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First monoclonal antibody approved using the Animal Efficacy Rule

FDA approves raxibacumab to treat inhalational anthrax

 

Silver Spring (December 14, 2012) - The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

 

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Drug can now be used before treatment with chemotherapy

FDA expands Zytiga’s use for late-stage prostate cancer

 

Silver Spring, MD, USA (December 10, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

 

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Sharp spike in computer-related injuries predicted for medical workers

 

ITHACA, N.Y. (December 3, 2012) – As U.S. health care goes high tech, spurred by $20 billion in federal stimulus incentives, the widespread adoption of electronic medical records and related digital technologies is predicted to reduce errors and lower costs – but it is also likely to significantly boost musculoskeletal injuries among doctors and nurses, concludes a Cornell University ergonomics professor in two new papers.

 

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NICE recommends depth of anaesthesia monitors

 

London, UK, (November 21, 2012) - Healthcare guidance body NICE has today (21 November) published final guidance recommending the use of the Bispectral Index (BIS, Covidien), E-Entropy (GE Healthcare) and Narcotrend-Compact M (MT MonitorTechnik GmbH & Co) EEG-based depth of anaesthesia monitors as options in patients receiving total intravenous anaesthesia and in patients who are considered at higher risk of adverse outcomes during any type of general anaesthesia. This includes patients who are at higher risk of unintended awareness and patients who are at higher risk from excessively deep anaesthesia.

 

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Alcohol provides protective effect, reduces mortality substantial

 

Chicago, Ill., USA (November 19, 2012) - Injured patients were less likely to die in the hospital if they had alcohol in their blood, according to a study from the University of Illinois at Chicago School of Public Health -- and the more alcohol, the more likely they were to survive. "This study is not encouraging people to drink," cautions UIC injury epidemiologist Lee Friedman, author of the study, which will be published in the December issue of the journal Alcohol and is now online. That's because alcohol intoxication -- even minor inebriation -- is associated with an increased risk of being injured, he says.

 

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EMA Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012

 

London (November 16, 2012) - This page provides an overview of the opinions adopted at the November 2012 meeting of the CHMP and other important outcomes.
In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.
To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’.

The Agency publishes a new page following the CHMP meeting each month.


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New measures to minimise the risk of gas embolism during spray application

European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil

 

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of risk-minimisation measures for the fibrin sealants Evicel and Quixil to minimise the risk of gas embolism when these medicines are applied as spray during surgery.

 

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EMA recommends approval of first vaccine for meningitis B

Vaccine to provide broad coverage against meningococcal group B infections

 

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero, a new vaccine intended for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B. There is currently no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B.

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Advocacy for planned home birth not in patients' best interest

 

  • Home-birth-like experience in hospitals ultimately safer, more satisfying, and more cost effective for patients

 

Philadelphia, PA (November 13, 2012) – Advocates of planned home birth have emphasized its benefits for patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. A clinical opinion paper published in the American Journal of Obstetrics and Gynecology critically evaluates each of these claims in its effort to identify professionally appropriate responses of obstetricians and other concerned physicians to planned home birth.

 

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Xarelto® (Rivaroxaban)

Landmark Phase III Study of Bayer’s Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients with Coronary or Peripheral Artery Disease

 

  • 20,000-patient study will be conducted in collaboration with Population Health Research Institute
  • Composite of cardiovascular death, myocardial infarction and stroke as primary efficacy endpoint
  • Rivaroxaban is the first novel oral anticoagulant under assessment in this high risk patient population

 

Berlin, Germany (November 13, 2012) – Bayer HealthCare announced today the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to date, investigating the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

 

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Patients shy away from asking healthcare workers to wash hands

Patient empowerment seen as possible tool to raise hand hygiene behaviors

 

Chicago, Ill., USA (November 12, 2012) – According to a new study published online today, most patients at risk for healthcare-associated infections (HAIs) agree that healthcare workers should be reminded to wash their hands, but little more than half would feel comfortable asking their physicians to wash. The study is published in the December issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. The study points to the need for patient empowerment to improve hand hygiene of healthcare workers.

