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Food and Drug Administration (FDA)

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[News] FDA likely to further restrict or ban morcellation
At the end of a 2-day Obstetrics and Gynecology Devices advisory panel meeting this month to assess the risks for patients undergoing morcellation during minimally invasive myomectomy or hysterectomy, the US Food and Drug Administration (FDA) indicated that it is seeking to more stringently restrict morcellation because of the danger of spreading cancerous tissue beyond the uterus. (Source: The Lancet Oncology)
Source: The Lancet Oncology - July 29, 2014 Category: Cancer & Oncology Authors: Vicki Brower Tags: News Source Type: research

Use of internet search logs to evaluate potential drug adverse events.
Abstract Internet search logs provide an abundant source of data that can be explored for purposes such as identifying drug exposure-adverse event relationships. The methodology to rigorously conduct such evaluations is not well characterized, and the utility of such analyses is not well defined. In this issue, White and colleagues propose an approach using Internet search logs for this purpose and compare it to parallel analyses conducted using the US Food and Drug Administration's spontaneous reporting database. PMID: 25056395 [PubMed - in process] (Source: Clinical Pharmacology and Therapeutics)
Source: Clinical Pharmacology and Therapeutics - July 28, 2014 Category: Drugs & Pharmacology Authors: Sarntivijai S, Abernethy DR Tags: Clin Pharmacol Ther Source Type: research

AcelRx stock feels the pain after FDA rejects drug-device
AcelRx Pharmaceuticals Inc., which late last week had to tamp down investor enthusiasm after a leak that its pain drug system was approved by regulators, lost more than 30 percent in pre-market trading Monday after the Food and Drug Administration rejected the drug-device. The Redwood City company's stock tumbled $3.84 per share, to $6.99, as investors dealt with the repercussions of the FDA sending the drug-device, called Zalviso, back to AcelRx with a list of questions. The stock closed Friday… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 28, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

AcelRx stock feels the pain after FDA rejects drug-device
AcelRx Pharmaceuticals Inc., which late last week had to tamp down investor enthusiasm after a leak that its pain drug system was approved by regulators, lost nearly 30 percent in pre-market trading Monday after the Food and Drug Administration rejected the drug-device. (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 28, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

AcelRx stock feels the pain after FDA rejects drug-device
AcelRx Pharmaceuticals Inc., which late last week had to tamp down investor enthusiasm after a leak that its pain drug system was approved by regulators, lost more than 30 percent in pre-market trading Monday after the Food and Drug Administration rejected the drug-device. The Redwood City company's stock (NASDAQ: ACRX) tumbled $3.84 per share, to $6.99, as investors dealt with the repercussions of the FDA sending the drug-device, called Zalviso, back to AcelRx with a list of questions. The stock… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 28, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

Studies of psychiatry products in children result in 30 labeling changes [FDA UPDATE]
(Source: AAP News)
Source: AAP News - July 28, 2014 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Pediatric & Maternal Health Staff, Division of Psychiatry Products Tags: FDA Update, Psychiatry/Psychology Source Type: research

AcelRx pain drug system rejected by FDA
AcelRx Inc.’s automated pain drug delivery system was rejected by the Food and Drug Administration, the Redwood City company said late Friday. The FDA’s rebuff may be temporary: AcelRx President and CEO Richard King said the company plans to answer the agency’s questions and ask again by the end of the year for approval. But the decision has repercussions for AcelRx (NASDAQ: ACRX) in the time-is-money world of drug and device development. Not only will AcelRx not be able to sell its system,… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 26, 2014 Category: Hospital Management Authors: Ron Leuty Source Type: research

AcelRx pain drug system rejected by FDA
AcelRx Inc.’s automated pain drug delivery system was rejected by the Food and Drug Administration, the Redwood City company said late Friday. The FDA’s rebuff may be temporary: AcelRx President and CEO Richard King said the company plans to answer the agency’s questions and ask again by the end of the year for approval. But the decision has repercussions for AcelRx (NASDAQ: ACRX) in the time-is-money world of drug and device development. Not only will AcelRx not be able to sell its system,… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 26, 2014 Category: Biotechnology Authors: Ron Leuty Source Type: research

