Ophthalmalogical-focused developer EyeGate Pharma said this week that the Phase 3 study of its EGP-437 delivered through its EyeGate II drug delivery system did not show non-inferiority to the prednisolone acetate ophthalmic solution control group. The Phase 3 study was evaluating the safety and efficacy of the EGP-437 with the EyeGate II in patients with […]
Clinical Trials
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus […]
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 […]
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 […]
Kala Pharma wins FDA nod for twice-daily ocular corticosteroid
The FDA has approved Kala Pharmaceuticals’ (NASDAQ:KALA) Inveltys to treat post-operative inflammation and pain following ocular surgery. Inveltys is the first twice-daily (BID) ocular corticosteroid approved for this indication, according to the Waltham, Mass. company. While corticosteroids are used following ocular surgery to control inflammation and pain, physicians prescribe ocular steroids to achieve a rapid […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
Ichor touts use of electroporation drug-delivery system in cervical cancer trial
Ichor Medical Systems said today that its TriGrid electroporation drug-delivery system was tapped for a Phase Ib/II clinical trial to administer an investigational therapeutic HPV DNA vaccine, GX-188E, developed by Genexine Inc. The trial is designed to test the efficacy of a DNA vaccine combined with an anti-PD-1 therapy in patients with HPV-induced advanced non-resectable […]
Xeris Pharmaceuticals kicks off dual-hormone artificial pancreas trial
Xeris Pharmaceuticals (NSDQ:XERS) said last week that it launched a Phase I trial of its ready-to-use liquid glucagon in a closed-loop, dual-hormone artificial pancreas system. Automated insulin delivery systems represent the latest advancement in diabetes management. But these technologies fall short of performing the tasks of a human pancreas – they deliver insulin, but they […]
Novocure inks collaboration for pivotal pancreatic cancer trial
Novocure (NSDQ:NVCR) and US Oncology Research said today that the groups are collaborating on a phase III pivotal trial designed to test Novocure’s Tumor Treating Fields with nab-paclitaxel and gemcitabine in patients with unresectable locally advanced pancreatic cancer. Using a network of community-based oncology practices, US Oncology Research plans to open 10 clinical trial sites to […]
BioEclipse looks to synergistic therapies to topple stubborn cancers
For the last 20 years, Pamela Contag has studied cancer. And in that time, the world’s understanding of cancer has changed dramatically. “I remember when people were saying ‘One gene, one protein,” which we now know is wrong,” she told Drug Delivery Business News. “And then we thought cancer was a disruption in proliferation and really […]