 

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FDA approves Xeljanz for rheumatoid arthritis

 

Silver Spring, MD, USA (November 6, 2012) - The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

 

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National Senior Safety Week – Drug safety for seniors

Is your memory playing tricks on you? Check your medicine cabinet!

 

Montreal, Canada (November 6, 2012) - Common medication to treat insomnia, anxiety, itching or allergies can have a negative impact on memory or concentration in the elderly, according to Dr. Cara Tannenbaum, Research Chair at the Institut universitaire de gériatrie de Montréal (IUGM, Montreal Geriatric University Institute) and Associate Professor of Medicine and Pharmacy at the University of Montreal (UdeM). Up to ninety percent of people over the age of 65 take at least one prescription medication. Eighteen percent of people in this age group complain of memory problems and are found to have mild cognitive deficits. Research suggests there may be a link between the two.

 

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Drug doesn't significantly lower risk of major heart problems in dialysis patients

 

Stanford, CA, USA (November 5, 2012) - In one of the largest and longest trials involving patients with kidney failure, a study led by an international team of researchers found that cinacalcet — a drug commonly prescribed to patients with kidney failure and a disturbance of bone and mineral metabolism known as secondary hyperparathyroidism — does not significantly reduce the risk of death or major cardiovascular events.

 

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FDA expands use of Xarelto to treat, reduce recurrence of blood clots

 

Silver Spring, MD, USA (November 2, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

 

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Study suggests too much risk associated with SSRI usage and pregnancy

 

Antidepressants should only be prescribed with great caution

 

Boston, MA, USA (October 31, 2012) – Elevated risk of miscarriage, preterm birth, neonatal health complications and possible longer term neurobehavioral abnormalities, including autism, suggest that a class of antidepressants known as selective serotonin reuptake inhibitors (SSRI) should only be prescribed with great caution and with full counseling for women experiencing depression and attempting to get pregnant, say researchers at Beth Israel Deaconess Medical Center, Tufts Medical Center and MetroWest Medical Center.

 

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Researchers invent a quick-release medical tape that minimizes neonatal skin injury

No more tears from tears

 

Boston, MA, USA (October 29, 2012) Commercial medical tapes on the market today are great at keeping medical devices attached to the skin, but often can do damage—such as skin tissue tearing—once it's time to remove them. A research team from Brigham and Women's Hospital (BWH) has invented a quick-release tape that has the strong adhesion properties of commercial medical tape, but without the ouch factor upon removal.

The team was led by Jeffrey Karp, PhD, BWH Division of Biomedical Engineering, Department of Medicine, senior study author in collaboration with The Institute for Pediatric Innovation which defined the need and requirements for a new neonatal adhesive based on national surveys of neonatal clinicians.

 

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Hot flashes can come back after SSRI

 

Cleveland, Ohio, USA (October 24, 2012) - Hot flashes and night sweats can return after women stop using escitalopram—an antidepressant—to treat these menopause symptoms, according to a study published online this month in Menopause, the journal of the North American Menopause Society. This is typical of stopping hormone therapy as well.

 

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Can Diabetes Devices be Damaged by Airport Security Scanners?

 

New Rochelle, NY(October 24, 2012) — Full-body or X-ray scanners used for airport security screening may affect the function of insulin pump or continuous glucose monitoring (CGM) devices. People with diabetes can present a travel letter obtained from their physicians to avoid possible damage caused by exposure to imaging equipment in airports. The risk to these sensitive devices posed by scanners and the low-pressure conditions on airplanes are the focus of the Editorial “Navigating Airport Security with an Insulin Pump and/or Sensor,” published in Diabetes Technology & Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The Editorial is available free on the Diabetes Technology & Therapeutics website.

