Check-Cap wins conditional IDE approval for C-Scan pilot study
Check-Cap (NSDQ:CHEK) said today it won conditional approval from the FDA for its investigational device exemption application to launch a pilot study of its C-Scan system. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods.
Orchard Expects to Hire 100, Expands Gene Therapy Manufacturing in Bay Area
Orchard Therapeutics is expanding its physical footprint in California. The U.K.-based company signed a long-term lease to build out a gene therapy manufacturing facility in Fremont, Calif. The 150,000-square-foot facility will add to the company’s presence in the Bay Area.
Robust Pipeline for Treatments for Diabetic Eye Disease with Dr. Patrik De Haes Oxurion
Dr. Patrik De Haes, CEO, Oxurion discusses the need for new treatments for diabetic eye disease, a leading cause of blindness in people of working age worldwide.
Transcranial Magnetic Brain Stimulation to Treat Depression and OCD: Interview with Stanford’s Dr. Nolan Williams
Orchard’s Gene Therapy for Rare Immune Disease Works for Over a Year
A single dose of a gene therapy developed by Orchard Therapeutics can restore immune function for at least a year in patients with X-linked chronic granulomatous disease (X-CGD).
Alkahest doses first patient in Phase II Parkinson’s drug trial
Alkahest has dosed the first subject in a Phase II clinical trial of GRF6021 to treat Parkinson’s disease associated with mild cognitive impairment or dementia.
Redhill Planning NDA For H. Pylori Antibiotic Following Second Phase III Readout
RedHill Biopharma Ltd. plans to submit an NDA to FDA next half for Talicia (RHB-105) as first-line treatment of Helicobacter pylori infection regardless of ulcer status after reporting that the antibiotic met the primary endpoint in the Phase III ERADICATE Hp2 trial in the indication.