Chugai launched Zelboraf vemurafenib in Japan to treat unresectable melanoma with a BRAF mutation. The mutation is identified using the cobas 4800 BRAF V600 Mutation Test from Roche (SIX:ROG; OTCQX:RHHBY, Basel, Switzerland), which is the...
BC Week In Review | Feb 2, 2015
Clinical News

Zelboraf vemurafenib regulatory update

Chugai said Japan approved Zelboraf vemurafenib to treat unresectable melanoma with a BRAF V600 mutation. The company also said Japan approved Roche’s cobas 4800 BRAF V600 Mutation Test as a companion diagnostic for Zelboraf --...
BC Week In Review | Feb 2, 2015
Clinical News

Cobas 4800 BRAF V600 Mutation Test regulatory update

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) said Japan approved Roche’s cobas 4800 BRAF V600 Mutation Test as a companion diagnostic for Zelboraf vemurafenib to identify patients with metastatic melanoma tumors with a mutation in...
BioCentury | Aug 11, 2014
Regulation

LDT blurred Lines

FDA's release of draft guidance in a congressional notice officially put down a marker on the agency's plans for a risk-based framework for regulating laboratory-developed tests. Some stakeholders think the proposed oversight could better align...
BC Week In Review | Apr 14, 2014
Clinical News

Zelboraf vemurafenib regulatory update

Chugai submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Zelboraf vemurafenib to treat BRAF V600 mutation-positive melanoma. Chugai has Japanese rights to the oral small molecule inhibitor of the oncogenic...
BC Week In Review | Apr 14, 2014
Clinical News

Cobas 4800 BRAF V600 Mutation Test regulatory update

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan) said Roche submitted an application last month to Japan's Ministry of Health, Labor and Welfare (MHLW) for its cobas 4800 BRAF V600 Mutation Test. The PCR-based nucleic acid...
BC Extra | Apr 10, 2014
Company News

Chugai seeks Japanese approval of Zelboraf

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) submitted an NDA to Japan's Ministry of Health, Labor and Welfare (MHLW) for Zelboraf vemurafenib to treat BRAF V600 mutation-positive melanoma. Chugai has Japanese rights to the oral small molecule...
BC Week In Review | Feb 27, 2012
Clinical News

Cobas 4800 BRAF V600 Mutation Test regulatory update

CBLPath Inc. (Ocala, Fla.) said it received approval from the New York State Department of Health to perform in-house testing with Roche's cobas 4800 BRAF V600 Mutation Test to identify patients with metastatic melanoma tumors...
BC Innovations | Dec 15, 2011
Cover Story

Splicing out BRAF's resistance

U.S. researchers have uncovered a mechanism by which melanomas expressing mutant BRAF acquire resistance to targeted drugs. 1 The findings represent the first time a splice variant has been implicated in cancer drug resistance. The...
BC Week In Review | Dec 12, 2011
Clinical News

Cobas 4800 BRAF V600 Mutation Test regulatory update

Roche said Health Canada approved its cobas 4800 BRAF V600 Mutation Test to identify patients with metastatic melanoma tumors with a mutation in the BRAF gene. The PCR-based nucleic acid test detects a mutation at...
Items per page:
1 - 10 of 20