Days after classifying one recall for the Alaris infusion pump, the FDA has issued another Class I recall for the device. On Friday of last week, the FDA issued a Class I recall — the most serious kind — for the BD (NYSE:BDX) Alaris because there is a risk of the keypad lifting up due to […]
Virta Health raises $133M Series E for diabetes reversal tech
Virta Health announced today that it raised $133 million in a Series E equity financing round led by Tiger Global. San Francisco-based Virta said in a news release that the funds will accelerate its efforts to drive the adoption of its telehealth-based diabetes reversal treatment that aims to reverse the chronic disease while removing the […]
Another BD Alaris infusion pump recall is Class I
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 […]
Amgen completes $1.9B acquisition of Five Prime Therapeutics
Amgen (NSDQ:AMGN) announced today that it successfully completed its $1.9 billion acquisition of Five Prime Therapeutics (NSDQ:FPRX). Thousand Oaks, Calif.-based Amgen has officially acquired South San Francisco-based Five Prime for $38 per share in cash, reaching an equity value of approximately $1.9 billion. The acquisition was initially announced on March 4, 2021. As of the […]
Oncopeptides seeks EU marketing authorization for multiple myeloma treatment
Oncopeptides announced today that it submitted an application for European marketing authorization of its melflufen therapeutic. Conditional marketing authorization from the European Medicines Agency (EMA) is the aim for the company after its pivotal phase 2 Horizon study provided positive outcomes with melflufen (melphalan flufenamide) in treating relapsed refractory multiple myeloma, according to a news […]
Horizon touts data from trials for thyroid eye disease infusion treatment
Horizon Therapeutics announced today that study results highlight the success of its Tepezza infusion for treating thyroid eye disease. Dublin, Ireland-based Horizon’s Tepezza proved in pooled Phase 2 and Phase 3 clinical trial data that it significantly improves proptosis (eye bulging) and diplopia (double vision) for TED patients in different subgroups, with most maintaining a […]
Genentech touts study results for spinal muscular atrophy drug in babies
Genentech today touted two-year data evaluating the use of its Evrysdi therapeutic in infants with symptomatic Type 1 spinal muscular atrophy (SMA). South San Francisco, Calif.-based Genentech’s Firefish Phase 2/3 global study for Evrysdi (risdiplam) in infants between 1-7 months old showed that the orally administered (liquid or feeding tube) therapeutic continued to improve motor […]
Innocoll Biotherapeutics initiates Phase 3 trials for collagen drug-device
Innocoll Biotherapeutics announced today that it initiated two Phase 3 trials to support a label expansion for its collagen drug-device implant. Athlone, Ireland-based Innocoll’s trials are seeking label expansion for the FDA-approved Xaracoll (bupivacaine hydrochloride) implant, according to a news release. INN-CB-024, a Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety […]
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 […]
OncoSec wins CE mark for electroporation device to treat solid tumors
OncoSec Medical (NSDQ:ONCS) announced today that it received CE mark approval for its next-generation device to enable better uptake of anti-cancer therapies. GenPulse, part of OncoSec’s electroporation device platform for treating solid tumors, is designed to apply short electric impulses to a tumor, according to a news release. Get the full story at our sister site, […]
