Aztreonam News and Research

RSS

Gilead announces results from Phase III clinical trial of Cayston, TIS in cystic fibrosis patients

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution (TIS) in cystic fibrosis (CF) patients with Pseudomonas aeruginosa (P. aeruginosa) achieved its co-primary endpoint of superiority of Cayston for mean actual change in forced expiratory volume in one second (FEV1, a measure of lung function) percent predicted across three treatment cycles (six months).

22 Oct 2010

Gilead Sciences third quarter total revenues increase 8% to $1.94 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended September 30, 2010. Total revenues for the third quarter of 2010 were $1.94 billion, up 8 percent compared to total revenues of $1.80 billion for the third quarter of 2009. Net income for the third quarter of 2010 was $704.9 million, or $0.83 per diluted share, compared to net income for the third quarter of 2009 of $673.0 million, or $0.72 per diluted share.

20 Oct 2010

Gilead Sciences second-quarter total revenues increase 17% to $1.93 billion

Gilead Sciences, Inc. announced today its results of operations for the quarter ended June 30, 2010. Total revenues for the second quarter of 2010 were $1.93 billion, up 17 percent compared to total revenues of $1.65 billion for the second quarter of 2009. Net income for the second quarter of 2010 was $712.1 million, or $0.79 per diluted share, compared to net income for the second quarter of 2009 of $571.4 million, or $0.61 per diluted share.

21 Jul 2010

APP Pharmaceuticals receives FDA approval to market Aztreonam for Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., announced today that it has received approval from the U.S. Food and Drug Administration to market Aztreonam for Injection, USP in two dosage strengths. Aztreonam is therapeutically equivalent to the reference-listed drug Azactam, which is marketed by Bristol-Myers Squibb.

21 Jun 2010

Phase III clinical trial data of Cayston versus TIS in CF patients with P. aeruginosa presented at ECFC 2010

Gilead Sciences, Inc. today announced that its head-to-head Phase III clinical trial of Cayston (aztreonam for inhalation solution) versus tobramycin inhalation solution in cystic fibrosis patients with Pseudomonas aeruginosa achieved one of its co-primary endpoints of non-inferiority for mean percent change in forced expiratory volume in one second (FEV1) percent predicted after 28 days of treatment.

19 Jun 2010

FDA issues approval for Gileads's Cayston for respiratory symptoms in cystic fibrosis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Cayston® (aztreonam for inhalation solution) as a treatment to improve respiratory symptoms in cystic fibrosis patients with Pseudomonas aeruginosa. Cayston’s safety and efficacy have not been established in pediatric patients below the age of 7, patients with forced expiratory volume in one second of less than 25 percent or greater than 75 percent predicted, or patients colonized with Burkholderia cepacia.

23 Feb 2010

Gilead Sciences receives FDA approval for new inhaled antibiotic in treatment of CF

The U.S. Food and Drug Administration approved an important new inhaled antibiotic called Cayston® (aztreonam for inhalation solution) today for the treatment of cystic fibrosis. The drug was made possible by significant support from the Cystic Fibrosis Foundation, including a $1 million investment by a Foundation subsidiary to help develop the therapy.

22 Feb 2010

Heilongjiang Tianlong Pharmaceutical changes R&D focus to antibiotics and cardiac drugs

China Sky One Medical, Inc., a leading fully integrated pharmaceutical company developing and producing over-the-counter drugs in the People's Republic of China ("PRC"), today announced that Heilongjiang Tianlong Pharmaceutical Company ("Tianlong"), the Company's wholly owned subsidiary, will change its R&D focus from external use medicines to antibiotics and cardiac drugs.

22 Jan 2010

FDA Drugs Advisory Committee recommends approval for Gilead Sciences' aztreonam for inhalation solution

Gilead Sciences, Inc. today announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended that aztreonam for inhalation solution be approved for the treatment of infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF).

11 Dec 2009

Anti-Infective Drugs Advisory Committee to review aztreonam for inhalation solution

Gilead Sciences, Inc. today announced that aztreonam for inhalation solution, an investigational product for the treatment of infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF), is scheduled to be reviewed by the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) on December 10, 2009.

27 Oct 2009

European Commission grants conditional marketing authorization for Gilead's Cayston

Gilead Sciences, Inc. announced today that the European Commission has granted conditional marketing authorization for Cayston® 75 mg powder and solvent for nebuliser solution (aztreonam lysine) for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa (P. aeruginosa) in patients with cystic fibrosis (CF) aged 18 years and older.

28 Sep 2009

Clinical data on CXA-101 to be presented at ICAAC

Calixa Therapeutics Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of novel antibiotics for the treatment of antibiotic-resistant infections, will present pre-clinical and clinical data in 20 posters at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) that is being held in San Francisco on September 12 to 15, 2009.

14 Sep 2009

FOCUS 1 and FOCUS 2 clinical trial results released

Forest Laboratories, Inc today presented at the 49th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in San Francisco new data from a complete analysis of FOCUS 1 and FOCUS 2, two global multicenter Phase III studies of ceftaroline for the treatment of community-acquired pneumonia (CAP) in hospitalized patients.

14 Sep 2009

Wyeth shows new Phase III data about its investigational antibiotic, tigecycline

Wyeth Pharmaceuticals recently presented exciting new Phase III data about its investigational antibiotic, tigecycline, based on a clinical trial in patients with complicated intra-abdominal infections (cIAI).

4 Nov 2004

Corus Pharma selected as a biotech company to watch

Corus Pharma announced yesterday that it has been selected as a member of FierceBiotech's annual "The Fierce 15." FierceBiotech Editor-in-Chief John D. Carroll observed "We applaud Corus' ongoing commitment to increasing the quality of life for people living with cystic fibrosis."

29 Jul 2004