Beta Bionics has raised $57.5 million from 24 investors to help fund the development of its iLet bionic pancreas, according to a document filed with the SEC this week. The Mass.-based company is offering equity and securities as part of the indefinite round. Beta Bionics’ dual-chamber bionic pancreas is designed to use blood glucose data […]
Senseonics wins coverage from Aetna for Eversense glucose monitor
Senseonics (NYSE:SENS) said this week that won coverage from health plan provider Aetna for its Eversense continuous glucose monitoring system. Aetna provides coverage for roughly 22 million people in the U.S., according to Senseonics, making it the third largest commercial health plan provider in the country. “We are pleased that one of the largest national payers […]
Flexion reports data from Phase II bilateral osteoarthritis trial
Flexion Therapeutics (NSDQ:FLXN) touted data today from a Phase II trial assessing the bilateral dosing of its extended-release triamcinolone acetonide injection in people with bilateral osteoarthritis. The study found that bilateral injections of Flexion’s Zilretta therapy resulted in lower plasma concentrations of triamcinolone acetonide compared to immediate-release triamcinolone acetonide in crystalline suspension (TAcs). The company also […]
Takeda presents Phase III data for subcutaneous ulcerative colitis drug
Takeda Pharmaceutical (TYO:4502) touted results from a Phase III trial assessing the efficacy and safety of an investigational subcutaneous formulation of vedolizumab, a gut-selective biologic designed for adults with moderately to severely active ulcerative colitis. The 383-patient Visible 1 pivotal Phase III trial included an intravenous vedolizumab reference arm. Patients who achieved clinical response after six […]
Novocure touts Phase II pancreatic cancer pilot study
Novocure (NSDQ:NVCR) today touted the results of a Phase II pilot trial designed to test the feasibility, safety and efficacy of its Tumor Treating Fields therapy in patients with unresectable, advanced pancreatic cancer. The St. Helier, N.J.-based company’s Optune device uses electric fields, called Tumor Treating Fields, to disrupt cell division, inhibit tumor growth and trigger […]
AcelRx shares fall as Sen. Markey calls on FDA to reject opioid painkiller
Shares in AcelRx (NSDQ:ACRX) fell last week after U.S. Sen. Ed Markey (D-Mass) called on the FDA to reject the drugmaker’s opioid painkiller, Dsuvia. The senator noted that the product, which is designed for use in medically-supervised settings, consists of sufentanil – an opioid that is up to 10 times as powerful as fentanyl. “Even in […]
FDA proposes global harmonization of standards for generic drug developers
The FDA has proposed that the International Council on Harmonisation set global standards for generic drug developers, according to a report from FDA chief Dr. Scott Gottlieb. The U.S. regulatory agency argued that companies making generic drugs should be able to implement a single global drug development program and file for approval across multiple markets […]
Valeritas launches wearable insulin delivery device in Italy
Valeritas (NSDQ:VLRX) said today that its wearable insulin delivery device has launched in Italy. The Bridgewater, N.J.-based company inked an exclusive distribution deal with Movi SpA to bring its V-Go device to the more than 2 million people in Italy with Type 2 diabetes. “We are happy to announce the V-Go Wearable Insulin Delivery device is […]
FDA deals warning letter to Ocular over eye sealant
Ocular Therapeutix (NSDQ:OCUL) said today that it received a warning letter from the FDA over its ReSure hydrogel ocular wound sealant. The warning letter, dated Oct. 17, relates to Ocular’s compliance with data collection and reporting obligations in a post-approval device exposure registry study, according to the company. The registry study was a condition for approval […]
Novaliq touts topline data for dry eye disease drug
Novaliq today touted topline data from the first pivotal trial of its CyclASol 0.1% drug designed to treat dry eye disease. The company is hoping to position its 0.1% cyclosporine A product as advantageous compared to other ophthalmic treatments, noting that its EyeSol technology helps boost the drug’s efficacy and provide an earlier onset of […]
