BioCentury | Jun 17, 2013
Clinical News

Aridol mannitol Bronchial Challenge Test Kit regulatory update

Pharmaxis said FDA placed its Aridol mannitol Bronchial Challenge Test Kit to assess bronchial hyperresponsiveness in patients >=6 years of age who do not have clinically apparent asthma on an import alert list, which prevents...
BioCentury | Nov 14, 2011
Clinical News

Aridol mannitol Bronchial Challenge Test Kit regulatory update

Pharmaxis said the Centers for Medicare & Medicaid Services (CMS) assigned a J-code for reimbursement of its Aridol mannitol Bronchial Challenge Test Kit to assess bronchial hyperresponsiveness in patients >=6 years of age who do...
BioCentury | May 5, 2011
Cover Story

LIGHTs out for asthma

Two years after Kyowa Hakko Kirin Co. Ltd. granted sanofi-aventis Group an exclusive license to an antibody against the tumor necrosis factor ligand LIGHT to treat irritable bowel disease, researchers at the La Jolla Institute...
BioCentury | Feb 28, 2011
Company News

Pharmaxis sales and marketing update

Pharmaxis launched its Aridol mannitol Bronchial Challenge Test Kit in the U.S. to assess bronchial hyperresponsiveness in patients six years of age and older who do not have clinically apparent asthma. The indirect bronchial challenge...
BioCentury | Jan 10, 2011
Finance

Buyside View XIX: Commercial Risk

Michael Flanagan Senior Writer BioCentury's 19th Annual Buyside View finds money managers entering 2011 cautiously optimistic about biotech's prospects, particularly as some of the high-profile compounds have already reported some data, lowering risk. Amidst the...
BioCentury | Jan 3, 2011
Finance

Trickle-down effect

Although companies in the $1-$1.9 billion market cap range were the big winners for 2010 with a 28% gain, last quarter saw gains migrate into lower rungs of the market cap ladder. Small caps with...
BioCentury | Oct 11, 2010
Clinical News

Aridol Bronchial Challenge Test Kit regulatory update

FDA approved an NDA from Pharmaxis for its Aridol Bronchial Challenge Test Kit to assess bronchial hyperresponsiveness in patients 6 years of age and older who do not have clinically apparent asthma. The company plans...
BioCentury | Oct 11, 2010
Finance

Regulatory Milestones

Regulatory milestones Human Genome Sciences Inc. (NASDAQ:HGSI) was off $0.16 to $29.15 last week when it said it would discontinue development of Zalbin albinterferon alfa-2b after FDA issued a complete response letter for a BLA...
BioCentury | Oct 6, 2010
Company News

FDA approves Pharmaxis' Aridol

FDA approved an NDA from Pharmaxis Ltd. (ASX:PXS; Pink:PXSLY) for Aridol Bronchial Challenge Test Kit to assess bronchial hyperresponsiveness in patients six or older who do not have clinically apparent asthma. The company plans to...
BioCentury | May 3, 2010
Finance

Regulatory Milestones

Regulatory milestones Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) gained $0.12 to $3.22 last week after the company submitted a complete response to a 2006 FDA approvable letter for Zenvia dextromethorphan/quinidine to treat pseudobulbar affect (PBA). Pharmaxis Ltd....
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