April 30, 2008

• Teva Gets Pulmonary Hypertension Drug FDA Approval
  (Globes) -- Petah Tikva-based Teva received approval for its epoprostenol, the first generic version of GlaxoSmithKline’s Flolan for Injection. Teva’s approval is for the 0.5 mg base/vial and 1.5 mg base/vial strengths as well as the sterile diluent.
  

• Glaxosmithkline's Volibris Receives Authorisation From The European Commission For The Treatment Of Functional Class II And III PAH
  (Medical News Today) -- Ambrisentan is the first non-sulphonamide class endothelin receptor antagonist (ERA) and the first PAH medicine approved for WHO Functional Class II patients in Europe.
  

• Business Is Personal For Satellite Radio, Drug Entrepreneur
  (AP) -- Martine Rothblatt founded Sirius Satellite Radio from a desire to link people together. She founded United Therapeutics from a desperation to save her daughter's life.
  

• Before Brain Death
  (Chicago Sun-Times) -- Most transplanted organs come from donors who are declared brain dead. But more surgeons are returning to the "non-beating heart donation," in which organs are removed from patients who have minimal brain function but are taken off life support with family members' consent.
  

• “The Global Learning Series” To Raise Awareness Of PAH In An Episode Called “Understanding The Heart”
  (Business Wire) -- The show will be distributed this fall to public television stations and several cable television stations throughout the country and globally on both the web and U.S. Government Voice of America (VOA) Television.
  

• Drug From Genentech And Biogen Fails As A Lupus Treatment
  (New York Times) -- The companies said that their drug Rituxan did not achieve any of seven measures of effectiveness in a late-stage patient trial.
  

• Judge Won't Disqualify Himself In Diet-Drug Case
  (Louisville Courier-Journal) -- U.S. District Judge William O. Bertelsman rejected motions to recuse himself in the criminal trial of Shirley Cunningham Jr., William Gallion and Melbourne Mills Jr., which is set to begin May 12.
  

• Ambrisentan: A New Drug For Pulmonary Arterial Hypertension
  (Medscape) -- Ambrisentan, a diphenyl propionic acid derivative ( Figure 1. PubChem CID:6918493), represents a valuable addition to the treatment alternatives for this orphan disease, which include prostacyclin (Flolan), inhaled nitric oxide, iloprost (a prostacyclin analog), sildenafil (a PDE5 inhibitor), and conventional Ca++ channel blockers (e.g., verapamil and nifedipine).
  

• Terminal Illness Can't Dim Her Optimism
  (Whittier Daily News) -- Sanchez, of Whittier, has had primary pulmonary hypertension for 11 years and wears the pump which delivers medicine through a catheter into her heart.
  

• InterMune Announces Progress On Pirfenidone In IPF
  (InterMune) -- InterMune, Inc. announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF).
  

• Organ Donation: A Crisis Among Minorities
  (Insight News) -- The need for transplants is particularly high among minorities, especially among African Americans. Of the 83,000 people on the national transplant waiting list, approximately fifty percent are minorities, according to United Network for Organ Sharing.
  

• Double Lung, Heart Transplant Patient Wants Saultites To Know Signing Card Will Save Lives
  (The Sault Star) -- She was diagnosed with Eisenmenger's Syndrome, which is often accompanied by pulmonary hypertension, or pressure on the lungs.
  

• La Jolla Lupus Drug Shows Positive Late-Stage Data
  (Reuters) -- The company said the rate at which antibody levels were maximally reduced appeared to be more rapid in the higher 900 mg dose group than in the lower 300 mg or 100 mg dose groups.
  

• Nasal Surgery Helps Ease Sleep Apnea Symptoms
  (HealthDay News) -- Surgery to remove nasal obstructions improves quality of life for people with obstructive sleep apnea (OSA) and reduces symptoms of nasal blockages, according to a study by researchers in Taiwan.
  

• MEPs Back Europe Organ Donor Card
  (BBC) -- MEPs voted overwhelmingly on Tuesday for the creation of a card and hotline that would operate across Europe.
  

• Human Genome Sciences Completes Enrollment in First of Two Phase 3 Lymphostat-B(R) Trials
  (HGS) -- “We continue to be excited by LymphoStat-B’s potential. Assuming it is successful in Phase 3, we believe that LymphoStat-B could represent a breakthrough in the treatment of SLE,” said H. Thomas Watkins, President and Chief Executive Officer, HGS.
  

• GPs Miss Raynaud's
  (Irish Medical Times) -- Patients suffering from Raynaud’s or scleroderma are not getting the medical help they need, with an average diagnosis coming three years after first presenting with symptoms, according to a survey of 1,000 affected patients carried out by the Irish Raynaud’s and Scleroderma Society (IRSS).
  

