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 […]
MassMedic: New England suited to be drug delivery device powerhouse
The Massachusetts Medical Device Industry Council (MassMedic) believes New England is capable of growing in the drug delivery device space. In a recently published report written by Alira Health’s Aude Ouesanga, Laure Girard and Marie Vaillant and shared by MassMedic, a shift in the space was highlighted in terms of devices enabling therapeutic delivery to […]
Glytec launches new insulin management system
Glytec announced today that it introduced the latest version of its eGlycemic Management System (eGMS) for managing insulin. Waltham, Mass.-based Glytec’s eGMS is centered around the FDA-cleared Glucommander algorithm, which leverages real-time and historical data to recommend insulin dosing by learning each patient’s insulin sensitivity and anticipating future needs, leading to a personalized treatment regime […]
Pyxis Oncology closes $152M Series B
Biologics developer Pyxis Oncology announced today that it closed a Series B financing round worth $152 million. Cambridge, Mass.-based Pyxis had its financing round co-led by Arix Bioscience and RTW Investments. Existing investors including Leaps by Bayer, Longwood Fund, Agent Capital and Ipsen also contributed to the $152 million, which brings Pyxis’ total funding to […]
