Telithromycin is the first ketolide antibiotic to enter clinical use and is sold under the brand name of Ketek. It is used to treat community acquired pneumonia of mild to moderate severity. After significant safety concerns, the US Food and Drug Administration sharply curtailed the approved uses of the drug in early 2007.
A new chemical entity (NCE) is, according to the U.S. Food and Drug Administration, a drug that contains no active moiety that has been approved by the FDA in any other application submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act.
The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Peter Marks, M.D., PhD. CBER is responsible for assuring the safety, purity, potency, and effectiveness of biologics and related products. Not all biologics are regulated by CBER. Monoclonal antibodies and other therapeutic proteins are regulated by the FDA Center for Drug Evaluation and Research (CDER).
Esperanza Alcantara Icasas-Cabral is a Filipino cardiologist and clinical pharmacologist. She served as Secretary of the Department of Health in the Philippines, taking office in January 2010 to replace Francisco Duque after his appointment as head of the Civil Service Commission. Before her appointment as Secretary of Health she was previously the Secretary of the Department of Social Welfare and Development, replacing Corazon Soliman. Cabral is married to Bienvenido Villegas Cabral, an ophthalmologist.
Cold Capsule IV and Cold Capsule V were extended release oral capsules (pill) used to control cold symptoms.
Pixantrone is an experimental antineoplastic (anti-cancer) drug, an analogue of mitoxantrone with fewer toxic effects on cardiac tissue. It acts as a topoisomerase II poison and intercalating agent. The code name BBR 2778 refers to pixantrone dimaleate, the actual substance commonly used in clinical trials.
Axitinib, sold under the brand name Inlyta, is a small molecule tyrosine kinase inhibitor developed by Pfizer. It has been shown to significantly inhibit growth of breast cancer in animal (xenograft) models and has shown partial responses in clinical trials with renal cell carcinoma (RCC) and several other tumour types.
President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA) on September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices. It was sponsored by Reps. Joe Barton and Frank Pallone and passed unanimously by the Senate.
Vernakalant is a pharmaceutical drug for the acute conversion of atrial fibrillation, a kind of irregular heartbeat, in form of an intravenous infusion. It has been approved for use in the European Union and the UK since 2010. The US Food and Drug Administration denied approval in 2008 and 2019.
Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used as a second-line treatment for Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab specifically targets the CD19 antigen present on B cells. In December 2014, it was approved by the US Food and Drug Administration under the accelerated approval program; marketing authorization depended on the outcome of clinical trials that were ongoing at the time of approval.
Tanezumab is a monoclonal antibody against nerve growth factor as a treatment for pain via a novel mechanisms different from conventional pain-killer drugs. Tanezumab was discovered and developed by Rinat Neuroscience and was acquired by Pfizer in 2006.
Genta Incorporated was a biopharmaceutical company started in La Jolla, California, which discovered and developed innovative drugs for the treatment of patients with cancer. Founded in 1989 by a highly skilled entrepreneur, the company focused on a novel technology known as antisense, which targets gene products that are associated with the onset and progression of serious diseases. At that time, only Ionis Pharmaceuticals, Inc. was conducting significant research with this technology. Antisense is a short span of oligonucleotides – modified DNA structures ranging from about 12-24 bases that selectively bind to specific RNA. The intent is to block expression of an aberrant protein that contributes to the disease of interest. Genta in-licensed three different antisense molecules that blocked Bcl-2, a fibroblast growth factor (FGF), and the gene c-myb, respectively.
The Instituto Bioclon S.A. de C.V. was formed in 1990 to research and develop F(ab’)2 antivenoms. On May 6, 2015 they received approval from the FDA to commercialize ANAVIP becoming their second drug approved by the FDA after ANASCORP. Both are commercialized in the US by Rare Disease Therapeutics, Inc. The company is performing clinical trials to get approval for a third drug, ANALATRO, designed to treat black widow spider envenomation.
Barcode technology in healthcare is the use of optical machine-readable representation of data in a hospital or healthcare setting.
The Dermatologic And Ophthalmic Drugs Advisory Committee (DODAC) receives requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration (FDA). The committee, consisting of members from academic and clinical dermatology, ophthalmology, biostatistics, the general public, and the pharmaceutical industry, makes non-binding recommendations to both the CDER and CBER divisions of the FDA about the advisability of approving new medications to treat dermatologic and ophthalmic conditions.
Plazomicin, sold under the brand name Zemdri, is an aminoglycoside antibiotic used to treat complicated urinary tract infections. As of 2019 it is recommended only for those in whom alternatives are not an option. It is given by injection into a vein.
Waun Ki Hong was Professor of Medicine at The University of Texas MD Anderson Cancer Center, where he served as chairman of the Department of Thoracic/Head & Neck Medical Oncology from 1993 to 2005 and as head of the Division of Cancer Medicine from 2001 to 2014. He was also an American Cancer Society Professor and the Samsung Distinguished University Chair in Cancer Medicine emeritus.
Umbralisib, sold under the brand name Ukoniq, is a medication for the treatment of marginal zone lymphoma (MZL) and follicular lymphoma (FL). It is taken by mouth.
Padeliporfin, sold under the brand name Tookad, is a medication use to treat men with prostate cancer.
