Pear Therapeutics announced today that it entered into multiple agreements to bolster its prescription digital therapeutics (PDT) platform. Boston-based Pear Therapeutics’ agreements are set to add to its library of digital biomarkers, machine learning algorithms, sensor-based technologies and digital therapeutics, according to a news release. The agreements have been struck with technology companies including Empatica, […]
Drug-Device Combinations
Seelos, Aptar sign deal for Bidose system to deliver ketamine candidate
Seelos Therapeutics (NSDQ:SEEL) announced today that it partnered with AptarGroup (NYSE:ATR) for the Bidose liquid system device. The agreement includes the co-exclusive use and supply of Aptar Pharma’s Bidose device to deliver Seelos’ intranasal ketamine product candidate, SLS-002, for treating suicidality, depression and post-traumatic stress disorder (PTSD). Under the agreement, Seelos garners certain rights to […]
Amneal completes acquisition of Kashiv Specialty Pharmaceuticals
Amneal Pharmaceuticals (NYSE:AMRX) announced today that it completed the acquisition of a 98% interest in Kashiv Specialty Pharmaceuticals. Bridgewater, N.J.-based Amneal develops, manufactures and distributes generic and specialty drug products. Kashiv Specialty Pharmaceuticals, a wholly-owned subsidiary of Kashiv BioSiences, develops complex generics, novel drugs and innovative drug delivery platforms, according to a news release. No […]
Welldoc, Dexcom expand diabetes management tech partnership
Welldoc announced today that it will offer its BlueStar digital health solution with Dexcom’s G6 CGM system as a single platform. Columbia, Md.-based Welldoc’s FDA-cleared BlueStar system offers guidance to individuals through the self-management of diabetes, while Dexcom’s G6 continuous glucose monitoring (CGM) system measures glucose levels just beneath the skin’s surface and wirelessly transmits […]
Prescryptive to offer benefit coverage for Pear Therapeutics opioid use disorder treatments
Pear Therapeutics announced today that Prescryptive Health will offer and administer benefit coverage for its digital therapeutics. Boston-based Pear Therapeutics’ reSET and reSET-O, two FDA-cleared prescription digital therapeutics (PDTs) for treating substance and opioid use disorder, have been added to Prescryptive’s formularies and are being administered as standard pharmacy benefits for its members, according to […]
Fresenius Kabi, Corvida Medical ink U.S. distribution deal for drug-transfer device
Fresenius Kabi announced that it entered into a U.S. distribution agreement with Corvida Medical for the HALO closed system drug-transfer device (CSTD). Under the distribution agreement, Lake Zurich, Ill.-based Fresenius Kabi will be the exclusive U.S. distributor for the HALO CSTD, an airtight and leak-proof CSTD designed to prohibit the transfer of environmental contaminants into […]
Eyenovia appoints Dr. Julia Haller to board of directors
Eyenovia (NSDQ:EYEN) announced today that it appointed renowned ophthalmologist Dr. Julia Haller to its board of directors. New York-based Eyenovia adds the experienced Haller to its board as it continues to develop the MydCombi fixed-combination mydriatic agent for potential use in comprehensive eye exams with a formulation for touchless fixed-combination microdosing to improve the patient […]
FDA approves inhaled pulmonary hypertension treatment from United Therapeutics
United Therapeutics (NSDQ:UTHR) announced today that it received FDA approval for its Tyvaso inhalation solution for pulmonary hypertension. Research Triangle Park, N.C.-based United Therapeutics’ Tyvaso (treprostinil) inhalation solution is designed to treat patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD) to improve exercise ability, according to a news release. With approval, Tyvaso now […]
B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study
B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX. Bethlehem, Pa.-based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA […]
Regeneron touts results of NIH-sponsored EYLEA injection study
Regeneron Pharmaceuticals (NSDQ:REGN) announced data supporting the use of its EYLEA injection in NPDR patients. Protocol W, a NIH-sponsored trial to evaluate the EYLEA (aflibercept) injection in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR), without center-involved diabetic macular edema (CI-DME), had its initial results published in JAMA Ophthalmology. At two years, the primary […]