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Appeals Court Panel Says Pharmacists Must Distribute Emergency Contraception Under Washington State Regulation
A three-judge panel of the U.S. Circuit Court of Appeals for the 9th Circuit on Wednesday unanimously ruled to lift an injunction blocking Washington state officials from penalizing pharmacists who refused to dispense the emergency contraception pill Plan B, the Los Angeles Times reports (Williams, Los Angeles Times, 7/9). The panel said the district court judge who issued the injunction refused to consider women"s need for EC (Egelko, San Francisco Chronicle, 7/9). The panel"s ruling is part of a larger case before the district court involving the constitutionality of a 2007 state regulation requiring pharmacies to stock and dispense EC. Joyce Roper, an assistant attorney general for Washington state, said the appeals court ruling means that the 2007 regulation will take immediate effect.The plaintiffs in the case, Stromans -- a supermarket pharmacy owner -- and two pharmacists employed elsewhere, argued that the state regulation requiring pharmacists to stock and dispense EC violated their First Amendment right to freedom of religion (Los Angeles Times, 7/9). The regulation said that pharmacies must stock and fill legally prescribed prescriptions but allowed individual pharmacists to object on moral or religious grounds if another pharmacist was available, in person or by telephone, to fill the order (San Francisco Chronicle, 7/9). The plaintiffs argued that the regulation would force them to choose between following their religious beliefs and keeping their jobs. They contended that EC prevents implantation of a fertilized egg, which they equated with abortion. The U.S. District Court in Seattle awarded the plaintiffs the temporary injunction in November 2007, pending trial on the constitutionality of the regulation (Los Angeles Times, 7/9). Plan B contains a high dose of a drug found in most birth control pills that generally prevents ovulation or the fertilization of an egg. Recent research suggests that it does not prevent a fertilized egg from implanting in the uterus (Woodward, AP/Seattle Post-Intelligencer, 7/8). FDA in April lowered the age limit for nonprescription purchase of Plan B from 18 to 17 (San Francisco Chronicle, 7/9). Appeals Panel Returns Case to District CourtThe appeals court panel ruled that the freedom to exercise one"s religion "does not relieve an individual of the obligation to comply with a valid and neutral law of general applicability." The panel added, "Any refusal to dispense -- regardless of whether it is motivated by religion, morals, conscience, ethics, discriminatory prejudices or personal distaste for a patient -- violates the rules" (Los Angeles Times, 7/9). The panel ordered the district judge to reconsider the 2007 regulation under Supreme Court standards that allow states to pass neutral laws that may affect religious practices. According to the panel, the regulation does not aim to interfere with religious practices or beliefs and is intended to promote patients" health. In addition, the panel said the district court judge did not consider how the injunction would affect "sexually active women of childbearing age who will be denied reasonable access to Plan B" (San Francisco Chronicle, 7/9). According to the Times, the panel"s ruling could foretell future judgments in the case, including that a patient"s right to timely medication surpasses a pharmacist"s personal beliefs (Los Angeles Times, 7/9).
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Geography And History Shape Genetic Differences In Humans
New research indicates that natural selection may shape the human genome
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The National Association Of Boards Of Pharmacy (NABP) Moves To Next Phase Of Technician Recognition And Regulation
The Pharmacy Technician Certification Board (PTCB) is proud to announce a new recommendation issued by the National Association of Boards of Pharmacy (NABP) Task Force on Standardized Pharmacy Technician Education and Training which encourages state boards of pharmacy to require certification by the PTCB.
Endocrinology

Bionovo's Estrogen Receptor Beta Selective Drugs Have Unique Gene Expression And Cell Type Specificity

Bionovo, Inc. (Nasdaq: BNVI) announced that a study of the gene regulation in multiple cell lines by several of their estrogen receptor beta (ERb) candidates will be published in Public Library of Science One. "In this study we show that plant-derived ERb compounds are as selective as synthetic compounds, but regulate different genes. Specifically, we have discovered that these compounds do not promote breast or endometrial cancer in animal models, unlike many estrogen therapies. This suggests that these plant-derived ERb-selective compounds could lead to safer, more attractive alternative therapies for menopausal symptoms," said Dr. Dale Leitman, the Principal Investigator of the study. The publication describes the analyses of three distinct classes of ERb selective drugs. The study determines the relative ER selectivity and pattern of gene expression of the three classes of ERb selective compounds compared to the natural hormone estradiol, which non-selectively regulates both ERa and ERb . The most significant finding in the study was that the ERb-selective compounds regulate a number of genes differently than estradiol, a hormone therapy commonly used to treat women"s health issues. This discovery indicates that ERb agonists might be safer than current estrogens used in hormone therapy. The study also demonstrates the cell type selectivity of Menerba (MF101) and Liquiritigenin, two of Bionovo"s ERb selective drugs, in different cell types. These compelling findings will serve as a strong impetus for Bionovo, Inc. to continue investigating the unique abilities of their drugs to safely and effectively treat menopausal symptoms. "It is essential that new drug candidates demonstrate drug selectivity and tissue specificity in order to minimize adverse effects, particularly when the drug is being developed for the treatment of common, recurring symptoms associated with menopause, such as hot flashes. This is particularly important when developing drugs that mediate their effects through estrogen receptors, which are responsible for many functions in the body and are present in a range of different tissues. Bionovo stands alone in its dedication to identifying novel pathways in estrogen receptor signaling as drug targets for the treatment of women"s conditions," said Isaac Cohen, Chairman and CEO of Bionovo, Inc. "We have been endeavoring to develop more selective drugs in women"s health, and Dr. Leitman"s study highlights the solid scientific underpinnings of our ER beta selective drugs and underlines the deep biological understanding we have of the mechanisms through which they work." Bionovo, Inc. Bionovo is a pharmaceutical company focused on the discovery and development of safe and effective treatments for women"s health and cancer, markets with significant unmet needs and billions in potential annual revenue. The company applies its expertise in the biology of menopause and cancer to design new drugs derived from botanical s which have novel mechanisms of action. Based on the results of early and mid-stage clinical trials, Bionovo believes they have discovered new classes of drug candidates within their rich pipeline with the potential to be leaders in their markets. Bionovo is headquartered in Emeryville, California and is traded on the NASDAQ Capital Market under the symbol, "BNVI". Forward Looking Statements This release contains certain forward-looking statements relating to the business of Bionovo, Inc. that can be identified by the use of forward-looking terminology such as "believes," "expects," or similar expressions. Such forward-looking statements involve known and unknown risks and uncertainties, including uncertainties relating to product development, efficacy and safety, regulatory actions or delays, the ability to obtain or maintain patent or other proprietary intellectual property protection, market acceptance, physician acceptance, third party reimbursement, future capital requirements, competition in general and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. Bionovo, Inc


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