Categories
Cardiovascular
Diagnostics
Endocrinology
Health Insurance
Medical Devices
Mental Health
Nutrition
Oncology
Public Health
Sexual Health
Popular Articles

Sucampo Initiates Pivotal Phase 3 Efficacy Trial Of Lubiprostone For Chronic Idiopathic Constipation In Japan
Sucampo Pharmaceuticals, Inc. (NASDAQ:SCMP), an international biopharmaceutical company, announced that its subsidiary, Sucampo Pharma, Ltd., has initiated enrollment and completed the randomization of the first patient into the pivotal phase 3 efficacy trial of lubiprostone for chronic idiopathic constipation (CIC) in Japan.

ACOG Refines Fetal Heart Rate Monitoring Guidelines
Refinements of the definitions, classifications, and interpretations of fetal heart rate (FHR) monitoring methods were issued today in new guidelines released by The American College of Obstetricians and Gynecologists (ACOG). The objective of the guidelines is to reduce the inconsistent use of common terminology and the wide variability that sometimes occurs in FHR interpretations. ACOG"s Practice Bulletin, published in the July 2009 issue of Obstetrics & Gynecology, supports the recommendations of the Eunice Kennedy Shriver National Institute of Child and Health Development workshop* on electronic fetal monitoring (EFM) held in April 2008.
News of the day
Coverage Of Abortion Services In Federal Health Plan Remains Controversial
Advocates on both sides of the abortion-rights debate are "preparing for a renewed battle" over insurance coverage of abortion services in health care reform efforts, the AP/Atlanta Journal-Constitution reports. Abortion-rights opponents say that current restrictions on federal funding for abortion services should carry over to any insurance sold under new health insurance exchanges proposed under reform legislation. However, abortion-rights supporters say that carrying over the restrictions would deny abortion coverage to millions of women who currently have it through employer-sponsored coverage and are likely to join the exchanges.A variation in how the questions were asked yielded different results but significant proportions of private plans were found to cover abortion services. A Guttmacher Institute study found that 87% of typical employer-sponsored health plans covered abortion services in 2002, and a 2003 Kaiser Family Foundation study found that 46% of workers covered by employer-sponsored plans had coverage for abortion services.A Congressionally imposed provision of law known as the Hyde Amendment currently prevents the use of federal Medicaid funds for abortion services except in cases of rape, incest or life endangerment. States that choose to cover abortion services for low-income women through Medicaid must use their own funding to do so. Other Congressionally imposed restrictions prohibit abortion coverage for federal employees, women in the military and other women who rely on the federal government for their health care coverage. An overhaul of the health care system would "create a stream of federal funding not covered by the restrictions," including federal subsidies to offset the cost of health insurance for low- and middle-income people purchasing public or private health insurance though an exchange, the AP/Journal-Constitution reports.Congressional Proposals The plan passed by the Senate Health, Education, Labor and Pensions Committee is "still largely silent" on the issue of coverage for abortion services, the AP/Journal-Constitution reports. Both the House and Senate bills leave the decision on whether the public plan would include abortion coverage to the HHS secretary.In the House Energy and Commerce Committee, members approved an amendment that would allow the public plan to cover abortion services through the use of beneficiary premiums but not federal funds. In addition, the amendment says that private plans in the insurance exchanges could choose whether to cover abortion services, but no federal subsidies could be used to pay for the procedure. The amendment -- proposed by Rep. Lois Capps (D-Calif.), who supports abortion rights -- also would allow plans that do not cover abortions under any circumstances to be offered through insurance exchanges. Capps said that her amendment aims to appease both sides of the abortion-rights debate, adding, "Our country allows for both sides, and our health plan should reflect that as well."Comments Abortion-rights opponents say that they cannot accept a public insurance plan that would cover abortion services and that private plans in insurance exchanges should offer coverage for abortion services as a separate option, the AP/Journal-Constitution reports. Richard Doerflinger, associate director of antiabortion activities for the U.S. Conference of Catholic Bishops, said the group "want[s] to see people who have no health insurance get it," but coverage for abortion is "a sticking point." He said that there can be a "result where nobody has to pay for other people"s abortions," adding, "We don"t want health care reform to be the vehicle for mandating abortion."However, abortion-rights supporters argue that prohibiting coverage for abortion services would deny health care to women who have abortion services coverage through their private plans. Heidi Hartmann, president of the Institute for Women"s Policy Research, said that applying current restrictions for low-income women and federal employees to a program meant for the middle cla
Medical Devices

