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Food and Drug Administration (FDA)

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[Comment] New antibiotics for skin and skin-structure infections
On April, 2014, WHO published a report showing the present situation of antimicrobial resistance in many regions of the world and underlining the risk of a global post-antibiotic era in which even common infections can be lethal. However, only one antibiotic (delafloxacin) is in phase 3 development for treatment of these infections and just two (dalbavacin and oritavancin) are in assessment by the European Medicines Agency and the US Food and Drug Administration. (Source: The Lancet Infectious Diseases)
Source: The Lancet Infectious Diseases - July 22, 2014 Category: Infectious Diseases Authors: Evelina Tacconelli, Winfried V Kern Tags: Comment Source Type: research

Kansas City clinic will provide new HIV prevention method
Family Health Care, a Kansas City clinic focused on the underserved, is opening a new clinic designed to help prevent the spread of HIV through a new method. The PrEP Care clinic uses a relatively new approach in which people with a high risk of acquiring HIV are prescribed a regimen of daily pills. The Food and Drug Administration approved the use of the drugs in 2012, and in May 2014 the Centers for Disease Control and Prevention released its guidelines for the use of pre-exposure prophylaxis,… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 21, 2014 Category: American Health Authors: Brianne Pfannenstiel Source Type: research

Pancreatic cancer treatment that almost never was lands key FDA win
Aduro BioTech Inc.'s immune system-boosting treatment for fighting deadly pancreatic cancer won "breakthrough therapy" designation from regulators, the small Berkeley company said Monday. The breakthrough therapy tag can accelerate approval of badly needed drugs from years to 60 days by speeding the Food and Drug Administration review of drugs that are a "substantial improvement" over existing therapies. The designation carries no assurance that the FDA ultimately will approve Aduro's treatment,… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 21, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Raleigh drug company moves forward with 'female Viagra'
After running into some regulatory hurdles, a Raleigh company developing what it hopes will become the “female Viagra” got its feet back underneath itself and is again pressing toward FDA approval with the help of investments of more than $4 million. Sprout Pharmaceuticals raised $4.3 million of a $15 million round and will use the money predominantly for additional clinical work that company executives agreed to with the U.S. Food and Drug Administration. The private drug development company… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 21, 2014 Category: Hospital Management Authors: Jason deBruyn Source Type: research

Clinical relevance of stem cell therapies in amyotrophic lateral sclerosis
Russell H Morgan, Amit K SrivastavaNeurology India 2014 62(3):239-248Amyotrophic lateral sclerosis (ALS), characterized by the progressive loss of both upper and lower motor neurons, is a fatal neurodegenerative disorder. This disease is often accompanied by a tremendous physical and emotional burden not only for the patients, but also for their families and friends as well. There is no clinically relevant treatment available for ALS. To date, only one Food and Drug Administration (FDA)-approved drug, Riluzole, licensed 18 years ago, has been proven to marginally prolong patients' survival without improving the qual...
Source: Neurology India - July 18, 2014 Category: Neurology Authors: Russell H MorganAmit K Srivastava Source Type: research

An analysis of FDA-approved drugs for infectious disease: Antibacterial agents.
Abstract Drugs targeting infectious diseases have greatly improved public health. A study to evaluate all US Food and Drug Administration (FDA)-approved new molecular entities (NMEs) reveals that the number of new agents targeting infectious disease peaked during the 1990s and declined rapidly thereafter. Molecules targeting bacterial pathogens represent the most common component of anti-infectives followed by antivirals and antifungals. Focusing on antibacterial agents, an increase in new NMEs predominated from the 1960s through to the 1990s, dropping sharply thereafter. Obsolescence and resistance has eliminated ...
Source: Drug Discovery Today - July 17, 2014 Category: Drugs & Pharmacology Authors: Kinch MS, Patridge E, Plummer M, Hoyer D Tags: Drug Discov Today Source Type: research

