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Monday, February 21, 2011

John Muir Health and MuirLab Select AT&T Healthcare Community Online

Walnut Creek, California, February 16, 2011   AT&T* announced that John Muir Health and MuirLab have contracted with AT&T to deploy AT&T Healthcare Community Online, AT&T’s flagship Health Information Exchange (HIE) solution.
AT&T Healthcare Community Online will enable the Lab Information System of MuirLab and its client hospitals to easily exchange information and share applications in a highly secure manner to improve communications and information access and facilitate better quality of care.
MuirLab is the laboratory service and diagnostic center for John Muir Health, which includes two medical centers and several outpatient facilities. MuirLab also supports 30 outpatient lab draw sites in the greater East Bay region as well as Sacramento, and services over 300 Skilled Nursing Facilities throughout 18 counties of Northern California. It is a full-service lab facility offering comprehensive clinical and anatomic pathology testing. MuirLab’s 56,000 square foot, state-of-the-art testing facility in Concord, California features the most current innovations in total lab automation and clinical lab equipment.

“AT&T Healthcare Community Online fits the needs of MuirLab perfectly and is designed to scale as our needs expand,” said Eric Saff, Senior Vice President and Chief Information Officer, John Muir Health. “It’s a value-added service that will improve laboratory services to patients and help us broaden our business model to meet the needs of even more medical communities.”
AT&T Healthcare Community Online is an industry leading cloud-based service designed to facilitate MuirLab’s ongoing improvements in specimen handling accuracy and to enhance turn-around time for test results -- ultimately reducing costs and delivering better patient care. Additionally, by utilizing AT&T Healthcare Community Online’s provider dashboard, John Muir Health will improve the process for requesting and retrieving diagnostic results and maximize the capacity and efficiency of MuirLab.
Under this contract, AT&T will configure, deploy, and manage the connectivity interfaces for bidirectional clinical messaging between MuirLab and its constituents. Additionally, MuirLab will have a customizable User Interface (UI) with the ability to modify aspects of AT&T Healthcare Community Online.
Since hospitals and physician practices vary greatly in how they operate and in their level of technology adoption, AT&T Healthcare Community Online will allow message delivery regardless of the preferred communication method. The platform provides MuirLab with a flexible and highly secure clinical messaging and interface capability to and from any available data source and supports multiple delivery mechanisms such as messaging to a hospital, to a message center portal, to fax or combined delivery to all three.
AT&T will demonstrate AT&T Healthcare Community Online and other healthcare solutions at the HIMSS11 conference Feb. 20-24 in Orlando at booth #4862.
Learn more information about AT&T ForHealth.
*AT&T products and services are provided or offered by subsidiaries and affiliates of AT&T Inc. under the AT&T brand and not by AT&T Inc.

Wednesday, February 16, 2011

Generic Drug Makers Ready Pay FDA User Fees.

Generic Drug industry is pushing forward an unified plan on proposal to pay user fees to the FDA. These user fees, like the branded drug manufactures pay, will speedup approval of drugs and plant inspections. Generic drugs now take an average of 2½ years to get approval.

In a conversation with WSJ Health Blog, Mylan President Heather Bresch has indicated that the Generic Drug Industry is willing to pay in order to get a level playing filed with brand name drugs.
Talking about the drugs that being imported in to USA (More than half of both generic and Brand Name Drugs are imported from various parts of the world);
“You’re giving those drugs to your children, Don’t you want to know that they were made in safe conditions?  We are ready to put our money where our mouth is,” says Bresch who presides over Mylan which has 18 processing facilities, 11 of them overseas.
Faster approval will help generic drug companies in producing and selling drugs like Pfizer’s Lipitor and Bristol-Myers Squibb and Sanofi-Aventis’s Plavix, whose patents are set to expire this year and next.


Friday, February 11, 2011

Pharmacy Compounding! What Is It?

An educational video to introduce and educate general public what pharmacy compounding is and the role FDA plays in the process. It highlights the risks and benefits associated with the practice and the medical necessity for it.

Wednesday, February 09, 2011

Value of Dietary Management with L-methylfolate in Depression Treatment.

