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Alkermes Initiates Two New Clinical Trials Of ALKS 33
Alkermes, Inc. (NASDAQ: ALKS) announced the initiation of two new clinical trials of ALKS 33, an oral opioid modulator for the potential treatment of addiction and other nervous system disorders. Study ALK33-004 is a phase 1 clinical trial designed to examine the ability of ALKS 33 to block the effects of an opioid following a single oral dose of ALKS 33 in healthy, non-dependent, opioid-experienced subjects. Study ALK33-003 is a phase 1 clinical trial designed to evaluate the pharmacokinetics, safety and tolerability of multiple doses of ALKS 33 in healthy volunteers.

New Protein Center Opens At The University of Copenhagen
On the 4th June, the Faculty of Health Sciences at the University of Copenhagen will open the doors of its new research center, The Novo Nordisk Foundation Center for Protein Research. The Center is the result of a historic donation from the Novo Nordisk Foundation, which in 2007 gave the University 80 million euros for its establishment.
News of the day
Supreme Court Nominee Sotomayor Prepares For Meetings With Key Senators
Supreme Court nominee Judge Sonia Sotomayor is scheduled to meet with key senators today as Republican leaders indicate that they will try to slow her confirmation process over the summer, the Washington Post reports. Sotomayor, in preparation for her meetings, has been working with White House lawyers to complete a 10-page Senate questionnaire, which aims to reveal details of her legal work, professional associations, personal finances, speeches, and legal and other writings. White House officials said the document will be finished "in the next couple of days." Senate Majority Leader Harry Reid (D-Nev.) said that he will provide Sotomayor"s background information to Republicans "as quickly as possible," adding that he "want[s] to make sure she"s ready to go" when the next Supreme Court term begins in October. Sotomayor is scheduled to meet today with Reid, Senate Minority Leader Mitch McConnell (R-Ky.), Senate Judiciary Committee Chair Patrick Leahy (D-Vt.) and the panel"s ranking member, Jeff Sessions (R-Ala.). She also is scheduled to meet with Sens. Jon Kyl (R-Ariz.), Richard Durbin (D-Ill.), and New York Democrats Charles Schumer and Kirsten Gillibrand, the Post reports.While Sotomayor prepares for her meetings, Republican leaders indicated that they will try to impede President Obama"s push to confirm her before the Senate leaves for summer recess on Aug. 7. McConnell said that the GOP will determine its own schedule regarding Sotomayor"s confirmation, adding that although the GOP will "insist that the confirmation process be conducted in a fair and professional manner, ... respectful doesn"t mean rushed." Senior Senate aides from both parties said that a deal to expedite the confirmation process is unlikely, despite informal negotiations between Sessions and Leahy (Fletcher/Murray, Washington Post, 6/2). Sessions said it would be his "preference" for a confirmation after the August recess but before October. He added that there are "some things that have been raised that we need to explore" and that Sotomayor "deserves an opportunity to deal with the complaints against her" (Rushing, The Hill, 6/1).Conservative Groups Push for Filibuster According to the New York Times "The Caucus," a coalition of conservative groups recently sent a letter to McConnell urging Republicans to filibuster Sotomayor"s confirmation. The letter, which was obtained by the Times, is signed by a range of conservative groups, including antiabortion-rights groups, gun-rights advocates, evangelical leaders and others. Manuel Miranda, a former judicial adviser to former Senate Majority Leader Bill Frist (R-Tenn.), organized the letter. Although Miranda has criticized Democratic filibusters in the past, he said that a Republican filibuster of Sotomayor would help the GOP promote its differences with the Democratic Party on judicial philosophy and the role of the courts. However, Senate Republican leaders thus far have shown little interest in a filibuster, according to the "The Caucus" (Savage, "The Caucus," New York Times, 6/1). The Post reports that the GOP likely does not have enough votes to block Sotomayor"s confirmation with a filibuster, but Republicans could be able to slow the process until September. In this case, Sotomayor still would be able to take her place on the bench when the court reconvenes Oct. 1 (Washington Post, 6/2).The AP/USA Today reports that Republicans are taking a "two-sided strategy" in which they are urging for a respectful debate against Sotomayor while still allowing conservative commentators -- such as Rush Limbaugh and former House Speaker Newt Gingrich (R-Ga.) -- to criticize her, the AP/USA Today reports. By allowing the political attacks from commentators, Republicans who are facing re-election "can avoid potential backlash if they derail a historic nomination," the AP/USA Today reports (AP/USA Today, 6/1).
Diagnostics

ACOG Issues Revision Of Labor Induction Guidelines

Revised guidelines on when and how to induce labor in pregnant women were issued by The American College of Obstetricians and Gynecologists (ACOG). The guidelines provide physicians with guidance regarding which induction methods may be most appropriate under particular circumstances, as well as the safety requirements, and risks and benefits of the different methods. ACOG"s Practice Bulletin "Induction of Labor" is published in the August 2009 issue of Obstetrics & Gynecology. The rate of labor induction in the US has more than doubled since 1990. In 2006, more than 22% (roughly 1 out of every 5) of all pregnant women had their labor induced. The goal of labor induction is to artificially stimulate uterine contractions so that pregnant women can deliver vaginally. As with all procedures, the risks must be weighed against the benefits to the woman and the fetus. "There are certain health conditions, in either the woman or the fetus, where the benefit of inducing labor is clear-cut," says Susan Ramin, MD, from the University of Texas Medical School in Houston who helped lead the development of ACOG"s Practice Bulletin. "And, there are some nonmedical situations in which induction also may be prudent, for instance, in rural areas where the distance to the hospital is just too great to risk waiting for spontaneous labor to happen at home." In circumstances like these, the ACOG recommendations say the gestational age of the fetus should be determined to be at least 39 weeks or that fetal lung maturity must be established before induction. Cervical ripening is the first component to labor induction. If the cervix is not sufficiently dilated, then drugs or mechanical cervical dilators should be used to ripen the cervix before labor is induced. Once the cervix is dilated, labor can be induced with oxytocin, membrane stripping, rupture of the amniotic membrane, or nipple stimulation. Misoprostol, a medication for peptic ulcers, is a commonly used off-label drug that both ripens the cervix and induces labor. The ACOG guidelines indicate that inducing labor with misoprostol should be avoided in women who have had even one prior cesarean delivery due to the possibility of uterine rupture (which can be catastrophic). According to ACOG, there are a number of health conditions that may warrant inducing labor but physicians should take into account maternal and infant conditions, cervical status, gestational age, and other factors. Some examples in which labor induction is indicated include (but are not limited to) gestational or chronic hypertension, preeclampsia, eclampsia, diabetes, premature rupture of membranes, severe fetal growth restriction, and postterm pregnancy. "There are certain situations where labor induction is contraindicated," says Dr. Ramin. These situations include (but are not limited to) transverse fetal position, umbilical cord prolapse, active genital herpes infection, placenta previa, and women who have had a previous myomectomy (fibroid removal) from the inside of the uterus, according to ACOG. "A physician capable of performing a cesarean should be readily available any time induction is used in the event that the induction isn"t successful in producing a vaginal delivery," notes Dr. Ramin. Although rare, there are potential complications with some methods of labor induction. "These guidelines will help physicians utilize the most appropriate method depending on the unique characteristics of the pregnant woman and her fetus." Practice Bulletin #107, "Induction of Labor," is published in the August 2009 issue of Obstetrics & Gynecology. American College of Obstetricians and Gynecologists


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