Seven new medicines recommended for approval

EMA-Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013

London (April 26, 2013) - This page provides an overview of the opinions adopted at the April 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes. 

• The Committee recommended the approval of the first combined tissue-engineered medicine to be authorised across the European Union (EU). MACI (matrix-induced autologous chondrocyte implantation) is an advanced-therapy medicinal product (ATMP) intended for the repair of cartilage defects.
• The Committee also gave a positive recommendation for the approval of Nuedexta, the first medicine for pseudobulbar effect approved in the EU.
• Four medicines to treat cancer received a positive opinion by the Committee:  Erivedge, for the treatment of advanced basal cell carcinoma; Xtandi, for the treatment of prostate cancer and the two generic medicines Capecitabine Sun and Imatinib Accord.
• The CHMP also recommended that Spedra should be granted a marketing authorisation for the treatment of erectile dysfunction.

Vitamin D May Lower Diabetes Risk in Obese Children and Adolescents, MU Study Finds

Columbia, Mo., USA (March 26, 2013) – Childhood and adolescent obesity rates in the United States have increased dramatically in the past three decades. Being obese puts individuals at greater risk for developing Type 2 diabetes, a disease in which individuals have too much sugar in their blood. Now, University of Missouri researchers found vitamin D supplements can help obese children and teens control their blood-sugar levels, which may help them stave off the disease.

European Medicines Agency investigates findings on pancreatic risks with GLP-1-based therapies for type 2 diabetes

London (March 26, 2013) - The European Medicines Agency is investigating findings by a group of independent academic researchers that suggest an increased risk of pancreatitis (inflammation of the pancreas) and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with so-called GLP-1-based therapies (glucagon-like peptide 1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors).

Vitamin D benefits breathing in tuberculosis patients

Chevy Chase, MD, USA (March 26, 2013) - Maintaining adequate levels of vitamin D can help people breathe better and may even protect against tuberculosis (TB), according to a recent study accepted for publication in The Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

The study of more than 10,000 Korean adults found that lung function improved when people had absorbed more vitamin D into their bodies. Vitamin D is absorbed primarily through sunlight, with a healthy diet as a secondary source.

FDA

Temporary Tattoos May Put You at Risk

Silver Spring, MD, USA (March 25, 2013) - Spring break is on the way, or maybe summer vacation. Time to pack your swim suit, hit the beach, and perhaps indulge in a little harmless fun. What about getting a temporary tattoo to mark the occasion? Who could it hurt to get a temporary tattoo?

It could hurt you, if you actually get one. Temporary tattoos typically last from three days to several weeks, depending on the product used for coloring and the condition of the skin. Unlike permanent tattoos, which are injected into the skin, temporary tattoos marketed as "henna" are applied to the skin's surface.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.