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 […]
Cellphire Therapeutics closes $15M Series A
Long-term stabilization and platelet storage product developer Cellphire Therapeutics announced that it closed a $15 million Series A financing round. Rockville, Md.-based Cellphire develops Thrombosomes and Cryopreserved Platelets (CPP) in bleeding patients. The former is a platelet-based, freeze-dried hemostatic agent, while CPP — frozen platelets — is being developed for the U.S. Army to fill […]
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 […]
BlueStar Genomics gains breakthrough nod for pancreatic cancer test
Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test. San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release. The test uses a standard blood draw to assess whether an individual has an abnormal epigenomic […]
Lyndra Therapeutics appoints Jenkins, Fernandes to executive roles
Lyndra Therapeutics announced today that it appointed Abigail Jenkins and Jacqueline Fernandes to executive positions at the company. Jenkins will take over as chief commercial & business officer, while Fernandes assumes the role of VP of data compliance and information technology at the Watertown, Mass.-based developer of oral, long-acting, sustained-release therapeutics. “We are pleased to […]
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 […]