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Allergan Receives Complete Response Letter For BOTOX(R) (Botulinum Toxin Type A) For Treatment Of Upper Limb Spasticity In Adults
Allergan, Inc. (NYSE:AGN) today announced it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding the Company"s Supplemental Biologics License Application (sBLA) for BOTOX® (Botulinum Toxin Type A) to treat upper limb spasticity in post-stroke adults. Allergan submitted its sBLA for this indication in the third quarter of 2008.
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Family Of Murdered Abortion Provider Tiller Announces Permanent Closure Of Clinic
The family of murdered Kansas abortion provider George Tiller announced on Tuesday that his Wichita clinic will not re-open, leading some abortion-rights advocates to voice concern about access to the procedure, the New York Times reports. Tiller was one of a handful of abortion providers who performed the procedure in the second and third trimesters of pregnancy, and women for decades have traveled to the clinic from across the U.S. and other countries. The clinic, Women"s Health Care Services, also was Kansas" only clinic outside the Kansas City area (Davey, New York Times, 6/10). The Tiller family said in a statement that the clinic will be "permanently closed" effective immediately. The family also said it does not plan to be involved "in any similar clinic" but will "honor Dr. Tiller"s memory through private charitable activities" (Slevin/Stein, Washington Post, 6/10).While abortion-rights advocates expressed empathy for the family, some added that they also are concerned that the clinic"s closure could have devastating effects for women who learn of fatal health problems late in their pregnancies, the Times reports. Nancy Northup, president of the Center for Reproductive Rights, said, "It is unacceptable that antiabortion intimidation and violence has led to the closing of Dr. Tiller"s clinic." She added, "Not only have we lost a fearless defender of women"s fundamental health and rights in Dr. Tiller"s murder, but the closing of his clinic leaves an immediate and immense void in the availability of abortion" (New York Times, 6/10). Suzanne Poppema, board chair of Physicians for Reproductive Choice and Health and a retired ob-gyn who performed abortions, said that abortions later in pregnancy would still be available, including through university hospitals that do not advertise the service. The closing is "not going to stop people who want to provide the service, but it will slow them down," she said. Marla Patrick, Kansas coordinator for the National Organization for Women, said abortion-rights advocates are working to open another Wichita-based clinic that provides abortions later in pregnancy (Bello, USA Today, 6/10). The AP/Yahoo! News reports that Kansas state law permits abortion after 21 weeks" gestation only if continuing the pregnancy would endanger the woman"s life or cause a "substantial and irreversible impairment" of a major bodily function, which courts have interpreted to include the mental health of the woman (Hegman/Hanna, AP/Yahoo! News, 6/9).According to the Times, some abortion-rights advocates had hoped other abortion providers would take over Tiller"s work at the clinic. LeRoy Carhart, a Nebraska abortion provider who also worked with Tiller, said he is "currently exploring every option to be able to continue to make second- and early, medically indicated third-trimester abortions available." Warren Hern, a Colorado abortion provider who performs procedures later in pregnancy, said, "Where does it end? The antiabortion fanatics got exactly what they wanted" (New York Times, 6/10). According to the Wall Street Journal, abortion-rights opponents" response to the closure was "subdued." Some expressed concern that antiabortion-rights extremists would think that violence "gets results where legal protest doesn"t," the Journal reports (Simon, Wall Street Journal, 6/10). Troy Newman, president of Operation Rescue, said that while the group is "thankful" that the clinic is closed, they "wish it would have come through the peaceful, legal channels that we were pushing" (New York Times, 6/10).Broadcast CoverageMSNBC"s "The Rachel Maddow Show" on Tuesday reported on the clinic"s closure and included a discussion with Susan Hill, president of the National Women"s Health Organization, about violence against abortion providers and an increase in the hostility of protesters outside abortion clinics since Tiller"s murder (Maddow, "The Rachel Maddow Show," MSNBC, 6/9). NPR"s "All Things Considered" on Tuesday also reported on the clinic"s closure ("All Things
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Affymax Reports Phase 2 Clinical Trial Data Supporting Hemoglobin Increases With Once-Per-Month Hematide Regardless Of Patient Baseline Renal Function
Affymax, Inc. (Nasdaq:AFFY) today announced data from a post hoc analysis of 120 patients in a Phase 2 clinical trial of Hematide™ in non-dialysis chronic kidney disease (CKD) patients. The data suggest that there is no major impact of baseline renal function as measured by Estimated Glomerular Filtration Rate (eGFR) on the monthly Hematide dose required to increase and maintain hemoglobin (Hgb) values within target range in non-dialysis CKD patients. The data were presented by Iain C. Macdougall, M.D. at the World Congress of Nephrology meeting being held in Milan, Italy.
Diagnostics

Rush University Medical Center Performs First Colorectal Surgeries In The U.S. Using Prosurgics' FreeHand Laparoscopic Camera Controller

Rush University Medical Center and surgical robotics company Prosurgics announce the completion of the first colorectal surgeries in the U.S. using the FreeHand® laparoscopic camera controller. Surgeons Dr. Marc Brand and Dr. Theodore Saclarides of Rush University Medical Center in Chicago successfully completed three laparoscopic hemi-colectomies using the laparoscopic camera controller. Although FreeHand is used widely in Europe, and has application in a variety of surgical specialties, these were the first procedures of this type to be performed in the U.S. Dr. Brand operated the FreeHand system during the procedures, which took place on June 22. FreeHand is an affordable 15 lb. robotic device that gives surgeons direct control of the laparoscopic camera via a small, lightweight hands-free controller worn on the surgeon"s head. Gentle head movements permit precise scope positioning. It provides a rock-steady image and faster surgery after a very rapid learning curve. After using FreeHand, Dr. Brand said, "A laparoscopic colectomy is uniquely challenging in that a wide field of view is required, from the ribs to the pelvis. FreeHand provided visual coverage of the entire area. It also gave me control so that I did not have to interrupt dissection to reposition the camera, or tell a person holding the camera what to do; returning control of the camera view to the surgeon allows for the image to lead the procedure instead of follow it. It"s like having an extra pair of hands. The image was excellent and very steady and no one had to be in the O.R. just to hold the "scope." Bill Perry, President of Prosurgics Inc., said, "We are delighted to have done these advanced cases at this outstanding medical center and that FreeHand performed so well. FreeHand makes procedures quicker and less stressful, and is a great teaching tool as well. A growing number of leading centers across the U.S. are seeing the benefits of FreeHand in a variety of surgical specialties." About Prosurgics Prosurgics is dedicated to pioneering a new generation of innovative but affordable surgical robots. Its range of robotic solutions helps improve patient outcomes and healthcare economics in hospitals around the world. The company"s technology portfolio encompasses image guided and tele-manipulator systems, surgical planning and intra-operative navigation. With offices in the UK (Bracknell), USA (Cupertino, CA) and Germany and a global network of expert distributors, Prosurgics delivers innovative and effective solutions for today"s surgeons and hospitals around the world. Rush University Medical Center


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