The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending a change to the terms of the marketing authorization for Imbruvica (ibrutinib) in the European Union to indicate the treatment of adult patients with Waldenström's macroglobulinemia who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.
FDA granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia who harbor an isocitrate dehydrogenase-1 (IDH1) mutation.
Baylor Research Institute and the Translational Genomics Research Institute extended a collaboration focused on accelerating early detection and treatments for patients with a broad range of cancers.
Palmetto GBA issued a draft local coverage determination for the Oncotype DX prostate cancer test developed by Genomic Health Inc. Palmetto is a Medicare Administrative Contractor that assesses molecular diagnostic technologies.
FDA granted a Fast Track Designation for evofosfamide (previously known as TH-302), administered in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. \
Eli Lilly and Company and BioNTech AG entered into a research collaboration to discover novel cancer immunotherapies.
FDA approved the cobas KRAS Mutation Test for diagnostic use.
Venetoclax was granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia in previously treated patients with the 17p deletion genetic mutation.
Member companies of the Pharmaceutical Research and Manufacturers of America invested an estimated $51.2 billion last year in the research and development of new innovative treatments and cures. The figure represents the majority of all biopharmaceutical R&D spending, both public and private, in the U.S.
DanDrit Biotech USA Inc. signed a collaboration agreement with GISCAD Foundation, an Italian group focused on cancers of the digestive tract.
