The FDA this week published a finalized guidance document for companies developing new buprenorphine depot products for the treatment of opioid use disorder. The agency is hoping to boost the development of modified-release buprenorphine products, like drug-eluting implants. In the document, the FDA detailed the studies needed to support approval for these products through the 505(b)(2) […]
Flowonix wins FDA nod for infusion pump software
Flowonix Medical said yesterday that it won FDA approval to market the updated software used to program the company’s Prometra infusion system. The clinician programmer software, which Flowonix plans to launch in February, includes automatic calculations and increased dosing flexibility during bridge bolusing, according to the company. Flowonix’s programmable Prometra pump is indicated for intrathecal […]
Study: Use of long-acting reversible contraception spiked after 2016 election
In a study published this week in JAMA Internal Medicine, researchers reported that use of long-acting reversible contraception increased in the month following the 2016 presidential election. Adjusting for seasonal trends and patient characteristics, the researchers from Brigham & Women’s Hospital found that insertion of contraceptives such as intrauterine devices increased by 21.6% after the […]
Audion touts Ph1 results for hearing loss drug
Audion Therapeutics touted positive results yesterday from a Phase I trial of the company’s hearing loss drug. In 15 people with mild to moderate sensorineural hearing loss, Audion tested the safety and tolerability of its LY3056480 mediated Notch inhibitor. The drug is designed to regenerate the inner ear sensory hair cells that are lost over […]
FDA doubles down on warfarin test strip recall
The FDA this week alerted patients and doctors about test strips used to monitor levels of the blood thinner warfarin, expanding and reiterating its warning that the products shouldn’t be used to adjust a person’s drug dosage. The agency’s latest notice is related to the Class I recall of Roche‘s CoaguChek meters and test strips, […]
Reva Medical cuts 44% of workforce
Reva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company. In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction. “While we continue to see strong interest in Fantom Encore and are excited about […]
Lyndra raises $55m for long-acting drug delivery capsule
Lyndra Therapeutics said today that it raised $55 million in a Series B round to support the development of its oral drug delivery system. All of the investors from the company’s $23 million Series A round resubscribed for the Series B round, Lyndra reported. New investors included the Bill & Melinda Gates Foundation. Lyndra’s oral […]
BioCorRx wins $5.6m grant for sustained release naltrexone implant
BioCorRx (OTC:BICX) announced this month that it won a two-year grant from the NIH’s National Institute on Drug Abuse to support the development of its sustained release naltrexone implant for the treatment of opioid use disorder. The grant includes $2.8 million for Feb. 1, 2019 to Jan. 31, 2020, followed by $2.8 million for the second […]
BTG touts use of radiopaque drug-eluting bead
BTG (LON:BTG) said this month that an Australian patient was treated with its radiopaque drug-eluting bead. The DC Bead Lumi product is the first commercial drug-eluting bead that can be loaded with doxorubicin or irinotecan to treat tumors in patients with hepatocellular carcinoma and liver metastases from colorectal cancer, according to BTG. The beads’ radiopacity enable […]
Circassia inks exclusive ventilator commercialization deal with AIT Therapeutics
Circassia Pharmaceuticals said last week that it inked a deal for the exclusive commercialization rights to AIT Therapeutics’ nitric oxide device, AirNOvent, in the U.S. and China. Using an electric voltage, the portable AirNOvent system produces nitric oxide from the nitrogen and oxygen in the air. According to the terms of the deal, Circassia is […]
