Dementia drug 'keeps patients out of nursing homes'

Donepezil is used to slow the decline of people with mild to moderate dementia.

But it tends not to be given to patients in the late stage of the disease, because of a lack of evidence that it helps.

However the study of 295 people led by University College London experts, has produced evidence that challenges that.

The participants were split into groups with some being given donepezil, some another dementia drug memantine and others a dummy pill, the journal Lancet Neurology reported.

Of those given donepezil, sold under the brand name Aricept, 20% were living in a nursing home within a year, compared to 37% of those not given it.

The study is part of a follow-up analysis of data first collected three years ago, which showed some improvement when the drug was given to people with moderate to late-stage dementia.

Benefits

Researchers said more investigation was needed to fully unpick the reasons for a nursing home admission.

But they said their study provided evidence that needed to be considered when it comes to prescribing practices.

Some 60,000 people in the UK take the drug which helps to maintain brain function and the ability to cope with everyday activities such as eating and dressing.

About 70% of older people in care homes and nursing homes have dementia - with the average cost of that care ranging between £30,732 and £34,424.

Although such care is means-tested, a large chunk of the cost is borne by the individual.

In comparison, a year's supply of donepezil can cost as little as £21.59, according to the Alzheimer's Society.

Lead researcher Prof Robert Howard said: "Our previous work showed that, even when patients had progressed to the moderate or severe stages of their dementia, continuing with donepezil treatment provided modest benefits in cognitive function and in how well people could perform their daily activities.

"Our new results show that these benefits translate into a delay in becoming dependent on residential care, an event that many people dread."

Dr Doug Brown, director of research and development at the Alzheimer's Society, which co-funded the trial together with the Medical Research Council (MRC), said: "These robust findings are of real significance to people with dementia who want to continue living at home for as long as possible. We urge clinicians to consider the implications of this research and adjust their prescribing patterns accordingly."

Ref : http://www.thelancet.com/journals/laneur/article/PIIS1474-4422(15)00258-6/abstract

Dementia drug 'keeps patients out of nursing homes'  

IMBRUVICA (ibrutinib) wins Prix Galien USA 2015 Award in Best Pharmaceutical Agent category

In continuation of my update ibrutinib

Today, IMBRUVICA® (ibrutinib) was awarded the prestigious Prix Galien USA 2015 Award in the category of Best Pharmaceutical Agent. The Prix Galien Award is considered to be the industry's highest accolade and recognizes the vital technical, scientific and clinical research skills necessary to develop medicines. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company, and the win recognizes the work of both companies.

"Our journey with ibrutinib and our strategic partner, Pharmacyclics, has been exciting and rewarding since day one," said Peter F. Lebowitz, M.D., Ph.D., Global Head, Oncology, Janssen Research & Development, LLC. "We're honored to be recognized by the awards committee, especially among such a remarkable field of innovative compounds."

To qualify, medicines needed to be deemed innovative in the field of medicine and approved by the U.S. Food and Drug Administration (FDA) within the past five years. Since the inception of the award, Janssen has received 26 Prix Galien awards, including three in the U.S. and four at the international level.

The Prix Galien was created in France in 1970 in honor of Galen, the father of medical science and modern pharmacology. Worldwide, the Prix Galen is regarded as the equivalent of the Nobel Prize in biopharmaceutical and medical technology research, honoring significant advances in pharmaceutical research. Until the inception of Prix Galien, this particular field of research was largely unrecognized. Following the success of the original Prix Galien award in France more than 40 years ago, several additional countries have instituted local versions of the award.

IMBRUVICA (ibrutinib) wins Prix Galien USA 2015 Award in Best Pharmaceutical Agent category

Lithium chloride could offer effective treatment against osteoarthritis

Bioengineers from Queen Mary University of London (QMUL) have shown for the first time that lithium chloride, a common drug used to treat mental health disorders, could offer an effective treatment against osteoarthritis by disrupting the length of the cells' antennae called primary cilia.

Publishing in the journal FASEB, the scientists show that medical manipulation of the primary cilia, which are tiny hair-like structures protruding from the surface of most human cells, disrupts a key biological process called 'Hedgehog Signalling'.

Osteoarthritis is a painful disease affecting millions of people. It results from the cartilage breaking down at the joints and leads to difficulties in moving around and being active. Being able to control Hedgehog Signalling has previously been shown to reduce the severity of arthritis.

