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, […]
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 The Irvine, Calif.-based company’s NDA was withdrawn in October last year, after a contract manufacturer was not prepared for its pre-approval inspection.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 […]
Trump calls for speedier approval process, while Sanders takes aim at drug prices
In his 1st address to Congress, President Donald Trump called for speeding up drug approvals within the FDA. Earlier that day, Sen. Bernie Sanders (I-Vermont) proposed a bill to allow the importation of prescription drugs from Canada in the hopes of lowering drug prices. The new administration has been critical of drug prices, with Trump saying that […]
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 […]
BioCardia, Johns Hopkins treats first patient with CardiAmp cell therapy in Phase III trial
Johns Hopkins, the Maryland Stem Cell Research Fund and BioCardia (NSDQ:BCDA) said today that the 1st patient has been treated in a pivotal Phase III trial of the CardiAmp cell-based therapy for the treatment of ischemic heart failure. The investigational therapy was designed to deliver a dose of a patient’s own bone marrow cells directly […]
Gamida Cell touts first patient treated in Phase III NiCord trial
Gamida Cell said today that the 1st patient has been treated in the Phase III registration trial of its NiCord cell graft for patients with blood cancer. The treatment is a graft derived from umbilical cord blood which has been expanded and enriched with stem and progenitor cells, according to the company. The Jerusalem-based company’s […]
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 […]