Committee for Medicinal Products for Human Use Jan. 30 adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ruxience , intended for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris.
FDA and the Federal Trade Commission signed a joint statement Feb. 3 on enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products.
Predictive Technology Group and Atrin Pharmaceuticals are collaborating to develop molecular diagnostic tools to improve selection of cancer patients who would most benefit from treatment with DNA Damage and Response inhibitors, including Atrin's and other small molecule ATR inhibitors.
FDA granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients ages 16 and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
FDA has granted priority review for GlaxoSmithKline's Biologics License Application seeking approval of belantamab mafodotin for patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
Myriad Genetics has submitted a supplementary premarket approval application to FDA for its BRACAnalysis CDx test as a companion diagnostic to AstraZeneca's and Merck's PARP inhibitor Lynparza for men with metastatic castration-resistant prostate cancer.
Evotec SE and Indivumed GmbH entered into a research collaboration to discover and develop first-in-class therapeutics for the treatment of non-small cell lung cancer. The goal of the precision medicine collaboration is to deliver highly effective treatments for NSCLC patients.
Health Canada has approved Keytruda in combination with Inlyta for first-line treatment of patients with advanced renal cell carcinoma.
Responders who worked at the World Trade Center site after the attacks on Sept.11, 2001, have an increased overall cancer incidence, compared to the general population, particularly in thyroid cancer, prostate cancer, and, for the first time ever reported, leukemia, according to a Mount Sinai study published in JNCI Cancer Spectrum Jan. 14.
FDA has accepted a supplemental New Drug Application for Rubraca (rucaparib) and granted priority review status to the application with a Prescription Drug User Fee Act date of May 15.
