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EMA

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013

 

London (March 23, 2013) - This page provides an overview of the opinions adopted at the March 2013 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.

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

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Report by World Health Organization, UCLA School of Nursing shows nursing, midwifery can have major impact on lifestyles changes, health outcomes

Nurses can play key role in reducing deaths from world's most common diseases

 

Los Angeles, Cal., USA (March 19, 2013) - Nurses and midwives can play a critical role in lessening people's risk of cardiovascular diseases, cancers, chronic respiratory disease and diabetes, according to a groundbreaking new report issued by the World Health Organization and co-authored by a UCLA nursing professor.

 

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Living in a sunny climate does not improve vitamin D levels in hip fracture patients

 

CHICAGO, Ill., USA (March 19, 2013) – While it is well known that a majority of hip fracture patients of all ages and both sexes have insufficient or deficient levels of vitamin D, a new study presented today at the 2013 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS) looks at whether or not living in a warm, sunny climate improves patient vitamin D levels.

 

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FDA approves Osphena for postmenopausal women experiencing pain during sex

 

Silver Spring, MD, USA (February 26, 2013) - The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.

 

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FDA alerts health care providers of recall of anemia drug Omontys

 

Silver Spring, MD, USA (February 24, 2013) - The U.S. Food and Drug Administration is alerting health care providers and patients of a voluntary nationwide recall of all lots of Omontys Injection by Affymax, Inc., of Palo Alto, Calif., and Takeda Pharmaceuticals Company Limited, of Deerfield, Ill. The recall is due to reports of anaphylaxis, a serious and life-threatening allergic reaction. Omontys is used to treat anemia in adult dialysis patients.

 

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Preventing chronic pain with stress management

 

Montreal, Canada (February 24, 2013) - For chronic pain sufferers, such as people who develop back pain after a car accident, avoiding the harmful effects of stress may be key to managing their condition. This is particularly important for people with a smaller-than-average hippocampus, as these individuals seem to be particularly vulnerable to stress. These are the findings of a study by Dr. Pierre Rainville, PhD in Neuropsychology, Researcher at the Research Centre of the Institut universitaire de gériatrie de Montréal (IUGM) and Professor in the Faculty of Dentistry at Université de Montréal, along with Étienne Vachon-Presseau, a PhD student in Neuropsychology. The study appeared in Brain, a journal published by Oxford University Press.

 

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FDA approves new treatment for late-stage breast cancer

 

Silver Spring, MD, USA (February 22, 2013) - The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. In these HER2-positive breast cancers, the increased amount of the HER2 protein contributes to cancer cell growth and survival.

 

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CDC: Drug overdose deaths increase for 11th consecutive year

Opioids drive continued increase in drug overdose deaths

 

Atlanta, GA, USA (February 20, 2013) - Drug overdose deaths increased for the 11th consecutive year in 2010, according to an analysis from the Centers for Disease Control and Prevention. The findings are published today in a research letter, “Pharmaceutical Overdose Deaths, United States, 2010,” in the Journal of the American Medical Association (JAMA).

 

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Agency requires post-approval safety studies to assess rare events

FDA approves new silicone gel-filled breast implant

 

Silver Spring, MD, USA (February 20, 2013) - The U.S. Food and Drug Administration today approved the Natrelle 410 Highly Cohesive Anatomically Shaped Silicone-Gel Filled Breast Implant to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. Natrelle 410 implants are manufactured by Allergan, Inc.

 

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Delirium can lead to short- and long-term confusion and memory problems

Simple measures to promote sleep can reduce delirium in intensive care patients

 

Baltimore, Maryland, USA (February 20, 2013) - A hospital is not the best place to get a good night's sleep, especially in a noisy intensive care unit. It's a cause for concern because studies have shown that a lack of sleep can cause patients to experience delirium—an altered mental state that may delay their recovery and lead to short and long-term confusion and memory problems.

 

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Can Insurers Save Money by Providing Free Diabetes-Related Medications and Supplies?

 

New Rochelle, NY (February 20, 2013) Reducing financial barriers to medication access—a strategy known as value-based insurance design (VBID)—can improve medication adherence and management of chronic diseases such as diabetes. The economic and patient-perceived benefits of eliminating co-payments for diabetes-related medications and supplies are described in a trend-setting study published in Population Health Management, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The article is available on the Population Health Management website.

