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House Report Blames FDA for Drug Shortages - Renal Business Today |
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WASHINGTON—The recent nationwide shortages of critical drugs, including oncology agents, are largely the FDA's fault, according to a congressional committee report.
Since Margaret Hamburg, MD, became FDA commissioner in 2010, "the FDA has failed to ensure that enforcement and compliance activities are conducted in a manner that does not create unnecessary shortages of critical drugs," reads the report issued by the House Committee on Oversight and Government Reform.
The committee said that "although the shortages have been attributed to a myriad of factors from a lack of raw materials to increased demand, [an investigation found that] the crisis was largely sparked by actions of the Food and Drug Administration."
When the FDA responds to a manufacturing problem involving producers of generic injectable drugs, the result is that "companies producing generic injectable drugs have taken their manufacturing off-line simultaneous to other generic competitors also going off-line. These simultaneous shutdowns diminish the ability of competitors to alleviate the shortages with increased production," the report noted.
The FDA's regulatory interference in the production process has "effectively" forced the shutdown of 30 percent of the total manufacturing capacity of four of the largest manufacturers of injectable drugs: Bedford Laboratories, Hospira Pharmaceuticals, Sandoz Pharmaceuticals, and Teva Pharmaceuticals, according to the committee, which is chaired by Rep. Darrell Issa (R-Calif.).
Of the 219 drugs listed on the American Society of Health System Pharmacists shortage list as of February 21, at least 128 (58%) were produced by at least one facility undergoing FDA remediation, according to the report. A committee review of those manufacturer shutdowns over the last two years "did not find any instances where the shutdown was associated with reports of drugs harming customers."
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Kidney Disease an Important Risk Factor in Patients Undergoing ... - Renal Business Today |
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PARSIPPANY, N.J.— Orthopedic surgery patients with Stage 3B chronic kidney disease (CKD) are at high risk for blood clots despite standard treatment with the anticoagulant enoxaparin, according to a recently published study.
Blood clots and post-operative bleeding were reduced with use of desirudin, a new type of anticoagulant.
Results of the study, entitled “Impact Of Stage 3B Chronic Kidney Disease On Thrombosis And Bleeding Outcomes After Orthopedic Surgery In Patients Treated With Desirudin Or Enoxaparin: Insights From A Randomized Trial,” were published online ahead of print on June 4, 2012.
Desirudin, a direct thrombin inhibitor (DTI), works on a different part of the clotting system than enoxaparin. Desirudin is approved in the U.S. and Europe for the prevention of blood clots in patients undergoing orthopedic surgery. It is sold under the trade name Iprivask in the U.S. and Revasc in Europe. Desirudin, like enoxaparin, is administered by injection under the skin.
"The analysis indicates that patients with advanced kidney disease need to be approached differently when we consider issues of anticoagulation,” said Andrew Shorr, MD, Department of Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC, the study’s principal investigator. “The differential effects we observed between desirudin and enoxaparin demonstrate that a one-size-fits all strategy does not necessarily represent a careful balancing of risks and benefits.”
Major orthopedic surgery and advanced age are important risk factors for blood clots, which can be life-threatening. CKD is common in elderly patients undergoing orthopedic surgery and these patients have a four-fold increase in risk for blood clots as well as an increased risk for bleeding due to reduced elimination of anticoagulants. However, few studies have investigated anticoagulant performance in these high risk patients.
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Trends Shaping US Pharmaceutical Industry Strategies - Renal Business Today |
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PALM BEACH GARDENS, Fla.—MMC International has announced the release and availability of the 13th Edition of Trends Shaping U.S. Pharmaceutical Industry Strategies report by healthcare industry expert and award winning author Edmund L. Valentine.
The 13th Edition of MMC's "Trends" report is designed to challenge conventional thinking, fight "Group Think", inject fresh/different ways of looking at pharmaceuticals, and question product development, marketing, business development, and company strategies. It is an effective tool for the orientation of senior management employees new to the pharmaceuticals industry and serves as an excellent reference source for presentations and issues discussions.
The 13th Edition of "Trends" provides insights to how the transformation of the respective United States healthcare industry interrelated market segments/stakeholders will redefine how drugs are identified, developed, reimbursed, launched, marketed, prescribed, dispensed, and taken by patients. The period to 2020 presents opportunities for companies to redefine industry norms in select therapeutic and/or product categories to create a competitive advantage. Strategically managed companies will anticipate and capitalize on industry change, innovate and prosper; the remainder will be broken up, acquired, merged or driven out of business.
