EyePoint Pharmaceuticals (NSDQ:EYPT) said this week that the Centers for Medicare and Medicaid Services approved transitional pass-through status and reimbursement of its dexamethasone intraocular suspension, Dexycu. The FDA-approved product is designed to treat inflammation following cataract surgery using a single, intraocular dose of long-acting dexamethasone. “The receipt of pass-through status and the assignment of a […]
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Livongo adds compatibility with Abbott’s FreeStyle Libre Pro
Livongo Health said today it will integrate continuous glucose data from Abbott‘s (NYSE:ABT) FreeStyle Libre Pro system into its Livongo for Diabetes system, touting it as the first such system to integrate data from Abbott’s FreeStyle Libre Pro. With the integration, users of the FreeStyle Libre Pro will be able to see a visual snapshot of […]
Exosome therapeutics dev Evox raises $45m in Series B
Exosome therapeutics company Evox Therapeutics said today that it raised $45.4 million (GBP £35.5 million) in a Series B round of financing. The funding round was led by Redmile Group, new investments from GV, formerly known as Google Ventures, and Cowen Healthcare Investments, the Oxford, U.K.-based company said. The round was joined by Panacea Healthcare […]
Inovio launches Ph1 study of Hep C vaccine
Inovio Pharmaceuticals (NSDQ:INO) and its partner, GeneOne Life Science (KSE:011000), said today that the companies have dosed the first patient in a Phase I study designed to test a preventive vaccine against hepatitis C infection. The companies plan to recruit 24 study participants to evaluate Inovio’s GLS-6150 candidate. Participants will include people who have a sustained […]
FDA warns of flesh-eating genital infection linked to diabetes drug
The FDA this week warned of serious flesh-eating bacterial infections, or necrotizing fasciitis, reported by patients taking sodium-glucose cotransporter-2 (SGLT2) inhibitors intended for treating type 2 diabetes. The federal watchdog said that between March 2013 and May 2018, 12 cases of Fournier’s gangrene, a rare but life-threatening bacterial infection of the tissue under the skin […]
Otsuka inks collab deal to bring Abilify Mycite drug-device combo to US
Otsuka Pharmaceutical (TYO:4578) said today it inked a collaborative deal with health management group Magellan Health to distribute its drug-device combo Abilify Mycite in the US. The Tokyo-based pharmaceutical company touted the Abilify Mycite system as the first FDA-approved drug-device combo designed to track drug ingestion, and said that the tracking data will be integrated into […]
ivWatch wins CE Mark for continuous IV site monitor
ivWatch said today that it won CE Mark clearance for its intravenous infiltration/extravasation monitoring device. The company’s ivWatch Model 400, which has FDA clearance, is sold in the U.S. through group purchasing contracts with Premier and Vizient. ivWatch also touted that it obtained ISO 13485:2016 certification through the Medical Device Single Audit Program. “Peripheral IV […]
ALR Technologies inks Indian marketing deal for diabetes management device
ALR Technologies and Aspire Cerebro Advertising have inked a marketing deal in India for the ALRT diabetes management system. Aspira Cerebro Advertising plans to create a comprehensive marketing plan for the ALRT Diabetes Solution system, with the intent of bringing the technology to India’s estimated 100 million diabetes patients. “Our model enables pharmaceutical companies to […]
BD inks UAE insulin pen distro deal with Julphar
Pharmaceutical manufacturer Julphar said yesterday it inked a deal with BD (NYSE: BDX) to supply disposable insulin pens to the United Arab Emirates. Through the deal, individuals will be able to purchase BD’s Vystra disposable pens featuring Julphar’s human insulin formulations, including its Jusline R, Jusline N and Jusline 30/70. The same system is slated to be […]
GlucoMe, Merck ink Vietnamese diabetes study deal
GlucoMe said last week it inked a pilot collaboration deal with Merck (NYSE:MRK) looking to evaluate GlucoMe’s digital diabetes platform at several hospitals in Vietnam. Israel-based GlucoMe said that the project was scheduled to begin this month, and that it will compare GlucoMe’s digital diabetes care system against the current standard of care in the country. The […]