Centocor Ortho Biotech Products, L.P. and Amgen Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Risk Evaluation and Mitigation Strategy (REMS) for erythropoiesis-stimulating agents (ESAs), which include PROCRIT® (Epoetin alfa), Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa)…
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Two studies were conducted to assess the performance of a commercially available neck-mounted activity meter to detect cows about to ovulate in two paddock-based Holstein-Friesian dairy herds. The activity monitoring system recorded cow activity count in 2-hourly periods. Study I investigated the ability of the system to detect cow ovulatory periods in dairy herds managed in two different Australian environments and breeding systems using five activity alert algorithms. Herd 1 consisted of approximately 130 milking cows calving year-round in a sub-tropical environment and kept in a single dry lot paddock. Herd 2 consisted of approximately 400 milking cows calving seasonally… Continue reading
The Special Feature of the November/December 2009 issue of the Journal of the American Pharmacists Association JAPhA® is a “White paper on designing a risk evaluation and mitigation strategies (REMS) system to optimize the balance of patient access, medication safety, and impact on the health care system.” The paper results from the input of an expert panel of stakeholders convened by the American Pharmacists Association (APhA) to explore standardized solutions to REMS development and implementation…
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UroToday.com – Randomized three-dimensional conformal radiotherapy dose escalation studies have consistently shown improved biochemical control rates for prostate cancer. This benefit was associated with the problem of increased rectal toxicity. The increasing implementation of image-guided radiotherapy (IGRT) allows a reduction of safety margins around the clinical target volume (CTV). Thus, the same or improved local tumour control with lower rectal toxicity due to reduced rectal volume within the target volume can be expected…
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In the online edition of the British Journal of Urology, the Department of Urology at the University of Miami reported on the impact of prior pelvic radiotherapy (XRT) on the occurrence of uretero-intestinal anastomosis (UIA) stricture at subsequent urinary diversion.
Pelvic XRT can potentially affect small blood vessels and induce tissue fibrosis. In patients who have not had prior pelvic XRT, the incidence of UIA stricture with urinary diversion ranges from 1% to 9%. This patient cohort was retrospectively identified at the University of Miami from 1992 to 2008. A total of 526 patients were identified, and of these… Continue reading
Bayer Schering Pharma AG, Germany, is progressing with the development of florbetaben to support Alzheimer diagnosis. On the occasion of the 95th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), the company announced the enrollment of first patients in an international clinical Phase III trial to evaluate the efficacy and safety of florbetaben (BAY 94-9172) PET imaging in the detection of beta-Amyloid deposition in the brain. The trial will include both subjects with and without manifest dementia (e.g. Alzheimer’s disease [AD]). In the previous Phase II trial, florbetaben has successfully demonstrated its potential to detect… Continue reading
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Designer waters are popular in the 21st century and many stone patients ask if they can consume their fluid intake with these products, such as Gatorade. We, as clinicians managing these stone patients, can now be reassured that this fluid is equivalent to water in their daily fluid consumption.
In this prospective, crossover study normal and hypercalcuric patients were placed on a monitored stone prevention diet for the entire duration of the study. The subjects then consumed 2 liters of Gatorade for one week and then 2 liters of water for one week and performed 24 hour… Continue reading
arGentis Pharmaceuticals, LLC announced that it will collaborate with the University of Tennessee Health Science Center (UTHSC) and the Veterans Affairs Medical Center of Memphis (VAMC) to initiate the first human clinical evaluation of an oral altered peptide ligand (APL), ARG301, in a Phase I study of Rheumatoid Arthritis patients.
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An article by Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, titled “A Difficult Balance – Pain Management, Drug Safety, and the FDA,” appears in the Nov. 26, 2009 issue of The New England Journal of Medicine.
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The Swedish biotech company Karo Bio (Reuters: KARO.ST) announced that Merck & Co., Inc., through an affiliate, plans to enter a clinical phase IIa trial with the collaboration’s lead investigational drug candidate, MK-6913, identified as part of their joint research collaboration. No milestone payment to Karo Bio is associated with the initiation of phase II clinical development.
