Transplant News and Research

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Team liberates cellular hostages by silencing Toxoplasma gondii's back-seat driving

Scientists studying a cunning parasite that has commandeered the cells of almost half the world's human population have begun to zero in on the molecular signals that must be severed to free the organism's cellular hostages.

23 Apr 2010

QF-CMV test helps predict transplant recipients at increased risk of CMV disease after surgery

New international guidelines published in the journal Transplantation reinforce the use of a new type of blood test to assess cytomegalovirus (CMV) risk in solid organ transplant recipients (i.e. transplant recipients). This blood test, QuantiFERON®-CMV (QF-CMV), is the first commercially-available blood test to allow physicians to monitor a person's risk of CMV disease. Most commonly used in the transplant setting, QF-CMV may predict which transplant recipients are at increased risk of CMV disease after transplant surgery.

23 Apr 2010

New blood test to determine patients at low risk for rejection of transplanted hearts

After his heart transplant in 2005, Ramon Llenado underwent a biopsy every week, then every month, then every three months. Most heart transplant patients face a lifetime of these invasive tests, which involve snipping out tiny pieces of heart to check for possible organ rejection.

23 Apr 2010

Astellas Pharma extends tender offer for OSI Pharmaceuticals

Astellas Pharma Inc. announced today that it has extended its all-cash tender offer for $52 per share for all of the currently outstanding shares of common stock (including the associated stock purchase rights) of OSI Pharmaceuticals, Inc. to 5:00 p.m. New York City time on Monday, May 17, 2010, unless further extended.

23 Apr 2010

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Sagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration had granted tentative approval of adenosine injection, USP, the generic equivalent of Astellas Pharmaceuticals' Adenoscan®, in 60 mg per 20 mL and 90 mg per 30 mL vials. IMS data indicate that the 2009 U.S. innovator market for these adenosine presentations approximated $124 million. The Company plans to launch the product upon expiry of applicable innovator patents.

23 Apr 2010

Genetic tests that may replace biopsies

Genetic tests conducted on blood samples may replace the current biopsies when it comes to checking if immune systems are rejecting new organs of heart transplant patients. The test would be far less invasive and uncomfortable as compared to the biopsies, not to mention more affordable.

23 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Valor Medical's CEO, H. Clark Adams, announced today that Valor's European clinical trial was finalized with 30 patients treated. Mr. Adams stated, "The trial took longer than expected because there are current approved therapies which were used as a first line of therapy. Patients who were enrolled to be treated with Valor's Neucrylate were not always acceptable candidates for these standard-of-care therapies.

22 Apr 2010

Vical presents Phase 2 trial results of TransVax CMV vaccine at World Vaccine Congress

Vical Incorporated announced today that the company's TransVax cytomegalovirus vaccine elicited sustained increases in both cellular and antibody immune responses compared with placebo through the final 12-month follow-up in an ongoing Phase 2 trial in hematopoietic cell transplant recipients.

22 Apr 2010

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

Alexion Pharmaceuticals, Inc. today announced financial results for the quarter ended March 31, 2010.

22 Apr 2010

IL-10 Gene Therapy helps repair damaged lungs found unfit for transplant

Promising research brings hope for the almost two thousand lung transplant candidates who currently make up The United Network for Organ Sharing's (UNOS) wait list. A new technique that uses gene therapy to help repair damaged lungs previously found unfit for transplant shows promise for addressing the critical shortage of healthy donor organs.

22 Apr 2010

International Day for Fighting Infection focuses on hospital infection control

Hospital acquired infections are the focus for the 3rd International Day for Fighting Infection, being marked on St. George’s Day, as experts meet to look at the evolution of infection control in hospitals.

22 Apr 2010

ISHLT announces new guidelines for heart transplant recipients

The International Society for Heart and Lung Transplantation (ISHLT) today announces new guidelines to standardize care for heart transplant patients worldwide. The guidelines demonstrate a united effort to decrease complications, improve outcomes and increase patient survival rates among heart transplant recipients. The guidelines will be presented during today's symposium The ISHLT Guidelines for Heart Transplant Recipients: Towards an International Consensus at the ISHLT 30th Annual Meeting and Scientific Sessions at the Hilton Chicago.