 

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Results of the TRILOGY ACS Angiographic Cohort presented at TCT 2012

Study finds that prasugrel may reduce cardiovascular events among patients managed medically after an angiogram for acute coronary syndrome

 

Miami, FL, USA (October 24, 2012) – A study has found that the anti-clotting medication prasugrel reduced cardiovascular events among patients who present with an acute coronary syndrome and are managed medically after an angiogram is performed to determine coronary anatomy. Results of the TRILOGY ACS trial, Angiographic Cohort were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

 

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Challenging Parkinson's dogma

 

Boston, MA, USA (October 24, 2012) - Scientists may have discovered why the standard treatment for Parkinson's disease is often effective for only a limited period of time. Their research could lead to a better understanding of many brain disorders, from drug addiction to depression, that share certain signaling molecules involved in modulating brain activity.

 

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Study of Heavily Pre-Treated Myeloma Patients

Pomalidomide Demonstrated Significant Progression-Free Survival and Overall Survival Advantages in Phase III

 

Boudry, Switzerland (October 23, 2012) - Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that its phase III, multi-center, randomized, open-label study (MM-003) of pomalidomide plus low-dose dexamethasone compared to high-dose dexamethasone in patients with relapsed and/or refractory multiple myeloma was reviewed by a data safety monitoring board (DSMB). The DSMB determined MM-003 met the primary endpoint of improvement in progression-free survival (PFS) at the PFS final analysis. Additionally, at the OS interim analysis, the study crossed the superiority boundary for overall survival (OS), a key secondary endpoint that the study was also powered to evaluate. Improvements in PFS and OS were both highly statistically significant and clinically meaningful. As a result, the DSMB recommended that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed-over to the pomalidomide plus low-dose dexamethasone arm.

 

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Excessive ICU noise may harm patients

 

Atlanta, Georgia, USA (October 22, 2012) - New research shows that overnight noise levels in the medical ICU (MICU) often exceed recommended levels, which could potentially lead to worse outcomes. Researchers from Yale University School of Medicine reviewed 70 MICU patient charts and recorded in-room activities between midnight and 4:00 AM. Based on this chart review and via direct observation, they also identified the key elements of nocturnal patient disruption.

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 October 2012

London (October 19, 2012) - At the start of its October 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Dr Ian Hudson as its new vice-chair for a three-year mandate.
Dr Hudson brings outstanding experience and expertise from a long career in regulatory medicine and drug development, particularly in the areas of anti-infectives and oncology. He currently holds the position of Director of the Licensing Division at the Medicines & Healthcare Products Regulatory Agency in London. Dr Hudson has been a member of CHMP since 2004.
The opinions adopted by the CHMP at the October 2012 meeting and other important outcomes are listed in the table below.

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European Medicines Agency finalises review of recent published data on cardiovascular safety of NSAIDs

 

Pharmacovigilance Risk Assessment Committee (PRAC) to consider need for updated treatment advice for diclofenac in follow-on review

 

London, UK (October 19, 2012) - The European Medicines Agency has finalised a review of recently published information on the cardiovascular safety of non-steroidal anti-inflammatory drugs (NSAIDs).

The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that evidence from newly available published data sources, including meta-analysis of clinical trials and observational studies, and the results of a European Union-funded independent research project, the ‘safety of non-steroidal anti-inflammatory drugs' (SOS) project, on the cardiovascular safety of this class of medicines confirm findings from previous reviews, conducted in 2005 and 2006.

 

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European Medicines Agency reviews hypothesis on Pandemrix and development of narcolepsy

 

No new concerns for Pandemrix or other vaccines on the basis of available evidence

 

London (October 19, 2012) - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), at the request of the Agency’s Executive Director Guido Rasi, has reviewed preliminary research results by the Finnish National Institute of Health and Welfare (THL) investigating differences in the immunological response triggered by different pandemic influenza vaccines as a potential root cause for the development of narcolepsy in persons vaccinated with Pandemrix.

