Omega-3 fatty acids may prevent some forms of depression

Omega-3 fatty acids may prevent some forms of depression 

FDA Approves New Obesity Drug Contrave

In continuation of my update on Contrave

The U.S. Food and Drug Administration's approval of a new weight-loss drug on Wednesday marks the third time the agency has given its blessing to a new diet medication since 2012.

Called Contrave, the medicine is a combination of two approved drugs: naltrexone, which treats alcohol and drug addiction, and bupropion, which treats depression and seasonal affective disorder and is used to help smokers quit.

The agency said in a news release that Contrave can be used by obese adults and by overweight adults who have at least one other weight-related condition or illness, such as high blood pressure or type 2 diabetes.

According to the U.S. Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese, the FDA said in its news release.

"Obesity continues to be a major public health concern," said Dr. Jean-Marc Guettier, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research. "When used as directed in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, Contrave provides another treatment option for chronic weight management."

FDA Approves New Obesity Drug Contrave  

Anamorelin drug safe and well tolerated in advanced non-small cell lung cancer, Phase III trial reveals

A new drug, anamorelin, improves appetite and body mass in patients with advanced lung cancer who are suffering cancer anorexia and cachexia, according to phase III data presented at the ESMO 2014 Congress in Madrid, Spain.

"Anorexia and cachexia are among the most troubling and distressing symptoms of advanced cancer, for both patients and their families," says the study's principal investigator, Dr Jennifer Temel from the Department of Medicine, Massachusetts General Hospital, Boston, USA.

Symptoms of the wasting syndrome can include a loss of weight and muscles, together with fatigue, weakness, and loss of appetite. The condition is very common in patients with advanced lung cancer. Anamorelin aims to address the symptoms by mimicking the effects of the so-called "hunger hormone" ghrelin, which is secreted by the stomach.

The large, randomized controlled ROMANA 1 and 2 trials are the first phase III studies examining the impact of anamorelin on anorexia-cachexia in patients with advanced lung cancer.

In the ROMANA studies, patients with unresectable stage III or IV non-small cell lung cancer with cachexia were randomized to receive either 100 mg anamorelin or placebo, given orally each day for 12 weeks.

Among 484 participants in ROMANA 1, those taking anamorelin experienced a median increase in lean body mass of 1.10 kg in 12 weeks, compared to a loss of 0.44 kg for those taking placebo. Body weight increased in the anamorelin arm by an average of 2.2 kg, compared to 0.14 kg in the placebo arm of the study. Patient symptoms or concerns regarding anorexia-cachexia, including appetite, also significantly improved over 12 weeks in patients taking anamorelin. The most frequent drug-related adverse events included hyperglycemia and nausea.

In ROMANA 2, 495 participants with advanced non-small cell lung cancer experiened similar benefits. Body weight increased by 0.95 kg on average, compared to a loss of 0.57 kg for those receiving placebo, and patient symptoms/concerns regarding anorexia-cachexia significantly improved over 12 weeks.

Patients receiving anamorelin did not experience improvements in their muscle strength, as measured by hand grip strength, although Temel notes that particular test can be difficult to administer in this patient population.

Anamorelin drug safe and well tolerated in advanced non-small cell lung cancer, Phase III trial reveals

Oral afatinib significantly improves progression-free survival in patients with head and neck cancer

The tyrosine kinase inhibitor afatinib significantly improved progression-free survival compared to methotrexate in patients with recurrent or metastatic squamous cell carcinoma of the head and neck after failure of platinum-based chemotherapy, the results of a phase III trial show.

Presented at the ESMO 2014 Congress in Madrid, the Lux-Head & Neck 1 trial showed that patients who received treatment with 40 mg/day oral afatinib had a 20% reduction in risk of progression or death compared to patients who received methotrexate, with a median progression-free survival of 2.6 months.

"The improvement in progression-free survival was associated with a significant delayed worsening of symptoms (such as pain, swallowing and global health status) versus chemotherapy. Patients treated with afatinib had less pain over time than patients treated with methotrexate. "These are important outcomes for patients with these conditions," notes study author Dr Jean-Pascal Machiels, a medical oncologist at Institut Roi Albert II, Cliniques Universitaires St. Luc, in Brussels, Belgium.

