00:12 , Feb 28, 2017 |  BC Extra  |  Clinical News

Merck CMV prophylaxis headed for U.S., EU submissions

Merck & Co. Inc. (NYSE:MRK) said it will submit applications in the U.S. and EU this year for letermovir (MK-8228) to prevent cytomegalovirus (CMV) infection in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplantation...
08:00 , Feb 29, 2016 |  BC Week In Review  |  Clinical News

Brincidofovir: Additional Phase III data

Additional data from the double-blind, international Phase III SUPPRESS trial in 452 CMV-seropositive hematopoietic stem cell transplant (HSCT) recipients showed that 51% of patients who received twice-weekly 100 mg oral brincidofovir had clinically significant CMV...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Clinical News

Maribavir: Additional Phase II data

Shire disclosed in its 2014 earnings that additional data from a double-blind, U.S. Phase II trial in about 120 transplant recipients ages >=12 with resistant or refractory CMV infection showed that twice-daily 400, 800 and...
07:00 , May 6, 2013 |  BC Week In Review  |  Clinical News

Maribavir: Interim Phase II data

ViroPharma disclosed on its 1Q13 earnings call that interim data from 36 patients with asymptomatic CMV infection in a European Phase II trial showed that twice-daily oral maribavir led to undetectable plasma CMV DNA in...
07:00 , May 6, 2013 |  BC Week In Review  |  Clinical News

Maribavir: Interim Phase II data

ViroPharma disclosed on its 1Q13 earnings call that interim data from 13 patients in a U.S. Phase II trial showed that twice-daily oral maribavir led to undetectable plasma CMV DNA in 92% of patients....
07:00 , Sep 24, 2012 |  BC Week In Review  |  Company News

Roche sales and marketing update

Roche launched its Cobas AmpliPrep/Cobas TaqMan CMV Test in the U.S. as an aid in managing solid organ transplant patients who are undergoing anti-cytomegalovirus (CMV) therapy. The in vitro nucleic acid amplification test quantifies...
07:00 , Jul 16, 2012 |  BC Week In Review  |  Clinical News

Cobas AmpliPrep/Cobas TaqMan CMV Test regulatory update

FDA approved a PMA from Roche for its Cobas AmpliPrep/Cobas TaqMan CMV Test as an aid in managing solid organ transplant patients who are undergoing anti-cytomegalovirus (CMV) therapy. Roche plans to launch the test in...
07:00 , Jun 11, 2012 |  BC Week In Review  |  Clinical News

Maribavir: Phase II started

ViroPharma began a European Phase II trial to compare 400, 800 and 1,200 mg oral maribavir twice daily vs. Valcyte valganciclovir for up to 12 weeks in about 160 patients who received hematopoietic stem...
07:00 , Apr 11, 2011 |  BC Week In Review  |  Clinical News

Cobas AmpliPrep/Cobas TaqMan CMV Test regulatory update

Roche received CE mark approval in the EU for its Cobas AmpliPrep/Cobas TaqMan CMV Test as an aid in diagnosing and managing cytomegalovirus (CMV) infection. Roche said the product is already available in Europe. The...
07:00 , Mar 15, 2010 |  BC Week In Review  |  Clinical News

CMX001: Phase II started

Chimerix began a double-blind, placebo-controlled, dose-escalation, U.S. Phase II trial to evaluate oral CMX001 in about 120 patients. Initial dosing of CMX001 will begin at 40 mg once weekly for 13 weeks following stem cell...