FDA approves SynCardia's artificial heart power pack
The U.S. Food and Drug Administration has given the nod to Tucson-based SynCardia Systems Inc. to begin marketing in the U.S. its Freedom portable driver that powers the company's total artificial heart. Not only does that mean the company will begin hiring more people to make and sell the device, but it also means reducing the length of stay in hospitals for heart transplant patients. Before SynCardia invented the Freedom portable driver, U.S. patients were stuck in the hospital for years because… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 16, 2014 Category: Biotechnology Authors: Angela Gonzales Source Type: research

FDA approves SynCardia's artificial heart power pack
The U.S. Food and Drug Administration has given the nod to Tucson-based SynCardia Systems Inc. to begin marketing in the U.S. its Freedom portable driver that powers the company's total artificial heart. Not only does that mean the company will begin hiring more people to make and sell the device, but it also means reducing the length of stay in hospitals for heart transplant patients. Before SynCardia invented the Freedom portable driver, U.S. patients were stuck in the hospital for years because… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 16, 2014 Category: Hospital Management Authors: Angela Gonzales Source Type: research

Genentech aims to extend Avastin to cervical cancer
Regulators will clear a path for review of Genentech Inc.'s Avastin — one of the world's best-selling cancer drugs — as the company tries to extend the drug's use to certain types of cervical cancer. South San Francisco-based Genentech, the U.S. biotech unit of Swiss drug maker Roche, said the Food and Drug Administration granted priority review to Avastin plus chemotherapy to treat women with persistent, recurring or metastatic cervical cancer. The priority review designation allows FDA staff… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 15, 2014 Category: American Health Authors: Ron Leuty Source Type: research

Skin cancer drug combo with Genentech sends Exelixis stock soaring
A combination of drugs from two South San Francisco biotech companies helped patients with an advanced skin cancer live longer without their disease worsening than if they took one of the drugs alone, according to early data from a clinical trial. The strong, albeit preliminary, results will push Genentech Inc. to seek Food and Drug Administration approval of the drug combo targeting deadly melanoma by the end of the year. The news sent the stock of Exelixis (NASDAQ: EXEL) up more than 18 percent,… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 14, 2014 Category: American Health Authors: Ron Leuty Source Type: research

Duke drug development spinoff begins glaucoma trial
Duke University spinoff Aerie Pharmaceuticals began enrolling patients in a Phase 3 trial to test its glaucoma treatment. It’s an important step because a Phase 3 trial is typically the last trial before a pharmaceutical developer submits a new drug application (NDA) with the U.S. Food and Drug Administration. Aerie (Nasdaq: AERI) executives say they expect to file an NDA by mid-2016 if the trial goes to plan. In late June, Aerie reported positive results from a Phase 2b trial, sending shares… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 14, 2014 Category: Biotechnology Authors: Jason deBruyn Source Type: research

ReWalk Robotics, maker of robotic exoskeleton, seeks to raise $57.5M with IPO
ReWalk Robotics, an Israeli company that makes wearable robotic exoskeletons for paraplegics recently approved by the U.S. Food and Drug Administration, filed paperwork Thursday seeking to go public and is hoping to raise $57.5 million. Intended for individuals with spinal chord injuries, the ReWalk device picks up on the movements in a person’s upper body. The software, largely contained in an attached backpack, translates the movement into the gait of a walk within the robotic legs and knees. The… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 11, 2014 Category: Biotechnology Authors: David Harris Source Type: research

Anacor nails fungus drug approval
In a race to reach people with a painful and ugly toenail fungus, Anacor Pharmaceuticals Inc. won early regulatory approval Tuesday to sell its topical treatment. The Palo Alto company (NASDAQ: ANAC), which expected a decision from the Food and Drug Administration by July 29, said Tuesday that the FDA approved Kerydin to treat onychomycosis, a fungal infection of the nail and nail bed. But while Kerydin is the first antifungal of its type approved for onychomycosis, Anacor is far from alone in… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 8, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

