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 […]
United Therapeutics posts Street-beating Q1
United Therapeutics (NSDQ:UTHR) today announced first-quarter results that came in well ahead of the consensus forecast. The Research Triangle Park, N.C.-based company posted profits of $28.3 million, or 61¢ per share, on sales of $379.1 million for the three months ended March 31, 2021, for a -79.4% bottom-line slide on sales growth of 6.4%. Adjusted […]
Kala Pharmaceuticals rises before hours on mixed bag Q1
Kala Pharmaceuticals (NSDQ:KALA) announced shares ticked up before hours today on first-quarter results that were mixed compared to the consensus forecast. The Watertown, Mass.-based company posted losses of -$30.4 million, or -49¢ per share, on sales of $3.2 million for the three months ended March 31, 2021, for a -38.5% bottom-line slide despite revenues that […]
Teva Pharmaceuticals launches generic Erythromycin tablets in U.S.
Teva Pharmaceuticals (NYSE:TEVA) announced today that it launched generic Erythromycin oral tablets in the U.S. Parsippany, N.J.-based Teva — a U.S. affiliate of Tel Aviv, Israel-based Teva Pharmaceutical Industries — launched the 250 mg- and 500 mg-strength generic Erythromycin tablets, which are a therapeutic equivalent for the reference listed drug Erythromycin from Arbor Pharmaceuticals, according to […]
