07:00 , Aug 1, 2016 |  BC Week In Review  |  Clinical News

AGT-182: Phase I/IIa data

Data from the first cohort of 4 Hunter syndrome patients ages >=18 in the open-label, international Phase I/IIa Breaking Barriers trial showed that once-weekly 1 mg/kg IV AGT-182 for 8 weeks was generally well tolerated....
08:00 , Jan 18, 2016 |  BioCentury  |  Strategy

Shire's serial story

The most obvious benefits Shire plc expects to gain by acquiring Baxalta Inc. are a slew of new products and the cash to make subsequent acquisitions the company couldn't have made on its own. But...
07:00 , Jul 27, 2015 |  BC Week In Review  |  Company News

ArmaGen, Shire deal

ArmaGen Inc. (formerly ArmaGen Technologies Inc.) received an undisclosed milestone payment from Shire under a 2014 deal granting Shire rights to AGT-182. The milestone was triggered by the start of patient dosing in a...
07:00 , Jul 13, 2015 |  BC Week In Review  |  Clinical News

AGT-182: Phase I started

ArmaGen began an open-label, dose-escalation, U.S. Phase I trial to evaluate 1 and 3 mg/kg IV AGT-182 once weekly for 8 weeks in about 12 patients. The trial start triggered an undisclosed milestone payment to...
07:00 , Jul 28, 2014 |  BioCentury  |  Finance

Highlights of weekly biotech stock moves

Regulatory milestones Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) gained $5.79 to $167.04 last week after EMA accepted and granted accelerated assessment to an MAA for asfotase alfa to treat hypophosphatasia (HPP). The company expects to complete a rolling...
07:00 , Jul 28, 2014 |  BC Week In Review  |  Company News

Shire, ArmaGen deal

ArmaGen granted Shire exclusive, worldwide rights to develop and commercialize AGT-182, which is in development to treat mucopolysaccharidosis type II (MPS-II, Hunter’s syndrome). ArmaGen will receive $15 million up front in cash and equity....
00:58 , Jul 24, 2014 |  BC Extra  |  Company News

ArmaGen licenses AGT-182 to Shire

ArmaGen Technologies Inc. (Calabasas, Calif.) granted Shire plc (LSE:SHP; NASDAQ:SHPG) exclusive, worldwide rights to develop and commercialize AGT-182, which is in development to treat mucopolysaccharidosis type II (MPS-II, Hunter's syndrome). ArmaGen will receive $15 million...
07:00 , Jun 16, 2014 |  BioCentury  |  Regulation

Signal crossing

FDA's workshop on neurological symptoms in inborn errors of metabolism revealed conflicts between how caregivers would like symptoms assessed and what drug companies need to test to get therapies approved. The June 10 workshop was the...
08:00 , Jan 27, 2014 |  BC Week In Review  |  Clinical News

AGT-182 regulatory update

The European Commission granted Orphan Drug designation to AGT-182 from ArmaGen to treat mucopolysaccharidosis type II (MPS-II, Hunter's syndrome). The product is slated to enter clinical testing for MPS-II this half and has Orphan Drug...
07:00 , Jul 29, 2013 |  BC Week In Review  |  Clinical News

AGT-182 regulatory update

ArmaGen said FDA granted Orphan Drug designation for AGT-182 to treat mucopolysaccharidosis type II (MPS-II, Hunter's syndrome). The product is slated to enter clinical testing for MPS-II next half. AGT-182 is iduronate-2-sulfatase (IDS) formulated...