Antares Pharma And Population Council Announce Preliminary Positive Phase 2 Trial Results

Antares Pharma, Inc. (NYSE Amex: AIS) and the Population Council announced preliminary positive results from the Phase 2 trial for a novel contraceptive gel containing the progestin Nestorone and the bio-identical estrogen estradiol (NES/E2) utilizing the Antares ATD (advanced transdermal delivery) gel system. The trial is a dose finding, open-label, cross-over study to evaluate the effect of NES/E2 transdermal gel delivery on ovulation suppression in normal ovulating women. Eighteen women have participated in the trial, which is taking place in three sites: Los Angeles, California; Santo Domingo, Dominican Republic; and Santiago, Chile, and is scheduled to conclude active treatment in October 2009. The preliminary data shows that all doses suppress ovulation. In addition, no serious adverse events have been recorded, and there have been no instances of skin irritation to date in the study. Each woman in the study receives three separate doses of the gel for 21 days, separated by a washout month in which no products are administered. The primary objective of the study is to find the lowest acceptable dose of the NES/E2 gel to achieve appropriate therapeutic levels for effective contraception (ovulation suppression), as measured by progesterone levels and ultrasound evaluation of follicular development. Secondary objectives include determining the plasma profile of estradiol needed to reach estrogen replacement levels and to maintain regular bleeding patterns. General safety and tolerability of the NES/E2 gel, including any local skin irritation, is also being assessed. This study follows on the successful completion of a Phase 1 study, which found an effective combined dose that consistently delivered Nestorone. In the Phase 1 study, serum levels, following multiple administrations, matched the target range expected to provide effective contraception. Blood levels for estradiol were also, on average, within the range for maintenance of a normal estrogenic environment and likely resulting in regular bleeding patterns. Commenting on the progress of the current study, Regine Sitruk-Ware, executive director for research and development in the Reproductive Health Program of the Population Council, said, "We are encouraged by the preliminary results for this study. This is the first time these formulations have been used with ovulating women, and thus far they are meeting our expectations for both safety and efficacy." Antares senior vice president and managing director of the pharmaceutical group Dario Carrara Ph.D., said, "We are very pleased with the progress of the study and that the interim results validate the product concept. A transdermal gel offers an excellent opportunity to provide safe and effective contraception through an innovative drug delivery system in a large and growing global market segment." The National Survey of Family Growth has revealed that 31 percent of women discontinue use of reversible contraceptives for method-related reasons within six months of starting use, and 44 percent do so within 12 months. The novel NES/E2 transdermal gel offers a potentially attractive contraceptive option, in that both the formulation and the active compounds are designed to reduce the adverse events profile observed with current contraceptive methods and therefore could result in higher continuation rates by users. Worldwide contraception product sales in 2005 were $3.6 billion, with projections of approximately $4.5 billion by 2010, as reported by Thomson Pharma®. Under the terms of a joint development agreement, Antares is responsible for research and development activities as they relate to ATD formulation and manufacturing, using the Population Council"s patented and other proprietary information covering the compound. The Population Council is responsible for research on Nestorone and clinical trial design development and management. Together the parties expect to partner Nesterone with a worldwide or regional organization in order to commercialize it. About Nestorone® Nestorone is a fourth-generation synthetic progestin contraceptive derived from progesterone that has no androgenic hormonal effects and a good safety profile. It is not active when administered orally and is therefore especially appropriate for topical application as well as for use when breastfeeding. About ATD™ Gel Technology ATD™ Gel Technology is a hydroalcoholic transdermal gel containing less than 50 percent ethanol and a patented mixture of penetration enhancers. The matrix including Nestorone and bio-identical estradiol is designed to simultaneously deliver both drugs across the skin in a controlled and sustained fashion over a 24-hour period, and result in therapeutic plasma levels. The gel is crystal clear and cosmetically appealing, and dries readily after application to the abdomen, thighs, arms, or shoulders without leaving residues. Due to the low ethanol content, the gel is minimally irritating, as demonstrated by a similar FDA-approved formulation using ATD™ Gel Technology, ELESTRIN™ (low-dose estradiol for treating menopausal hot flashes). Antares Pharma


Add your comment:
Name:
Site address: http://
Your message:
Enter today\\\\'s date, 2 digits
(spam protection):

© Copyright 2009