Anacor nails fungus drug approval
In a race to reach people with a painful and ugly toenail fungus, Anacor Pharmaceuticals Inc. won early regulatory approval Tuesday to sell its topical treatment. The Palo Alto company (NASDAQ: ANAC), which expected a decision from the Food and Drug Administration by July 29, said Tuesday that the FDA approved Kerydin to treat onychomycosis, a fungal infection of the nail and nail bed. But while Kerydin is the first antifungal of its type approved for onychomycosis, Anacor is far from alone in… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 8, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Four Health Data Networks Illustrate The Potential For A Shared National Multipurpose Big-Data Network [Building Rapid-Learning Systems]
This article describes our experience in developing data networks that repurpose electronic health records and administrative data. The four programs we feature are the Food and Drug Administration’s Mini-Sentinel program (which focuses on medical product safety), the National Patient-Centered Clinical Research Network (PCORnet, comparative effectiveness research), the National Institutes of Health’s Health Care Systems Research Collaboratory Distributed Research Network (biomedical research), and ESPnet (public health surveillance). Challenges to these uses of electronic health data include understanding the f...
Source: Health Affairs - July 8, 2014 Category: Global & Universal Authors: Curtis, L. H., Brown, J., Platt, R. Tags: Access To Care, Health Professions Education, Health Promotion/Disease Prevention, Health Reform, Hospitals, Physicians, Quality Of Care, Health Spending, Health Information Technology, Affordable Care Act Building Rapid-Learning Systems Source Type: research

Medical devices; neurological devices; classification of the transcranial magnetic stimulator for headache. Final order.
Abstract The Food and Drug Administration (FDA) is classifying the transcranial magnetic stimulator for headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcranial magnetic stimulator for headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 25016622 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - July 8, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Penn gets FDA 'breakthrough' designation for experimental cancer therapy
The Food and Drug Administration granted “breakthrough therapy” status Monday to a new personalized cellular cancer treatment developed by researchers at the University of Pennsylvania’s Perelman School of Medicine. The breakthrough therapy designation was created by the FDA to expedite the development and review of new medicines that treat serious or life-threatening conditions — if the therapy has demonstrated substantial improvement over an available therapy. Penn said its investigational… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 7, 2014 Category: Hospital Management Authors: John George Source Type: research

Penn gets FDA 'breakthrough' designation for experimental cancer therapy
The Food and Drug Administration granted “breakthrough therapy” status Monday to a new personalized cellular cancer treatment developed by researchers at the University of Pennsylvania’s Perelman School of Medicine. The breakthrough therapy designation was created by the FDA to expedite the development and review of new medicines that treat serious or life-threatening conditions — if the therapy has demonstrated substantial improvement over an available therapy. Penn said its investigational… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 7, 2014 Category: Biotechnology Authors: John George Source Type: research

The Limits of Evidence in Drug Approval and Availability: A Case Study of Cilostazol and Naftidrofuryl for the Treatment of Intermittent Claudication.
This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. METHODS: A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in ...
Source: Clinical Therapeutics - July 7, 2014 Category: Drugs & Pharmacology Authors: Hong H, Mackey WC Tags: Clin Ther Source Type: research

Critical Drug Shortages: Implications for Emergency Medicine / Escasez Crítica de Medicamentos Fundamentales: Implicaciones para la Medicina de Urgencias y Emergencias
Abstract Prescription drug shortages have become increasingly common and more severe over the past decade. In addition, reported shortages are longer in duration and have had a greater effect on patient care. Some of the causes of current drug shortages are multifactorial, including the consolidation of drug manufacturers, quality problems at production plants that restrict the supply of drugs, and a lack of financial incentives for manufacturers to produce certain products, particularly generic medications. Generic injectable medications are most commonly affected by shortages because the production process is complex and...
Source: Academic Emergency Medicine - July 5, 2014 Category: Emergency Medicine Authors: Maryann Mazer‐Amirshahi, Ali Pourmand, Steven Singer, Jesse M. Pines, John Anker Tags: Special Contribution Source Type: research