Lithium chloride could offer effective treatment against osteoarthritis

Praziquantel treatment safe for pregnant women after first trimester

A study by Rhode Island Hospital researchers confirmed that a drug used to treat a disease afflicting millions of people in developing countries is safe to give pregnant women following their first trimester. The finding could prove critical to the care of pregnant women and lactating women with schistosomiasis, a disease caused by a parasitic worm, who were denied the drug out of concern for their health and the health of their fetuses.

Authored by Jennifer F. Friedman, M.D., Ph.D., MPH, director of clinical studies for the Center for International Health Research at Rhode Island Hospital, the study found that praziquantel does not lead to adverse events for the pregnant woman or her newborn. The study was published today in The Lancet Infectious Diseases.

"Millions of women, many of whom are in a multi-year, cyclical pattern of pregnancy and breast-feeding, are denied praziquantel," said Friedman. "The accumulation of evidence shows that commencement of this treatment after the first trimester does not adversely affect the mother or fetus. We wanted to conduct this study to demonstrate that this drug is safe after the first trimester, and we remain hopeful that public health policies will change. Deferring treatment only exacerbates the morbidity of the patients."

Praziquantel treatment safe for pregnant women after first trimester

Mylan announces U.S. launch of generic Fusilev for Injection

Mylan N.V. (Nasdaq: MYL) today announced the U.S. launch of Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials, which is the generic version of Spectrum Pharmaceuticals' Fusilev® for Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for rescue use after high-dose methotrexate therapy in osteosarcoma. Levoleucovorin is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists.

Levoleucovorin Calcium Injection 10 mg (base)/mL; 175 mg (base)/17.5 mL and 250 mg (base)/25 mL Single-use Vials had U.S. sales of approximately $200 million for the 12 months ending June 30, 2015, according to IMS Health.

Currently, Mylan has 259 ANDAs pending FDA approval representing $98.5 billion in annual brand sales, according to IMS Health. Fifty of these pending ANDAs are potential first-to-file opportunities, representing $33.4 billion in annual brand sales, for the 12 months ending December 31, 2014, according to IMS Health.

Mylan announces U.S. launch of generic Fusilev for Injection

Early trial results in lung cancer

Results from early phase trials investigating different therapeutic agents in lung cancer patients were presented during the third Presidential Session at the European Cancer Congress in Vienna, Austria. Here we summarise two studies reported at the session.

Erlotinib (structure) plus bevacizumab promising in EGFR T790M-positive advanced NSCLC patients. 

Rolf Stahel, from University Hospital Zurich in Switzerland, presented the findings of the BELIEF trial [1] on behalf of his fellow investigators from the Spanish Lung Cancer Group and the European Thoracic Oncology Platform. The phase II trial enrolled 109 patients with metastatic or locally advanced non-squamous non-small-cell lung cancer (NSCLC) harbouring activating epidermal growth factor receptor (EGFR) mutations (either the exon 19 deletion or the exon 21 L858R point mutation).

Of these, 37 (33.9%) patients also carried the EGFR T790M mutation at baseline, while the remaining 72 participants were negative for T790M.

Patients were treated with a combination of everolimus and bevacizumab on the basis of previous preclinical results suggesting that inhibiting both the EGFR and vascular EGFR pathways could be beneficial in the presence of the T790M mutation, explained Stahel.

After a median follow-up of 17.5 months, progression-free survival (PFS) was a median of 13.8 months in the overall cohort, with times of 16.0 and 10.5 months for the T790M-positive and -negative groups, respectively. The corresponding 1-year PFS rates were 56.7%, 72.4% and 49.4%.

Complete responses were achieved by 6.4% of all study participants, 8.1% of those positive for T790M and 5.6% of T790M-negative patients, while partial responses were achieved by 69.7%, 62.2% and 73.6% of patients, respectively.

Early trial results in lung cancer

New synthetic process helps study key molecule involved in diabetes, inflammation, aging

A synthetic process developed at Yale University will allow researchers to study a key molecule involved in diabetes, inflammation, and human aging.

The new process synthesizes glucosepane, which is considered a critical chemical link in both diabetes and aging. It is also an independent risk factor for long-term microvascular complications in diabetes.

