Navidea to seek approval for Lymphoseek in Europe

Navidea Biopharmaceuticals (AMEX:NAVB) intends to file a Marketing Authorization Application (MAA) in the EU for Lymphoseek, its radioactive diagnostic tracing agent, based on clinical data accumulated from completed pivotal studies and supporting clinical literature. Navidea also has been advised by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use that it has [...]

Neoprobe gets positive scientific advice from EMA for RIGScan CR

Neoprobe (AMEX:NEOP) received positive scientific advice late last week from the European Medicines Agency (EMA) on the development of RIGScan CR, its proprietary radiopharmaceutical for the detection of colorectal cancer. Among other things, the European regulatory body confirmed the opportunity for Neoprobe to consider evaluating a humanized RIGScan antibody for clinical development and commercialization. The [...]

Talon to seek accelerated approval of Marqibo

Talon Therapeutics (OTCBB:TLON) plans to submit a new drug application with the FDA for priority review of its Marqibo oncology drug in the second quarter this year and is hoping for accelerated approval in the final quarter of the year. “We are seeking accelerated approval based on data from our Phase 2 RALLY study where [...]

Bellus and Celtic start Phase 3 study of Kiacta

Bellus Health (TSX:BLU) and Celtic Therapeutics have initiated a confirmatory Phase 3 clinical study of Kiacta as a treatment for AA amyloidosis, a life-threatening orphan disease that occurs in patients with long-lasting inflammatory conditions, most commonly due to rheumatoid arthritis. The 230-patient study at 90 sites in 30 countries is designed to confirm the safety [...]