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, […]
Medtronic launches 7-day infusion set for diabetes in Europe
Medtronic (NYSE:MDT) announced today that it launched the Medtronic Extended infusion set for diabetes in select European countries. Fridley, Minn.–based Medtronic touts the Extended infusion set as the first and only infusion set that a diabetes patient can wear for up to seven days, as most typically infusion pumps that deliver insulin to the body […]
SciNeuro inks licenscing deal with Eli Lilly for targeted antibody therapies
SciNeuro Pharmaceuticals announced today that it entered into an exclusive licensing agreement with Eli Lilly for antibody therapies. Under the agreement, Shanghai-based SciNeuro obtained an exclusive license to develop and commercialize alpha-synuclein targeted antibodies developed by Lilly within Greater China, which includes mainland China, Hong Kong, Macau and Taiwan, according to a news release. The […]
CeQur raises $115M for wearable insulin delivery device
CeQur announced today that it closed an oversubscribed equity financing round with proceeds of $115 million. Lucerne, Switzerland/Marlborough, Mass.–based CeQur said in a news release that it plans to use the funds to advance the commercial plans for the CeQur Simplicity wearable insulin delivery device. The company’s plans include market development, a phased commercial launch […]
Terumo launches therapeutic interventional oncology team
Terumo (TSE: 4543) announced that it has launched a global therapeutic interventional oncology team, effective April 1, 2021. Leuven, Belgium-based Terumo said in a news release that team’s introduction reflects its aspiration to be a global leader in the interventional oncology space by focusing on improving quality of life and survival. Team members work in […]
GH Research closes $125M oversubscribed Series B
GH Research Ireland announced that it closed an oversubscribed Series B financing round with proceeds of $125 million. Dublin, Ireland-based GH develops the GH001 therapeutic, a drug product for 5-MeO-DMT administration through a proprietary inhalation approach. A Phase 1 healthy volunteer trial showed GH001 to be well-tolerated while defining a dose range and individualized dosing […]
BioCorp, Roche launch Mallya smart insulin pen in France
BioCorp and Roche Diabetes Care France announced the launch of the Mallya smart insulin pen device in France. Developed by BioCorp, Mallya is an intelligent sensor for insulin injection pens that has CE mark approval in Europe. The platform is compatible with any disposable insulin pen. It enables reliable monitoring for doses selected for injection and it offers […]
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, […]