• Actelion And Nippon Shinyaku Enter Into A License Agreement On Novel PAH Compound
  (Actelion) -- NS-304, originally discovered and synthesized by Nippon Shinyaku, is an orally available long acting prostaglandin I2 receptor agonist), which stimulates PGI2 receptor in blood vessels and exerts vasodilating effects.
  

• Transplant Center Has Shortest Wait Time In U.S.
  (Post-Bulletin) -- Mayo in Jacksonville touts one of the largest transplant programs in the Southeast, while at the same time "maintaining above-national-average survival rates."
  

• Ionic Air Purifiers' Dirty Little Secret: They Don't Get Rid Of Dust
  (LA Times) -- There's another thing that separates ionic air purifiers from other technologies: To varying degrees, all ionic air purifiers release ozone, a potential pollutant.
  
  High concentrations of ozone may cause difficulty breathing in PH patients.

• Minimizing Risks During Right Heart Catheterization In PAH
  (Medscape) -- Severe pulmonary arterial hypertension (PAH) increases the risk for complications during right heart catheterization (RHC) (asystole, fatal arrhythmias, etc). Are there any real numbers on death rate, associated level of PAH, and complications?
  

• Judge Eyes Fen-Phen Assets
  (Herald-Leader) -- A special judge apparently intends to authorize fen-phen plaintiffs to go after the assets of companies associated with former attorneys Shirley Allen Cunningham Jr. and William Gallion, including sale of their interest in 2007 Horse of the Year Curlin.
  

• Vasculopathic Diseases Complicate Pregnancy
  (Medscape/Reuters) -- Women with systemic sclerosis, primary pulmonary hypertension, or sickle cell disease are at increased risk for having complicated pregnancies, according to study findings reported in the April issue of Obstetrics & Gynecology.
  

• Next Target For Genentech’s Rituxan: Lupus
  (WSJ) -- Results of a Rituxan trial in lupus are due in a few weeks, Dow Jones Newswires reports. Even if they’re positive, they may not be enough to win approval for the drug — but they could drive off-label use of Rituxan, which is already being given to some lupus patients who fail other therapies. More data, which could be enough for FDA approval, are expected next year.
  

• Heart And Lung Transplant Patients May No Longer Need Biopsies
  (Science Daily) -- Non-invasive testing using gene-based blood or urine samples called biomarkers could offer transplant patients personalized care and medication and may replace the need for costly, invasive biopsy procedures that can be risky for patients.
  

• Popular Impotence Drugs May Cause Sudden Deafness
  (NaturalNews) -- Also receiving a label change will be blood pressure drug Revatio.
  

• Obese Fare Well After Heart Transplant
  (WebMD) -- In a study of 430 patients who underwent a heart transplant at Temple University Hospital in Philadelphia over a 10-year period, there were no major differences in survival rates among patients with lean, moderately obese, or extremely obese bodies.
  

• Heart Transplant Survival Studies Clash
  (WebMD) -- Two studies show conflicting data on survival rates for African-Americans who undergo successful heart transplant surgery. Both studies were presented yesterday at the 28th annual meeting and scientific sessions of the International Society for Heart and Lung Transplantation.
  

• Co-Payments Go Way Up For Drugs With High Prices
  (New York Times) -- Health insurance companies are rapidly adopting a new pricing system for very expensive drugs, asking patients to pay hundreds and even thousands of dollars for prescriptions for medications that may save their lives or slow the progress of serious diseases.

• Organ Donation: A Crisis Among Minorities
  (Newswise) -- The number of people needing organ transplants is rising faster than the number of donors, according to statistics from the U.S. Department of Health and Human Services. Roughly 77 people receive organ transplants per day in the United States, but 18 people die each day waiting for transplants that will never happen due to the shortage of available organs.
  

• Safety Alert For CellCept And Myfortic
  (FDA MedWatch) -- FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy.
  

• Study Suggests Obstructive Sleep Apnea May Be Associated With Coronary Artery Calcification
  (MedWire News) -- Writing in the journal Chest, Francisco Lopez-Jimenez (Mayo Clinic College of Medicine, Rochester, Minnesota) and colleagues suggest that "OSA identifies patients at risk for coronary disease and may represent a highly prevalent modifiable risk factor."
  

• Aradigm Initiates Trial Of Lung Rx's Inhaled Treprostinil
  (Aradigm) -- Aradigm Corporation today announced it initiated a bridging clinical trial of inhaled treprostinil utilizing its AERx Essence(R) pulmonary delivery system. The trial in healthy volunteers is being conducted in the United Kingdom.
  

• Ventricular Septal Defect: A Vanishing Disease
  (Gather.com) -- Academic medical centers have the capability well-established in prenatal diagnosis and perinatal treatment which encourage the eradification and hopeful extinction of this defect.
  

