A federal grand jury last week indicted Sanovas president & CEO Larry Gerrans on three counts of wire fraud and money laundering for alleged schemes to pay cash for a home and “myriad” personal expenses. Gerrans has denied the charges via a company spokesman. According to federal prosecutors and the FBI, Gerrans “employed a number of […]
Respiratory
Gala Therapeutics wins FDA IDE nod for early feasibility trial of RheOx system
Gala Therapeutics said today it won FDA investigational device exemption approval to conduct an early feasibility study of its RheOx system designed to treat individuals with chronic bronchitis. The study will look to enroll up to 15 patients at five sites in the US, the Menlo Park, Calif.-based company said. “Patients with Chronic Bronchitis suffer […]
ResMed, Google’s Verily ink sleep-apnea-focused joint venture deal
ResMed (NYSE:RMD) and Google (NSDQ:GOOG) life sciences company Verily said today they inked a new joint venture deal aiming to develop software solutions to improve diagnosis, treatment and care for sleep apnea and other breathing related sleep disorders. The new US-based joint venture will use sleep apnea knowledge from San Diego-based ResMed and Verily’s data analytics technologies in its […]
Novartis steps in to compete with Mylan’s Epipen
Adamis Pharmaceuticals (NSDQ:ADMP) said this week that it inked an exclusive deal with Novartis‘ (NYSE:NVS) Sandoz unit to distribute and commercialize its Symjepi emergency allergy treatment. The agreement puts Novartis in the position to compete directly with Mylan‘s (NSDQ:MYL) EpiPen auto-injector. The pharma giant has been under pressure in recent months thanks to manufacturing delays that have caused an Epipen shortage in […]
Japan approves Inspire Medical’s obstructive sleep apnea neurostim device
Inspire Medical Systems said this week it won approval from Japan’s Ministry of Health, Labour and Welfare for its Inspire therapy system, now cleared to treat moderate to severe obstructive sleep apnea. The Inspire system is a closed-loop, pacemaker-like system designed to stimulate nerves to keep airways open during sleep to treat obstructive sleep apnea. […]
Pulmonx wins FDA approval for Zephyr endobronchial valve
The FDA today granted pre-market approval under its breakthrough devices designation to the Zephyr endobronchial valve made by Pulmonx for treating severe emphysema. Emphysema, a chronic obstructive pulmonary disease, causes irreversible damage to the lung’s alveoli, trapping air during exhalation that in turn can cause the diseased tissue to grow larger and pressure healthy lung tissue. The […]
Fresca Medical wins de novo nod from FDA for Curve sleep apnea device
Fresca Medical said today it won FDA de novo approval for its Curve positive airway pressure delivery system designed to treat obstructive sleep apnea. The Curve CPAP system includes a flow generator, air delivery hose and nasal pillow patient interface, the San Clemente, Calif.-based company said. The system also features the company’s SmartValve technology which […]
FDA panel votes against BTG’s PneumRX Elevair
An FDA advisory committee panel yesterday voted against approving BTG‘s PneumRX’s Elevair endobronchial coil system intended for treating patients with severe emphysema. The panel voted 7 to 5 in favor of the device’s safety, but 8 to 3 that the benefits do not outweigh the risks, and 5 to 7 that the device was effective […]
FDA rejects Mylan’s Advair generic in win for GSK
Shares in Mylan (NSDQ:MYL) dropped -5% yesterday after the pharmaceutical company revealed that it received the dreaded ‘complete response letter’ from the FDA, denying its application for a generic version of GlaxoSmithKline‘s (NYSE:GSK) blockbuster Advair respiratory drug. Canonsburg, PA-based Mylan noted that the CRL was due to “minor deficiencies” identified in its application and that it expects […]
Pulmatrix touts Ph1 data for inhaled COPD therapy
Pulmatrix (NSDQ:PULM) touted data today from a dose-ranging Phase I trial of its once-daily inhaled therapy designed for people with chronic obstructive pulmonary disease. The company’s product is a reformulation of tiotropium bromide, the active component in Boehringer Ingelheim’s blockbuster drug, Spiriva. Get the full story at our sister site, Drug Delivery Business News.
Intuitive Surgical drops $15m, inks collab dev and licensing deal in Broncus Medical Series A
Broncus Medical said today it raised $15 million in a Series A from robotic surgery giant Intuitive Surgical (NSDQ:ISRG). The investment comes in three parts, including the $15 million equity investment, a technology development collaborative agreement and a licensing deal that will put Broncus Medical’s intellectual properties in Sunnyvale, Calif.-based Intuitive’s hands. Broncus Medical is developing […]