In a study published this week in the journal Science, senior author David Spiegel and his colleagues describe the new synthesis, as well as a new synthetic methodology, which may have applications beyond the current research.

"Glucosepane forms in all human beings during the aging process, and also forms during various diseases, including diabetes," said Spiegel, a professor of chemistry and pharmacology at Yale. "It is unknown what role glucosepane might play in aging and in these diseases, but several hypotheses have been proposed. With access to synthetic glucosepane, we will now be able to generate tools to examine the role this molecule plays in human health and also, perhaps, develop molecules to inhibit or reverse its formation."

Until now, it has been difficult to study glucosepane effectively. There is a scarcity of chemically homogeneous glucosepane available for scientists to examine -- due to its unusual structure and properties -- and researchers have been forced to rely on time-consuming extraction protocols to obtain usable material.

Glucosepane contains a rare isomer of imidazole, which has never before been observed in natural molecules, other than those in the glucosepane family. Spiegel and his colleagues developed a new methodology for synthesizing this imidazole form. The process requires only eight steps.

In an accompanying article in Science, Dale L. Boger of the Scripps Research Institute wrote that the Yale study represents "an important, yet largely underexplored, frontier for chemistry with broad implications in human health." Boger said Spiegel's methodology "is important in its own right and will find applications well beyond that envisioned by the authors."

New synthetic process helps study key molecule involved in diabetes, inflammation, aging

Study could lead to better understanding of metabolic processes behind type 2 diabetes

Scientists in Sweden have discovered that human intestinal flora regulates the levels of the body's main antioxidant, glutathione, which fights a host of diseases. The findings could lead to new probiotic-delivering foods, and a better understanding of the metabolic processes behind diseases such as type 2 diabetes.

Chalk up another reason why your gut bacteria is so critical to your health — and why it could be the key to preventing a host of diseases. Scientists in Sweden have discovered that human intestinal flora regulates the levels of the body's main antioxidant, glutathione, which fights a host of diseases.

The study could lead to new probiotic-delivering foods, and a better understanding of the metabolic processes behind diseases such as type 2 diabetes, says co-author Adil Mardinoglu, a systems biology researcher at Stockholm's KTH Royal Institute of Technology.

Published in the scientific journal, Molecular Systems Biology, the findings help complete our understanding of how nonessential amino acids are synthesized to equip the body's cells with detoxifying agents and antioxidants, Mardinoglu says.

Study could lead to better understanding of metabolic processes behind type 2 diabetes

Cranberry juice consumption may protect against cardiovascular disease

In continuation of my updates on Cranberries

Results from a new study presented at the Cranberry Health Research Conference preceding the annual Berry Health Benefits Symposium 2015 in Madison, WI, revealed that cranberry juice consumption may play a role in protecting against cardiovascular disease. Presented by principal investigator, Ana Rodriguez-Mateos, PhD, from the Division of Cardiology, Pulmonology and Vascular Medicine at the University Duesseldorf, Germany, the research uncovered a potent, dose-dependent relationship between cranberry juice and improved vascular function. Because vascular dysfunction, including limitations in blood flow, is a central feature in the development of atherosclerosis - improving vascular function can have a powerful, beneficial effect on a person's cardiovascular health.

"Cranberry juice is a rich source of phytonutrients, including proanthocyanidins, anthocyanins and phenolic acids," explains Dr. Rodriguez-Mateos. "Due to this robust profile of polyphenols, our team sought to evaluate the immediate vascular impact of drinking one, 450 ml (or 16 ounces) glass of cranberry juice with a different range of concentrations of cranberry-polyphenols."

Cranberry juice consumption may protect against cardiovascular disease

Veltassa (patiromer for oral suspension) gets FDA approval for treatment of hyperkalemia

The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.

"Too much potassium in the blood can lead to dangerous, even fatal, changes in heart rhythm," said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research. "It is important to have treatment options for hyperkalemia available to patients."

Potassium, a mineral that is delivered to the body by food, is needed for cells to function properly. The kidneys remove potassium from the blood to maintain a proper balance of potassium in the body. But when the kidneys are not able to remove enough potassium from the blood, the level of potassium can get too high. Hyperkalemia typically occurs in patients with acute or chronic kidney disease or heart failure, particularly in those who are taking drugs that inhibit the renin-angiotensin-aldosterone system, which regulates blood pressure and fluid balance in the body.