COVINGTON, La.--(BUSINESS WIRE)--Data published in the January issue of Innovations in Clinical Neuroscience, www.psychiatrymmc.com, suggest when L-methylfolate, a medical food available commercially as Deplin®, and by prescription, is used for dietary management of depression in combination with an antidepressant drug at the start of depression therapy, it results in significantly more patients experiencing major improvement and more rapid improvement than antidepressant monotherapy alone.1
Approximately 70 percent of major depressive disorder (MDD) patients have a genetic abnormality that results in an imbalance of L-methylfolate2, the only form of folate that crosses the blood-brain barrier to help regulate neurotransmitters associated with depression.3
“Administering adjunctive agents such as L-methylfolate early in therapy as opposed to sequential drug use, or delaying a second agent, may represent a paradigm shift in the therapy of major depressive disorder,” said study author Lawrence D. Ginsberg, MD, of Red Oak Psychiatry in Houston. “Too often patients fail to respond to initial treatment and months go by before we are able to layer in additional medications. What we have found is that there are clear synergies between antidepressant drugs and L-methylfolate that result in better patient outcomes earlier in therapy.”
Major depressive disorder (MDD) is a chronic and recurrent disease affecting more than 18 million people in the United States, ranking it along with heart disease, cancer and diabetes among the nation’s most common ailments.4 Up to 50 percent of patients being treated for depression fail to reach remission.5
About the Study
Researchers performed a retrospective two-arm chart review of 242 adults, ages 18-70, with a primary diagnosis of MDD, a Clinical Global Impression - Severity (CGI-S) score of four (moderately ill) or five (markedly ill) and who were experiencing some degree of functional impairment. Charts of eligible patients were divided into a combination therapy arm of 95 patients administered selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) in combination with dietary management using 7.5-15 mg of L-methylfolate at initiation of therapy and a control arm of 147 patients using SSRI or SNRI monotherapy at therapy onset.
Data were recorded on patient characteristics before and after antidepressant therapy using the CGI-S Scale.
The primary outcome measure used in the study was a two-point decline in the CGI-S score, a seven-point scale developed by the National Institute of Mental Health. The CGI-S score is a clinician-determined measure that takes into account all available information, including knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function.
The Results
More than two and a half times as many patients in the combination SSRI/SNRI drug + L-methylfolate medical food arm achieved major improvement than those in the control arm. 18.5 percent of the L-methylfolate and antidepressant treated patients showed a major improvement at 60 days in depression symptoms represented by a 2 points or greater reduction in CGI-S versus 7.04 percent of the control group (p = 0.01). Among patients with greater functional impairment (CGI-S = 5), 40 percent of patients in the combination arm improved significantly within 60 days compared to 16.3 percent of patients in the control group (p= 0.02). The patients who received dietary management with L-methylfolate + SSRI/SNRI experienced a more rapid improvement than the monotherapy patients. Median time to a 2-point or greater CGI-S reduction in the combination group was 177 days compared to 231 days for the control group (p= 0.03).
Discontinuation rates due to adverse events were significantly lower in the combination group (17.9 percent) versus the antidepressant monotherapy group (34 percent) (p=0.0078), although the overall rates of adverse events in both groups were not statistically different.1
1. Ginsberg LD, Oubre A, Daoud Y. Innov Clin Neurosci. 2011;8(1):19-28.
2. Kelly C, McDonnell A, Johnston T, et al. J Psychopharmacol. 2004;18(4):567-71.
3. Stahl SM. CNS Spectrums. 2007;12(10):739-44.
4. The National Institute of Mental Health (NIMH). (n.d.).
5. Zajecka, John. J Clin Psychiatry. 2003;64[suppl 15]:7-12.

Monday, February 07, 2011

Drug Sample Accountability and Compliance For Pharmaceutical Companies

BEDMINSTER, N.J.--(BUSINESS WIRE)--Cegedim Relationship Management today announced that five of the top ten global pharmaceutical companies rely on its Sample Management and Reconciliation Services for accurate accounting of their sampling activity. Cegedim Relationship Management’s Compliance Solutions Division has expertly met companies’ sample reconciliation needs since 2000, supporting sample inventory reconciliation for tens of thousands of sales representatives to date.
As companies seek to account for all samples distributed to fulfill the federal requirements of the Prescription Drug Marketing Act (PDMA), valuable company time and resources can be consumed. However, outsourcing this critical task can lower the risk of costly errors and relieve sales representatives and remote staff of the day to day administrative burden. This frees sales representatives to maximize their profitable time in the field, and home office personnel to focus on higher value compliance responsibilities.
Flexible and efficient, Sample Reconciliation Services can be delivered via their client’s existing software system or via Cegedim Relationship Management’s industry leading sample management software, Sample Guardian™. Regardless of which technology companies choose, they benefit from Cegedim Relationship Management’s proven, proprietary method, powered by BuzzeoPDMA, and 20-plus years of market-leading consulting services and comprehensive federal and state regulatory compliance capabilities.
In addition to saving time and increasing accuracy, this service also reduces the cost of reconciliation. One Cegedim Relationship Management client who is utilizing Sample Reconciliation Services estimates that they will save more than $5 million over their previous in-house solution in a five year period. Their services include on-going sample inventory reconciliation, annual inventory and sales representative closeouts.
“It's not just an add-on function," explained Bill Buzzeo, Vice President and General Manager of Global Compliance Solutions at Cegedim Relationship Management. “It’s a core competency. Regulatory compliance is what we do, and we keep up with day-to-day changes so our customers don't have to. We’re the experts, and that’s why we’re the go-to company for this service.”