Recurrent or metastatic squamous cell carcinoma of the head and neck often has a poor outcome, Machiels explains. "This is a poor prognosis population and a disease that does not get enough attention from the scientific community, because this group of patients often has severe co-morbidities and social problems such as alcoholism and tobacco use."

"Frequently these patients have a relapse in the head and neck area. This location is responsible of many symptoms that are difficult to palliate: pain, breath disorder and swallowing difficulties."

Afatinib is a compound that irreversibly blocks the ErbB family of cell surface receptors, which includes epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), HER3 and HER4. Around 90% of squamous cell carcinomas of the head and neck overexpress EGFR.

Oral afatinib significantly improves progression-free survival in patients with head and neck cancer

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

In continuation of my update on Isavuconazole

Isavuconazole demonstrates successful outcomes in treatment of mucormycosis

Phase III trial: Rolapitant lessens chemotherapy-induced nausea and vomiting

Rolapitant reduces nausea and vomiting in patients receiving cisplatin-based chemotherapy, according to the results of a phase III trial presented for the first time today at the ESMO 2014 Congress in Madrid, Spain.

Dr Martin Chasen, lead author and medical director, Palliative Care, Ottawa Hospital Cancer Centre, Canada, said: "This agent makes a significant difference in the way people tolerate their chemotherapy. Patients experienced no loss in quality of life and, in fact, many saw meaningful improvements. One of the patients in the rolapitant cohort reported that he had just finished 18 holes of golf one week after receiving chemotherapy. This is in sharp contrast to many patients on current standard anti-emetics that are too ill to get out of bed within a week after each cycle of cisplatin."

"We must treat nausea and vomiting, not just the cancer," added Chasen, emphasising that some patients are extremely sensitive to cisplatin effects and recalling that he had one or two patients with curable cancers who refused treatment after one round of cisplatin. "They preferred to die," he said.

The phase III trial investigated rolapitant, a novel antagonist of the NK-1 receptor, for the prevention of severe nausea and vomiting often experienced by patients receiving cisplatin-based chemotherapy, which may cause dose reductions and treatment discontinuation. The multicentre trial randomised 532 patients 1:1 to receive rolapitant plus granisetron/dexamethasone or placebo plus granisetron/dexamethasone prior to cisplatin-based chemotherapy.

Phase III trial: Rolapitant lessens chemotherapy-induced nausea and vomiting

Crizotinib drug effectively halts growth of ROS1-positive lung tumors

In continuation of my update on crizotinib

Treatment with the targeted therapy drug crizotinib effectively halts the growth of lung tumors driven by rearrangements of the ROS1 gene. In an article receiving Online First publication in the New England Journal of Medicine to coincide with a presentation at the European Society for Medical Oncology meeting, an international research team reports that crizotinib treatment led to significant tumor shrinkage in 36 of 50 study participants and suppressed tumor growth in another 9.

"Prior to this study, there were a handful of reports describing marked responses to crizotinib in individual patients with ROS1-positive lung tumors," says Alice Shaw, MD, PhD, of the Massachusetts General Hospital (MGH) Cancer Center, lead author of the NEJM report. "This is the first definitive study to establish crizotinib's activity in a large group of patients with ROS1-positive lung cancer and to confirm that ROS1 is a bona fide therapeutic target in those patients."

Crizotinib currently is FDA-approved to treat non-small-cell lung cancers (NSCLC) driven by rearrangments in the ALK gene, which make up around 4 percent of cases. An MGH Cancer Center report published in 2012 reported that 1 to 2 percent of NSCLCs are driven by rearrangements in ROS1, which encodes a protein with significant structural similarities to that encoded by the ALK gene.