 

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Cost-effectiveness of medicare drug plans in schizophrenia and bipolar disorder

 

Pittsburgh, Pennsylvania (February 19, 2013) – A new study published online today in the American Journal of Managed Care found that in Medicare Part D, generic drug coverage was cost-saving compared to no coverage in bipolar disorder and schizophrenia, while also improving health outcomes. Researchers from the University of Pittsburgh School of Medicine, the Pitt Graduate School of Public Health, and Western Psychiatric Institute and Clinic of UPMC note that policymakers and insurers should consider generic-only coverage, rather than no gap coverage, to both conserve health care resources and improve health.

 

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FDA

Novo Nordisk receives Complete Response Letter in the US for Tresiba® and Ryzodeg®

 

Bagsværd, Denmark (February 10, 2013) – Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applications for Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form.

In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013.

 

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Multiple myeloma

FDA approves Pomalyst for advanced multiple myeloma

 

Silver Spring, MD, USA (February 8, 2013) - The U.S. Food and Drug Administration today approved Pomalyst (pomalidomide) to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs.

Multiple myeloma is a form of blood cancer that primarily affects older adults and arises from plasma cells in the bone marrow. According to the National Cancer Institute, approximately 21,700 Americans are diagnosed with multiple myeloma and 10,710 die yearly from the disease.

 

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Breast Milk Reduces Risk of Sepsis and Intensive Care Costs in Very-Low-Birth-Weight Infants

 

Chicago, Ill., USA (February 6, 2013) — Feeding human breast milk to very-low-birth-weight infants greatly reduces risk for sepsis and significantly lowers associated neonatal intensive care unit (NICU) costs, according to a study by Rush University Medical Center researchers.

 

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Low vitamin D levels may increase risk of Type 1 diabetes

 

Boston, MA, USA (February 4, 2013) – Having adequate levels of vitamin D during young adulthood may reduce the risk of adult-onset type 1 diabetes by as much as 50%, according to researchers at Harvard School of Public Health (HSPH). The findings, if confirmed in future studies, could lead to a role for vitamin D supplementation in preventing this serious autoimmune disease in adults. The study was published online February 3, 2013 and will appear in the March 1 print edition of the American Journal of Epidemiology.

 

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Influenza

Patients can emit small, influenza-containing particles into the air during routine care

 

Winston-Salem, NC, USA (January 31, 2013) - A new study suggests that patients with influenza can emit small virus-containing particles into the surrounding air during routine patient care, potentially exposing health care providers to influenza. Published in The Journal of Infectious Diseases, the findings raise the possibility that current influenza infection control recommendations may not always be adequate to protect providers from influenza during routine patient care in hospitals.

 

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Eating deep-fried food is associated with an increased risk of prostate cancer

 

  • Frequent, regular consumption has strongest effect and is linked to more aggressive disease

 

Seattle, WA, USA (January 28, 2013) – Regular consumption of deep-fried foods such as French fries, fried chicken and doughnuts is associated with an increased risk of prostate cancer, and the effect appears to be slightly stronger with regard to more aggressive forms of the disease, according to a study by investigators at Fred Hutchinson Cancer Research Center.

 

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FDA approves Gleevec for children with acute lymphoblastic leukemia

 

Silver Spring, MD, USA (January 25, 2013) - The U.S. Food and Drug Administration today approved a new use of Gleevec (imatinib) to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL).

ALL is the most common type of pediatric cancer, affecting approximately 2,900 children annually, and progresses quickly if untreated. Children with Ph+ ALL have a genetic abnormality that causes proteins called tyrosine kinases to stimulate the bone marrow to make too many immature white blood cells. This leaves less room for healthy white blood cells needed to fight infection.

 

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FDA approves three new drug treatments for type 2 diabetes

 

Silver Spring, MD,USA (January 25, 2013) - The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochloride) tablets, and Oseni (alogliptin and pioglitazone) tablets.

 

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Novartis Europharm Ltd withdraws its marketing authorisation application for Ruvise (imatinib mesilate)

 

London, UK (January 24, 2013) - The European Medicines Agency has been formally notified by Novartis Europharm Ltd of its decision to withdraw its application for a centralised marketing authorisation for the medicine Ruvise (imatinib mesilate), 100 and 400 mg film-coated tablets. It was intended to be used for adults as add-on therapy for the treatment of pulmonary arterial hypertension (PAH).

