Pharmaceutical industry
The US Food and Drug Administration (FDA) has approved a Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include Aranesp, EPOGEN, and PROCRIT. As part of the REMS, a Medication Guide explaining the risks and benefits of ESAs must be provided to all patients receiving ESAs. The
Pharmaceutical industry
Alkermes, Inc., a biotech company specializing in proprietary drug delivery technologies, continues to develop treatments for CNS disorders, alcoholism, and diabetes. The company has two approved products on the market: Risperdal Consta, a longer-lasting injectable version of Johnson & Johnson's schizophrenia drug Risperdal, and Vivitrol, for the treatment
Pharmaceutical industry
Zelos Therapeutics, Inc. has initiated a seven-day clinical study of a nasal spray formulation of ZT-034 (teriparatide), a non-injectable alternative to Eli Lilly and Company's Forteo (teriparatide [rDNA origin]). The study aims to evaluate the efficacy and safety of the nasal spray formulation in comparison to the marketed
Pharmaceutical industry
As the situation in Haiti continues to deteriorate following the devastating earthquake, American pharmaceutical research and biotechnology companies are stepping up to provide critical aid. Donations from companies like Abbott, Amgen, and GlaxoSmithKline have already reached $20 million, with the total amount still growing. PhRMA President and CEO Billy Tauzin
Pharmaceutical industry
The global small molecule kinase inhibitors market is projected to reach significant revenue, driven by the increasing demand for targeted cancer therapies and the approval of several new drugs in the pipeline. The market is diversified into various product segments, with Gleevec/Glivec, Tarceva, Sutent, Nexavar, Sprycel, Iressa, Tykerb/Tyverb,
Pharmaceutical industry
Spine Pain Management, Inc., a provider of medical spine injection procedures, has announced the opening of its second clinic in Dallas, Texas, in collaboration with Forest Park Medical Center. This strategic move is part of the company's nationwide "roll-out" strategy, aiming to establish a minimum of
Pharmaceutical industry
Generex Biotechnology Corporation, the leader in drug delivery for metabolic diseases through the inner lining of the mouth, has reached an agreement with a major nationwide pharmacy chain to market its proprietary Crave-NX(TM) 7-Day Diet Aid Spray throughout the pharmacy's network of over 7,000 stores. This
Pharmaceutical industry
The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) has voted 12 to 1 against recommending approval of Tarceva (erlotinib) for first-line maintenance use in advanced or metastatic non-small cell lung cancer (NSCLC) patients whose cancer has not progressed after platinum-based chemotherapy. This decision was based
Pharmaceutical industry
In a meeting held recently, the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one against recommending the approval of Tarceva for first-line maintenance use in patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer has not progressed following first-line
Pharmaceutical industry
In a phase II study, the investigational antibody-drug conjugate, T-DM1, demonstrated promising results in women with advanced HER2-positive breast cancer who had received multiple prior medications. The study, conducted by Genentech, showed that T-DM1 shrank tumors in 33% of the participants, who had an average of seven previous treatments, including
Pharmaceutical industry
Genentech, a wholly owned member of the Roche Group, and Biogen Idec recently announced that three-year follow-up data from the pivotal Phase III CLL8 trial showed that Rituxan, in combination with fludarabine and cyclophosphamide (FC) chemotherapy, significantly improved overall survival in patients with previously untreated chronic lymphocytic leukemia (CLL). The
Pharmaceutical industry
Champions Biotechnology, an oncology drug development company, has entered into an exclusive licensing agreement with Yale University and Southern Research Institute for the development of Bithionol, a compound that shows potential for treating various types of cancer. Researchers at Yale and Southern Research discovered that Bithionol, initially used to treat
