Glaukos (NYSE:GKOS) announced today that it entered into a settlement with Ivantis to terminate a three-year-old patent infringement lawsuit. San Clemente, California-based Glaukos’ patent infringement lawsuit, initiated on April 14, 2018, in the U.S. District Court for the Central District of California, Southern Division, concerned Ivantis’ Hydrus Microstent for reducing eye pressure in glaucoma patients. […]
Food & Drug Administration (FDA)
FDA approves Impel NeuroPharma’s nasal spray for treating migraines
Impel NeuroPharma (NSDQ:IMPL) announced today that the FDA approved its Trudhesa nasal spray for treating migraine in adults. Seattle-based Impel NeuroPharma plans to launch Trudhesa commercially early next month. The company’s shares took a massive hit, though, dropping -19.3% at $18.65 per share by market close and continuing to slide down -0.8% at $18.50 after […]
Glaukos submits supplemental PMA application for iStent Infinite
Glaukos (NYSE:GKOS) announced today that it submitted a supplemental premarket approval application to the FDA for its iStent Infinite system. San Clemente, California–based Glaukos designed the iStent Infinite trabecular micro-bypass system for use in a standalone procedure to reduce elevated intraocular pressure (IOP) in patients with open-angle glaucoma uncontrolled by prior surgery or medical therapy. […]
Baxter working on software upgrade for serious Spectrum IQ problems
Baxter (NYSE:BAX) this week issued an urgent medical device correction for all of its Spectrum IQ infusion pumps. Earlier this month, FDA designated a recall of Baxter’s Dose IQ safety software program as Class I, its most serious level. Baxter designed the Dose IQ as a standalone computer-based software program that allows care providers to […]
FDA approves supplemental new drug application for Xeris’ hypoglycemia treatment
Xeris Pharmaceuticals (NSDQ:XERS) announced today that the FDA approved its supplemental new drug application for the Gvoke kit. Chicago-based Xeris’ Gvoke (Ogluo in Europe) a ready-to-use pre-mixed, pre-measured glucagon injection for treating severe hypoglycemia for people with diabetes ages 2 and above. The kit will be available as a 1 mg/0.2 mL single dose vial […]
FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion
Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its Lyumjev rapid-acting insulin. Indianapolis-based Eli Lilly’s Lyumjev (insulin lispro-aabc injection) 100 units/mL holds indication to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump. The […]
Baxter has a serious recall involving infusion pump software
The FDA issued a Class I recall — the most serious kind of recall — for Baxter’s Dose IQ safety software program. Baxter designed its Dose IQ safety software as a standalone computer-based software program that allows care providers to create a drug library of pre-programmed dosing information for specific medications, which are delivered into […]
Cigarette maker Philip Morris acquires another inhaled therapeutic company
Philip Morris (NYSE:PM) announced today that it acquired OtiTopic and its late-stage inhalable acetylsalicylic acid (ASA) treatment. Los Angeles-based OtiTopic develops the Asprihale patented dry powder inhalation ASA treatment to treat acute myocardial infarction as a self-administered aerosol. According to a news release, early clinical trials have shown that the product catalyzed peak plasma concentration […]
Vaxart stock soars after FDA approves IND application for oral COVID-19 vaccine tablet
Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. South San Francisco-based Vaxart’s S+N oral tablet SARS-CoV-2 vaccine candidate […]
Abbott CMO Dr. Nick West touts latest iteration of drug-eluting stent
Abbott executive Dr. Nick West believes the company offers the “best-in-class” drug-eluting stent with its Xience platform. When Abbott (NYSE:ABT) CMO & divisional VP of global medical affairs for its vascular business Dr. Nick West looks back at his use of drug-eluting stents in the early 2000s, all he sees now is innovation. As a practicing interventional cardiologist, West […]