Veltassa (patiromer for oral suspension) gets FDA approval for treatment of hyperkalemia

Orange pigment may have potential as anti-cancer drug

An orange pigment found in lichens and rhubarb called parietin may have potential as an anti-cancer drug, scientists at Winship Cancer Institute of Emory University have discovered.

The results are scheduled for publication on October 19 in Nature Cell Biology.

Parietin, also known as physcion, could slow the growth of and kill human leukemia cells obtained directly from patients, without obvious toxicity to human blood cells, the authors report. The pigment could also inhibit the growth of human cancer cell lines derived from lung and head and neck tumors when grafted into mice.

A team of researchers led by Jing Chen, PhD, discovered the properties of parietin because they were looking for inhibitors for the metabolic enzyme 6PGD (6-phosphogluconate dehydrogenase). 6PGD is part of the pentose phosphate pathway, which supplies cellular building blocks for rapid growth. Researchers have already found 6PGD enzyme activity increased in several types of cancer cells.

"This is part of the Warburg effect, the distortion of cancer cells' metabolism," says Chen, professor of hematology and medical oncology at Emory University School of Medicine and Winship Cancer Institute. "We found that 6PGD is an important metabolic branch point in several types of cancer cells."

This work represents a collaboration among three laboratories at Winship led by Chen, Sumin Kang, PhD, assistant professor of hematology and medical oncology, and Jun Fan, PhD, assistant professor of radiation oncology. Co-first authors are postdoctoral fellows Ruiting Lin, PhD, and Changliang Shan, PhD, and former graduate student Shannon Elf, PhD, now at Harvard.

The Winship team obtained cancer cells from a patient with acute lymphoblastic leukemia, and found doses of physcion/parietin that could kill half the leukemia cells in culture within 48 hours, while the same doses left healthy blood cells unscathed. A more potent derivative of the pigment called S3 could cut the growth of a lung cancer cell line by a factor of three over 11 days, when the cells were implanted into mice.

Ref : http://www.emoryhealthsciblog.com/tag/jing-chen/

Orange pigment may have potential as anti-cancer drug

Ixazomib’s phase 3 study in relapsed/refractory multiple myeloma presented

Takeda Pharmaceutical Company Limited today announced that it will present Phase 3 data from the TOURMALINE-MM1 ixazomib clinical trial at the 57th American Society of Hematology (ASH) Annual Meeting to be held in Orlando, Florida from December 5 to 8, 2015.

A total of 19 company-sponsored abstracts representing the breadth and depth of Takeda’s hematology-oncology portfolio were accepted for presentation at this year’s meeting.

We are particularly looking forward to this year’s ASH annual meeting. We will be presenting pivotal data on the ixazomib program, as well as the five year overall survival data for ADCETRIS in relapsed/refractory Hodgkin lymphoma.

The success of these two programs, in addition to data we will be presenting on VELCADE and our pipeline, is the realization of decades of commitment to patients with hematological malignancies.

Dixie-Lee Esseltine, MD, FRCPC, Vice President, Oncology Therapeutic Area Unit, Takeda.

“This is the first time Phase 3 data will be presented for ixazomib, an oral, once-weekly proteasome inhibitor which, if approved, would enable the first all-oral triplet regimen containing a proteasome inhibitor for the treatment of relapsed/refractory multiple myeloma,” said TOURMALINE-MM1 Principal Investigator Philippe Moreau, M.D., University of Nantes, France.

“In working with Takeda Oncology on the evolution of proteasome inhibition, we continue to strive towards providing new options to address the unmet needs of patients with multiple myeloma.”

Ixazomib is the first oral proteasome inhibitor in late stage clinical development. The TOURMALINE-MM1 study is an international, randomized, double-blind, placebo-controlled Phase 3 clinical trial which was designed to evaluate the superiority of once-a-week oral ixazomib plus lenalidomide and dexamethasone vs. placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma.

Ixazomib has been granted Priority Review from the U.S. Food and Drug Administration (FDA) and Accelerated Assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency , respectively, validating the profound and continuing unmet need for new multiple myeloma treatments.