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Omni Bio Pharmaceutical, Inc. (“Omni Bio”) (OTCBB: OMBP) announced that its acting Chief Executive Officer, Dr. Charles A. Dinarello, will moderate a panel at the 8th World Congress on Trauma, Shock, Inflammation and Sepsis (“TSIS”) (http://www.tsis2010.org) in Munich, Germany on Friday, March 12, 2010. The panel on Alpha-1 Antitrypsin (“AAT”) as a Novel Therapeutic in Inflammatory Diseases will feature the following presentations: “Introduction and Background for AAT Safety in Humans and Experimental Models of AAT Protection,” by Dr…
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The majority of new cancer tests coming to market are proprietary assays with the test services being provided by certified labs opened by the IVD companies that developed the tests. All the major reference labs in North America and Europe are also offering a slew of in-house developed diagnostic tests. This shift is leading to greater profits for those companies offering test services, notes healthcare market research publisher Kalorama Information in its new report “The Worldwide Market for Cancer Diagnostics, 4th Edition.” Test services are not a new business model…
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House Speaker Nancy Pelosi signaled Friday that votes on a health care overhaul could come by the end of next week. Politico: During a Friday meeting with Democratic members, Pelosi told lawmakers to “clear their schedules for next weekend.” She also promised “to stay in session until the landmark vote, people present said afterwards.” Speculation continues that Pelosi doesn’t yet have the votes lined up to pass a reform bill, but that she’s close. “In addition, it looks like House Democrats won’t have to vote directly on a Senate bill they really don’t like. The speaker hasn’t made a final decision, but she told her… Continue reading
Roll Call: After initially indicating ”the Senate-passed health reform bill must be signed into law before Congress acts on companion reconciliation legislation, the Senate Parliamentarian has acknowledged that there are perhaps ways to draft a reconciliation measure that could move first.” But, if Democrats choose to pursue this approach, “they likely would have to narrow the scope of the reconciliation bill.” The Parliamentarian has noted that moving a broad reconciliation measure without the Senate measure first being signed into law “could create challenging procedural hurdles for Senate Democrats.” This week, Senate GOP leadership received word from the Parliamentarian’s office that… Continue reading
The government warned Friday that those chic baby slings that hip moms and dads are sporting these days can be dangerous, even deadly for their little ones. Go to Source… Continue reading
There are some harsh words for Democrats trying to overhaul health care in the Washinton Post this morning.
Comprehensive health care has been lost. If it fails, as appears possible, Democrats will face the brunt of the electorate’s reaction. If it passes, however, Democrats will face a far greater calamitous reaction at the polls. Wishing, praying or pretending will not change these outcomes.
Such rhetoric is common coming from Republicans these days, but this is different. The broadside comes in an opinion piece from Patrick H. Caddell and Douglas E. Schoen, pollsters for the last two Democratic presidents, Jimmy Carter and… Continue reading
Most youngsters grow out of having otherwise unexplained bone and muscle aches known as growing pains, researchers from Israel report.
Of 35 children who originally had growing pains, Dr. Yosef Uziel, at Meir Medical Center in Kfar-Saba, and co-investigators found that 18—or 51 percent—no longer had growing pains 5 years later, when they were about 13 years old.
Fourteen of the 17 who still had growing pains after 5 years said their episodes had decreased and become milder, the researchers report in The Journal of Pediatrics. Go to Source… Continue reading
A $6 million grant from the National Heart, Lung and Blood Institute (NHLBI) has funded the creation of ORBIT: Obesity Related Behavioral Intervention Trials to focus on reducing obesity and obesity-related deaths in New York City’s African-American and Latino communities.
“African-Americans and Latinos have been disproportionately affected by the obesity epidemic, and its related risks for diabetes and heart disease,” says Dr. Mary Charlson, the center’s director, the William T. Foley Distinguished Professor of Medicine at Weill Cornell Medical College, and chief of the Division of Clinical Epidemiology and Evaluative Sciences Research in the Department of Medicine and executive director of… Continue reading
