Acorda Therapeutics (NSDQ:ACOR) said today that it resubmitted its new drug application for Inbrija, an inhaled therapy for people with Parkinson’s disease. The Ardsley, N.Y.-based company was dealt a setback in August when the FDA told Acorda that it wouldn’t review its application for Inbrija, a move that sent ACOR shares tumbling. The FDA’s refusal to […]
Respiratory
Sunovion wins FDA nod for inhaled COPD therapy
The FDA has approved Sunovion Pharmaceutical‘s Lonhala Magnair system for the long-term treatment of airflow obstruction in people with chronic obstructive pulmonary disease, the company reported today. The drug-device combo, also known as Sun-101/eFlow, is the first nebulized long-acting muscarinic antagonist approved for the treatment of COPD in the U.S. The system includes a portable […]
Lung cancer expert: Smoking stigma still hurting patients, families and research
A number of therapies designed to treat patients with lung cancer have been approved this year, including products from Novartis (NYSE:NVS), Merck (NYSE:MRK) and Bristol-Myers Squibb (NYSE:BMY). That progress is exciting for Dr. Fred Hirsch, the head of the International Association for the Study of Lung Cancer. “We do have a lot of good things to tell the […]
GSK to use Owlstone’s breath biopsy device in Phase II COPD trial
GlaxoSmithKline (NYSE:GSK) is slated to use Owlstone Medical‘s breath biopsy device in a phase II trial of its drug for chronic obstructive pulmonary disease, danirixin. The diagnostics company’s breathalyzer will be used to help GSK identify which patients will most benefit from the drug, as well as evaluate the effects of danirixin, according to the pharma company. […]
Bayer’s antibiotic drug-device combo fails in late-stage trial
Bayer (ETR:BAYN) reported last week that its antibiotic drug-device combination product failed in a phase III trial. In the 725-patient Inhale trial, Bayer’s Amikacin Inhale did not out-perform a placebo as a treatment for Gram-negative pneumonia in patients on ventilators. Bayer licensed the rights to Nektar Therapeutics‘ (NSDQ:NKTR) antibiotic-delivery product for $175 million in 2007, according […]
GSK, Innoviva seek expanded label for triple inhaler
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data from the landmark Impact trial to the FDA in the hopes of landing an expanded label for the Trelegy Ellipta triple inhaler. The two companies are hoping that their therapy could be used to treat airflow obstruction and to reduce exacerbations in people with chronic obstructive pulmonary disease. Trelegy Ellipta, […]
Propeller Health, Express Scripts ink smart inhaler sensor deal
Propeller Health said today it inked a strategic partnership deal with Express Scripts (NSDQ:ESRX) to provide Propeller’s digital solutions to Express Script members. Through the deal, St. Louis-based Express Script members will be able to use inhaler sensors and connected mobile applications to manage their asthma or chronic obstructive pulmonary disease. The companies touted it as the largest […]
Startup aims to disrupt asthma, COPD space with digital inhaler
Formed just two years ago, pharma startup Pneuma Respiratory is developing a digital inhaler that it touts as the first of its kind. The company is looking to bring its technology to the more than 40 million people who suffer from asthma or chronic obstructive pulmonary disease in the U.S. They’re stepping into a highly […]
Bellerophon Therapeutics misses EPS estimates in Q3
Shares in Bellerophon Therapeutics (NSDQ:BLPH) fell slightly today after the company missed EPS expectations on Wall Street with its third quarter results. The Warren, N.J.-based company posted a net loss of -$7.6 million for the 3 months ended Sept. 30, for bottom-line loss of -81% compared with the same period last year. Adjusted to exclude 1-time […]
Report: Seven deaths from EpiPen failures this year
Defective EpiPens have been cited in seven deaths this year so far, according to reports made to the FDA and obtained by Bloomberg News. During the same period, the FDA has received 228 reports of EpiPen failures and at least 35 people were hospitalized as a result of those failures. Failure reports for Mylan‘s (NSDQ:MYL) life-saving […]