Rescue of Isomerase Activity for Disease-associated RPE65s [Protein Synthesis and Degradation]
Over 70 different missense mutations, including a dominant mutation, in RPE65 retinoid isomerase are associated with distinct forms of retinal degeneration; however, the disease mechanisms for most of these mutations have not been studied. Although some mutations have been shown to abolish enzyme activity, the molecular mechanisms leading to the loss of enzymatic function and retinal degeneration remain poorly understood. Here we show that the 26 S proteasome non-ATPase regulatory subunit 13 (PSMD13), a newly identified negative regulator of RPE65, plays a critical role in regulating pathogenicity of three mutations (L22P,...
Source: Journal of Biological Chemistry - July 4, 2014 Category: Chemistry Authors: Li, S., Izumi, T., Hu, J., Jin, H. H., Siddiqui, A.-A. A., Jacobson, S. G., Bok, D., Jin, M. Tags: Molecular Bases of Disease Source Type: research

On the Move: Big personnel changes in local biotech industry
Here's a summary of recent personnel changes and board appointments announced at Massachusetts biotech, pharmaceutical and medical device companies: Voyager Therapeutics, a gene therapy company in Cambridge developing treatments for diseases of the central nervous system, has named Robert G. Pietrusko as senior vice president of regulatory affairs. In his new role, Pietrusko will oversee all strategy and interactions with the U.S. Food and Drug Administration (FDA) and other agencies. Prior to Voyager,… (Source: bizjournals.com Health Care:Physician Practices headlines)
Source: bizjournals.com Health Care:Physician Practices headlines - July 3, 2014 Category: American Health Authors: By Patricia Resende Source Type: research

Teva takes new tactic in battle against generic versions of its MS drug
Teva Pharmaceuticals continued its efforts to ward generic competition for its multiple sclerosis drug Copaxone by filing a citizen’s petition with the Food and Drug Administration. Copaxone generated $3.8 billion in sales last year for Teva (NYSE: TEVA), an Israeli generic and branded pharmaceutical company that has its North American headquarters in North Wales, Pa. Last year, the courts invalidated key Teva patents for the multiple sclerosis drug, opening the door for generic competition… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 3, 2014 Category: Hospital Management Authors: John George Source Type: research

Evolution of Stroke Prevention in Nonvalvular Atrial Fibrillation Patients ∗
The PREVAIL (Watchman LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy) trial is the latest in the series of studies evaluating left atrial appendage (LAA) occlusion with the Watchman device (Boston Scientific, Natick, Massachusetts) as an alternative to warfarin therapy for the prevention of stroke in patients with nonvalvular atrial fibrillation (NVAF). The PREVAIL trial was initially designed as a follow-up study to PROTECT AF (Watchman Left Atrial Appendage Closure Technology for Embolic Protection in Patients With Atrial Fibrillation), which demonstrated noninferiority to warfa...
Source: Journal of the American College of Cardiology: Cardiovascular Imaging - July 3, 2014 Category: Radiology Source Type: research

Medical devices; physical medicine devices; classification of the nonpowered lower extremity pressure wrap. Final order.
Abstract The Food and Drug Administration (FDA) is classifying the nonpowered lower extremity pressure wrap into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 25016621 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - July 3, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Medical devices; neurological devices; classification of the transcutaneous electrical nerve stimulator to treat headache. Final order.
Abstract The Food and Drug Administration (FDA) is classifying the transcutaneous electrical nerve stimulator to treat headache into class II (special controls). The special controls that will apply to the device are identified in this order, and will be part of the codified language for the transcutaneous electrical nerve stimulator to treat headache classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. PMID: 25016620 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - July 3, 2014 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Prediction of individualized therapeutic vulnerabilities in cancer from genomic profiles
Motivation: Somatic homozygous deletions of chromosomal regions in cancer, while not necessarily oncogenic, may lead to therapeutic vulnerabilities specific to cancer cells compared with normal cells. A recently reported example is the loss of one of the two isoenzymes in glioblastoma cancer cells such that the use of a specific inhibitor selectively inhibited growth of the cancer cells, which had become fully dependent on the second isoenzyme. We have now made use of the unprecedented conjunction of large-scale cancer genomics profiling of tumor samples in The Cancer Genome Atlas (TCGA) and of tumor-derived cell lines in ...
Source: Bioinformatics - July 2, 2014 Category: Bioinformatics Authors: Aksoy, B. A., Demir, E., Babur, O., Wang, W., Jing, X., Schultz, N., Sander, C. Tags: SYSTEMS BIOLOGY Source Type: research

