Shares of Aprea Therapeutics plunged after the Boston-based company announced a late-stage cancer combination treatment failed to meet the primary endpoint of complete remission rate.
The U.S. Food and Drug Administration approved MorphoSys and Incyte’s Monjuvi (tafasitamab-cxix) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
Just a day after Hanmi Pharmaceutical announced a deal with Genentech, Boehringer Ingelheim terminated a license deal because of patient deaths.
Tonix Pharmaceuticals Holding Corp. said it would stop developing its drug for fibromyalgia after the treatment failed in a late-stage trial.
Irish drugmaker Shire Plc said it would buy the rights to an experimental bowel drug from Pfizer Inc to bolster its pipeline of gastrointestinal treatments.
Novartis received breakthrough therapy designation from the U.S. Food and Drug Administration for an investigational treatment for newly-diagnosed FLT3-mutated acute myeloid leukemia, the Swiss drugmaker said on Friday. Patients who received PKC412, also called midostaurin, combined with standard induction and consolidation chemotherapy experienced what Novartis called “a significant improvement in overall survival”. With the announcement, […]
The U.S. Food and Drug Administration has granted breakthrough therapy designation to AstraZeneca’s biggest new drug hope durvalumab as a treatment in bladder cancer, the drugmaker said on Wednesday. The experimental medicine is a so-called PD-L1 therapy that fights cancer by boosting the immune system. Breakthrough therapy designation expedites the development and review of […]
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.
Celldex vaccine improves long-term brain cancer survival in study
Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Clinical Data, Clinical Trials, Data, FDA/Regulatory, Genetics, glioblastoma Multiforme (GBM) Brain Cancer, Health, Immune System, Immune Systems, Mutations, Mutations, R&D, Shares, Shares, TumorsNew data from a midstage trial show that Celldex Therapeutics Inc’s experimental brain cancer vaccine, combined with standard therapy, continues to improve chances of survival for patients with recurrent cancer. The updated results sent shares of Celldex up $1.74, or 12 percent, to $16.23 on the Nasdaq. The therapy, designed to enlist the body’s immune […]
DARZALEX (daratumumab) Approved by U.S. FDA: First Human Anti-CD38 Monoclonal Antibody Available for the Treatment of Multiple Myeloma
Accelerated Drug Approvals, Approvals, Biotech, Biotechnology, Blood Cancers, Breakthrough Designation, Breakthrough Therapy, Breakthrough Therapy Designation, Breakthrough Therapy Designation, Clinical Trials, FDA/Regulatory, First-In-Class, Health, Human Anti-CD38 Monoclonal Antibody, Immunomodulatory Agents, Immunotherapy, Launches, Monoclonal Antibodies, Monoclonal Antibodies, Multiple Myeloma, Multiple Myeloma, Multiple Myeloma, New Drug Approvals, Priority Review, Priority Review, Product Launches, Proteasome Inhibitors, R&DFirst-in-class immunotherapy approved for multiple myeloma patients who have received three or more prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double refractory to a PI and an immunomodulatory agent PR Newswire, HORSHAM, PA, November 16, 2015 Janssen Biotech, Inc., a Janssen Pharmaceutical Company of […]