BC Week In Review | Sep 8, 2014
Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II/III final data

Final data from a double-blind, European and Canadian Phase II/III trial in 168 patients with AAT deficiency showed that twice-daily 160 mg inhaled AAT for 50 weeks missed the secondary endpoints of reducing the time...
BC Week In Review | May 19, 2014
Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II/III data

Top-line data from a double-blind, European and Canadian Phase II/III trial in 168 patients with AAT deficiency showed that twice-daily 160 mg inhaled AAT missed the primary endpoint of improving time to first moderate or...
BC Extra | May 17, 2014
Clinical News

Kamada slides on AAT miss, still planning MAA submission

Kamada Ltd. (Tel Aviv:KMDA; NASDAQ:KMDA) fell $4.74 (34%) to $9.08 in New York on Friday after reporting that twice-daily aerosolized alpha-1 antitrypsin (AAT) missed the primary endpoint in a 168-patient Phase II/III trial to treat...
BC Week In Review | Mar 31, 2014
Clinical News

Aerosolized Alpha-1 antitrypsin: Phase II started

Kamada began a double-blind, placebo-controlled, U.S. Phase II trial to evaluate 80 or 160 mg inhaled AAT twice daily for 12 weeks in 36 patients. Patients will be eligible to enroll in a 12-week, open-label...
BC Week In Review | Dec 3, 2012
Clinical News

Alpha-1 HC Aerosol recombinant alpha-1 proteinase inhibitor regulatory update

The European Commission granted Orphan Drug designation to Grifols' Alpha-1 HC Aerosol to treat cystic fibrosis (CF). The aerosolized formulation of alpha-1 proteinase inhibitor, an alpha 1-antitrypsin ( AAT ) inhibitor of elastase protease, is in Phase...
BC Week In Review | Oct 15, 2012
Clinical News

Recombinant Alpha1-Proteinase Inhibitor: Phase II started

Grifols began a double-blind, placebo-controlled, dose-escalation, U.S. Phase II trial to evaluate 100 and 200 mg Alpha-1 HC aerosol daily via nebulizer for 3 weeks in 30 patients. The product has Orphan Drug designation in...
BioCentury | May 2, 2011
Finance

Familiarity breeds content

European life sciences firm LSP raised €36 million ($52.5 million) last week in an IPO for its first in-house fund to invest in public companies. The firm is capitalizing on investors' familiarity with its venture...
BC Week In Review | Feb 21, 2011
Clinical News

Aerosolized Alpha-1 antitrypsin: Interim Phase II/III data

Interim data from a double-blind, placebo-controlled, European Phase II/III trial in patients with emphysema showed that inhaled AAT for 13 months was safe. The product, which uses the eFlow Nebulizer System from Pari, has Orphan...
BC Week In Review | Dec 20, 2010
Clinical News

Prolastin-C: Phase II started

Talecris began the double-blind, crossover, U.S. Phase II SPARK trial to compare 60 and 120 mg/kg doses of weekly IV Prolastin-C for 8 weeks in 30 patients. The 60 mg/kg dose is already approved to...
BC Week In Review | Nov 8, 2010
Company News

Talecris sales and marketing update

Talecris launched Prolastin-C in Canada to treat panacinar emphysema in patients with alpha1-antitrypsin ( AAT ) deficiency. The company said Prolastin-C, which is a more purified and concentrated formulation of its Prolastin alpha proteinase inhibitor, has replaced...
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