Crizotinib drug effectively halts growth of ROS1-positive lung tumors

FDA Approves Iluvien for Diabetic Macular Edema

pSivida Corp., a leader in the development of sustained release, drug delivery products for treating eye diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Iluvien for the treatment of diabetic macular edema (DME). It is indicated for patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). A single injection of the Iluvien micro-insert provides sustained treatment of DME for 36 months. Approximately 560,000 people in the U.S. are estimated to have clinically significant DME, the most frequent cause of vision loss in individuals with diabetes and the leading cause of blindness in young and middle-aged adults in developed countries. Iluvien is expected to be commercially available in the U.S. in early 2015.

FDA Approves Iluvien for Diabetic Macular Edema

Candidate H7N9 avian flu vaccine works better with adjuvant

Candidate H7N9 avian flu vaccine works better with adjuvant

Researchers Discover How Bacteria Resist Antibiotics in Hospitals

Tiny circles of DNA called plasmids appear to be the culprit. They can easily enter bacteria and move from one bacteria to another, and some carry a gene that makes bacteria drug-resistant, a new study finds.

"The plasmids we are talking about carry an antibiotic-resistant gene to a class of antibiotic called carbapenems," said the study's co-author, Dr. Tara Palmore, an infection control specialist at the U.S. National Institutes of Health.

Carbapenems are antibiotics of last resort, and carbapenem-resistant Enterobacteriaceae (CRE) are bacterial pathogens that pose a "formidable" threat to hospitalized patients, according to the research.

The incidence of CRE has quadrupled in the last decade in the United States, according to background information in the report. CRE has been detected in nearly 4 percent of hospitals and about 18 percent of long-term acute care facilities. In addition, the researchers noted, CRE are resistant to most, if not all, antibiotics. Investigations have reported a death rate of 40 percent to 80 percent from infection.

Given ongoing concerns that even bacteria like Klebsiella and Enterobacter -- which are found in the environment and in healthy stomachs -- are becoming increasingly resistant to last-resort antibiotics, the researchers set out to find some answers. Their report, published Sept. 17 inScience Translational Medicine, showed that plasmid transfer in hospitals is likely contributing to the increase in antibiotic-resistant bacteria.

Researchers Discover How Bacteria Resist Antibiotics in Hospitals

FDA Approves Triumeq for the Treatment of HIV-1 Infection

In continuation of my update on Triumeq

ViiV Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg, dolutegravir 50mg and lamivudine 300mg) tablets for the treatment of HIV-1 infection. Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

FDA Approves Triumeq for the Treatment of HIV-1 Infection

FDA Approves Contrave (bupropion/naltrexone) for Weight Management

In continuation of my update on bupropion/naltrexone

The U.S. Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

FDA Approves Contrave (bupropion/naltrexone) for Weight Management

The Nobel Prize in Physiology or Medicine 2014

The Nobel Prize in Physiology or Medicine 2014

FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis

 In continuation of my update on Apremilast (brand name Otezla) is an orally available small molecule inhibitor of phosphodiesterase 4 (PDE4). Apremilast specifically inhibits PDE4 and inhibits spontaneous production of TNF-alpha from human rheumatoid synovial cells. It has anti-inflammatory activity.

FDA Approves Otezla (apremilast) for Moderate to Severe Plaque Psoriasis

FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD

We know that, Tiotropium bromide,   is a long-acting, 24 hour, anticholinergic bronchodilator used in the management of chronic obstructive pulmonary disease (COPD). Tiotropium bromide capsules for inhalation are co-promoted by Boehringer-Ingelheimand Pfizer under the trade name Spiriva. It is also manufactured and marketed by Cipla under trade name Tiova.

Now Boehringer Ingelheim Pharmaceuticals, Inc. announced  that the U.S. Food and Drug Administration (FDA) approved Spiriva Respimat (tiotropium bromide) inhalation spray for the long-term, once-daily

FDA Approves Spiriva Respimat (tiotropium) for the Maintenance Treatment of COPD

FDA Approves Vitekta (elvitegravir) for HIV-1 Infection

We know that, Elvitegravir (EVG, formerly GS-9137) is a drug used for the treatment of HIV infection. It acts as an integrase inhibitor. It was developed by the pharmaceutical company Gilead Sciences, which licensed EVG from Japan Tobacco in March 2008.^[2][3][4]The drug gained approval by U.S. Food and Drug Administration on August 27, 2012 for use in adult patients starting HIV treatment for the first time as part of the fixed dose combination known as Stribild.

