FDA approved Epi proColon, a blood-based colorectal cancer screening test developed by Epigenomics AG. Epi proColon will be made available in the U.S. under a joint commercialization agreement with Epigenomics partner Polymedco. Epi proColon is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such... […]
The European Commission approved a two-dose schedule for Gardasil 9, for adolescent girls and boys aged 9 to 14, in the 31 countries regulated by the European Medicines Agency.
The University of Chicago and Evelo Biosciences entered into a license agreement to develop and commercialize a microbiome-based cancer immunotherapy. The cancer therapy, developed in the laboratories of UChicago researcher Thomas Gajewski, employs select gut microbes to boost the immune system’s attack on cancer cells and improve the efficacy of anti-cancer drugs. “This is the... […]
Sysmex Inostics, a subsidiary of Sysmex Corp., announced that its OncoBEAM RAS CRC test was granted CE mark approval. The CE mark is a mandatory conformity marking for certain products sold within the European Economic Area. The test, developed by Sysmex Inostics GmbH in collaboration with Merck, can now be accessed by patients with metastatic... […]
Halaven (eribulin) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, to extend Halaven’s license to include patients with unresectable liposarcomas who have received prior anthracycline containing therapy for advanced or metastatic disease. The opinion is based on phase III data demonstrating a median 7.2 month increase in... […]
FDA granted orphan drug designation for Iomab-B, a radioimmunotherapeutic that conditions relapsed and refractory acute myeloid leukemia patients for a hematopoietic stem cell transplant. Actinium Pharmaceuticals Inc., iomab-B’s sponsor, plans to begin a phase III trial in 150 relapsed and refractory AML patients over the age of 55. Iomab-B is a radioimmunoconjugate consisting of BC8,... […]
FDA approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease with additional kidney or lung abnormalities after hematopoietic stem cell transplantation. This is the first FDA-approved therapy for treatment of severe hepatic VOD. Hepatic VOD can occur in patients who receive chemotherapy and HSCT. The efficacy of Defitelio was investigated... […]
FDA published a draft guidance of recommendations for biosimilar product labeling.
FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia.
The University of Pennsylvania and Genisphere LLC formed a collaborative research agreement to study targeted nanotherapeutics. The collaboration between Genisphere, provider of the 3DNA drug delivery platform, and UPenn’s Theresa Busch, will utilize a breast cancer model to study photodynamic therapy. Photosensitizing drugs are administered to patients prior to surgery, and then activated by visible […]