• Exposing Pulmonary Hypertension
  (Akron Beacon-Journal) -- Akron General's clinic diagnoses and treats a little-known disease that is life-threatening.
  

• Sleep Apnea: A Stealthy Cause Of Depression
  (Gather.com) -- I bet most people will be surprised to hear that research has linked sleep apnea to depression. If you think about it, though, it makes sense that being sleep deprived could affect your body's chemistry and moods.
  

• Diet-Drug Defendant Wants Judge Removed From Case
  (Louisville Courier-Journal) -- Using extremely strong language, one of three suspended lawyers scheduled to be tried next month in Kentucky's fen-phen case has accused the judge of bias and asked that he be disqualified.
  

• Attorney Won't Testify In Diet-Drug Case
  (Louisville Courier-Journal) -- Cincinnati lawyer Stan Chesley, who helped negotiate Kentucky's $200 million fen-phen settlement, has disclosed he won't testify for three fellow lawyers accused of bilking their clients out of $46 million.
  

• Conference Will Give Transplant Experts A Chance To Debate Ethics
  (Chicago Tribune) -- At a national transplant ethics conference opening here Friday, doctors, psychologists, ethicists and others will grapple with the ever more complex decision-making that surrounds distribution of scarce organs to the tens of thousands of Americans desperate for a life-sustaining transplant.
  

• A Long Road
  (Ludington Daily News) -- Pulmonary hypertension leaves Ludington woman severely short of breath and — for years — looking for answers.
  

•   Former Minister Imported Vital Drugs To Help An Ill Constituent
  (ic Wales) -- Mr Ainger is campaigning for the drug licensing body Nice to reverse its position that funding for epoprostenol and other treatments for pulmonary arterial hypertension should cease for new adult patients on cost grounds.
  

• Boca Raton Man Turns To Art After Beating Fatal Ailment
  (Boca Raton News) -- He was a carpenter until doctors gave him the diagnosis – and told him we would likely never be able to work again. He was fitted with a pump that administered the drug, Flolan, through a catheter in his chest. The pump and catheter would remain with him 24 hours a day for 8 years.
  

• Church Plans Benefit Concert For Stuarts Draft Youth
  (Staunton News Leader) -- A month after his 10th birthday, Dakota was diagnosed with pulmonary arterial hypertension, or high blood pressure in the pulmonary artery.
  

•   When Is Someone Officially Dead?
  (MSNBC) -- Israelis in desperate need of an organ transplant can now breathe a little easier. A new law passed last week in the Israeli Knesset (parliament) will hopefully help bridge the gulf between Orthodox and secular Jews on the controversial issue of organ donation and help pave the way for more transplants.
  

• CPAP Reduces Mortality, Morbidity In Heart Failure With Sleep Apnea
  (Medscape) -- Therapy with continuous positive airway pressure (CPAP) is highly beneficial in patients with heart failure and obstructive sleep apnea, Japanese researchers report in the March issue of Chest.
  

• New Approach To Limiting Organ Damage In Sickle Cell Disease
  (EurekAlert) -- A new study, performed by Pierre-Louis Tharaux and colleagues, at INSERM U689, France, has indicated that a drug known as bosentan prevents experimentally induced VOC in a mouse model of SCD.
  

• April Is National Donate Life Month
  (OrganDonor.gov) -- National Donate Life Month was established in 2003. Every day in April, people across the U.S. make a special effort to celebrate the tremendous generosity of those who have saved lives by becoming organ, tissue, marrow, and blood donors and to encourage more Americans to follow their fine example.
  

• First Mosaic Laureate To Gain Doctorate For Work On Heart Function
  (HULIQ) -- Dutch medical researcher Christiaan Tji-Joong Gan has established that patients with a high blood pressure in the lungs die because the right ventricle is not capable of pumping blood against this pressure. Further, the right ventricle needs a longer rest phase between each pumping phase.
  

• ACC: Flu Vaccine Less Effective In Heart Failure Patients
  (MedPageToday) -- Patients with heart failure had a significantly (P=0.017) lower antibody response to one of the three influenza virus strains found in the vaccine compared with healthy patients, Orly Vardeny, Pharm.D., of the University of Wisconsin in Madison, told attendees at the American College of Cardiology meeting here.
  

•   Transplant Authority Needed - ILFA
  (Irish Health) -- “There is a pressing need for an independent Irish transplant authority as in Spain and Austria. The Irish Lung Fibrosis Association (ILFA) is now calling on the Minister for Health and the HSE to address this ongoing crisis”, Dr Egan said.
  

• Expert Witness Says Fen-Phen Defendant Relied On Colleague
  (Kentucky.com) -- William J. Gallion and two other lawyers relied heavily on the advice of famed trial lawyer Stan Chesley in the handling of a $200 million civil settlement with a diet drug manufacturer, according to an expert witness retained by Gallion.
  

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