Biogen Idec storms haemophilia markets
Nature Reviews Drug Discovery 13, 485 (2014). doi:10.1038/nrd4387 The FDA approved Biogen Idec's long-acting haemophilia A drug, months after approving its long-acting haemophilia B drug.The lowdown: In June, the US Food and Drug Administration (FDA) approved Biogen Idec's Eloctate for adults and children with haemophilia A. The recombinant drug is made (Source: Nature Reviews Drug Discovery)
Source: Nature Reviews Drug Discovery - July 1, 2014 Category: Drugs & Pharmacology Tags: News and Analysis Source Type: research

[Review] Drug–drug interactions with tyrosine-kinase inhibitors: a clinical perspective
In the past decade, many tyrosine-kinase inhibitors have been introduced in oncology and haemato-oncology. Because this new class of drugs is extensively used, serious drug–drug interactions are an increasing risk. In this Review, we give a comprehensive overview of known or suspected drug–drug interactions between tyrosine-kinase inhibitors and other drugs. We discuss all haemato-oncological and oncological tyrosine-kinase inhibitors that had been approved by Aug 1, 2013, by the US Food and Drug Administration or the European Medicines Agency. (Source: The Lancet Oncology)
Source: The Lancet Oncology - June 30, 2014 Category: Cancer & Oncology Authors: Roelof W F van Leeuwen, Teun van Gelder, Ron H J Mathijssen, Frank G A Jansman Tags: Review Source Type: research

Pediatric studies of 48 dermatology drugs result in new labeling [FDA UPDATE]
(Source: AAP News)
Source: AAP News - June 30, 2014 Category: Pediatrics Authors: Food and Drug Administration's Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Dermatology and Dental Products Tags: Dermatology, FDA Update Source Type: research

Emerging applications for ferumoxytol as a contrast agent in MRI
This article reviews the properties of ferumoxytol relevant to MRI as well as many of the uses for the agent currently under investigation.J. Magn. Reson. Imaging 2014. © 2014 Wiley Periodicals, Inc. (Source: Journal of Magnetic Resonance Imaging)
Source: Journal of Magnetic Resonance Imaging - June 30, 2014 Category: Radiology Authors: Mustafa R. Bashir, Lubna Bhatti, Daniele Marin, Rendon C. Nelson Tags: Review Article Source Type: research

Sodium-Glucose Linked Transporter 2 (SGLT2) Inhibitors-Fighting Diabetes from a New Perspective.
Abstract Sodium-Glucose linked transporter 2 (SGLT2) inhibitors are a new family of antidiabetic pharmaceutical agents whose action is based on the inhibition of the glucose reabsorption pathway, resulting in glucosuria and a consequent reduction of the blood glucose levels, in patients with type 2 diabetes mellitus. Apart from lowering both fasting and postprandial blood glucose levels, without causing hypoglycemia, SGLT2 inhibitors have also shown a reduction in body weight and the systolic blood pressure. This review paper explores the renal involvement in glucose homeostasis providing also the latest safety and...
Source: Advances in Therapy - June 28, 2014 Category: Drugs & Pharmacology Authors: Angelopoulos TP, Doupis J Tags: Adv Ther Source Type: research

Maryland wants to boost biotech with international companies
Maryland has a new strategy for growing biotechnology business: Roll out the welcome mat for international companies. International bio companies looking to break into the American market must first get approval from the U.S. Food and Drug Administration. The FDA regulates medical devices and drugs. The approval process can be complicated even for American companies that are somewhat familiar with the agency. Maryland wants to set up a support system to help international companies navigate the… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - June 27, 2014 Category: Pharmaceuticals Authors: Sarah Gantz Source Type: research