[Comment] New era for treatment in differentiated thyroid cancer
Multikinase inhibitors were introduced into clinical trials for radioactive iodine-refractory differentiated thyroid cancer a decade ago. In The Lancet, Marcia Brose and colleagues report the results of DECISION, the first phase 3 randomised, double-blind, placebo-controlled clinical trial with the multikinase inhibitor sorafenib in differentiated thyroid cancer. On the basis of this landmark trial, sorafenib received an orphan designation by the European Medicine Agency in differentiated thyroid cancer, and was approved by the US Food and Drug Administration (FDA) for treatment of radioactive iodine-refractory differentia...
Source: LANCET - July 26, 2014 Category: Journals (General) Authors: Sigurdis Haraldsdottir, Manisha H Shah Tags: Comment Source Type: research

RTP drug developer gets 'Fast Track' from FDA
Research Triangle Park’s Humacyte Inc. received “Fast Track” designation by the U.S. Food and Drug Administration, a valuable recognition for any drug developer. Fast Track designation means FDA intends to work more closely with Humacyte, giving company executives more regular and precise feedback on development, clinical trial design and the like. Before a pharmaceutical company may sell a new drug, it must receive approval from FDA. To receive approval, companies must submit what is called… (Source: bizjournals.com Health Care:Hospitals headlines)
Source: bizjournals.com Health Care:Hospitals headlines - July 25, 2014 Category: Hospital Management Authors: Jason deBruyn Source Type: research

Re: Jarow JP et al.: Clinical Trial Design For the Development of New Therapies for Non–muscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop (Urology 2014;83:262-265)
Noting that “… product development for non–muscle-invasive bladder cancer (NMIBC) has been stymied by difficulties in trial design and patient accrual”, this special report is, presumably, meant to spur development of products that treat NMIBC by offering guidance on acceptable trial designs. We are concerned that the result will be the exact opposite. (Source: Urology)
Source: Urology - July 25, 2014 Category: Urology & Nephrology Authors: John Amrhein, Ashish M. Kamat, Alvaro Morales Tags: Letters to the Editor Source Type: research

Reply by the Authors
We thank the authors of this letter for raising several important points that indicate a need to address any misunderstandings created by this article that summarizes the discussions held during a joint US Food and Drug Administration (FDA) and American Urological Association public workshop in May 2013. We would first like to clarify the differences between an FDA workshop and a formal FDA advisory committee meeting. Although both venues provide an opportunity to gain expert opinion on a topic; by statutory requirement, advisory committee members, who often deal with specific product applications, must be screened for pot...
Source: Urology - July 25, 2014 Category: Urology & Nephrology Authors: Jonathan Jarow, Paul G. Kluetz, Seth P. Lerner, Ke Liu, Rajeshwari Sridhara, Dean Bajorin, Sam Chang, Colin P.N. Dinney, Susan Groshen, Ronald A. Morton, Michael O’Donnell, Diane Zipursky Quale, Mark Schoenberg, John Seigne, Bhadrasain Vikram Tags: Letters to the Editor Source Type: research

Impact of fda actions, dtca, and public information on the market for pain medication
ABSTRACT Nonsteroidal anti‐inflammatory drugs (NSAIDs) are one of the most important classes of prescription drugs used by primary care physicians to manage pain. The NSAID class of products has a somewhat controversial history, around which a complex regulatory and informational environment has developed. This history includes a boxed warning mandated by the Food and Drug Administration (FDA) for all NSAIDs in 2005. We investigate the impact that various information shocks have had on the use of prescription medications for pain in primary care in the USA. We accomplish this by extracting data on nearly 600 000 patien...
Source: Health Economics - July 24, 2014 Category: Health Management Authors: W. David Bradford, Andrew N. Kleit Tags: Research Article Source Type: research

S1PR1 Involvement in Paclitaxel-induced Neuropathic Pain [Neurobiology]
The ceramide-sphingosine 1-phosphate (S1P) rheostat is important in regulating cell fate. Several chemotherapeutic agents, including paclitaxel (Taxol), involve pro-apoptotic ceramide in their anticancer effects. The ceramide-to-S1P pathway is also implicated in the development of pain, raising the intriguing possibility that these sphingolipids may contribute to chemotherapy-induced painful peripheral neuropathy, which can be a critical dose-limiting side effect of many widely used chemotherapeutic agents. We demonstrate that the development of paclitaxel-induced neuropathic pain was associated with ceramide and S1P forma...
Source: Journal of Biological Chemistry - July 24, 2014 Category: Chemistry Authors: Janes, K., Little, J. W., Li, C., Bryant, L., Chen, C., Chen, Z., Kamocki, K., Doyle, T., Snider, A., Esposito, E., Cuzzocrea, S., Bieberich, E., Obeid, L., Petrache, I., Nicol, G., Neumann, W. L., Salvemini, D. Tags: Molecular Bases of Disease Source Type: research