Purchaser of the 13th Edition of the Trends Shaping U.S. Pharmaceutical Industry Strategies report will be better positioned to: 1) capitalize on industry change, 2) positively contribute to their company's success, and 3) increase shareholder returns.
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The Shuman Law Firm Investigates DaVita, Inc. - MarketWatch (press release) |
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BOULDER, Colo., Jun 20, 2012 (BUSINESS WIRE) -- The Shuman Law Firm today announced that it is investigating potential claims against certain officers and directors of directors of DaVita, Inc. ("DaVita" or the "Company")
/quotes/zigman/268700/quotes/nls/dva DVA
+0.27%
. DaVita provides kidney dialysis and administrative services, including related laboratory services for medical facilities across the United States. DaVita's dialysis and related laboratory services business accounts for approximately 93% of the Company's consolidated net operating revenues.
DaVita is the subject of two qui tam lawsuits which allege that DaVita executives have, for many years, systemically overprescribed patients their medications related to kidney dialysis in order to receive the maximum reimbursement from the federal government. These actions have purportedly cost taxpayers millions of dollars in illegal and unjustified payments to DaVita. DaVita is also currently being investigated by multiple U.S. Attorneys, the U.S. Department of Justice and the U.S. Department of Health and Human Services regarding these claims.
If you currently own DaVita common stock and are interested in discussing your rights as a shareholder, or have information relating to this investigation, please contact Kip B. Shuman or Rusty E. Glenn toll-free at (866) 974-8626 or email Mr. Shuman at
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
or email Mr. Glenn at
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.
The Shuman Law Firm represents investors throughout the nation, concentrating its practice in securities class actions and shareholder derivative actions.
SOURCE: The Shuman Law Firm
The Shuman Law Firm
Kip B. Shuman, Esq., 866-974-8626
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or
Rusty E. Glenn, Esq., 866-974-8626
This e-mail address is being protected from spambots. You need JavaScript enabled to view it
www.shumanlawfirm.com
Copyright Business Wire 2012
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Kidney Specialists of Southern Nevada's Physicians Recognized as ... - PR Web (press release) |
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Las Vegas, Nevada (PRWEB) June 20, 2012
Kidney Specialists of Southern Nevada (KSOSN), a leading nephrology practice based in Las Vegas, announced its physicians have been recognized as Top Doctors by Las Vegas Life magazine. This represents the practice’s second consecutive year in which its physicians have received such distinction.
Las Vegas Life magazine partnered with Seattle-based Avvo to publish its “Top Doctors 2012” issue. Using a proprietary algorithm, Avvo rates professionals in the dental, legal and medical fields. Physicians are dynamically ranked on a 10-point scale which factors in peer endorsements, experience, education, training, research, publishing and awards. This year, the survey honored Marvin Bernstein, MD; Venugopal Botla, MD; Lawrence Lehrner, MD; Marc Leiserowitz, MD; Cristy Ann Robertson, MD and Vincent L. Yang, MD as top doctors in Nephrology.
“We are honored beyond words that of the ten physicians recognized in nephrology, six are doctors in our practice,” said Lawrence Lehrner, President of KSOSN. “We have made it a goal since day one to ensure our practice is delivering cutting edge treatments for patients battling kidney disease while also maintaining open communication with referring physicians in an effort to maximize care. It’s an incredible accomplishment to know that our efforts are recognized for what KSOSN is doing for kidney patients in Las Vegas.”
The Top Doctors issue is popular with readers as the survey results aid in their pursuit of the best medical care in the area. This year’s survey recognizes 270 physicians in 34 different specialties.
KSOSN is located at 500 South Rancho Drive, Suite # 12 in Las Vegas, Nevada. They can be reached at (702) 877-1887 or via the web at http://www.KSOSN.com.
About Kidney Specialists of Southern Nevada
Kidney Specialists of Southern Nevada (KSOSN) was established in Las Vegas by Allen Busby, MD in 1976. Over the past 30 years, the practice has grown to meet the needs of the region and will soon include 27 physicians as well as nurse practitioners and support staff in six offices across greater Las Vegas, a kidney health support program and a vascular access center. KSOSN offers the region’s most comprehensive kidney care services and offers patients their integrated Chronic Kidney Disease (CKD) support program. KSOSN’s integrated approach incorporates every aspect of nephrology with intensive patient education and support, close collaboration with dialysis centers, a range of in-center and at-home services and transplant nephrologists who are part of the region’s transplant team. For more information about KSOSN, their services and physicians, please visit their website at http://www.KSOSN.com or call (702) 877-1887.
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