Tobacco product use among adults - United States, 2012-2013.
This report provides the most recent national estimates of tobacco use among adults aged ≥18 years, using data from the 2012-2013 National Adult Tobacco Survey (NATS). The findings indicate that 21.3% of U.S. adults used a tobacco product every day or some days, and 25.2% used a tobacco product every day, some days, or rarely. Population-level interventions focused on the diversity of tobacco product use, including tobacco price increases, high-impact antitobacco mass media campaigns, comprehensive smoke-free laws, and enhanced access to help quitting, in conjunction with Food and Drug Administration (FDA) regulation of ...
Source: MMWR Morb Mortal Wkl... - June 27, 2014 Category: Epidemiology Authors: Agaku IT, King BA, Husten CG, Bunnell R, Ambrose BK, Hu SS, Holder-Hayes E, Day HR, Office on Smoking and Health, National Center for Chronic Disease Prevention and Health Promotion, CDC Tags: MMWR Morb Mortal Wkly Rep Source Type: research

[Editorial] Indian generic drug manufacturers in the spotlight
Concerns have arisen about safety and quality issues in the manufacture of pharmaceuticals in India, a major exporter of generic drugs to the USA and elsewhere. These concerns came into sharp focus last week when the US Food and Drug Administration (FDA) and UK Medicines and Healthcare Products Regulatory Agency (MHRA) issued two recalls of commonly taken drugs. On June 19, the FDA recalled 13 560 bottles of the antihypertensive drug, metoprolol succinate, from Dr Reddy's laboratory after a failed dissolution test. (Source: LANCET)
Source: LANCET - June 26, 2014 Category: Journals (General) Authors: The Lancet Tags: Editorial Source Type: research

Biosimilar granulocyte-colony-stimulating factor for healthy donor stem cell mobilization: need we be afraid?
This article reviews the available evidence on the use of biosimilar G-CSF in this setting. Aggregate clinical evidence supports the assessment by the EMA of biosimilar and originator G-CSF as highly biologically similar, with respect to desired and undesired effects. PMID: 24965197 [PubMed - as supplied by publisher] (Source: Transfusion)
Source: Transfusion - June 26, 2014 Category: Hematology Authors: Bonig H, Becker PS, Schwebig A, Turner M Tags: Transfusion Source Type: research

Use of EEG Beta-1 Power and Theta/Beta Ratio Over Broca's Area to confirm Diagnosis of Attention Deficit/Hyperactivity Disorder in Children.
This study examined theta and beta-1 power differences between ADHD and normal children, during tasks of selective attention, and elucidated topographical differences. EEGs were collected from 28 normal and 58 ADHD children, aged 6 to 14 years, using 31 scalp electrodes during auditory and visual tasks requiring selective attention. Spectral analysis was performed. Tbr was higher in ADHD than in normal children (2.60 vs 2.25, P = .007), with lower beta-1 (3.66 vs 4.22, P = .01), but no difference in theta power. There was lower beta-1 (P < .001) and higher tbr (P = .002) over Broca's area (electrode locations F7 and FC5...
Source: Clinical EEG and Neuroscience - June 26, 2014 Category: Neuroscience Authors: Sangal RB, Sangal JM Tags: Clin EEG Neurosci Source Type: research

Dietary Counseling: The Ingredient for Successfully Addressing the Use of Herbal Supplements and Probiotics in Chronic Kidney Disease
This article will discuss some of the more commonly used products and their potential positive and adverse effects on CKD patients. (Source: Advances in Chronic Kidney Disease)
Source: Advances in Chronic Kidney Disease - June 25, 2014 Category: Urology & Nephrology Authors: Judy Kirk, Karen S. Dunker Tags: Articles Source Type: research

Research in the CKD Clinic: Highs and Lows
Despite rates of CKD continuing to increase, the current evidence base used to guide CKD management is smaller than that for many other chronic diseases. Clinical investigators face multiple barriers to conducting research in patients with CKD. CKD patients have multiple comorbidities that make them a risky intervention target; thus, they are often excluded from trials. The lack of approved surrogate endpoints for kidney disease progression makes testing therapies to slow progression very challenging and expensive. Patients with CKD have higher rates of disability and lower educational status than the general population, w...
Source: Advances in Chronic Kidney Disease - June 25, 2014 Category: Urology & Nephrology Authors: Emily Decker, Jessica Kendrick Tags: Articles Source Type: research