[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

Inhaled Insulin: A Breath of Fresh Air? A Review of Inhaled Insulin.
Abstract PURPOSE: Despite many advances in diabetes care over the last century, some elements of insulin therapy remain inadequate for optimal care of the patient with diabetes. There is a need for improved pharmacokinetics and pharmacodynamics of rapid-acting insulin analogues to mimic physiologic insulin secretion. In addition, a major barrier to successful insulin therapy has been patient resistance. Alternative routes of insulin administration, including inhaled insulin, have been under investigation for several years. This review discusses the rationale for pulmonary delivery of insulin, compares previous inha...
Source: Clinical Therapeutics - July 17, 2014 Category: Drugs & Pharmacology Authors: Santos Cavaiola T, Edelman S Tags: Clin Ther Source Type: research

Cilostazol prevents the degradation of collagen Type II in human chondrocytes.
In this study, we reported that cilostazol is able to suppress the degradation of type II collagen in human chondrocytes induced by IL-1β. Mechanistically, cilostazol treatment leads to inhibiting the expression of IRF-1, thereby prevents the induction of MMP-13. Signal transducers and activator of transcription 1 (STAT1) has been reported to play an essential role in regulating the activation of IRF-1. Our results indicated that cilostazol suppresses the activation of STAT1 by mitigating the phosphorylation of STAT1 at Ser727 and tyrosine phosphorylation of STAT1 at position 701 (Tyr701). PMID: 25044117 [PubMed - as ...
Source: Biochemical and Biophysical Research communications - July 17, 2014 Category: Biochemistry Authors: Wang W, Kang W, Tang Q, Yao G, Chen Y, Cheng B, Kong K Tags: Biochem Biophys Res Commun 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

Absence of Amiodarone-Associated Optic Neuropathy
In 2008, the present author published an editorial in the American Heart Journal1 dealing with optic neuropathies (ON) associated with amiodarone use. Cited were data of amiodarone sales and US Food and Drug Administration (FDA) reports of amiodarone-associated ON for 2001 through 2006 (6 years). The IMS National Prescription Audit captured approximately 70% of all US retail prescription sales and projected the number to 100%. The IMS Integrated Patient Claims Database provided an estimate of the number of patients treated. (Source: Ophthalmology)
Source: Ophthalmology - July 11, 2014 Category: Opthalmology Authors: Joel S. Mindel Source Type: research

A rapid and sensitive LC-MS/MS method for the determination of Pulsatilla saponin D in rat plasma and its application in a rat pharmacokinetic and bioavailability study.
Abstract A simple, sensitive and specific liquid chromatography-tandem mass spectrometry method was developed and validated for the determination of Pulsatilla saponin D, a potential antitumor constituent isolated from Pulsatilla chinensis in rat plasma. Rat plasma samples were pretreated by protein precipitation with methanol. The method validation was performed in accordance with US Food and Drug Administration guidelines and the results met the acceptance criteria. The method was successfully applied to assess the pharmacokinetics and oral bioavailability of Pulsatilla saponin D in rats. Copyright © 2014 John W...
Source: Biomedical Chromatography : BMC - July 9, 2014 Category: Biomedical Science Authors: Ouyang H, Guo Y, He M, Zhang J, Huang X, Zhou X, Jiang H, Feng Y, Yang S Tags: Biomed Chromatogr 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

Truly personalized medicine?
Abstract The patient wished to receive an experimental drug that she was instrumental in developing. After her diagnosis, she had investigated treatments that might help her condition and discovered that a specific compound could be beneficial. To further the development of this potential drug, she obtained preclinical data, founded a company, and sought investment from venture capitalists. The company was about to begin phase I testing, but the clinical trial had not yet opened. In addition, she would not have been a candidate for the study, as it excluded patients with advanced disease. To be able to administer t...
Source: The Hastings Center Report - July 1, 2014 Category: Medical Ethics Authors: Smith LB, Cooke CR, Goldman EB Tags: Hastings Cent Rep 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