WILMINGTON, Del. – Incyte Corporation (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding its Biologics License Application (BLA) for retifanlimab, an intravenous PD-1 inhibitor, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the...
treatment News
HOUSTON, TX & SEATTLE, WA — Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma....
HOUSTON, TX & SEATTLE, WA — Indapta Therapeutics, Inc., a privately held biotechnology company developing next-generation differentiated cell therapies for the treatment of cancer and other immune-mediated diseases, today announced that the U.S. FDA has granted Fast Track designation for its lead clinical program, IDP-023, for the treatment of patients...
InDex Pharmaceuticals Holding AB (publ) announced that the U.S. Food and Drug Administration (FDA) has given clearance to start the phase III clinical study CONCLUDE in the United States. The study will evaluate the efficacy and safety of the first-in-class TLR9 agonist cobitolimod for the treatment of moderate to severe...
Solna, Sweden – InDex Pharmaceuticals on Tuesday announced that it is discontinuing the Phase III CONCLUDE program, which was evaluating its investigational immunomodulatory therapeutic cobitolimod in ulcerative colitis. The decision to terminate the late-stage study is in line with the recommendations of an Independent Data Monitoring Committee, which found during...
Bengaluru — The Indian government said on Thursday it was providing a full exemption from basic customs duty for rare disease therapies and Merck & Co Inc’s (MRK.N) cancer therapy Keytruda when such medicines were imported for personal use. The government said in a statement that while some drugs such...
NEWTON, Mass. — Inflammasome Therapeutics, a clinical-stage, private company developing a new class of inflammasome inhibitor drugs, Kamuvudines, as therapies for prevalent, degenerative diseases, announced the first patient has been dosed in a Phase 1 study of one of the company’s novel compounds in the treatment of diabetic macular edema...
Jena, Germany – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announces positive data from the third cohort of patients in the Phase IIa open-label study with vilobelimab in Pyoderma Gangrenosum (PG). “We are happy to see more patients responding with the...
Jena, Germany – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, announced today the achievement of target enrollment of the Phase IIa open label study of vilobelimab in patients with Pyoderma Gangrenosum (PG). Dr. Korinna Pilz, Global Head of Clinical Research and...
Jena, Germany – InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced the initiation of the Phase III program with vilobelimab in hidradenitis suppurativa (HS) patients with active draining tunnels. The new primary endpoint, called modified HiSCR (Hidradenitis Suppurativa Clinical Response),...