New Orleans – it is rare to see a doctor publicly hang another out to dry, let alone an investigator in a clinical trial, but that’s what appeared to happen earlier today in the CLL press briefing at the 2013 Annual Meeting of the American Society of Hematology.
New Orleans – Saturday at the annual meeting of the American Society of Hematology (ASH) is mainly focused on education and science, although there are also several hundred posters available for those in need of a data injection.
New Orleans – Novartis announced this morning that their novel pan-HDAC inhibitor, panobinostat (LBH589) in combination with bortezomib (Velcade) and dexamethasone significantly prolonged progression-free survival (PFS) of patients with Multiple Myeloma in the phase III PANORAMA-1 trial.
In the first part of his interview, Dr Jenkins shared with Biotech Strategy Blog the FDA perspective on what constitutes a breakthrough drug? Given he is one of the senior managers at the FDA and sits on the committee that decides whether to grant or deny a company’s breakthrough therapy request, his opinion counts.
The FDA approval earlier this week of ibrutinib (Imbruvica) for the treatment of mantle cell lymphoma (MCL), and the recent approval of GA101 / obinutuzumab (Gazyva), for previously untreated chronic lymphocytic leukemia (CLL) is good news for patients.
The Food and Drug Administration (FDA) today approved Roche/Genentech’s obinutuzumab (Gazyva), also known as GA101, for untreated Chronic Lymphocytic Leukemia (CLL) in combination with the chemotherapy chlorambucil. Updated CLL11 trial data will be presented at the 2013 annual meeting of the American Society of Hematology (twitter #ASH13) in New Orleans from December 7-10. Gazyva is the first drug with a Breakthrough Therapy Designation to be approved by the FDA.
Sydney – AstraZeneca AZD9291 is now ahead of Clovis Oncology CO-1686 in the race to bring a third-generation epidermal growth factor receptor (EGFR) inhibitor to market that targets the T790M resistance mutation.
Boston – at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference today, preclinical data was presented on a first-in-class antibody-drug conjugate (ADC) targeting guanylyl cyclase c (GCC) expression in pancreatic cancer.
Boston – at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference today we heard about CRLX101 (Cerulean Pharmaceuticals), a nanopharmaceutical in phase 2 development. The presentation highlighted the challenges and opportunities in cancer drug development.
Boston – At the AACR-EORTC-NCI Molecular Targets and Cancer Therapeutics conference, Susan Galbraith, M.D, Ph.D. Head of the Oncology Innovative Medicines Unit at AstraZeneca discussed the development of AZD9291, a potent and selective third-generation EGFR inhibitor of both activating and wild type T790M mutations in non-small cell lung cancer (NSCLC).