Phillips-Medisize announced today that it expanded its global manufacturing capacity through several collaborations and internal initiatives. Hudson, Wisconsin-based Phillips-Medisize, a Molex company, said its global reach now encompasses 36 world-class facilities with scalable, end-to-end capabilities tailored to help customers bring products to market quickly and efficiently from anywhere in the world. Get the full story […]
Drug-Device Combinations
Insulet announces board of director changes
Insulin delivery technology developer Insulet (NSDQ:PODD) announced today that it appointed Dr. Luciana Borio to its board of directors. Borio joins the board of Acton, Massachusetts–based Insulet, having served in key roles with the FDA, the National Security Council and the Council on Foreign Relations. She specializes in biodefense and medical countermeasures, emerging infectious diseases, […]
Report: Medtronic in negotiations to buy Israel-based insulin pump maker Triple Jump
Reports in Israel say that Medtronic (NYSE:MDT) has entered talks to acquire Triple Jump for $300 million. Calcalist reported that the proposed acquisition, which is in advanced negotiations, follows a 2020 investment into Triple Jump made by Medtronic that included an option to purchase the insulin pump maker. Triple Jump — a startup based in […]
AbbVie receives positive opinion from CHMP for injection that treats psoriatic arthritis
AbbVie (NYSE:ABBV) announced today that a European governing body recommended approval for its psoriatic arthritis treatment injection. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of risankizumab (SKYRIZI, 150 mg, subcutaneous injection at week 0, week 4 and every 12 weeks thereafter) alone or in combination with […]
Navidea names two appointments to its board of directors
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 […]