 

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European Medicines Agency recommends approval of first higher-strength insulin for treatment of patients with diabetes mellitus in the EU

 

London, UK (October 19, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has made a recommendation to give marketing authorisation to insulin degludec, a new basal analogue insulin for the treatment of diabetes mellitus in adults. It is introduced in a pre-filled pen in two formulations – 100 units/ml and 200 units/ml.

 

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Commonsense medical precautions ignored

Wide discrepancy in surveillance and control of infections in ICUs

 

New York, NY, USA (October 15, 2012) - Screening practices for multidrug-resistant organisms (MDROs) in intensive care units (ICUs) vary widely from hospital to hospital, according to a new study by researchers at Columbia University School of Nursing and published in the October 2012 issue of the American Journal of Infection Control.

Researchers found that of the hospitals surveyed, a little more than half (59 percent) routinely screened for methicillin-resistant Staphylococcus aurea, or MRSA. Other potentially deadly MDROs were screened for far less frequently: vancomycin-resistant Enterococcus (22 percent), gram-negative rods (12 percent), and C. difficile (11 percent).

 

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Kidney failure patients may be facing accelerated aging process

Quiz could determine death risk for kidney dialysis patients of all ages

 

Baltimore, Maryland, USA (October 12, 2012) - A simple six-question quiz, typically used to assess disabilities in the elderly, could help doctors determine which kidney dialysis patients of any age are at the greatest risk of death, new Johns Hopkins research suggests.

 

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Hospitals that cooperate on infection control fare better than hospitals acting alone

 

PITTSBURGH, PA, USA (October 9, 2012) – An individual hospital's infection control efforts have a ripple effect on the prevalence of a deadly and highly infectious bacterium in hospitals throughout its surrounding region, a multi-center research group led by the University of Pittsburgh demonstrated in a computer simulation-based study.

 

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NICE consults on new hypertension draft quality standard

 

London, UK (October 5, 2012) - NICE has today (5 October) launched a consultation on its draft quality standard for the management of patients with hypertension. NICE quality standards aim to help commissioners, healthcare and service providers deliver the best levels of quality, evidence-based patient care. They are derived from the best available evidence (usually NICE guidance or NICE accredited sources), and apply right across the NHS in England. The draft quality standard on hypertension describes measurable markers of high-quality, cost-effective care to drive improvements in the effectiveness, safety and experience of care for people with hypertension.

 

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Focus Diabetes

Process & technology innovation need to be employed in structured care

 

  • Personalized Diabetes Management supports improved diabetes therapy outcomes

 

Berlin, Germany (October 1, 2012) - Diabetes is a silent chronic disease in the beginning, but if not treated appropriately it deteriorates over time. Due to its secondary complications diabetes can be reckoned as dangerous. It requires healthcare professionals’ and patients’ continuous attention and therapy adaptation to optimally manage the condition to delay or even prevent the sequelae to arise. At the 2nd international scientific media symposium Focus Diabetes: Patients. Perspectives. Progress., facilitated by Roche Diabetes Care on the occasion of the 48th annual meeting of the European Association for the Study of Diabetes (EASD) in Berlin, renowned key opinion leaders discussed most recent approaches to personalize diabetes management and optimally manage glycemic control with the support of latest technological innovations. There was consensus amongst the experts about the fact that the presented concepts are able to substantially facilitate therapy decisions and are easy to implement into daily routines. This is in addition emphasized by current study results which demonstrate that the structured management of glycemic patterns in combination with data visualization can support enhanced doctor-patient collaboration, and can lead to patient motivation to better adherence and improved therapy outcomes1.

