Immune System Archives - Page 12 of 13

FDA approves Roche’s small cell lung cancer treatment

Approvals, Blockbusters, Extensive-Stage Small Cell Lung Cancer, FDA, FDA/Regulatory, Immune System, Immunotherapies, New Indications, Priority Review, Small cell lung cancer, Triple Negative Breast Cancer (TNBC)

Swiss drugmaker Roche Holding AG’s U.S. unit Genentech Inc. won approval for the immunotherapy Tecentriq for a tough-to-treat type of lung cancer.

March 18, 2019/by Reuters Health

Top 10 Pipelines To Watch: 2019 Annual Report

Analysts, Ankylosing Spondylitis (AS), Annual Reports, Antiretroviral Drugs, Atopic Dermatitis (Eczema), Autoimmune Diseases, B Cells, Big Pharma, Biologics, Biopharma, Biotechnology, Blockbusters, BRCA Gene, BRCA mutation, Breakthrough Therapy Designation, Business, Cancer, CAR-T Therapy, Cells, Chemotherapy, Clinical Data, Clinical Trials, Collaborations, Crohn's Disease, Cystic Fibrosis, Drug Discovery, EU, European Medicines Agency (EMA), Fast Track Designation, FDA, FDA/Regulatory, February 2019, Future Blockbusters, Gene Editing, Generalized Myasthenia Gravis (gMG), Genomics, HIV, Human Genome, Immune Cells, Immune System, Immune-Mediated Diseases, Immunotherapy, Inflammatory Diseases, Injectables, Innovation, Integrase strand transfer inhibitors, Issue Archives, Japan, M&A, Med Ad News, Monoclonal Antibodies, Multiple myeloma, Neoantigens, Neurology, Neuromyelitis Optica Spectrum Disorder (NMOSD), New Drug Applications, Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), Non-Small Cell Lung Cancer (NSCLC), Nonalcoholic Steatohepatitis (NASH), Nuclear Medicine, Oncology, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Precision Medicine, Prescription Drug User Fee Act (PDUFA), Priority Medicines (PRIME) Designation, Priority Review Voucher, Product Pipelines, Proteins, Psoriatic Arthritis, R&D, Radioligands, Rare Disorders, Research, Rheumatoid Arthritis, RNA Interference (RNAi), Sickle Cell Disease, Small Molecules, Special Reports, T-Cells, Top 10 Pipelines, Top 10 Pipelines To Watch, Tumors, Ulcerative Colitis, Ultra Rare Diseases

The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.

February 13, 2019/by Andrew Humphreys

Adaptive Biotechnologies and Genentech to Develop Personalized Cellular Therapies for Cancer

Autoimmune Conditions, Business, Cancer, Cell Therapy, Collaborations, Immune System, Infectious Diseases, Licensing, Neoantigens, Partnerships, Personalized Medicine, T-Cells

Adaptive Biotechnologies announced a worldwide collaboration and license agreement with Genentech – a member of the Roche Group – to develop, manufacture and commercialize novel neoantigen directed T-cell therapies for the treatment of a broad range of cancers.

January 4, 2019/by Business Wire

FDA Accepts Priority Review Of ALXN1210 As Treatment For Patients With Paroxysmal Nocturnal Hemoglobinuria

Blood Disorders, C5 Complement Inhibitors, Clinical Data, Clinical Trials, FDA/Regulatory, Immune System, Orphan Drug Designation, Paroxysmal Nocturnal Hemoglobinuria (PNH), Paroxysmal Nocturnal Hemoglobinuria (PNH), PDUFA, Priority Review

Alexion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration accepted for review the company’s Biologics License Application for approval of ALXN1210, an investigational long-acting C5 complement inhibitor, for the treatment of patients with paroxysmal nocturnal hemoglobinuria.

August 20, 2018/by Business Wire

European Commission Approves Bristol-Myers Squibb’s Opdivo For Adjuvant Therapy Melanoma Indication

Approvals, Blockbusters, European Commission, FDA/Regulatory, Immune System, Lymph Nodes, Melanoma, PD-1/PD-L1 inhibitors, Tumor Cells

The European Commission approved Bristol-Myers Squibb’s Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

July 31, 2018/by Business Wire

Biomarker Development: Unlocking the Promise of Cancer Immune Therapy

Biomarkers, Cancer, Checkpoint Inhibitors, Immune Cells, Immune System, Immune Therapies, Immuno-oncology, Immunotherapies, Issue Archives, June 2018, Microbiome, PD-1/PD-L1 inhibitors, Ras Mutations, Tumors

Emboldened by 2017’s back-to-back FDA approvals of the first drugs that use genetically engineered patient immune cells – Kymriah (tisagenlecleucel) to treat leukemia and Yescarta (axicabtagene ciloleucel) to combat large-B-cell lymphomas – immunotherapy researchers are continuing to revolutionizing cancer treatment. But uneven patient response rates and the side effects often associated with immunotherapies are putting high priority on accurately identifying which patients would benefit most from particular treatment options.

June 6, 2018/by Administrator

Vilcek Prizes Recognize Groundbreaking Accomplishments by Immigrant Scientists

Biomedical, Business, Immigrants, Immune System, Science, Technology, Vilcek Foundation

The Vilcek Foundation announced the winners of the 2018 Vilcek Prizes in Biomedical Science. Awarded annually, the prizes call attention to the breadth of immigrant contributions to science in the United States. In parallel, the Vilcek Foundation also awards prizes for immigrant accomplishments in the arts.

February 1, 2018/by Administrator

FDA Removes Clinical Hold on CEL-SCI Study

Clinical Hold, FDA, FDA/Regulatory, Head & Neck Cancer, Immune System, Immunotherapies, Oncology

CEL-SCI received a letter from the U.S. FDA stating that the clinical hold that had been imposed on the company’s Phase 3 cancer study with Multikine was removed.

August 14, 2017/by Business Wire

The outlook remains bright due to a favorable regulatory arena, support for biopharma-friendly legislation and development incentives, expanding scientific opportunities in key therapeutic areas such as immuno-oncology, and big pharma’s continued push to obtain innovation.

June 8, 2016/by Andrew Humphreys

Bio company stocks to watch

Biopharma, Biotech, Biotech/Biopharma, Biotechnology, Cholesterol, Clinical Trials, Gene Therapy, Glycobiology, Immune System, Immune Systems, Immuno-oncology, R&D, Stocks, Stocks

Here are five company stocks that some industry analysts say are under the radar and/or could be a great bargain in 2016 per BioSpace.com sources …

June 8, 2016/by Administrator