Qpex Biopharma announced today that it dosed the first patient in a Phase 1 study of its ORAvance inhibitor for bacterial infections. San Diego-based Qpex designed its ORAvance ultra-broad-spectrum oral beta-lactamase inhibitor for use in combination with beta-lactam antibiotics for drug-resistant gram-negative bacterial infections, according to a news release. ORAvance delivers QPX7728 in an oral […]
How PhysIQ is advancing digital therapeutics through its partnership with Janssen
Over the course of the last year and some change, the impact of digital health and the need for it has increased by an immeasurable amount. Virtual care became the norm after the COVID-19 pandemic hit, and, although a return to something resembling “normal” could be on the horizon, those at artificial intelligence-based technology developer PhysIQ see […]
Lyra Therapeutics rises on Q1 earnings
Lyra Therapeutics (NSDQ:LYRA) shares finished up on the day despite first-quarter results that missed the consensus earnings forecast. The Watertown, Mass.-based chronic rhinosinusitis (CRS) treatment developer posted losses of -$7.8 million, or -60¢ per share for the three months ended March 31, 2021, for a -84.4% bottom-line slide. Lyra’s EPS of -60¢ came in 48¢ […]
Virta Health touts one-year outcomes for diabetes reversal tech in Native American tribal nation
Virta Health announced today that one-year outcomes for its diabetes reversal tech proved successful on a number of levels. San Francisco-based Virta’s results came from its multi-year partnership with the Mashantucket Pequot Tribal Nation. Native Americans suffer from the highest rates of type 2 diabetes compared to any other ethnic group in the country, with […]
FDA accepts IND application for Samus Therapeutics’ oral glioma drug
Samus Therapeutics announced today that the FDA cleared its investigational new drug (IND) application for its glioma treatment. Boston-based Samus Therapeutics develops the PU-AD (icapamespib) orally administered small molecule drug for the treatment of recurrent malignant glioma, according to a news release. Under the IND, Samus will move forward with its Phase 1b study to […]
Camurus touts study of depot injection for opioid dependence
Camurus announced positive study results for its subcutaneous buprenorphine depot injections (Buvidal) for treating opioid dependence. Lund, Sweden-based Camurus’ 24-week, randomized, controlled trial compared patient-reported outcomes of opioid dependence treatment with subcutaneous weekly and monthly Buvidal depot injections against daily sublingual buprenorphine. Results were published in JAMA Network Open yesterday. “The depot evaluation – buprenorphine […]
Intersect ENT slides on mixed bag Q1
Intersect ENT (NSDQ:XENT) shares took a nosedive on first-quarter results that missed the consensus earnings forecast. XENT shares were down -9.4% at $19.06 per share in midday trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was down -0.8%. The Menlo Park, Calif.-based company posted losses […]
Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system
Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system. Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release. Bigfoot Unity smart pen caps offer on-demand […]
Tandem Diabetes Care beats The Street in Q1, raises guidance
Tandem Diabetes Care (NSDQ:TNDM) narrowed its losses year-over-year in Q1, with results beating the consensus forecast on Wall Street. The San Diego-based company yesterday evening posted losses of –$5 million, or –8¢ per share, on sales of $141 million for the three months ended March 31, 2021, reducing losses by nearly two-thirds on sales growth […]
Oncopeptides completes enrollment in Phase 2 multiple myeloma study
Oncopeptides announced today that it completed patient enrollment for its Phase 2 Port study of its multiple myeloma treatment. Waltham, Mass.-based Oncopeptides’ Port study is an open-label, randomized, crossover study comparing the safety, tolerability and efficacy of peripheral or central intravenous administration of Pepaxto (melphalan flufenamide) in combination with dexamethasone to treat relapsed refractory multiple […]
