Shares in Glaukos (NYSE:GKOS) rose today after the ophthalmological-focused medical device maker posted fourth quarter and full year 2018 earnings that topped expectations on Wall Street. The San Clemente, Calif.-based company posted profits of approximately $1.8 million, or 4¢ per share, on sales of approximately $54.1 million for the three months ended December 31, for bottom-line […]
Intersect ENT shares dip despite street-beating Q4 earnings
Shares in Intersect ENT (NSDQ:XENT) have fallen slightly today despite the medical device maker releasing fourth quarter and full year 2018 earnings that met consensus expectations from analysts on Wall Street. The Menlo Park, Calif.-based company posted losses of $5 million, or 16¢ per share, on sales of approximately $32.8 million for the three months ended […]
Medtronic wins expanded FDA indication for Resolute DES
Medtronic (NYSE:MDT) said today that it won expanded FDA approval for its Resolute drug-eluting stent platform, now cleared for treating patients with coronary artery disease and de novo chronic total occlusion. The new clearance covers the Resolute Onyx and Resolute Integrity devices, the Fridley, Minn.-based company said. “This expanded indication will allow physicians the option to treat […]
Biotronik wins FDA nod for Orsiro DES
Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience. The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly […]
Propeller Health study suggests 84% of asthma inhaler use performed incorrectly
ResMed (NYSE:RMD) subsidiary Propeller Health today released results from a new study exploring real-world use of asthma rescue and controller inhalers that indicated that the majority of users did not use their inhalers properly. Results from the research were published in The Journal of Allergy and Clinical Immunology: In Practice, the Madison, Wisc.-based company said. Data in the study […]
Former PixarBio worker pleads guilty in fraud case
A former PixarBio (OTC:PXRB) employee pleaded guilty last Friday to charges of fraud and obstruction, according to a recent report from the Boston Business Journal. The employee, Jay Herod, was accused of making false statements to the SEC and impeding their investigation, as well as manipulating company stock trades and misleading investors, according to the report. […]
Pulmatrix announces 1-for-10 reverse split, $1m offering
Pulmatrix (NSDQ:PULM) this week announced both a 1-for-10 reverse split of its stock and the closing of an offering which brought in approximately $905,000. On Tuesday, the Lexington, Mass.-based company said that it initiated a 1-for-10 reverse split of its common stock, putting a single share in the hands of each shareholder for each 10 shares they […]
FDA: West Pharma recall of Vial2Bag fluid transfer systems is Class I
The FDA recently labeled a select recall of West Pharmaceutical Services‘ (NYSE:WST) Vial2Bag fluid transfer systems over device functionality issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death. The West Whiteland Township, Penn.-based company’s Vial2Bag […]
FDA rejects Alkermes depression drug NDA
Alkermes (NSDQ:ALKS) said last Friday that the FDA rejected the company’s new drug application for its ALKS 5461 drug intended to treat patients with major depressive disorder. The Dublin, Ireland-based company’s ALKS 5461 once-daily oral medication is a fixed dose combination of buprenorphine and samidorphan, designed for patients with MDD for whom standard antidepressant therapies have […]
Baxter cleared from DoJ antitrust saline probe
Baxter (NYSE:BAX) said yesterday that it has been cleared from a U.S. Dept. of Justice antitrust probe, launched in 2017, investigating companies that market intravenous saline solutions. The probe came as hospitals endured a shortage of intravenous saline solutions, which are used to hydrate hospital patients. The shortage dates back to late 2013, after drugmakers told […]
