From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with […]
Respiratory
BD to divest stake in Vyaire Medical to Apax Partners in $435m deal
Becton Dickinson (NYSE:BDX) said today it agreed to divest itself of its minority stake in respiratory solutions joint venture Vyaire Medical to joint manager Apax Partners in a deal worth $435 million. The sale will put Vyaire Medical, which Apax and BD formed in 2016 around BD’s ventilation, respiratory diagnostics, vital signs and AirLife businesses, under direct control […]
Bellerophon Therapeutics misses EPS estimates in Q4
Shares in Bellerophon Therapeutics (NSDQ:BLPH) fell slightly today after the company missed earnings expectations on Wall Street with its fourth-quarter and full-year results. The Warren, N.J.-based company posted a net loss of -$24.2 million, or -44¢ per share, for the 3 months ended Dec. 31. The company’s bottom-line losses grew -227% compared with the same period […]
Adamis Pharma’s EpiPen alternative succeeds in human factors study
Adamis Pharmaceuticals (NSDQ:ADMP) has positioned its emergency allergy treatment as a cheaper alternative to Mylan‘s (NSDQ:MYL) EpiPen device. The company has also set out to prove that its epinephrine injector is easy to use, even by people using an auto-injector for the first time. Data from a human factors study conducted by Adamis were presented this week at […]
NIH: Asthma flare-ups not prevented by temporary increases to inhaled steroid dose
Temporarily increasing the amount of inhaled steroids that young children take when their asthma symptoms worsen does not prevent severe flare-ups, according to a new study from the National Institutes of Health. The findings buck traditional medical practice involving kids with mild-to-moderate asthma. Asthma flare-ups are common among children with asthma and most doctors recommend boosting […]
Acorda Therapeutics wins FDA NDA nod for Inbrija
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens. The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said. Read the whole story […]
GSK seeks expanded label for Trelegy Ellipta inhaler in EU
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) have submitted data to the European Medicines Agency in the hopes of expanding the label for its once-daily, triple combination inhaler, Trelegy Ellipta. The drug-device combo was approved in Europe in November last year as a maintenance treatment for adult patients with moderate to severe chronic obstructive pulmonary disease who are not adequately […]
Pulmatrix doses first patient in Ph1 Pulmazole trial
Pulmatrix (NSDQ:PULM) said today that the first patient was treated in a first-in-human study of Pulmazole – an inhaled formulation of the anti-fungal drug, itraconazole. The Lexington, Mass.-based company is evaluating its iSperse formulation of the drug as a treatment for asthma patients who have developed allergic bronchopulmonary aspergillosis. Get the full story at our sister […]
Teva launches breath-activated asthma aerosol in U.S.
Teva Pharmaceuticals (NYSE:TEVA) has launched its Qvar RediHaler inhalation aerosol in the U.S., marking the first time a breath-actuated inhaled corticosteroid is available for asthma patients as a prophylactic therapy. In contrast to traditional metered-dose inhalers, Teva’s Qvar RediHaler sends medication into the user’s lungs as they inhale. This feature eliminates the need for hand-breath coordination, […]
N8 Medical submits IDE app seeking 1st-in-human trial of CeraShield endotracheal tube
N8 Medical said today it submitted an investigational device exemption application to the FDA for a first-in-human study of its CeraShield endotracheal tube. The Dublin, Ohio-based company’s CeraShield ETT is a ceragenin-coated ETT designed to prevent the growth of biofilms and reduce potential for infection for intubated patients. “We are looking forward to bringing our […]
Innoviva posts Street-beating Q4, FY17 earnings
Shares in Innoviva (NSDQ:INVA) rose today after the company topped expectations on Wall Street with its fourth quarter and full-year financial results. The Brisbane, Calif.-based company posted profits of $58.4 million, or 55¢ per share, on sales of $69.5 million for the 3 months ended Dec. 31, for bottom-line growth of 129% on sales growth of 59% […]