FDA Approves Vitekta (elvitegravir) for HIV-1 Infection

Scripps Research Institute Chemists Modify Antibiotic to Vanquish Resistant Bacteria

Scientists at The Scripps Research Institute (TSRI) have devised a new antibiotic based on vancomycin that is powerfully effective against vancomycin-resistant strains of MRSA and other disease-causing bacteria.

The new vancomycin analog appears to have not one but two distinct mechanisms of anti-microbial action, against which bacteria probably cannot evolve resistance quickly.

“This is the prototype of analogues that once introduced will still be in clinical use a generation or maybe even two generations from now,” said Dale L. Boger, the Richard and Alice Cramer Professor of Chemistry at TSRI.

The report by Boger and members of his laboratory was published recently online ahead of print by the Journal of the American Chemical Society.

Increasing Reports of Resistance

Vancomycin entered clinical use in 1958, five years after its isolation from microbes in a soil sample gathered by an American missionary in Borneo. For nearly six decades it has been useful against a wide range of bacteria, and it remains a standard weapon against methicillin-resistant Staphylococcus aureus (MRSA), a major cause of hospital-acquired infections. A compound closely related to vancomycin also has been widely used to protect livestock.

Since the late 1980s, there have been increasing reports of vancomycin resistance in classes of bacteria that usually succumb to the antibiotic, including MRSA. Although vancomycin remains useful, scientists have been looking for new drugs to replace it in cases—often life-threatening—where it no longer can help patients.

The Boger laboratory has focused on inventing improved versions of vancomycin rather than entirely new compounds. “Vancomycin has lasted in clinical use for more than 50 years, in part because it isn’t very vulnerable to antibiotic resistance,” Boger said. “Our thought has been that if we find a vancomycin analog that addresses this current source of resistance we’ll get another 50 years of use out of it.”

Vancomycin works by binding to the building blocks of bacterial cell walls, in a way that prevents their proper assembly and leaves bacteria too leaky to live and replicate. The resistance comes from a single amino-acid alteration that some bacteria make to those building blocks, so that the antibiotic molecule can no longer get a firm grip. That drops vancomycin’s potency by a factor of about 1,000.

‘Incredibly Potent’

In 2012, Boger and his team reported making a vancomycin analog—informally termed vancomycin amidine—with a subtly altered binding pocket that fastens about equally well to the original and resistant sites on bacterial cell wall subunits. To get the precise structural modification they needed, they had to come up with a method for the “total synthesis” of this vancomycin-based compound—a controlled, step-by-step construction using organic chemistry reactions in the lab, rather than a natural enzyme-mediated production within cells.

“Years of work in this lab culminated in a total synthesis strategy that not only allowed us access to this target compound, but also gave us the ability to perform almost any other chemical modification of vancomycin that we wished,” said Akinori Okano, first author of the new report, who is an assistant professor of chemistry at TSRI.

Vancomycin amidine turned out to have acceptable level of activity against vancomycin-resistant and -sensitive bacteria, yet there was room for improvement. Thus in the new study, Okano, Boger and their colleagues used their vancomycin synthesis methods to add an additional feature to the molecule—a peripheral chlorobiphenyl (CBP), long known as a general booster of vancomycin’s potency.

“To our delight, the combination of these modifications led to an incredibly potent molecule, well beyond anything we had expected,” said Okano.

Scripps Research Institute Chemists Modify Antibiotic to Vanquish Resistant Bacteria

FDA Approves Tybost (cobicistat) for use in the treatment of HIV-1 Infection

We know that, Cobicistat (formerly GS-9350) is a licensed drug for use in the treatment of infection with the human immunodeficiency virus (HIV).

