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2006; Elsevier BV; Volume: 4; Issue: 3 Linguagem: Inglês
10.1111/j.1538-7836.2006.01863.x
ISSN1538-7933
Autores Tópico(s)Pharmaceutical Economics and Policy
ResumoGerman drugs and chemicals group, Bayer, has bought GlaxoSmithKline's business marketing blood pressure treatment telmisartan (Pritor® and PritorPlus®) in Europe, Bayer said. Pritor, which had an annual turnover of 65 million euros ($77.27 million) in 2005, provides ‘an excellent strategic fit for Bayer HealthCare's pharma business’, Bayer said in a statement. It did not disclose the price it paid for the unit. The acquisition will give Bayer HealthCare the right to market the drug, produced by German drugmaker Boehringer Ingelheim, in Italy, Spain, France, Greece, Portugal and 22 smaller European markets. Bayer's shares were up 1.8% at 36.28 € at 1353 GMT, outstripping the blue-chip DAX index which was up 0.8%. GlaxoSmithKline's shares were 0.3% lower at 1464 pence in London. http://www.bayer.com This is the first QSEAL certification awarded to Talecris Biotherapeutics. The company's predecessor, Bayer Biological Products, received QSEAL certification in 2001 – the first year PPTA (Plasma Protein Therapeutics Association) awarded QSEAL certification to plasma therapies manufacturers. All of the Talecris facilities received the QSEAL certification, including its primary manufacturing facility in Clayton, N.C.; its plasma testing facility in Raleigh, N.C.; and Precision Pharma's fractionation and contract manufacturing facility in Melville, N.Y. The certification is effective, pending required audits, through Sept. 2007. The other companies that have been awarded QSEAL status are Baxter BioScience, Biotest AG, Instituto Grifols and ZLB Behring. http://www.pptaglobal.org In a continuing effort to use modern information technology to help inform the public and health care providers and to further improve patient safety, the Food and Drug Administration (FDA) began requiring drug manufacturers to submit prescription drug label information to FDA in a new electronic format. This electronic format will allow healthcare providers and the general public to more easily access the product information found in the FDA-approved package inserts (‘labels’) for all approved medicines in the USA. Drug manufacturers are now required to submit to FDA prescribing and product information (i.e. the package insert or label) in a structured product labeling (SPL) format that provides accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format. Using embedded computer tags, the prescribing and product information in the SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied. http://www.fda.gov The European Medicines Agency launched an SME Office to provide administrative and procedural assistance to small and medium-sized enterprises (SMEs) seeking to develop and market new medicines. The launch follows the adoption of a new Commission Regulation aimed at promoting innovation and the development of new medicinal products by SMEs. Once the Regulation comes into effect, SME companies that are developing medicinal products for human or veterinary use will be able to benefit from a number of incentives, including: Administrative and procedural assistance from a dedicated group of people within the SME Office at the Agency; Fee reductions for scientific advice, inspections and (for veterinary medicines) establishment of maximum residue limits; Fee exemptions for certain administrative services of the EMEA; Deferral of the fee payable for an application for marketing authorization or related inspection; Conditional fee exemption where scientific advice is followed and a marketing application is not successful; Assistance with translations of the product-information documents submitted in the application for marketing authorization. http://www.emea.eu.int Men with high total cholesterol are much more likely to develop high blood pressure than men with low total cholesterol, according to a study in Hypertension: Journal of the American Heart Association. ‘Hypertension and lipids are both related to the risk of cardiovascular disease,’ said Howard Sesso, associate epidemiologist at Brigham and Women's Hospital and assistant professor of medicine at Harvard Medical School in Boston. ‘We took one step backwards to try to understand whether adverse lipid levels might predate the development of hypertension in men’. Researchers analyzed data from the Physicians’ Health Study, an ongoing clinical trial that collected baseline blood samples of 3110 men (average age 48) free from hypertension, cardiovascular disease and cancer at the start of the study. Over an average of 14-years follow up, about a third (1019) developed hypertension. The researchers measured total cholesterol and high-density lipoprotein (HDL) –‘good’ cholesterol – then calculated non-HDL cholesterol (defined as total cholesterol minus HDL cholesterol) and the ratio of total cholesterol to HDL cholesterol. ‘It appears that lipids do have a role in the development of hypertension,’ Sesso said. ‘We found a positive association between higher levels of total cholesterol, non-HDL cholesterol and total cholesterol-to-HDL cholesterol ratio and an increased risk of hypertension. Those men who had higher levels of HDL cholesterol had a significantly lower risk for developing hypertension than men who had the low levels of HDL cholesterol’. The researchers divided study participants into five groups, or quintiles, from the lowest levels to the highest for each lipid category. They found that men in the: highest fifth of total cholesterol were 23% more likely to develop hypertension than men in the lowest quintile for total cholesterol; highest quintile of non-HDL cholesterol were 39% more likely than those in the lowest quintile to develop hypertension; highest quintile for total cholesterol-to-HDL cholesterol ratio were at a 54% increased risk for hypertension compared with those in the lowest quintile in that category. They also found that men in the highest quintile for HDL levels had a 32% lower risk of developing hypertension than those in the lowest quintile. ‘When we notice an elevation of lipids in the absence of hypertension, it may indicate those patients are at greater risk of developing hypertension later on,’ Sesso said. http://www.americanheart.org Inhaling diesel exhaust at levels typically found in large cities may disrupt normal blood vessel and clotting activity, according to a first-of-its-kind study reported in Circulation: Journal of the American Heart Association. This may explain the link between air pollution and heart disease, said lead researcher Nicholas L. Mills, MRCP, an investigator at the Centre for Cardiovascular Science at the University of Edinburgh, UK. In the study, researchers found that exposure to diesel exhaust for 1 h during exercise caused a significant decrease in blood vessels’ natural ability to expand (dilate). Exposure to air pollution also decreased levels of an enzyme that helps prevent clots from forming. Air pollution contributes to death and illness involving the heart and blood vessels. Short-term exposure to air pollution can worsen existing problems and lead to hospitalization for heart attack and other heart and lung conditions. Long-term repeated exposure increases the risk of death from coronary heart disease, abnormal heart rhythms and heart failure. The researchers tested their hypothesis in 30 healthy, nonsmoking men 20–38 years old. The study participants underwent two separate 1-h evaluations, 2 weeks apart. Researchers conducted the test in a specially built diesel exposure chamber, where the men were exposed to either filtered air or diesel exhaust while riding a stationary bicycle and resting at 15-min intervals. The diesel exhaust was generated from an idling diesel engine. During the diesel exposures, the particle concentration was kept constant at 300 mcg/m3), a level comparable with curbside exposure on a busy street in a large city. Two and 6 h after being in the exposure chamber, the men received infusions of vasodilating drugs in one arm. Researchers measured blood flow in the infused and non-infused arms. They also drew blood before each exposure and 2 and 6 h afterwards. The researchers measured blood levels of tissue plasminogen activator (t-PA), a naturally occurring enzyme that dissolves blood clots, and plasminogen activator inhibitor type 1 (PAI-1), a substance that counterbalances the activity of t-PA to help maintain normal clotting activity. The vasodilators caused dose-related increases in forearm blood flow after exposure to filtered air and diesel exhaust. Forearm blood flow decreased significantly 2 h after diesel exposure, and the reduced response to the vasodilators persisted at 6 h. Infusion of the natural hormone bradykinin releases t-PA from the blood vessel wall, but this vascular response was significantly reduced 6 h after diesel exposure. http://www.americanheart.org
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