The FDA granted 510(k) clearance to the first automated robotic movement software designed for Corindus Vascular Robotics (OTC:CVRS) CorPath GRX percutaneous coronary intervention platform, the company reported today. The Rotate on Retract feature allows the person operating the CorPath GRX to navigate to a targeted lesion by automatically turning the guidewire upon joystick retraction. The software […]
NanOlogy looks to transform chemotherapy with localized delivery platform
Paclitaxel revolutionized cancer treatment when it was first used as a chemotherapeutic in the 1990s. But although the product is a powerful cancer killer, patients taking systemic doses of paclitaxel have to endure side effects such as peripheral neuropathy and hair loss. Marc Iacobucci and his team at NanOlogy believe they could replace the need for large, […]
Clearside Biomedical shares soar after eye drug succeeds in Ph3 trial
Clearside Biomedical (NSDQ:CLSD) shares soared more than 50% in pre-market activity today after the company reported that its suprachoroidal eye drug succeeded in a pivotal Phase III trial of patients with macular edema associated with non-infectious uveitis. The company’s drug, CLS-TA, is a proprietary suspension of a corticosteroid, triamcinolone acetonide, designed to be administered to the […]
Preparing for commercial launch, Nemaura boosts manufacturing capabilities
Nemaura Medical (NSDQ:NMRD) plans to expand into new manufacturing facilities in preparation for the commercial launch of its non-invasive glucose monitoring system. The company expects to win CE Mark approval for its sugarBeat system in the coming months and also hopes to launch additional trials in the U.S. to support a regulatory bid with the FDA. […]
Staar Surgical settles class action suit for $7m
Staar Surgical (NSDQ:STAA) inked a $7 million deal last year to settle claims that the company misled investors regarding regulatory violations spotted by the FDA at a Monrovia, Calif.-based manufacturing facility. The plaintiff, Edward Todd, initially alleged that Staar Surgical, ex-president & CEO Barry Caldwell, CFO Deborah Andrews and ex-CFO Stephen Brown failed to disclose problems […]
Tandem Diabetes sales up 40% in Q4
Shares in Tandem Diabetes Care (NSDQ:TNDM) rose yesterday after the insulin pump maker beat expectations on Wall Street with its fourth quarter and full-year results. The San Diego Calif.-based company reeled in its losses in Q4, posting a net loss of -$11.4 million on sales of $40.3 million for the 3 months ended Dec. 31, for […]
Aerie misses Q4 earnings estimates by 11¢
Shares in Aerie Pharmaceuticals (NSDQ:AERI) held steady today after the eye-drug maker missed earnings expectations on Wall Street with its fourth-quarter and full-year financial results. The Durham, N.C.-based company posted a net loss of -$58.5 million, or -$1.60 per share, for the 3 months ended Dec.31. Get the full story at our sister site, Drug Delivery Business News.
BioD investors claim accelerated $26.5m earnout after ex-CEO quits Integra
Former BioD investors are looking for an accelerated $26.5 million earnout after ex-CEO Russell Olsen resigned from Integra Lifesciences (NSDQ:IART). BioD merged with Derma Sciences for $80 million in Aug. 2016., which was later bought by Integra for $200 million. After the series of acquisition, Olsen told Integra that he believed his new job offer materially diminished […]
FDA panel to review Senseonics’ implantable CGM this month
A panel for the FDA is slated to review Senseonics‘ (NYSE:SENS) premarket approval application for its Eversense implantable continuous glucose monitoring system on March 29. The company’s device sends glucose data every five minutes to a transmitter, which then communicates that information to a mobile app, displaying the values in the real-time. The Eversense system […]
Mylan: Generic competition pushes EpiPen sales down
Mylan (NSDQ:MYL) revealed in its annual report yesterday that EpiPen sales in the U.S. were down $655.4 million last year compared to 2016. The company, which faces continued backlash over the price of its emergency allergy treatment, cited the launch of a generic version of its device, higher governmental rebates and increased competition as reasons for […]
Sorrento Therapeutics wins FDA nod for post-shingles pain patch
Shares in Sorrento Therapeutics (NSDQ:SRNE) soared today after the company announced that the FDA approved its ZTlido lidocaine pain patch designed to treat patients with post-shingles neuralgia. The company resubmitted its application for ZTlido to the FDA last year after it was rejected by the U.S. regulatory agency in 2016. Get the full story at our sister site, Drug […]