Eli Lilly (NYSE:LLY) today announced positive results from phase 3 clinical trials evaluating its once-weekly insulin efsitora alfa. The Indianapolis-based pharmaceutical giant evaluated its once-weekly insulin in insulin-naïve adults in the QWINT-1 study. These adults have type 2 diabetes and are using basal insulin for the first time. Additionally, Eli Lilly’s QWINT-3 trial looked at […]
Pharmaceuticals
Aptar Group’s Unidose system to deliver neffy nasal epinephrine
Aptar announced today that its Unidose liquid system received FDA approval to deliver ARS Pharmaceuticals’ neffy (epinephrine nasal spray). ARS won FDA approval last week for neffy as an emergency treatment for patients with Type I allergic reactions, including anaphylaxis. It marked a major innovation in epinephrine delivery as the first and only needle-free treatment […]
ARS Pharmaceuticals wins first FDA approval for needle-free, nasal epinephrine
ARS Pharmaceuticals (Nasdaq:SRPY) announced that it received FDA approval for its neffy (epinephrine nasal spray) 2 mg for treating of Type I allergic reactions. Approval includes the treatment of anaphylaxis, with the indication covering adults and children who weigh ≥30 kg (66 lbs.). It marks a major innovation in epinephrine delivery as the first and […]
FDA approves first opioid overdose reversal auto-injector from Purdue Pharma
Purdue Pharma announced that the FDA approved its new drug application (NDA) for the Zurnai (nalmefene injection) auto-injector. The single-dose auto-injector delivers 1.5 mg of nalmefene hydrochloride per actuation. It marks the approved first nalmefene hydrochloride auto-injector for the emergency treatment of known or suspected opioid overdose. The agency approved the first nasal spray formulation […]
This simple, needle-free COVID vaccination device might stop transmission
“Finally,” many of us thought when we received our first jabs to vaccinate us against COVID-19 back in 2020 and 2021. Nearly four years later, COVID is still surging, constantly mutating to create new variants that evade our immunity from prior infections and the latest vaccines. And if the immediate and long-term harm from SARS-CoV-2 […]
FDA says Alcyone Therapeutics can continue study of drug delivery implant
Alcyone Therapeutics announced today that the FDA approved continued enrollment in a study of its ThecaFlex DRx drug delivery system. The company can continue enrolling in the PIERRE FDA investigational device exemption study for the implantable medical device. It evaluates the system, comprised of a subcutaneous port and intrathecal catheter system. This system provides chronic […]
FDA concerns push Novo Nordisk once-weekly insulin timeline beyond 2024
Novo Nordisk announced that the FDA issued a Complete Response Letter (CRL) related to its once-weekly insulin submission. In the CRL, the FDA made requests for Novo Nordisk to complete before it can complete its review of a Biologics License Application (BLA). As a result, the insulin maker said it does not expect to fulfill […]
Roche, Genentech to reintroduce drug-eluting eye implant in U.S. following 2022 recall
Roche subsidiary Genentech today reintroduced its Susvimo therapy for delivery via ocular implant in the U.S. following a recall. The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. […]
Biora Therapeutics has positive oral drug delivery device data for treating ulcerative colitis
Biora Therapeutics shared positive topline results from a trial of its orally administered drug-device combination for treating ulcerative colitis (UC). BT-600, a proprietary liquid formulation of tofacitinib, is delivered directly to the colon using Biora’s ingestible NaviCap device. Biora designed NaviCap to improve patient outcomes by enabling therapeutic delivery directly to the site of the […]
Koru Medical gets regulatory nod in Japan for FreedomEdge drug delivery system
Koru Medical Systems (Nasdaq:KRMD) announced today that it received regulatory clearance in Japan for its FreedomEdge infusion system. Clearance covers the delivery of multiple drugs, including CSL Behring’s Hizentra subcutaneous immunoglobulin (SCIg), Takeda Pharmaceutical’s Cuvitru SCIg and Sobi’s Aspaveli paroxysmal nocturnal hemoglobinuria (PNH). FreedomEdge offers the convenient and efficient administration of large-volume subcutaneous therapies at […]
