08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Ravicti glycerol phenylbutyrate regulatory update

The European Commission approved Ravicti glycerol phenylbutrate from Horizon to treat urea cycle disorders (UCDs) in patients ages >=2 months. In February 2013, FDA approved the pre-prodrug of phenylacetic acid for chronic management of patients...
07:00 , Oct 5, 2015 |  BC Week In Review  |  Clinical News

Ravicti glycerol phenylbutyrate regulatory update

EMA’s CHMP recommended approval of Ravicti glycerol phenylbutyrate from Horizon as an adjunctive therapy for chronic management of patients aged >=2 months with urea cycle disorders (UCDs). In February 2013, FDA approved the pre-prodrug of...
07:00 , Sep 21, 2015 |  BC Week In Review  |  Clinical News

DiaPep277: Phase III data

Horizon Pharma plc (NASDAQ:HZNP, Dublin, Ireland) said that Clal Biotechnology Industries Ltd. (Tel Aviv:CBI, Tel Aviv, Israel) provided the Tel Aviv Stock Exchange notice of data from the double-blind, international Phase III DIA-AID 2 trial...
01:19 , Jul 16, 2015 |  BC Extra  |  Company News

Management tracks

Antibiotics developer Tetraphase Pharmaceuticals Inc. (NASDAQ:TTPH) named Jacques Dumas CSO. He was CSO at Idenix Pharmaceuticals Inc. , which Merck & Co. Inc. (NYSE:MRK) acquired. Antibacterial company Entasis Therapeutics Inc. (Waltham, Mass.) named Robin Isaacs...
01:01 , Jun 17, 2015 |  BC Extra  |  Company News

Management tracks

The Pharmaceutical Research and Manufacturers of America (PhRMA) elected five new board members. They are Werner Baumann, chairman of the board of management at the Bayer HealthCare AG subsidiary of Bayer AG (Xetra:BAYN); Giovanni Caforio,...
07:00 , May 11, 2015 |  BC Week In Review  |  Company News

Hyperion, Horizon Pharma deal

Horizon completed its acquisition of rare disease company Hyperion for $46 per share, or $1.1 billion (see BioCentury, April 6). Hyperion Therapeutics Inc. , South San Francisco, Calif.   Horizon Pharma plc (NASDAQ:HZNP), Dublin, Ireland...
07:00 , Apr 6, 2015 |  BC Week In Review  |  Company News

Hyperion Therapeutics Inc, Horizon Pharma deal

Last June, EMA accepted for review an MAA for Ravicti to treat UCD; Hyperion expects a decision from EMA’s CHMP in late 2015 or early 2016. Hyperion plans to submit an sNDA for Ravicti to...
01:06 , Mar 31, 2015 |  BC Extra  |  Company News

Horizon buying Hyperion for $1.1B

Horizon Pharma plc (NASDAQ:HZNP) will acquire rare disease company Hyperion Therapeutics Inc. (NASDAQ:HPTX) for $46 per share, or $1.1 billion in cash. The price represents an 8% premium to Hyperion's Friday close of $42.74. Horizon...
07:00 , Mar 9, 2015 |  BC Week In Review  |  Clinical News

Glycerol phenylbutyrate: Phase IV started

Hyperion began the open-label, U.S. Phase IV HPN-100-009 trial to evaluate oral Ravicti 3-6 times per day for 6-24 months in about 24 patients ages <2. Hyperion said the study is a postmarketing requirement. FDA...
08:00 , Mar 2, 2015 |  BC Week In Review  |  Company News

Hyperion Therapeutics Inc, Clal, Weizmann Institute of Science deal

Hyperion and Clal settled an ongoing dispute related to the development of DiaPep277 and partnered to complete the Phase III DIA-AID 2 trial of the compound to treat Type I diabetes. Hyperion is responsible for...