Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it appointed two new members to its board of directors. Thomas Forest Farb-Horch and Agnieszka Winkler joined Dublin, Ohio-based Navidea’s board, effective Oct. 7, each with a three-year term ending concurrently with the company’s 2024 annual stockholders meeting. According to a news release, Farb-Horch, a veteran of over three […]
Corium touts study results for once-daily ADHD capsule
Corium (NSDQ:CORI) today announced clinical data demonstrating the strong performance of its once-daily ADHD capsule. Boston-based Corium’s Azstarys oral capsule for treating ADHD symptoms (serdexmethylphenidate [SDX] and dexmethylphenidate [d-MPH]) received FDA approval in March as the first and only product containing a d-MPH oral prodrug for treating ADHD (attention deficit hyperactivity disorder) symptoms in patients […]
Massachusetts offers Medicaid coverage for Pear Therapeutics’ digital therapeutics
Pear Therapeutics announced today that MassHealth intends to cover the company’s prescription digital therapeutics (PDTs). MassHealth, Massachusetts’ Medicaid program, notified Pear of its plans to cover the FDA-authorized reSET and reSET-O PDTs for treating substance use disorder and opioid use disorder, respectively. The decision remains subject to certain customary conditions, including federal and state approvals as […]
Dexcom announces Garmin as first partner for real-time APIs
Dexcom (NYSE:DXCM) announced today that Garmin introduced its Dexcom Connect IQ apps on its smartwatch and cycling computer. Garmin today launched the apps to provide people using the Dexcom G7 continuous glucose monitor (CGM) with Type 1 and Type 2 diabetes a way to quickly see glucose levels and trends, even while working out. Apps […]
Insulet CEO Shacey Petrovic touts Omnipod 5, expects device launch this year
With FDA clearance imminent, Petrovic says Insulet’s latest device offers real change in diabetes care. Faced with either a bulky insulin pump or delivering multiple daily injections, Boston-based entrepreneur and venture capitalist John Brooks III sought an easier way to treat his young son’s newly diagnosed type 1 diabetes. He assembled a team of engineers […]
FDA to make decision on Corium’s transdermal patch for treating dementia next year
Corium (NSDQ:CORI) announced today that the FDA set a Prescription Drug User Fee (PDUFA) target action date for its Adlarity system. The FDA set the PDUFA target action date for Adlarity (donepezil transdermal system), a transdermal patch designed to treat dementia or Alzheimer’s disease, for March 11, 2022. If approved, Boston-based Corium’s once-weekly Adlarity patch […]
Metabolic disease reversal tech company Twin Health raises $140M Series C
Twin Health announced that it raised $140 million in a Series C financing round as it scales its service in the U.S. and globally. Mountain View, California-based Twin Health develops the Whole Body Digital Twin platform designed to help reverse and prevent chronic metabolic diseases while improving energy and health. According to a news release, […]
MedAlliance touts 18-month data for treating lesions with sirolimus-eluting balloon
MedAlliance today touted late-breaking clinical trial data demonstrating positive outcomes with its Selution SLR drug-eluting balloon. The company presented 18-month results from its Prestige below-the-knee (BTK) study evaluating the safety and performance of Selution SLR in treating long tibial occlusive lesions (TASC C & D) in patients with critical limb ischemia (CLI) at VIVA21. According to a […]
New BD syringe manufacturing lines are up and running in Nebraska
BD (NYSE:BDX) announced today that it increased its manufacturing capacity and domestic supply for syringes and needles. Franklin Lakes, N.J.-based BD’s new syringe and needle manufacturing lines, which were completed on an accelerated timeline, represent BD’s partnership with Department of Health and Human Services’ (HHS) Assistant Secretary for Preparedness and Response (ASPR). In July 2020, […]
FDA offers expanded clearance for DreaMed’s AI-based support system for type 2 diabetes
DreaMed Diabetes AI announced today that it received FDA clearance that expands its platform’s target population to cover type 1 and type 2 diabetes. Tel Aviv, Israel-based DreaMed’s Advisor Pro AI clinical decision support system assists healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using […]