The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall. BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails […]
Food & Drug Administration (FDA)
Better Therapeutics initiates real-world study for digital therapeutic for diabetes
Better Therapeutics announced today that it commenced a real-world evidence study to evaluate its treatment for Type 2 diabetes. Collaborating with Steward Health Care, Better Therapeutics is evaluating BT-001, an investigational, prescription digital therapeutic (PDT) designed to deliver a novel form of cognitive-behavioral therapy to patients with uncontrolled Type 2 diabetes, according to a news […]
Genentech wins FDA approval for Xolair prefilled syringe
Genentech announced today that the FDA approved its supplemental biologics license application for the Xolair prefilled syringe. South San Francisco-based Genentech touts the Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications as the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate to severe persistent allergic asthma, […]
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 […]
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 […]
BD expands recall of ChloraPrep 3 ml applicator
BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator. Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news […]
How Bionaut Labs aims to tackle brain tumors with microrobots
The roboticist Michael Shpigelmacher was one of the founders of PrimeSense, a robotic 3-D vision technology company Apple acquired in 2013. PrimeSense created technology empowering the Microsoft Xbox Kinect and the iPhone’s Face ID feature, allowing users to use facial recognition to unlock their phones. Now Shpigelmacher has set his sights on drug-delivery with Bionaut […]
FDA grants orphan drug designation for Steba Biotech’s urothelial cancer drug
Steba Biotech announced today that it received FDA orphan drug designation (ODD) for its Padeliporfin ImPACT for treating UTUC. Padeliporfin ImPACT (immune photo-activated cancer therapy) is designed to offer surgery-like efficacy combined with organ preservation through the intravenous delivery of an inactive drug, according to a news release. Once activated, the drug rapidly triggers the […]
FDA tentatively approves first generic version of Symbicort inhalation aerosol
Viatris (NSDQ:VTRS) and Kindeva Drug Delivery announced today that the FDA granted tentative approval of the first generic version of Symbicort. Symbicort, an inhalation aerosol is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD). The drug had U.S. branded sales of $3.5 billion for the 12 months ended January 2021, according […]