 

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Vaccinating children against rotavirus may indirectly protect adults too, study finds

 

Arlington, VA, USA (January 24, 2013) - Pediatric rotavirus vaccination also indirectly protects unvaccinated adults from the highly contagious cause of severe diarrhea and vomiting, suggests a new study published in Clinical Infectious Diseases and available online. The findings suggest pediatric immunization against the virus may be more cost effective than previously thought, given rotavirus-related health care costs among adults.

 

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FDA approves Exjade to remove excess iron in patients with genetic blood disorder

 

First imaging companion diagnostic to detect liver iron concentration also cleared

 

Silver Spring, MD, USA (January 23, 2013) - The U.S. Food and Drug Administration today expanded the approved use of Exjade (deferasirox) to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non-transfusion-dependent thalassemia (NTDT).

NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs.

 

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New NICE guidance on psychosis and schizophrenia in children and young people

 

London, UK (January 23, 2013) - New NICE guidance stresses that signs of psychosis and schizophrenia in children and young people need to be identified early to help ensure they receive the treatment and care they need to live with the condition. NICE, the healthcare guidance body, has today (23 January) published a new clinical guideline on the recognition and management of psychosis and schizophrenia in children and young people up to the age of 18.

 

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Hyperbaric treatment has significantly resuscitated activity in damaged brains, TAU researchers find

Oxygen Chamber Can Boost Brain Repair

 

Tel Aviv, Israel (January 23, 2013) - Stroke, traumatic injury, and metabolic disorder are major causes of brain damage and permanent disabilities, including motor dysfunction, psychological disorders, memory loss, and more. Current therapy and rehab programs aim to help patients heal, but they often have limited success.

 

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Mayo Clinic:

Proper techniques for newborn bathing and skin care basics

 

ROCHESTER, Minn. , USA (January 22, 2013) - Bathing a tiny newborn can be an exciting experience for parents, but it can also be intimidating. Newborns are small and vulnerable, slippery when wet, and the products marketed for their delicate skin can leave parents with abundant choices. As newborns are welcomed into the world, their skin needs to adapt to the new environmental changes around them. It's important for parents to understand proper bathing techniques and the appropriate skin care needed for their little one.

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 January 2013

 

London, UK (January 18, 2013) - This page provides an overview of the opinions adopted at the January 2013 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. The new public-health communication document on Agency’s recommendation to suspend Tredaptive, Pelzont and Trevaclyn combines the press release and question-and-answer document previously published following CHMP meetings. The Agency publishes a new page following the CHMP meeting each month.

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FDA approves Botox to treat overactive bladder

 

Silver Spring, MD, USA (January 18, 2013) - The U.S. Food and Drug Administration today expanded the approved use of Botox (onabotulinumtoxinA) to treat adults with overactive bladder who cannot use or do not adequately respond to a class of medications known as anticholinergics.

Overactive bladder is a condition in which the bladder squeezes too often or squeezes without warning. Symptoms include leaking urine (urinary incontinence), feeling the sudden and urgent need to urinate, and frequent urination.

 

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FDA approves Octaplas to treat patients with blood clotting disorders

 

Silver Spring, MD, USA (January 17, 2013) - The U.S. Food and Drug Administration today approved Octaplas, a pooled plasma (human) blood product for the replacement of clotting proteins (coagulation factors) in certain medical conditions where patients have insufficient levels. Clotting protein deficiencies can cause excessive bleeding or excessive clotting.

 

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Deodorants: Do we really need them?

 

Bristol, UK (January 17, 2013) - New research shows that more than 75 per cent of people with a particular version of a gene don't produce under-arm odour but use deodorant anyway. The study was based on a sample of 6,495 women who are part of the wider Children of the 90s study at the University of Bristol. The researchers found that about two per cent (117 out of 6,495) of mothers carry a rare version of a particular gene (ABCC11), which means they don't produce any under-arm odour.

