- Salix's NDA for crofelemer in HIV-associated diarrhea assigned priority review status
- Genentech's BLA for pertuzumab receives priority review status in previously untreated HER2-positive metastatic breast cancer indication
- FDA reviewers questions efficacy of NeurogesX's Qutenza pain patch in proposed new use
- Shire's Vyvanse approved for maintenance treatment in adults with ADHD
- FDA accepts Ziopharm's IND application for oral formulation of Zymafos
- Private FFS MA plans may be linked with higher costs for beneficiaries, GAO report shows
- Pediatric subspecialty telephone consultations may be cost-saving for Medicaid, research reveals
- Use of mental health services greater in health plans with parity in cost sharing, data find
- Public opinions appear split on health care affordability, satisfaction, survey finds
- In Brief: California Supreme Court
Discovery Labs' aerosol drug delivery system approved
What's This?
Discovery Laboratories Inc. received approval from the Food and Drug Administration to market the firm's Afectair technology, which was developed to simplify the delivery of aerosolized drugs to patients who require ventilator support. Afectair is a disposable ventilator circuit/patient interface connector that makes it easier to deliver aerosolized treatments to critical care patients who need ventilatory support from intermittent mechanical ventilation or continuous positive airway...
Discovery Laboratories Inc. received approval from the Food and Drug Administration to market the firm's Afectair technology, which was developed to simplify the delivery of aerosolized drugs to patients who require ventilator support.
Afectair is a disposable ventilator circuit/patient interface connector that makes it easier to deliver aerosolized treatments to critical care patients who need ventilatory support from intermittent mechanical ventilation or continuous positive airway pressure.
Discovery Labs noted that more than an estimated 1.3 million patients in the United States and European Union receive aerosolized drugs each year while requiring ventilator support, according to national health statistics and market assessment data. The company's projections show that Afectair could generate revenue of approximately $50 million to $75 million.
The firm said it is implementing a business plan that might permit commercial introduction of the technology later this year.
Orexo, J&J companies terminate drug discovery alliance 
What's This?
Orexo AB and Janssen Pharmaceuticals Inc. (formerly Ortho-McNeil-Janssen Pharmaceuticals Inc.) and Janssen Pharmaceutica NV, both Johnson & Johnson (J&J) companies, terminated their research collaboration and license...
Vertex's Kalydeco approved for CF
What's This?
The Food and Drug Administration approved Vertex Pharmaceuticals Inc.'s Kalydeco (ivacaftor), the first drug developed to treat the underlying cause of cystic fibrosis (CF).Kalydeco is indicated for patients aged 6 years or older who have CF and at least one copy of the G551D mutation in the CF transmembrane...
Greater CT use in emergency departments to evaluate common chest symptoms has not improved rate of clinically significant diagnoses, study indicates
What's This?
Despite dramatically increased usage of computer tomography (CT) in emergency departments (EDs) to evaluate common chest (CC) symptoms, the proportion of related ED visits associated with a clinically significant diagnosis has decreased, study data suggest.The data were obtained from the National Hospital Ambulatory Medical Care Survey. Two three-year periods were evaluated--from 1997 through 1999 and from 2005 through 2007....
Ikaria receives orphan drug designation for inhaled nitric oxide therapy as treatment for PAH
What's This?
Ikaria Inc. received an orphan drug designation from the Food and Drug Administration for the combined use of inhaled nitric oxide with the firm's next-generation INOpulse DS drug delivery system as a combination product for the treatment of pulmonary arterial hypertension (PAH). Ikaria noted that the inhalation of nitric oxide selectively relaxes the cells of the pulmonary vasculature, leading to...
- Trial of Janssen R&D's Doribax antibiotic in ventilator-assisted pneumonia stopped early because of safety concerns, low cure rate
- Vertex granted priority review designation for investigational CF therapy
- Pfizer's Prevnar 13 vaccine approved for use in older adults
- FDA advisory panel supports approval of Alexza's inhaled antipsychotic
- Astellas ends Vibativ agreement with Theravance
- Vertex granted priority review designation for investigational CF therapy
- Ikaria receives orphan drug designation for inhaled nitric oxide therapy as treatment for PAH
- Boehringer Ingelheim, Aveo sign manufacturing agreement for investigational NSCLC therapy
- Valeant plans to acquire private Australian pharmaceutical group
- Orexo, J&J companies terminate drug discovery alliance
