Search

Purpose Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals. Summary Selected drug approvals anticipated in the 12-month period covering the third quarter of 2024 through the second quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics selected from 54 novel drugs awaiting US Food and Drug Administration approval. New cell therapies for treating cancers continue to enter the drug pipeline, while novel targeted therapies for biliary tract, gastric, pancreatic, and breast cancers, as well as 3 subcutaneous versions of already approved drugs given intravenously, are awaiting approval. Additionally, many novel drugs are being developed for treatment of rare and ultra-rare diseases such as hereditary angioedema, macular telangiectasia, congenital adrenal hyperplasia, and Barth syndrome. Two new subcutaneous drugs for hemophilia, a new oral medication for hereditary angioedema, a novel monoclonal antibody for atopic dermatitis, and the first oral penem antibiotic are also in the pipeline. Conclusion New drugs with various indications for cancers and rare diseases continue to strengthen the drug pipeline. [ABSTRACT FROM AUTHOR]

Purpose Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing periodic updates on new and anticipated novel drug approvals. Summary Selected drug approvals anticipated in the 12-month period covering the second quarter of 2024 through the first quarter of 2025 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 52 novel drugs awaiting US Food and Drug Administration approval. New cellular and gene therapies for cancers continued to strengthen the pipeline, in addition to new drugs targeting previously untreatable conditions. Several novel drugs are being developed for rare and ultra-rare diseases such as hemophilia, Niemann-Pick disease type C, hereditary angioedema, and aromatic l -amino acid decarboxylase deficiency. Conclusion The current drug pipeline includes new drugs with various indications for cancers and rare diseases as well as diabetes, acute coronary syndrome, chronic skin disorder, and chronic obstructive pulmonary disease. [ABSTRACT FROM AUTHOR]

Purpose Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing periodic updates on new and anticipated novel drug approvals. Summary Selected drug approvals anticipated in the 12-month period covering the first quarter of 2024 through the fourth quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 59 novel drugs awaiting US Food and Drug Administration approval. This year's pipeline includes recently added drugs with various indications including oncology, infectious diseases, genetic disorders, and rare diseases. New cellular and gene therapies are rapidly evolving and being studied for several rare diseases and cancers. Conclusion More oncology agents, including gene therapies, oral agents, and monoclonal antibodies, are in the pipeline this year. Additional diseases targeted by new novel drugs, including cellular and gene therapies, are hemophilia, nonalcoholic steatohepatitis, Alzheimer's disease, and rare diseases such as galactosemia and epidermolysis bullosa. [ABSTRACT FROM AUTHOR]

Purpose Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by providing updates on new and anticipated novel drug approvals. Summary Selected drug approvals anticipated in the 12-month period covering the fourth quarter of 2023 through the third quarter of 2024 are reviewed. The analysis emphasizes drugs selected from 58 novel drugs awaiting FDA approval that are expected to have significant clinical and financial impact in hospitals and clinics. The pipeline includes recently added drugs with various indications, including oncology, infectious diseases such as complicated urinary tract infection and pneumonia, and rare diseases. Conclusion Cellular and gene therapies continue to strengthen the pipeline as potential new treatment options for genetic disorders, rare diseases, and cancer. Additional diseases treated by new agents include pulmonary arterial hypertension, chronic obstructive pulmonary disease, diabetes, and obesity. [ABSTRACT FROM AUTHOR]

Purpose Health-system pharmacists play a crucial role in monitoring the pharmaceutical pipeline to manage formularies, allocate resources, and optimize clinical programs for new therapies. This article aims to support pharmacists by sharing new and anticipated novel drug approvals. Summary Selected drug approvals anticipated in the 12-month period covering the second quarter of 2023 through the first quarter of 2024 are reviewed. The analysis emphasizes drugs expected to have significant clinical and financial impact in hospitals and clinics, as selected from 58 novel drugs awaiting Food and Drug Administration (FDA) approval at the time of data extraction. The pipeline includes drugs with various indications, such as oncology, inflammatory conditions, and rare diseases. Key developments in oncology are highlighted along with notable advancements in treating myelofibrosis, metastatic colorectal cancer, and low-grade gliomas. Cellular and gene therapies are anticipated to emerge prominently as treatment options for severe hemophilia A and sickle cell disease. Several monoclonal antibodies targeting autoimmune diseases are awaiting FDA approval. Conclusion Several new novel drugs in the pipeline are intended for use in treating cancers, autoimmune conditions, and rare diseases such as sickle cell disease. [ABSTRACT FROM AUTHOR]

Rivaroxaban, a Xa inhibitor, was recently approved (March 2013) in the setting of post-acute coronary syndromes (ACS) by the European Medicine Agency. This is in contrast to not being approved by the Food and Drug Agency in the United States for the same indication in 2012 and 2013. The FDA's decision was based on a lack of follow-up data for the patients enrolled in the study based on the pivotal Anti-Xa Therapy to Lower Cardiovascular Events in Addition to Standard Therapy in Subjects with Acute Coronary Syndrome (ATLAS-ACS 2-TIMI 51) trial. While both agencies have similar roles when functioning as drug regulatory bodies and goal of granting approval of safe and efficacious drugs, the difference in approval outcome in the case of rivaroxaban highlights the differences in drug review process when both agencies are presented with the same Phase 3 data to review. [ABSTRACT FROM AUTHOR]

The article offers information on the changes expected in the norms of the U.S. Food and Drug Administration (FDA). It states that the changes are reportedly expected to affect the professional related to clinical trials and development of drugs and devices. It states that the FDA wants to understand not only where the drugs work, but where they are suboptimal, so that an optimal dose can be selected for patients.