20:17 , Aug 16, 2017 |  BC Innovations  |  Emerging Company Profile

Aiming horizontal

SciBac Inc. is using old-school genetics to make therapeutic bacteria that can battle pathogenic organisms and antibiotic-resistant infections. The approach uses horizontal gene transfer to move therapeutic genes from newly discovered species into strains already...
21:57 , Feb 9, 2017 |  BC Week In Review  |  Company News

Debiopharm sales and marketing update

Debiopharm’s GenePOC Inc. company launched GenePOC CDiff and GenePOC GBS assays in Europe and the Middle East. The in vitro diagnostic tests, which run on GenePOC’s CE-IVD Marked revogene platform, detect Clostridium difficile toxin B...
23:25 , Dec 16, 2016 |  BC Extra  |  Company News

Celltrion biosimilar among CHMP recommendations

EMA’s CHMP recommended approval of a basket of candidates on Friday, including biologics from Pfizer Inc. (NYSE:PFE) and Celltrion Inc. (KOSDAQ:068270). CHMP recommended Pfizer’s Lifmior etanercept, a product identical to Enbrel, to treat rheumatoid arthritis, juvenile...
17:40 , Nov 15, 2016 |  BC Innovations  |  Distillery Therapeutics

Infectious disease

INDICATION: Clostridium Cell culture and mouse studies suggest inhibiting FZD1, FZD2 and/or FZD7 could help treat Clostridium difficile infection (CDI). In a human cell line treated with TcdB, knockout of FZD1, FZD2 or FZD7 decreased cell...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Clinical News

Zinplava bezlotoxumab regulatory update

FDA approved a BLA for Zinplava bezlotoxumab from Merck to reduce recurrence of Clostridium difficile infection (CDI) in adults receiving antibacterial drug treatment of CDI and are at high risk for recurrence. The company plans...
07:00 , Oct 24, 2016 |  BC Extra  |  Company News

FDA approves Zinplava to reduce CDI recurrence

Merck & Co. Inc. (NYSE:MRK) said FDA approved Zinplava bezlotoxumab to reduce the recurrence of Clostridium difficile infection in high-risk adult patients receiving antibacterial drugs. Merck plans to launch the drug next quarter. The...
07:00 , Jul 25, 2016 |  BC Week In Review  |  Clinical News

Bezlotoxumab regulatory update

Merck said FDA extended the PDUFA date to Oct. 23 from July 23 for a BLA for Zinplava bezlotoxumab to prevent Clostridium difficile infection recurrence. The company said FDA requested additional data and analyses from...
07:00 , Jul 21, 2016 |  BC Extra  |  Company News

FDA extends Zinplava review, requests more data

Merck & Co. Inc. (NYSE:MRK) said FDA extended its review of a BLA for Zinplava bezlotoxumab ( MK-6072) to prevent Clostridium difficile infection recurrence and requested additional data and analyses from the company's Phase...
07:00 , Jun 20, 2016 |  BC Week In Review  |  Clinical News

Zinplava bezlotoxumab regulatory update

FDA’s Antimicrobial Drugs Advisory Committee voted 10-5, with 1 abstention, that Merck provided substantial evidence that Zinplava bezlotoxumab is safe and effective to prevent recurrence of Clostridium difficile infection. The human mAb targeting C. difficile...
01:26 , Jun 10, 2016 |  BC Extra  |  Company News

FDA panel backs Merck anti-infective Zinplava

FDA's Antimicrobial Drugs Advisory Committee voted 10-5, with one abstention, that Merck & Co. Inc. (NYSE:MRK) provided substantial evidence that Zinplava bezlotoxumab is safe and effective to prevent Clostridium difficile infection recurrence in adults....