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Roche haemophilia drug gets fast FDA review in expanded use pharmaphorum
April 18, 2018
The FDA has granted ‘Breakthrough Therapy’ status for Roche’s Hemlibra (emicizumab) for people with haemophilia A without factor VIII inhibitors, as the Swiss firm aims to take market share from rivals including Shire.
Roche receives FDA clearance for cobas® CT/NG for cobas® 6800/8800 Systems biospace
April 17, 2018
Roche announced today that FDA has provided 510(k) clearance for cobas® CT/NG for use on the cobas® 6800/8800 Systems for the direct detection of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) DNA in both symptomatic and asymptomatic indivi
Roche Diagnostics Assay Receives FDA Clearance for STD Testing biospace
April 17, 2018
Roche said it has gained 510(k) clearance from the U.S. Food and Drug Administration (FDA) for cobas CT/NG for use on the cobas 6800/8800 Systems for the detection of chlamydia and gonorrhea in both symptomatic and asymptomatic patients.
NICE no for Roche’s Alecensa pharmatimes
April 12, 2018
The National Institute for Health and Care Excellence has turned down NHS funding for Roche’s Alecensa as a first-line treatment for lung cancer.
Roche Halts Colorectal Cancer Trial Recruitment After 4 Patient Deaths biospace
April 12, 2018
Roche announced it had temporarily halted recruiting patients to its Phase II MODUL clinical trial for metastatic colorectal cancer after four patient deaths
Roche closes $1.9bn Flatiron Health acquisition pharmaceutical-technology
April 11, 2018
Roche has completed the acquisition of healthcare technology and services company Flatiron Health for $1.9bn.
NICE rejects Roche MS drug Ocrevus pharmaceutical-technolog
April 11, 2018
The National Institute for Health and Care Excellence (NICE) has not granted NHS funding for multiple sclerosis (MS) drug ocrelizumab marketed by Roche.
Roche completes Flatiron Health acquisition biospectrumasia
April 10, 2018
Flatiron partners with more than 265 community cancer clinics, six major academic research centres, and 14 therapeutic oncology companies.
NICE u-turn sees Roche’s Tecentriq backed for lung cancer pharmatimes
April 10, 2018
Following an earlier negative decision NICE is now recommending NHS use of Roche’s immunotherapy Tecentriq for lung cancer.
Roche suffers Ocrevus knockback by NICE pharmafile
April 08, 2018
Roche’s multiple sclerosis drug, Ocrevus (ocrelizumab), has been a big new growth driver for the company, especially in the US, as it managed to bring in $902 million in sales during the 2017 financial year.

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