The U.S. Food and Drug Administration’s PDUFA dates for the last week of November 2020 include a review of Liquidia Technologies’ NDA for LIQ861 for the treatment of pulmonary arterial hypertension (PAH).
FDA Awards Fast Track Designation to Multiple Non-Covid-19 Candidates
Acid Disorders, Acute repetitive seizures, Coronavirus Disease (COVID-19) Pandemic, Fast Track Designation, FDA, Gene Therapy, Hypogammaglobulinemia, Imaging Agents, Infections and Myelokathexis) syndrome, Methylmalonic Acidemia (MMA), MPS Type VI, Non-Small Cell Lung Cancer (NSCLC), Phenylketonuria (PKU), Primary Mitochondrial Myopathy (PMM), Solid Tumors, WHIM (WartsWhile the world has largely been focused on the development of vaccines and therapeutics for Covid-19, the U.S. Food and Drug Administration has remained busy lining up potential approvals of medications for other diseases and illnesses.
ESMO News: AstraZeneca, Merck, Janssen, Amgen and More
Basal Cell Carcinoma, Blockbusters, Breast Cancer, Checkpoint Inhibitors, Clinical Data, Clinical Trial Endpoints, Clinical Trials, EGFR tyrosine kinase inhibitors (TKI), European Society for Medical Oncology (ESMO), Interim Data, MD Anderson Cancer Center, Melanoma, Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic non-small cell lung cancer, Non-Small Cell Lung Cancer (NSCLC), Overall Survival (OS), R&D, Renal Cell Carcinoma (RCC), Therapeutics, TumorsNumerous companies presented clinical trial data and updates at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.
A therapy jointly developed by Switzerland’s Roche Holding AG and Cambridge, Mass.-based Blueprint Medicines Corp. was approved by the U.S. health regulator for the treatment of patients with a type of non-small cell lung cancer (NSCLC).
FDA Approves Eli Lilly’s Precision Oncology Treatment for Certain Lung and Thyroid Cancers
Accelerated Approval, Approvals, FDA, FDA/Regulatory, Metastatic Rearranged During Transfection (RET) Fusion-Positive Non-Small Cell Lung Cancer (NSCLC), New Drug Approvals, Precision Oncology, Product Launches, RET Kinase Inhibitors, Safety Warnings, Specialty Pharmacies, TumorsEli Lilly is moving quickly to get the newly approved precision oncology treatment Retevmo for certain lung and thyroid cancers into the hands of patients.
FDA Action Alert: Blueprint, Bristol Myers Squibb, Clovis and Sunovion
Blockbusters, BRCA mutation, Clinical Trial Endpoints, FDA, FDA/Regulatory, Gastrointestinal Stromal Tumors, Metastatic Castration-Resistant Prostate Cancer (mCRPC), New Drug Applications, Non-Small Cell Lung Cancer (NSCLC), OFF Episodes, Parkinson's Disease, PDUFA, Sublingual film, Supplemental Biologics License Application, Supplemental New Drug Application (sNDA), TherapeuticsDespite the COVID-19 pandemic, the U.S. Food and Drug Administration has managed to stay fairly on track in terms of evaluating new drug and supplemental new drug applications. Here is a look at what is on the schedule for the next two weeks.
Thermo Fisher Scientific inked a deal with Janssen Biotech, part of Johnson & Johnson, to co-develop a companion diagnostic for cancer. The diagnostic test will support global clinical trial enrollment.
Indianapolis-based Eli Lilly announced the FDA’s Oncologic Drugs Advisory Committee voted 6-5 in favor of Cyramza (ramucirumab) plus erlotinib as a potential treatment for patients with untreated metastatic EGFR-positive non-small cell lung cancer (NSCLC).
Oncology Innovation
Annual Reports, Antibody-Drug Conjugates (ADCs), Biomarkers, Bladder Cancer, BRCA mutation, Breast Cancer, Clinical Trials, FDA/Regulatory, February 2020, Issue Archives, Non-Small Cell Lung Cancer (NSCLC), Oncology, Pancreatic Cancer, R&D, Targeted Therapies, Thyroid Cancer, Top 10 Pipelines To WatchOncology is one of the most exciting areas in healthcare, as novel therapies continue to emerge that move forward our molecular understanding of the disease and offer effective treatment advances. This Q&A explores oncology innovation with Kantar’s Stephanie Hawthorne, Vice President of Oncology and Specialty Therapeutics.
Researchers Develop New Class of Lung Cancer Drugs
Chemotherapy, Clinical Trials, Drug-resistant tumors, Francis Crick Institute, G12C KRAS inhibitors, IGF1R Pathway, KRAS gene, KRAS Mutations, Lung adenocarcinoma, Lung Cancer, mTOR Pathway, Mutations, R&D, Researchers, Science Translational Medicine, The Institute of Cancer Research (ICR)Working with a new class of drugs called G12C KRAS inhibitors, the Francis Crick Institute and Institute of Cancer Research developed product combos to stay ahead of drug-resistant tumors.