Ixazomib’s phase 3 study in relapsed/refractory multiple myeloma presented

New study compares effectiveness of clozapine with standard antipsychotics in adults with schizophrenia

In real-world settings, patients with schizophrenia whose symptoms do not respond to standard antipsychotic medications have better outcomes if they are switched to clozapine instead of another standard antipsychotic. They have fewer hospitalizations, stay on the new medication longer, and are less likely to need to use additional antipsychotics. These findings were published today in the American Journal of Psychiatry.

Schizophrenia is a serious mental disorder affecting up to one percent of the adult population. Antipsychotics are effective at relieving symptoms for most patients, but up to 30% do not respond well to standard treatments and are considered to have treatment-resistant schizophrenia. While trials have indicated that clozapine is effective for these cases, the effectiveness of clozapine in clinical practice has not previously been studied in depth.

Often when one traditional antipsychotic medication does not work, clinicians change to another traditional antipsychotic. Clozapine is often seen as a drug of last resort, although it is the only medication approved by the FDA for treatment-resistant schizophrenia.

The new study was conducted using national Medicaid data from 6,246 patients whose treatment patterns were consistent with treatment resistance. It is the largest study directly comparing the effectiveness of clozapine with standard antipsychotics in this population in routine practice settings.

The results are encouraging and timely because the FDA recently broadened access to clozapine. In the past access was limited, in part because of the risk of agranulocytosis, a condition that can make people susceptible to infections. A system has been in place for 25 years to successfully manage the risks of agranulocytosis, using regular monitoring of white blood cell levels. Leading clinicians thus believe the limits on use of clozapine have been overly restrictive. The new FDA rules still require regular blood monitoring, but allow prescribers to make decisions based on benefits and risks for individual patients rather than rigidly following universal standards.

New study compares effectiveness of clozapine with standard antipsychotics in adults with schizophrenia

Yoga exercise as effective as traditional pulmonary rehab in improving pulmonary function in COPD patients

Researchers from the Department of Pulmonary Medicine and Sleep Disorders and All India Institute of Medical Sciences, New Delhi, India, studied the effects of yoga as a form of pulmonary rehabilitation on markers of inflammation in the body. Results from this study showed yoga exercises provide improvements that are just as effective as traditional pulmonary rehabilitation methods in improving pulmonary function, exercise capacity, and indices of systemic inflammation.

Sixty patients with COPD were randomly divided into two groups, one of which was taught yoga exercises while the other underwent a structured pulmonary rehabilitation program. These groups were tested on shortness of breath, serum inflammation, and lung function tests. Each group participated in 1 hour of training twice a week for the first 4 weeks, then training every 2 weeks for 8 weeks, and the remaining weeks were at home. Results showed that yoga and pulmonary rehabilitation exercises resulted in similar improvements in pulmonary function, 6-minute walk distance, Borg scale, severity of dyspnea, quality of life, and levels of C-reactive protein after 12 weeks of training.

"This study suggests yoga may be a cost-effective form of rehabilitation that is more convenient for patients," said Mark J. Rosen, MD, Master FCCP, CHEST Medical Director. "The authors recommended adoption of yoga programs as an option as part of long-term management of COPD. These findings should be confirmed in new studies and the potential mechanisms explored."

Yoga exercise as effective as traditional pulmonary rehab in improving pulmonary function in COPD patients

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change

BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that the U.S. Food and Drug Administration (FDA) has approved the company's Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL® (buprenorphine and naloxone) buccal film (CIII).

The approval allows for the immediate release of BUNAVAIL inventory to wholesalers. BDSI will be shipping product to wholesalers this morning which should make product available in pharmacies as early as Friday.

The newly released product supplies are expected to satisfy current and anticipated demand, which has increased following the October 1 initiation of a contract providing exclusive, preferred formulary status for BUNAVAIL for Medicaid patients in the state of Tennessee.

"All of us at BDSI want to thank the Division of Anesthesia, Analgesia and Addiction Products at FDA for working with us in an expeditious and collaborative fashion to help allow patients benefiting from BUNAVAIL treatment to maintain uninterrupted availability," said Dr. Mark A. Sirgo, President and Chief Executive Officer. "We also want to thank all of the patients, physicians and other health providers, including pharmacists, for their patience and support during this period of inconvenience."

BDSI announces FDA approval of BUNAVAIL sNDA for manufacturing specification change