 

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Bayer HealthCare supports individualized diabetes treatment

What people with diabetes do really need

 

  • A patient-oriented approach is pivotal of successful blood glucose therapy

 

Berlin, Germany (October 1, 2012) – Bayer HealthCare is stressing the need to help health care professionals and people with diabetes to make better decisions for effective diabetes management. At a media round table organized on the occasion of the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin, Germany, a group of international experts came to the conclusion that a patient-focused approach combined with modern blood glucose monitoring systems of the next generation is pivotal of a successful future diabetes therapy. They agreed that standardized guidelines and accuracy norms for blood glucose monitoring systems are essential, however, each therapy might be individual to human behavior and constituency as many patients are still failing, for example, to reach HbA1c goals.

 

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Rutgers College of Nursing professor's research links increased hospital infections to nurse burnout

 

Newark, New Jersey, USA (September 28, 2012) - According to the Centers for Disease Control and Prevention, each year nearly 100,000 hospitalized patients die from infections acquired while undergoing treatment for other conditions. While many factors may contribute to the phenomenon, nurse staffing (i.e., the number of patients assigned to a nurse) has been implicated as a major cause.

 

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NICE issues final guidance on the use of drug to reduce the long term impact of strokes

 

London, UK (September 26, 2012) - NICE, the healthcare guidance body, has today (26 September) issued final guidance on the use of alteplase (Actilyse, Boehringer Ingelheim) for the treatment of acute ischaemic stroke. NICE has recommended alteplase within the NHS as long as treatment is started as early as possible within 4.5 hours after onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate imaging techniques.

 

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New FDA task force will support innovation in antibacterial drug development

 

Silver Spring, MD, USA (September 24, 2012) - The U.S. Food and Drug Administration today announced the formation of an internal task force that will support the development of new antibacterial drugs, a critical public health care goal and a priority for the agency.

 

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EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012

 

London, UK (September 21, 2012) - At the start of its September 2012 meeting, the Committee for Medicinal Products for Human Use (CHMP) elected Tomas Salmonson as its new chair for a three-year mandate.

Dr Salmonson brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency (MPA). He has been a member of the CHMP for more than 12 years.

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European Medicines Agency recommends first medical treatment for removal of eschar from severe burn wounds

 

Pineapple enzyme-based debriding agent adds new treatment option for burn wounds care management

 

London, UK (September 21, 2012) - The European Medicines Agency has recommended approval of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain), an orphan-designated medicine, for removal of eschar in adult patients with deep partial- and/or full-thickness thermal burn. Eschar is the dried-out, thick, leathery, black necrotic tissue that covers severe burn wounds. Its removal is essential to initiate the wound healing process and prevent further complications such as infections in burn victims.

 

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Preemies' brains reap long-term benefits from Kangaroo Mother Care

 

Quebec City, Canada (September 19, 2012) Kangaroo Mother Care -- a technique in which a breastfed premature infant remains in skin-to-skin contact with the parent's chest rather than being placed in an incubator -- has lasting positive impact on brain development, revealed Université Laval researchers in the October issue of Acta Paediatrica. Very premature infants who benefited from this technique had better brain functioning in adolescence -- comparable to that of adolescents born at term -- than did premature infants placed in incubators.

 

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Home birth

Birth is no reason to go to hospital

 

Copenhagen, Denmark (September 19, 2012) - A new Cochrane Review concludes that all countries should consider establishing proper home birth services. They should also provide low-risk pregnant women with information enabling them to make an informed choice. The review has been prepared by senior researcher, statistician Ole Olsen, the Research Unit for General Practice, University of Copenhagen, and midwifery lecturer PhD Jette Aaroe Clausen.

 

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New NICE quality standard for antenatal care

 

London, UK (September 17, 2012) - NICE has today (17 September) launched a new quality standard on the care that should be offered to women during their pregnancy. This new quality standard on antenatal care represents the first component of a suite of maternity quality standards which, along with intrapartum care and postnatal care, will form the core pathway. Other quality standards in development include hypertension in pregnancy, caesarean section and multiple pregnancy.

 

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