Propeller Health announced that it received FDA 510(k) clearance for connecting patients using its Symbicort Inhaler to its digital health platform. The Madison, Wis.-based company’s digital health platform already connects to inhalers used by asthma and COPD patients, including ones manufactured by Boehringer Ingelheim, GlaxoSmithKline, Novartis and Orion, along with other generic equivalents. Get the full […]
Baxter wins CE Mark for EVO IQ syringe system
Baxter (NYSE:BAX) announced that it received regulatory approval in Europe and Australia for its Evo IQ syringe infusion system. With CE Mark approval in Europe and a nod from Australia’s Therapeutic Goods Administration (TGA), the company expects hospitals in the United Kingdom, Ireland, Greece, Australia and New Zealand to be among the first to receive the […]
Ocular Therapeutix commences public offering
Ocular Therapeutix (NSDQ:OCUL) announced that it commenced an underwritten public offering of an undisclosed amount of its common stock. The Bedford, Mass.-based eye condition therapy developer filed with the SEC to confirm the offering with the shares at a par value of $0.0001 per share. The common stock at market close on May 18 prior to the announcement […]
Moderna reports positive early data out of COVID-19 vaccine trial
Moderna today touted positive interim clinical data from trials for its mRNA-1273 vaccine candidate against coronavirus (SARS-CoV-2). The Phase I study, led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), recorded positive early results from the first eight people tested, each of whom received two […]
FDA clears Nanobiotix to start cancer treatment trial
Nanobiotix (PAR:NANO.PA) announced that the FDA designated its cancer treatment trial with the University of Texas MD Anderson Cancer Center as “safe to proceed.” The trial, co-developed by Nanobiotix and MD Anderson, is set to evaluate the safety and feasibility of NBTXR3 activated-by-radiation therapy for patients with locally advanced (LAPC) or borderline resectable (BRPC) cases of […]
AbbVie gains U.S. nod for $63B Allergan takeover
Pharmaceutical giant AbbVie (NYSE:ABBV) has won U.S. antitrust approval for its purchase of Allergan (NYSE:AGN) for $63 billion in cash and stock. The purchase is seen as a hedge against the impending expiration of U.S. patents on AbbVie’s blockbuster drug, Humira. North Chicago-based AbbVie announced the deal in June 2019, but ran up against U.S. Federal Trade Commission […]
Tandem Diabetes Care posts wider-than-forecast losses in Q1
Tandem Diabetes Care (NSDQ:TNDM) posted first-quarter results that beat the revenue consensus on Wall Street but missed on earnings. The San Diego-based company — maker of insulin pumps and other diabetes management devices — reported losses of -$14.9 million, or -25¢ per share, on sales of $97.9 million for the three months ended March 31, for […]
Dexcom shares up on Street-beating Q1 results
Dexcom (NSDQ:DXCM) posted first-quarter results today that beat the consensus forecast on Wall Street but dropped its financial guidance for the year. The San Diego-based company reported profits of $19.9 million, or 21¢ per share, on sales of $405.1 million for the three months ended March 31 on sales growth of 44.4% compared with Q1 2019. […]
Soligenix soars on COVID-19 vaccine licensing agreement with Boston Scientific
Soligenix (NSDQ:SNGX) skyrocketed up 89% in premarket trading this morning after announcing today that it entered into an exclusive worldwide licensing agreement with Boston Scientific (NYSE:BSX) for its CoVaccine HT novel vaccine adjuvant for COVID-19. Shares of SNGX were up 12.5% at $1.58 per share in mid-morning trading today as well. Boston Scientific’s BTG Specialty Pharmaceuticals […]
B. Braun lands FDA EUA for use of infusion pumps with nebulizers to treat COVID-19
B. Braun Medical announced that it received FDA emergency use authorization to use its infusion pumps with nebulizers to treat patients with COVID-19. The Bethlehem, Pa.-based company’s authorization win includes its Perfusor space syringe infusion pump, Infusomat space volumetric infusion pump and Outlook ES pump systems. The pumps can be used for tracheal delivery of continuous […]
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