22 Apr 2010

Gen-Probe's PROGENSA PCA3 assay helps determine necessity of initial biopsy in prostate cancer suspect men

Gen-Probe's PROGENSA® PCA3 assay can help predict the outcome of initial prostate biopsies in men suspected of having prostate cancer, according to a study of the molecular urine test presented in a scientific poster last week at the 25th annual European Association of Urology (EAU) Congress in Barcelona, Spain.

22 Apr 2010

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

StemCells, Inc. announced today that it has submitted a protocol to the FDA for initiation of a second clinical trial of its proprietary HuCNS-SC human neural stem cells in neuronal ceroid lipofuscinosis, which is also often referred to as Batten disease.

22 Apr 2010

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

The US Food and Drug Administration (FDA) has approved Zortress® (everolimus) oral tablets for the prevention of rejection of kidney transplants in adult patients at low-to-moderate immunologic risk. Zortress is to be given in combination with reduced doses of the calcineurin inhibitor (CNI) cyclosporine, as well as basiliximab and corticosteroids.

22 Apr 2010

Study analyzes effects of untimely and sudden parental death on childhood development

Losing a parent to suicide makes children more likely to die by suicide themselves and increases their risk of developing a range of major psychiatric disorders, according to a study led by Johns Hopkins Children's Center that is believed to be the largest one to date on the subject.

22 Apr 2010

Seattle Genetics, Agensys present ASG-5ME ADC preclinical data at 101st AACR

Seattle Genetics, Inc. and Agensys, Inc., an affiliate of Tokyo-based Astellas Pharma Inc., today reported preclinical data with ASG-5ME, an antibody-drug conjugate (ADC) that is being co-developed by both companies for the treatment of solid tumors. In models of human prostate and pancreatic cancer, ASG-5ME was found to have potent and long lasting antitumor activity. The findings were presented at the 101st Annual Meeting of the American Association for Cancer Research (AACR) being held in Washington, D.C.

22 Apr 2010

"Destination therapy" for end-stage heart failure patients

Federal approval for an alternative therapy to heart transplantation led to a new lease on life for a UT Southwestern Medical Center patient who suffered from heart failure for nearly a decade.

21 Apr 2010

Tips on how to live joyful life with a chronic disease now available in audio version

Award winning speaker and author Lori Hartwell today released a 6-CD unabridged set of her renowned book, Chronically Happy: Joyful Living in Spite of Chronic Illness, which relates her optimism for life despite living with kidney disease for over 40 years.

21 Apr 2010

Transplant News and Research

Team liberates cellular hostages by silencing Toxoplasma gondii's back-seat driving

QF-CMV test helps predict transplant recipients at increased risk of CMV disease after surgery

New blood test to determine patients at low risk for rejection of transplanted hearts

Astellas Pharma extends tender offer for OSI Pharmaceuticals

FDA grants tentative approval for Sagent Pharmaceuticals' adenosine injection

Genetic tests that may replace biopsies

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Valor Medical's European cerebral aneurysm clinical trial finalized with 30 patients treated

Vical presents Phase 2 trial results of TransVax CMV vaccine at World Vaccine Congress

Alexion Pharmaceuticals reports total revenues of $117.6M from net product sales of Soliris

IL-10 Gene Therapy helps repair damaged lungs found unfit for transplant

International Day for Fighting Infection focuses on hospital infection control

ISHLT announces new guidelines for heart transplant recipients

Gen-Probe's PROGENSA PCA3 assay helps determine necessity of initial biopsy in prostate cancer suspect men

StemCells to initiate second clinical trial of HuCNS-SC human neural stem cells in NCL

FDA approves Novartis Pharmaceuticals' Zortress for preventing rejection of kidney transplants

Study analyzes effects of untimely and sudden parental death on childhood development

Seattle Genetics, Agensys present ASG-5ME ADC preclinical data at 101st AACR

"Destination therapy" for end-stage heart failure patients

Tips on how to live joyful life with a chronic disease now available in audio version

Sensing a Healthier Future

Achieving and maintaining ISO/IEC 27001 and BS 10012 certifications

Expanding research and clinical options for children with cancer

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