 

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FDA permits marketing of first test that can simultaneously identify 11 causes of infectious gastroenteritis

 

Silver Spring, MD, USA (January 15, 2013) - On Jan. 14, the U.S. Food and Drug Administration allowed marketing for the first test that can simultaneously detect 11 common viral, bacterial, and parasitic causes of infectious gastroenteritis from a single patient sample. Infectious gastroenteritis is an inflammation of the stomach and intestines caused by certain viruses, bacteria, or parasites. Common symptoms include vomiting and diarrhea, which can be more severe in infants, the elderly, and people with suppressed immune systems. Gastroenteritis can be spread easily through person-to-person contact and contaminated food, water, and surfaces.

 

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Major step toward an Alzheimer's vaccine

 

Quebec City, Canada (January 15, 2013) — A team of researchers from Université Laval, CHU de Québec, and pharmaceutical firm GlaxoSmithKline (GSK) has discovered a way to stimulate the brain's natural defense mechanisms in people with Alzheimer's disease. This major breakthrough, details of which are presented today in an early online edition of the Proceedings of the National Academy of Sciences (PNAS), opens the door to the development of a treatment for Alzheimer's disease and a vaccine to prevent the illness.

 

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Reminder about risk of impaired activities the morning after use for all insomnia drugs

FDA requiring lower recommended dose for certain sleep drugs containing zolpidem

 

Silver Spring, MD, USA (January 10, 2013) - The U.S. Food and Drug Administration today announced it is requiring the manufacturers of Ambien, Ambien CR, Edluar and Zolpimist, widely used sleep drugs that contain the active ingredient zolpidem, to lower current recommended doses. Ambien and Ambien CR are also available as generics. New data show that zolpidem blood levels in some patients may be high enough the morning after use to impair activities that require alertness, including driving.

 

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FDA issues draft guidance on abuse-deterrent opioids

 

Silver Spring, MD, USA (January 9, 2013) - The U.S. Food and Drug Administration today issued a draft guidance document to assist industry in developing new formulations of opioid drugs with abuse-deterrent properties.

The document “Guidance for Industry: Abuse-Deterrent Opioids – Evaluation and Labeling,” explains the FDA’s current thinking about the studies that should be conducted to demonstrate that a given formulation has abuse-deterrent properties, how those studies will be evaluated by the agency, and what labeling claims may be approved based on the results of those studies.

 

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Can blood pressure drugs reduce the risk of dementia?

 

San Diego, Cal., USA (January 7, 2013) – People taking the blood pressure drugs called beta blockers may be less likely to have changes in the brain that can be signs of Alzheimer's disease and other types of dementia, according to a study released today that will be presented at the American Academy of Neurology's 65th Annual Meeting in San Diego, March 16 to 23, 2013.

 

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New pathway to reduce paradoxical pain

The pain puzzle: Uncovering how morphine increases pain in some people

 

Quebec City & Toronto, Canada (January 6, 2013) - For individuals with agonizing pain, it is a cruel blow when the gold-standard medication actually causes more pain. Adults and children whose pain gets worse when treated with morphine may be closer to a solution, based on research published in the January 6 on-line edition of Nature Neuroscience.

 

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Telestroke networks can be cost-effective for hospitals, good for patients

 

Augusta, Ga., USA (December 17, 2012) – Telestroke networks that enable the remote and rapid diagnosis and treatment of stroke can improve the bottom line of patients and hospitals, researchers report. A central hub hospital delivering rapid stroke diagnosis and treatment partnering with typically smaller spoke hospitals in need of those services means more patients recover better and the network – and hospitals – make money, according to a study in the American Heart Association journal Circulation: Cardiovascular Quality and Outcomes.

 

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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012

 

London, UK (December 14, 2012) - This page provides an overview of the opinions adopted at the December 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.

 

Positive recommendations on new medicines

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Selincro offers treatment in conjunction with psychosocial support

EMA recommends approval of medicine for reduction of alcohol consumption

 

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction of alcohol consumption in adults with alcohol dependence.

 

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Updated advice to reduce risk of gas embolism during spray application

EMA recommends new advice on safer use of fibrin sealant spray applications

 

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of new instructions for healthcare professionals using the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) to optimise the safe use of these medicines when applied as spray during surgery.

 

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Drug approved 3 months ahead of schedule

FDA approves Iclusig to treat two rare types of leukemia

 

Silver Spring, MD, USA (December 14, 2012) - The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

 

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