Like ritonavir (Norvir), cobicistat is of interest for its ability to inhibit liver enzymes that metabolize other medications used to treat HIV, notably elvitegravir, an HIV integrase inhibitor. By combining cobicistat with elvitegravir, higher concentrations of the latter are achieved in the body with lower dosing, theoretically enhancing elvitegravir's viral suppression while diminishing its adverse side-effects. In contrast with ritonavir, the only other booster approved for use as a part of HAART, cobicistat has no anti-HIV activity of its own.. 

 Now U.S. Food and Drug Administration (FDA) has approved Tybost (cobicistat), a CYP3A inhibitor used in combination with atazanavir or darunavir for the treatment of human immunodeficiency virus type 1 (HIV-1) infection..

FDA Approves Tybost (cobicistat) for use in the treatment of HIV-1 Infection

Bacterial communication molecules can be manipulated to prevent cancer cells from spreading

Bacterial communication molecules can be manipulated to prevent cancer cells from spreading

Rosuvastatin promotes bone growth in mice with achondroplasia symptoms

Skeletal dysplasia is a group of rare diseases that afflict skeletal growth through abnormalities in bone and cartilage. Its onset hits at the fetal stage and is caused by genetic mutations. A mutation in the gene encoding fibroblast growth factor receptor 3 (FGFR3) has been associated with two types of skeletal dysplasia, thanatophoric dysplasia (TD), a skeletal dysplasia that cause serious respiratory problems at birth and is often lethal, and achondroplasia (ACH), which causes stunted growth and other complications throughout life. Several experimental treatments have been considered, but none are commercially available.

The need for new drug compounds that can combat skeletal dysplasia has led the Noriyuki Tsumaki group at CiRA, Kyoto University, to consider iPS cell technology. In a joint study with Associate Professor Hideaki Sawai of Hyogo College of Medicine and Team Leader Shiro Ikegawa of RIKEN, Professor Tsumaki's team screened molecules based on their ability to rescue TD-iPSCs from degraded cartilage. Molecules known to affect FGFR3 signaling and/or the metabolism of chondrocytes, the cells responsible for growing cartilage, were identified as good candidates. More importantly, so too were statins, a class of drugs renown for their action against cholesterol and investigated because they have anabolic and protective effects on chondrocytes.

The authors used iPS cells generated from the fibroblasts of both healthy individuals (WT-iPSC) and TD patients (TD-iPSC). Chondrocytes differentiated from TD-iPSC produced less cartilage than those from WT-iPSC and also had a lower proliferation rate and greater apoptosis, properties that were attributed to a gain of function by the mutated FGFR3. Adding statin recovered the cartilage formation in TD-iPSC and increased the proliferation rate. Coincidently, the group observed increased expressions of SOX9, a chondrocytic transcription factor, and of COL2A1 and ACAN, two cartilage extracellular components, all of which are down-regulated in TD patients. Moreover, statin treatment was found to accelerate the degradation of the FGFR3 protein in chondrogenically differentiated TD-iPSC, a process inhibited in TD cases.

Read more at :https://www.cira.kyoto-u.ac.jp/e/pressrelease/news/140918-110738.html

Rosuvastatin promotes bone growth in mice with achondroplasia symptoms

FDA Approves Cerdelga (eliglustat) for Type 1 Gaucher Disease

The U.S. Food and Drug Administration today approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder.

Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials to collect in the spleen, liver and bone marrow. The major signs of Gaucher disease include liver and spleen enlargement, low red blood cell counts (anemia), low blood platelet counts and bone problems.

Cerdelga is a hard gelatin capsule containing eliglustat that is taken orally. In patients with Gaucher disease Type 1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them. Type 1 Gaucher disease is estimated to affect about 6,000 people in the United States.

FDA Approves Cerdelga (eliglustat) for Type 1 Gaucher Disease

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

In continuation of my update on Ellipta (fluticasone furoate)

GlaxoSmithKline plc  announced that the Food and Drug Administration has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm

FDA Approves Arnuity Ellipta (fluticasone furoate) for the Treatment of Asthma

FDA Approves Triumeq for the Treatment of HIV-1 Infection

ViiV Healthcare announced today that the U.S. Food and Drug Administration (FDA) has approved Triumeq (abacavir 600mg (below-Ist), dolutegravir (below -IInd) 50mg and lamivudine (below IIIrd respectively) 300mg) tablets for the treatment of HIV-1 infection.  Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor (INSTI) dolutegravir, with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir and lamivudine.

