FDAnews Drug Daily Bulletin
April 15, 2005
| Vol.
2 No.
75
Medicare should quickly adopt a comprehensive electronic prescribing system based on a technologically advanced uniform national standard to realize the full benefits of eprescribing under the new Medicare prescription drug benefit, the Pharmaceutical Care Management Association (PCMA) recently told the Centers for Medicare & Medicaid Services (CMS). Momentum is building on Capitol Hill for legalizing the importation of pharmaceuticals into the U.S., says the head of the Senate health panel that would shepherd through any authorizing legislation. Israel's new data exclusivity provision for pharmaceutical products, which provides market protection for novel drugs, has drawn the ire of U.S. brand trade group PhRMA, which contends the measure has a loophole that could cut exclusivity periods even shorter than proposed. Echoing recent criticism of the FDA's oversight of drug products, a new British parliamentary report cites "significant failings" in the ability of UK health officials to regulate the domestic pharmaceutical industry. Spectrum Pharmaceuticals announced that it has entered into an exclusive agreement with Cura Pharmaceuticals Co., Inc. for the marketing and distribution of carboplatin injection. Connetics, a specialty pharmaceutical company focused on dermatology, announced it has signed an agreement with Ventiv Commercial Services Group (VCS), a division of Ventiv Health, whereby VCS will provide sales support for certain Connetics products to primary care physicians (PCP) and pediatricians. Sawai Pharmaceutical, a Japanese pharmaceutical specialized in manufacturing generic products, announced on April 13 that it has basically agreed with Nihon Schering on an upcoming business transfer. Curis extended its agreement with Genentech to fund Curis's ongoing research to treat solid tumor cancers. Dutch biotechnology company Crucell N.V. announced that it has signed a manufacturing contract with the Vaccine Research Center (VRC), part of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH), for the manufacture of vaccines against Ebola infections. Cystic Fibrosis Foundation Therapeutics, the drug discovery and development affiliate of the Cystic Fibrosis Foundation, and Galapagos, a genomics-based drug discovery company, have initiated a two-year target discovery alliance. Xsira Pharmaceuticals announced that it has in-licensed worldwide rights to develop adenosine as an analgesic for the reduction of postoperative pain following surgery. Pfizer Japan announced April 12 that it has received approval to manufacture VFEND, its proprietary antifungul agent, from the Ministry of Health, Labor and Welfare.VFEND, which has a broad antifungul spectrum, is proven effective against Aspergillus, a type of fungus. |
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