Insights from analysis for harmful and potentially harmful constituents (HPHCs) in tobacco products.
Abstract A total of 20 commercial cigarette and 16 commercial smokeless tobacco products were assayed for 96 compounds listed as harmful and potentially harmful constituents (HPHCs) by the US Food and Drug Administration. For each product, a single lot was used for all testing. Both International Organization for Standardization and Health Canada smoking regimens were used for cigarette testing. For those HPHCs detected, measured levels were consistent with levels reported in the literature, however substantial assay variability (measured as average relative standard deviation) was found for most results. Using an ...
Source: Regulatory Toxicology and Pharmacology : RTP - June 25, 2014 Category: Toxicology Authors: Oldham MJ, DeSoi DJ, Rimmer LT, Wagner KA, Morton MJ Tags: Regul Toxicol Pharmacol Source Type: research

AHN shifting to 3-D breast imaging technology
Allegheny Health Network is preparing a big push into breast-imaging technology by upgrading mammography scanners at each of its facilities. The new scanning procedure, called tomosynthesis, gives doctors a clearer view of abnormal tissue than conventional mammograms. The Food and Drug Administration approved the technology in 2011, but only Bedford, Mass.-based Hologic Inc. has so far received approval for the scanners. AHN’s Jefferson Hospital installed a Hologic unit last fall at its Bethel… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 24, 2014 Category: Biotechnology Authors: Kris B. Mamula Source Type: research

Critical acral ischemia leading to multiple finger amputation: Side effect of long‐term (>30 cycles) pemetrexed maintenance treatment in a patient
Summary Pemetrexed is being used in United States (U.S.) for maintenance treatment of non‐squamous non‐small cell lung cancer for 4 years, after it was approved for this indication by U.S. Food and Drug Administration in July 2009. Here we report the first case of digital ischemia requiring amputation, likely due to long‐term pemetrexed maintenance treatment. A 68‐year‐old female with lung adenocarcinoma developed painful fingers after 32 cycles of maintenance pemetrexed treatment. The signs and symptoms initially mimicked Raynaud's phenomenon, but rapid progression ensued to ischemic gangrene of the digits. Comp...
Source: British Journal of Clinical Pharmacology - June 24, 2014 Category: Drugs & Pharmacology Authors: Neha Gupta, Sahil Gupta, Shipra Gandhi, Hassan Hatoum, Grace Dy Tags: Letter Source Type: research

Resurrected cancer drug faces regulators
Nature 510, 7506 (2014). http://www.nature.com/doifinder/10.1038/510454a Author: Heidi Ledford Despite a chequered history, olaparib is finally before the US Food and Drug Administration. (Source: Nature)
Source: Nature - June 24, 2014 Category: Research Authors: Heidi Ledford Tags: News Source Type: research

Reply Regarding the Effect of Dabigatran Plasma Concentrations
We would like to respond to Dr. Rao's questions concerning our paper (1). First, it is incorrect to state that any data on dabigatran and plasma levels were suppressed. This information has been submitted to all regulatory authorities as part of the original registration process of dabigatran etexilate for reduction of stroke in patients with atrial fibrillation. These data have also been in the public domain since the U.S. Food and Drug Administration (FDA) Advisory Committee meeting in September 2010, before marketing approval (2). (Source: Journal of the American College of Cardiology: Cardiovascular Interventions)
Source: Journal of the American College of Cardiology: Cardiovascular Interventions - June 23, 2014 Category: Cardiology Source Type: research