To learn more, please visit: www.cegedim.com/rm.

Danaher To Acquire Beckman Coulter, Inc, For $5.8 Billion

ORANGE COUNTY, Calif., Feb. 7, 2011 /PRNewswire-FirstCall/ -- Beckman Coulter, Inc. (NYSE: BEC), a leading developer, manufacturer and marketer of products that simplify, automate and innovate complex biomedical testing, and Danaher (NYSE: DHR), a diversified technology leader that designs, manufactures, and markets innovative products and services to professional, medical, industrial, and commercial customers, announced today that they have entered into a definitive merger agreement under which Danaher will acquire all of Beckman Coulter's outstanding common stock for $83.50 per share in cash (without interest), representing an approximate 45% premium over the closing price of Beckman Coulter's common stock on December 9, 2010 before rumors of an acquisition entered the marketplace. The transaction is valued at approximately $6.8 billion, including debt assumed and net of cash acquired.

An affiliate of Danaher is expected to commence a tender offer (the "Offer") for all of Beckman Coulter's outstanding common stock within the next seven business days and will remain open for a minimum of 20 business days following commencement of the Offer. The Offer is expected to be conditioned upon, among others, at least a majority of the outstanding Beckman Coulter shares being tendered, as well as the satisfaction of other customary conditions. The transaction is structured as a tender offer for all outstanding shares of Beckman Coulter followed by a merger. Approval of the transaction by Danaher shareholders is not required. The transaction is expected to be completed in the first half of 2011.

"Following a very comprehensive and competitive process, the Board of Directors voted unanimously to accept Danaher's proposal. We believe this transaction maximizes Beckman Coulter shareholder value while strengthening the company's position as a leader in biomedical testing to the benefit of our customers and their healthcare patients around the world. Our company's rich history, strong brand, broad product portfolio and long-standing customer relationships are major sources of value in the transaction, enabling us to leverage our global commercial infrastructure and installed base to expand opportunities in both mature and emerging markets around the world. Longer term, we will have significant opportunities to leverage our relationships across our large installed base of automated systems in hospital laboratories with that of Danaher." said Bob Hurley, Beckman Coulter's President and Chief Executive Officer.

Beckman Coulter would become part of Danaher's Life Sciences & Diagnostics segment, joining Danaher's Leica, AB Sciex, Radiometer and Molecular Devices businesses.

"Beckman Coulter is an iconic company with a great brand, broad reach and technology leadership; well positioned in the markets it serves. Beckman provides an excellent complement to our existing Life Sciences & Diagnostics businesses. Being part of Danaher, Beckman associates will have the opportunity to leverage the power of the Danaher Business System, including the processes by which Danaher accelerates growth through new product innovation and driving sales, marketing and service, as well as its strength in continuously expanding margins." said Danaher's President and CEO, H. Lawrence Culp, Jr.,

Thursday, February 03, 2011

American Regent Recalls Sodium Thiosulfate Injection, USP.Manufactured By Luitpold Pharmaceuticals.

his voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination. Glass delamination can occur with high pH solutions when the surface glass from the vial separates into thin layers, resulting in glass particles with a flaky appearance.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation. American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Sodium Thiosulfate Injection, USP is indicated in the treatment of cyanide poisoning.

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via email atpv@luitpold.com, by fax to (610) 650-7781 or (610) 650-0170 or by phone at 1-800-734-9236. TO EXPEDITE HANDLING PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS EMAIL ADDRESS OR FAX OR PHONE.

Recallr: American Regent Recalls Luitpold Pharmaceuticals' Sodium Thiosulfate Injection, USP.


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