FDA Approves Triumeq for the Treatment of HIV-1 Infection

FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

In continuation with my update on Movantik(naloxegol)

The U.S. Food and Drug Administration today approved Movantik(naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain.

FDA Approves Movantik (naloxegol) for Opioid-Induced Constipation

Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

Pfizer Inc. today announced it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

Pfizer Announces Submission of Palbociclib New Drug Application to the FDA

Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.

FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

Amgen announced the U.S. Food and Drug Administration (FDA) has granted priority review designation for ivabradine for the treatment of chronic heart failure (HF). Ivabradine is an oral drug that inhibits the I_f current ("funny" current) in the sinoatrial node, the body's cardiac pacemaker.  Ivabradine works to slow the heart rate without negative effects on myocardial contractility or ventricular repolarization.  Heart failure is a common condition that affects approximately 26 million worldwide, including approximately 5.1 million people in the U.S. 

FDA Grants Amgen Priority Review Designation For Ivabradine For The Treatment Of Chronic Heart Failure

FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

In continuation of my update on Apixaban (BMS-562247-01, tradename Eliquis)

Bristol-Myers Squibb Company and Pfizer Inc.  announced the U.S. Food and Drug Administration (FDA) has approved a Supplemental New Drug Application (sNDA) for Eliquis for the treatment of DVT and PE, and for the reduction in the risk of recurrent DVT and PE following initial therapy. Combined, DVT and PE are known as VTE. It is estimated that every year, approximately 900,000 Americans are affected by DVT and PE.

FDA Approves Eliquis (apixaban) for the Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

Actavis plc (NYSE: ACT) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' New Drug Application (NDA) for eluxadoline, an investigational drug for the treatment of diarrhea and abdominal pain in men and women with diarrhea predominant Irritable Bowel Syndrome (IBS-D). Actavis' NDA for eluxadoline has been granted priority review status by the FDA.

Actavis Announces FDA Acceptance for Filing of NDA for Eluxadoline

FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

In continuation of my update on Lirglutide

Novo Nordisk today announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the Food and Drug Administration (FDA) has completed its meeting regarding the New Drug Application (NDA) for Saxenda, the intended brand name for liraglutide 3 mg, a once-daily human GLP-1 analogue for the treatment of obesity.

FDA Advisory Committee Votes 14-1 in Favor of Saxenda (liraglutide) for Obesity

New class of compounds protect brain cells from traumatic brain injury

A new class of compounds has now been shown to protect brain cells from the type of damage caused by blast-mediated traumatic brain injury (TBI). Mice that were treated with these compounds 24-36 hours after experiencing TBI from a blast injury were protected from the harmful effects of TBI, including problems with learning, memory, and movement.

Traumatic brain injury caused by blast injury has emerged as a common health problem among U.S. servicemen and women, with an estimated 10 to 20 percent of the more than 2 million U.S. soldiers deployed in Iraq or Afghanistan having experienced TBI. The condition is associated with many neurological complications, including cognitive and motor decline, as well as acquisition of psychiatric symptoms like anxiety and depression, and brain tissue abnormalities that resemble Alzheimer's disease.

"The lack of neuroprotective treatments for traumatic brain injury is a serious problem in our society," says Andrew Pieper, M.D., Ph.D., senior study author and associate professor of psychiatry, neurology, and radiation oncology at the University of Iowa Carver College of Medicine. "Everyone involved in this work is motivated to find a way to offer hope for patients, which today include both military personnel and civilians, by establishing a basis for a new treatment to combat the deleterious neuropsychiatric outcomes after blast injury."

It is known that TBI, as well as certain neurodegenerative diseases, damages axons - the tendril-like fibers that sprout from brains cells (neurons) and form the connections called synapses. In TBI, axon damage is followed by death of the neuron. The new study, published Sept. 11 in the journal Cell Reports, shows that a group of compounds, called the P7C3 series, blocks axon damage and preserves normal brain function following TBI.

