Numerous companies presented clinical trial data and updates at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
Researchers are having a hard time getting their hands on specimens for their work on new treatments, diagnostics, and cures.
US FDA Accepts Regulatory Submission for Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer
Breakthrough Therapy Status, Clinical Trials, CNS, EGFR tyrosine kinase inhibitors (TKI), FDA, Metastases, Mutations, New England Journal of Medicine, Non-Small Cell Lung Cancer (NSCLC), Priority Review Status, Supplemental New Drug Application (sNDA)AstraZeneca announced that the U.S. Food and Drug Administration accepted a supplemental New Drug Application for the use of Tagrisso (osimertinib) – a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central nervous system metastases – in the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR mutations.
Amgen announced that the U.S. FDA approved the supplemental Biologics License Application for Vectibix (panitumumab) for patients with wild-type RAS metastatic colorectal cancer.
A targeted drug being developed by Pfizer Inc. held advanced lung cancer in check longer than AstraZeneca’s Iressa in newly diagnosed patients, but with a higher rate of side effects, according to data.
The U.S. FDA granted full approval for Tagrisso (osimertinib) 80-mg once-daily tablets for treating metastatic EGFR T790M mutation-positive NSCLC.
Nearly two decades ago, the promise of precision medicine began making its mark on the pages of medical journals – along with speculation that “therapy with the right drug at the right dose in the right patient” – would define the future of medical treatment.
Just a day after Hanmi Pharmaceutical announced a deal with Genentech, Boehringer Ingelheim terminated a license deal because of patient deaths.
2016 Annual Report: Top 10 Pipelines
"Bad" LDL Cholesterol, Alzheimer's Diseases, Approvals, Big Pharma, Biologics License Application (BLA), Biosimilars, Biotech, Biotech/Biopharma, Biotechnology, Bispecific CD19-directed CD3 T cell engager (BiTE) antibodies, Blockbusters, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Cells, Chimeric Antigen Receptor T Cell Therapy (CART), Cholesterol, Chronic Lymphocytic Leukemia, Clinical Trials, Collaboration, Collaborations, Collaborations, Cystic Fibrosis, Deals, Diabetes, DNA, EGFR Inhibitors, Europe, European Commission, FDA, FDA/Regulatory, February 2016, Glucagon-Like Peptide-1 (GLP-1) Analogs, Immune Response, Immune System, Immune Systems, Immunotherapies, Influenza, Inhalers, Issue Archives, Mantle Cell Lymphoma (MCL), Monoclonal Antibodies, Multiple Myeloma, NDA, Neuroscience, New Drug Application (NDA), New Molecular Entities, Non-Small Cell Lung Cancer, Oncology, Pain, Parkinson's, Parkinson's Disease, Plaque Psoriasis, Potential Blockbusters, Psoriasis, R&D, Sales, SGLT2 Inhibitors, Special Reports, Specialty Therapy, Technology, TGF-Beta Inhibitors, The New England Journal of Medicine (NEJM), Therapeutics, Top 10 Pipelines, Transforming Growth Factor-beta (TGFb), Type 1 Diabetes, Type 2 Diabetes, Vaccines, Waldenstrom’s macroglobulinemiaThe pharma industry’s R&D concentration has been shifting towards specialty therapy areas as research and development returns decline for some leaders.
Genentech (RHHBY) has partnered with several pharmaceutical companies, including AbbVie (ABBV), Clovis Oncology (CLVS) and Immune Design Corp. (IMDZ), as it ramps up its oncology pipeline. On Wednesday, Genentech and its partner AbbVie announced its promising experimental leukemia drug Venetoclax yielded a positive result in reducing the number of cancer cells in patients with previously […]