08:00 , Jan 4, 2016 |  BioCentury  |  Finance

Big band swing

Many investors treated biotech's dismal 3Q15 as a buying opportunity, and the effects were apparent in 4Q15. All of the market cap bands showed positive gains save for the microcaps. Big biotechs led the charge...
08:00 , Dec 21, 2015 |  BC Week In Review  |  Clinical News

Bridion sugammadex regulatory update

FDA approved Bridion sugammadex from Merck to reverse the effects of neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium in adults undergoing surgery. Merck plans to launch the cyclodextrin derivative next month, at which...
08:00 , Dec 15, 2015 |  BC Extra  |  Company News

FDA approves Merck's Bridion

FDA approved Bridion sugammadex from Merck & Co. Inc. (NYSE:MRK) to reverse the effects of neuromuscular blockade induced by muscle relaxants rocuronium or vecuronium. Merck spokesperson Pamela Eisele said the company plans to launch the...
01:36 , Nov 5, 2015 |  BC Extra  |  Clinical News

FDA reviewers accept sugammadex data

In sugammadex from Merck & Co. Inc. (NYSE:MRK), agency reviewers said the company has resolved the agency's concerns over the integrity of hypersensitivity data and asked panelists to vote on whether there are sufficient data...
07:00 , Oct 5, 2015 |  BioCentury  |  Finance

Event planner

For investors who are not inclined to sit it out until the volatility abates, the fourth quarter is bursting with late-stage catalysts. There are no fewer than 17 PDUFA dates on the calendar before year...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Clinical News

Bridion sugammadex regulatory update

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet on Nov. 6 to discuss an NDA from Merck for Bridion sugammadex to reverse neuromuscular blockade due to muscle relaxants rocuronium or vecuronium. The PDUFA...
07:00 , May 4, 2015 |  BC Week In Review  |  Clinical News

Bridion sugammadex regulatory update

FDA issued a complete response letter to Merck for an NDA for sugammadex to reverse neuromuscular blockade due to muscle relaxants rocuronium or vecuronium. Merck said FDA asked for additional sensitivity analyses regarding the data...
07:00 , Mar 30, 2015 |  BC Week In Review  |  Clinical News

Bridion sugammadex regulatory update

FDA cancelled the March 18 meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss Merck’s sugammadex to reverse neuromuscular blockade due to muscle relaxants rocuronium or vecuronium. The company expects to receive...
00:53 , Mar 17, 2015 |  BC Extra  |  Company News

Merck expects third FDA rejection for sugammadex

FDA canceled Wednesday's meeting of its Anesthetic and Analgesic Drug Products Advisory Committee to discuss sugammadex ( MK-8616 ) from Merck & Co. Inc. (NYSE:MRK). The company said it expects to receive a complete response...
07:00 , Oct 6, 2014 |  BioCentury  |  Finance

4Q14 Financial Markets Preview: Commercial race in HCV

HCV and cancer immunotherapy again top the list of milestones in 4Q14, as investors expect approval of three new HCV regimens plus clinical data for combos looking to challenge Gilead Sciences Inc. and AbbVie Inc....