Smiths Medical plans to distribute its CADD infusion systems to non-hospital-based providers through a preferred partnership with Medical Specialties Distributors, the company reported today. As part of its new distribution model, Smiths will also make its infusion pumps and sets available to providers outside of the hospital setting through InfuSystem (NYSE:INFU) and Integrated Medical Systems. The […]
Clearside Biomedical enrolls first patient in Ph3 macular edema trial
Clearside Biomedical (NSDQ:CLSD) has enrolled the first patient in a Phase III trial evaluating its eye drug combined with an intravitreally-administered anti-VEGF agent as a treatment for macular edema associated with retinal vein occlusion. The company’s drug, CLS-TA, is a proprietary suspension of triamcinolone acetonide designed to be administered in the space located between the choroid […]
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 […]
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 […]
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 […]
FDA to review Sanofi’s subcutaneous injection as asthma treatment
The FDA plans to review Sanofi‘s (NYSE:SNY) Dupixent monoclonal antibody as an add-on maintenance treatment in adults with moderate-to-severe asthma, according to the pharmaceutical company. The U.S. regulatory agency is slated to decide whether it will approve this new indication for Dupixent by Oct. 20. Sanofi’s drug, a subcutaneous injection delivered using a pre-filled syringe, […]
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. […]
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. Adjusted to exclude 1-time items, earnings per share were -$1.38, behind […]
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 […]
