Tandem Diabetes Care (NSDQ:TNDM) said today that it released a software update using the company’s Tandem Device Updater tool for its t:slim insulin pumps purchased before April 2015. It marks the 1st time an insulin pump manufacturer has provided a software update that employs customers’ personal computers. The Mac and PC-compatible tool remotely overhauls Tandem’s insulin pump software, […]
Drug-Device Combinations
Study: Patient error cuts dose in half for inhalers
Researchers from Rice University and Baylor College of Medicine have identified patient errors that cause inhaler users to get about half as much medicine as they should from each dose. The team said that clinicians have known for years that patients don’t use their inhalers as prescribed, but inhaler-dosing studies tend to focus on the rare cases […]
Aerie resubmits NDA for Rhopressa eye drops
Aerie Pharmaceuticals (NSDQ:AERI) said today that it resubmit a New Drug Application for the company’s Rhopressa eye drops. The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection. Aerie’s Rhopressa eye drops specifically target the eye’s trabecular network – the diseased tissue responsible for […]
Mylan posts Street-beating Q4 earnings
Shares in Mylan (NSDQ:MYL) rose today after the EpiPen-maker met expectations on Wall Street with its 4th quarter results. The Canonsburg, Pa.-based company posted profits of $417.5 million, or $1.57 per share, on sales of $3.27 billion for the 3 months ended Dec. 31, for bottom-line growth of 114.5% on sales growth of 31.3% compared with the same […]
Intersect ENT reels in losses, beats revenue estimates for Q4
Shares in Intersect ENT (NSDQ:XENT) fell slightly today even though the drug-device company met expectations on Wall Street with its 4th quarter results. The Menlo Park, Calif.-based company pared losses to -$4.8 million, or -17¢ per share, on sales of $24.2 million for the 3 months ended Dec. 31, for bottom-line growth of 15.8% on sales growth […]
DexCom beats Street with Q4 earnings
Shares in DexCom Inc. (NSDQ:DXCM) rose today after the medical device maker met expectations on Wall Street with its 4th quarter results. The San Diego-based company posted a loss of -$7.4 million, or -9¢ per share, on sales of $171.2 million for the 3 months ended Dec. 31, for bottom-line loss of -593.3% on sales growth […]
FDA asks Titan for more info before clinical trial of ropinirole implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA put a hold on the clinical trial of its ropinirole implant and told the company to submit more information to the federal watchdog. After it completed an initial review of the implant’s Investigational New Drug application, the FDA asked Titan for final release test data on its ropinirole […]
Clearside bails on AMD, all-in on diabetic macular edema
Clearside Biomedical (NSDQ:CLSD) said today it will redirect its R&D efforts from its pre-clinical axitinib wet age-related macular degeneration therapy to its Zuprata diabetic macular edema treatment. The Alpharetta, Ga.-based company said that recent trial results from other companies investigating combination therapies for wet AMD have led Clearside to reconsider its proprietary suspension formulation of […]
OncoSec wins fast track designation for electroporation combo therapy
OncoSec Medical (NSDQ:ONCS) said today that it won Fast Track Designation from the FDA for its ImmunoPulse IL-12 electroporation gene therapy for the treatment of metastatic melanoma. The biotech company’s electroporation device is designed to locally deliver DNA-based interleukin-12 to stimulate the immune system and fight off cancer cells. The ImmunoPulse device delivers a sequence […]
Intersect ENT wins FDA nod for Propel Contour steroid-releasing implant
Intersect ENT (NSDQ:XENT) said today that it won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses. The Menlo Park, Calif.-based company’s portfolio of steroid-releasing implants are used in patients undergoing ethmoid, frontal or maxillary surgeries to treat chronic sinusitis. “The approval of Propel […]