Assessment of the risk of salmonellosis from internally contaminated shell eggs following initial storage at 18 °C (65 °F), compared with 7 °C (45 °F).
Abstract In the U.S., chicken-breeder farms that supply hatcheries typically store and transport eggs intended for broiler production at a temperature of 18.3 °C (65 °F). However, in case of surplus, some of these eggs may be diverted to human consumption. According to the U.S. Food and Drug Administration's 'Egg Safety Final Rule,' shell eggs intended for human consumption are required to be held or transported at or below 7.2 °C (45 °F) ambient temperature beginning 36 h after time of lay. We adapted a risk assessment model developed by the U.S. Department of Agriculture's Food Safety Inspection Service,...
Source: Food Microbiology - June 21, 2014 Category: Food Science Authors: Pouillot R, Hoelzer K, Ramirez GA, deGraft-Hanson J, Dennis SB Tags: Food Microbiol Source Type: research

Emerging therapeutic options for the management of hepatitis C infection.
Abstract Until recently the traditional treatment for hepatitis C infection included pegylated interferon and ribavirin combination therapy. The sustained virological response (SVR) seen with this combination is poor and requires lengthy treatment to achieve. Additionally, significant side effects and numerous contraindications prevented many patients from being successfully treated with this therapy. In 2011, two new protease inhibitors, telaprevir and boceprevir, were approved for use with pegylated interferon and ribavirin in the United States by the United States Food and Drug Administration. These agents have ...
Source: World Journal of Gastroenterology : WJG - June 21, 2014 Category: Gastroenterology Authors: Thompson JR Tags: World J Gastroenterol Source Type: research

The challenge of indication extrapolation for infliximab biosimilars.
Abstract A biosimilar is intended to be highly similar to a reference biologic such that any differences in quality attributes (i.e., molecular characteristics) do not affect safety or efficacy. Achieving this benchmark for biologics, especially large glycoproteins such as monoclonal antibodies, is challenging given their complex structure and manufacturing. Regulatory guidance on biosimilars issued by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency indicates that, in addition to a demonstration of a high degree of similarity in quality attributes, a reduced number of nonclinical ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 21, 2014 Category: Biotechnology Authors: Feagan BG, Choquette D, Ghosh S, Gladman DD, Ho V, Meibohm B, Zou G, Xu Z, Shankar G, Sealey DC, Russell AS Tags: Biologicals Source Type: research

[Correspondence] Adverse drug reaction: pomalidomide-induced liver injury
Survival after multiple myeloma has improved with the use of immunomodulatory drugs—thalidomide, lenalidomide, and pomalidomide. Pomalidomide, the latest immunomodulatory drug to be approved by the US Food and Drug Administration, was developed by modifying thalidomide's chemical structure to increase potency and improve safety. Pomalidomide undergoes extensive cytochrome P450-mediated metabolism and has a toxicity profile mainly characterised by myelosuppression. Here, we discuss the first case of pomalidomide-induced hepatotoxicity reported under post-marketing surveillance. (Source: LANCET)
Source: LANCET - June 20, 2014 Category: Journals (General) Authors: Rajwanth R Veluswamy, Stephen C Ward, Kendra Yum, Rebecca B Abramovitz, Luis M Isola, Sundar Jagannath, Samir Parekh Tags: Correspondence Source Type: research

Medline Industries will hire up to 200 when it reopens former Triad/H&P Industries plant
Medline Industries Inc., a manufacturer and distributor of medical supplies, bought Triad Group and its H&P Industries plant in Hartland out of bankruptcy and now announced it will reopen the plant and hire up to 200 employees there. Medline will invest $8 million to renovate and equip the facility with the latest technology and safety systems to help meet the regulations of the federal Food and Drug Administration, according to a press release Wednesday afternoon from Gov. Scott Walker’s office.… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - June 18, 2014 Category: Biotechnology Authors: Rich Kirchen Source Type: research

Medline Industries will hire up to 200 when it reopens former Triad/H&P Industries plant
Medline Industries Inc., a manufacturer and distributor of medical supplies, bought Triad Group and its H&P Industries plant in Hartland out of bankruptcy and now announced it will reopen the plant and hire up to 200 employees there. Medline will invest $8 million to renovate and equip the facility with the latest technology and safety systems to help meet the regulations of the federal Food and Drug Administration, according to a press release Wednesday afternoon from Gov. Scott Walker’s office.… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - June 18, 2014 Category: Hospital Management Authors: Rich Kirchen Source Type: research