BioCentury | May 19, 2017

Breathe in, cash out

By installing a proven CEO and ponying up sufficient cash to clear Phase II development, Genoa Pharmaceuticals Inc. ’s investors believe the company is primed to reach value inflection. Genoa raised $62 million in a...
BioCentury | Mar 3, 2014
Clinical News

Arikace amikacin: Extension study data

An interim DSMB review of 98 evaluable CF patients with chronic P. aeruginosa infection who completed the first year of the 2-year, open-label CLEAR-110 extension study showed that once-daily 560 mg Arikace was well tolerated...
BioCentury | Nov 25, 2013
Company News

Cornerstone Therapeutics sales and marketing update

...Cornerstone launched Bethkis tobramycin inhalation solution in the U.S. to manage Pseudomonas aeruginosa infections in patients... patients with cystic fibrosis (CF). The wholesale acquisition cost for a 28-day supply of Bethkis...
BioCentury | Nov 4, 2013
Clinical News

Tobramycin inhalation solution regulatory update

Teva Pharmaceutical Industries Ltd. (NYSE:TEVA, Petah Tikva, Israel) said FDA approved its generic version of TOBI from Novartis to treat chronic pulmonary infection caused by Pseudomonas aeruginosa in cystic fibrosis (CF) patients. Teva said pursuant...
BioCentury | Sep 16, 2013
Company News

Activaero, Chiesi deal

...a drug-device combination product using Activaero's Flow and Volume Controlled Inhalation Technology (FAVORITE) and Chiesi's Bethkis...
BioCentury | Jul 15, 2013

Highlights of weekly biotech stock moves

Regulatory milestones Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) gained $1.91 (11%) to $19.40 Independence Day week after the European Commission approved Iclusig ponatinib to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL)....
BioCentury | Jul 15, 2013
Clinical News

Arikace: Phase III data

The open-label, European and Canadian Phase III CLEAR-108 trial in 302 CF patients with chronic P. aeruginosa infection showed that once-daily 560 mg Arikace met the primary endpoint of non-inferiority to twice-daily 300 mg TOBI...
BioCentury | Jul 2, 2013
Clinical News

Insmed falls on Phase III data for lung infection compound

Insmed Inc. (NASDAQ:INSM) slid $2.24 (19%) to $9.72 on Monday after reporting data from the Phase III CLEAR-108 trial evaluating Arikace amikacin to treat Pseudomonas aeruginosa infection in cystic fibrosis (CF) patients. Once-daily Arikace administered...
BioCentury | Apr 29, 2013
Clinical News

AeroVanc: Phase II started

Savara began a double-blind, placebo-controlled, U.S. Phase II trial to evaluate twice-daily 32 and 64 mg AeroVanc for 28 days in about 80 patients. Patients with co-infected with Pseudomonas aeruginosa will undergo a 28-day run-in,...
BioCentury | Jan 14, 2013
Clinical News

Aeroquin: Phase III data

The open-label, international Phase III 209 trial in 282 CF patients with P. aeruginosa infection showed that twice-daily 240 mg Aeroquin for the first 28 days of a 56-day cycle met the primary endpoint of...
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