Pieper led the team of scientists that discovered the P7C3 compound several years ago at UT Southwestern Medical Center. Subsequent studies showed that the root compound and its active analogs protect newborn neurons from cell death and also protect mature neurons in animal models of neurodegenerative diseases, including Parkinson's disease and amyotrophic lateral sclerosis (ALS).

The researchers have also previously shown efficacy of P7C3 molecules in brain injury due to concussion, and plan to investigate whether these compound might be applicable in stroke as well, given that there appear to be common factors mediating neuronal cell death in these conditions.
Ref : http://www.cell.com/cell/abstract/S0092-8674(10)00672-0

New class of compounds protect brain cells from traumatic brain injury

Prana's PBT2 receives FDA Orphan Drug designation for treatment of Huntington disease

Prana's PBT2 receives FDA Orphan Drug designation for treatment of Huntington disease

Two Vaccines Help Cut Bacteria That Cause Meningitis, Study Finds

Two new vaccines can reduce the spread of meningitis by reducing the number of meningitis-causing bacteria that people carry, according to a new study.

Researchers tested the two vaccines -- MenACWY-CRM and 4CMenB -- on volunteers aged 18 to 24. MenACWY-CRM cut meningitis-causing bacteria populations in the nose and throat by 39 percent and 4CMenB lowered those populations by 20 to 30 percent.

Two Vaccines Help Cut Bacteria That Cause Meningitis, Study Finds 

New Drug May Fight Serious Respiratory Virus in Infants

 An experimental drug shows promise in treating respiratory syncytial virus (RSV), a leading cause of pneumonia in infants, researchers report.

"We are finally making major progress in being able to treat human RSV infections -- the world's second leading cause of serious viral pneumonia, second only to influenza virus," said study author Dr. John DeVincenzo, a professor of pediatrics at the University of Tennessee College of Medicine in Memphis.

"There is no current treatment or vaccine for RSV pneumonia, and so patients were previously forced to get over the virus by themselves," he said. RSV is the leading cause of hospitalization among infants in the United States, the researchers noted.

In this small study of 140 adults, the drug, dubbed GS-5806, reduced the amount of the virus in the systems of those who received the medication.

"For the first time, we showed that once we reduce the amount of virus in patients, they very quickly started to feel better," DeVincenzo said.

New Drug May Fight Serious Respiratory Virus in Infants  

Drug Gives 'New Hope' Against Heart Failure, Expert Says

In a head-to-head comparison, an experimental drug was more effective than standard treatment at preventing deaths and hospitalizations in heart failure patients.

According to the study authors, the trial was stopped early because of the marked benefit of the new drug, dubbed LCZ696. [LCZ696 is an investigational combination drug consisting of two antihypertensives (blood pressure lowering drugs), valsartan (left below) and AHU-377 (right below), in a 1:1 mixture. It is being developed by Novartis. The combination is often described as a dual-acting angiotensin receptor-neprilysin inhibitor (ARNi)]

In the trial, 26.5 percent of those getting the standard medication, enalapril (Vasotec), either died or were hospitalized due to heart failure, compared with 21.8 percent of those on the new drug. Enalapril belongs to a class of blood pressure-lowering medications known as ACE inhibitors.

"LCZ696 could become the new gold standard, replacing ACE inhibitors," said lead researcher Dr. John McMurray, a professor of cardiology at the British Heart Foundation Cardiovascular Research Center at the University of Glasgow, in Scotland.

LCZ696 combines two blood pressure drugs -- an angiotensin II receptor blocker (ARB) and the neprilysin inhibitor known as sacubitril.

"We found that LCZ696 was superior to the gold-standard ACE inhibitor for heart failure -- an ACE inhibitor being the absolute cornerstone of treatment for this problem," he said.

Not only did LCZ696 beat enalapril, but it did that even when added to other treatments, McMurray noted.

"The new treatment was very well tolerated, with no significant safety concerns," he added.

Drug Gives 'New Hope' Against Heart Failure, Expert Says