01:06 , Jun 8, 2016 |  BC Extra  |  Company News

FDA reviewers question efficacy of Merck's bezlotoxumab

In briefing documents released ahead of an advisory committee meeting to discuss an NDA for bezlotoxumab ( MK-6072) from Merck & Co. Inc. (NYSE:MRK) to prevent recurrences of Clostridium difficle infection, FDA reviewers said...
00:08 , Apr 15, 2016 |  BC Extra  |  Company News

FDA panel to discuss Merck's bezlotoxumab

FDA's Antimicrobial Drugs Advisory Committee will meet June 9 to discuss a BLA from Merck & Co. Inc. (NYSE:MRK) for bezlotoxumab ( MK-6072) to prevent Clostridium difficile infection recurrence. The candidate is under Priority...
08:00 , Feb 1, 2016 |  BC Week In Review  |  Clinical News

Bezlotoxumab regulatory update

FDA accepted and granted Priority Review to a BLA from Merck for bezlotoxumab to prevent recurrence of Clostridium difficile infection. The PDUFA date is July 23. An MAA for the human mAb targeting C. difficile...
02:24 , Jan 28, 2016 |  BC Extra  |  Company News

Priority Review for Merck's bezlotoxumab

Merck & Co Inc. (NYSE:MRK) said FDA accepted for filing and granted Priority Review to a BLA for bezlotoxumab ( MK-6072) to treat recurrent Clostridium difficile infection. Its PDUFA date is July 23. Merck...
07:00 , Oct 15, 2015 |  BC Innovations  |  Distillery Therapeutics

Therapeutics: Clostridium difficile toxin B (TcdB)

Infectious disease INDICATION: Clostridium In vitro and mouse studies suggest ebselen could be repurposed to treat Clostridium difficile infection (CDI). Screening of a small molecule library in an assay for binding to the cysteine protease domain of...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Bezlotoxumab: Phase III data

The double-blind, international Phase III MODIFY I trial in 1,452 patients receiving standard of care (SOC) antibiotics for CDI showed that a single IV infusion of 10 mg/kg bezlotoxumab alone and in combination with 10...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Bezlotoxumab: Phase III data

The double-blind, international Phase III MODIFY II trial in 1,203 patients receiving standard of care (SOC) antibiotics for CDI showed that a single IV infusion of 10 mg/kg bezlotoxumab alone and in combination with 10...
03:58 , Sep 22, 2015 |  BC Extra  |  Clinical News

Merck's bezlotoxumab meets in two Phase III trials

Merck & Co. Inc. (NYSE:MRK) said bezlotoxumab ( MDX-1388) met the primary endpoint in two Phase III trials to treat Clostridium difficile infection recurrence. The company said bezlotoxumab alone and in combination with actoxumab...
08:00 , Feb 1, 2010 |  BC Week In Review  |  Clinical News

MDX-066: Final Phase II data

Final data from the double-blind, U.S. and Canadian Phase II CA-GCDX-06-02 trial in 200 patients receiving standard of care antibiotics metronidazole or vancomycin showed that a single IV infusion of 10 mg/kg MDX-066 plus 10...
07:00 , Jul 27, 2009 |  BioCentury  |  Strategy

Medarex pipeline

Medarex pipeline Therapeutics Product [Partner] Target Status [Lead indication] Ipilimumab (MDX-010) [Bristol-Myers Squibb Co. (NYSE:BMY)] CTLA-4 (CD152) receptor Ph III [melanoma] MDX-1100 Chemokine CXC motif ligand 10...