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Aggressive thyroid cancer: targeted therapy with sorafenib.
Authors: Corrado A, Ferrari SM, Politti U, Mazzi V, Miccoli M, Materazzi G, Antonelli A, Ulisse S, Fallahi P, Miccoli P Abstract Sorafenib (Nexavar), is a multikinase inhibitor, which has demonstrated both anti proliferative and anti-angiogenic properties in vitro and in vivo, inhibiting the activity of targets present in the tumoral cells [c-RAF (proto-oncogene serine/threonine-protein kinase), BRAF, (V600E)BRAF, c-KIT, and FMS-like tyrosine kinase 3] and in tumor vessels [c-RAF, vascular endothelial growth factor receptor (VEGFR)-2, VEGFR-3, and platelet-derived growth factor receptor β]. Sorafenib was initially...
Source: Minerva Endocrinologica - June 29, 2015 Category: Endocrinology Tags: Minerva Endocrinol Source Type: research

Evaluation of neurocognitive development discussed at FDA workshop [FDA UPDATE]
(Source: AAP News)
Source: AAP News - June 29, 2015 Category: Pediatrics Authors: Food and Drug Administration Office of Pediatric Therapeutics, Division of Pediatric and Maternal Health Tags: FDA Update, Neurology Source Type: research

APEC Workshop Report of Good Review Practices on Medical Products
As part of the implementation of the 2020 Good Review Practices (GRevP) Roadmap championed by Chinese Taipei in the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC), the Taiwan Food and Drug Administration (TFDA) organized 2 workshops. The purpose of these workshops was to address the fundamental elements of a well-designed regulatory review system, to provide complementary modules for GRevP and approaches to the exchange and the use of product assessment reports between regulatory authorities, and to further promote regulatory efficiencies and best practices. The workshops brough...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Lin, H.-Y., Chen, S. J.-Y., Gau, C.-S., Liu, L.-L. Tags: Regulatory Science Source Type: research

Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management
Background: The mission of the US Food and Drug Administration (FDA) can be viewed as a pendulum that swings between protecting public health and patient safety and promoting the public health through the drug review and approval process. Two decades of legislation have by and large provided the FDA with additional resources under the successive reauthorizations of the Prescription Drug User Fee Acts (PDUFA) to provide a necessary infusion of funds to hire medical experts, scientists, and epidemiologists, among other disciplines, to expedite review of new drug and biologic applications. However, a renewed attention to pote...
Source: Therapeutic Innovation and Regulatory Science - June 29, 2015 Category: Drugs & Pharmacology Authors: Slomiany, M., Bitar, R., Kruse, S., Jeffers, S., Berkowitz, K., Hassan, M. Tags: Product Safety Source Type: research

Prevalence of Structure Function Claims: 2006-2007 Food Label and Package Survey
Publication date: 2015 Source:Procedia Food Science, Volume 4 Author(s): Tomoko Shimakawa , Martine Ferguson The Food and Drug Administration (FDA) studies product labels from the United States (U.S.) food supply through the Food Label and Package Survey (FLAPS) to monitor industry responses to FDA regulations and policies on foods. The 2006-2007 FLAPS data were analyzed to obtain prevalence, food sources, and claim types of structure function (SF) claims. The SF claims describe the role of a nutrient or food component intended to maintain the normal structure or function of body (e.g., calcium builds strong bones). FDA ...
Source: Procedia Food Science - June 27, 2015 Category: Food Science Source Type: research

New insights in the treatment of radioiodine refractory differentiated thyroid carcinomas: to lenvatinib and beyond
During the past two decades, several key somatic mutations associated with development and progression of differentiated thyroid cancer (DTC) have been revealed. Historically, the treatment for advanced DTC is challenging after patients become refractory to radioactive iodine. The response to doxorubicin, the only chemotherapy agent approved by the US Food and Drug Administration, is disappointing either as monotherapy or combination therapy. Because of the lack of effective systemic treatment coupled with increased understanding of molecular and cellular pathogenesis, multiple kinase inhibitors (MKIs) as an alternative th...
Source: Anti-Cancer Drugs - June 26, 2015 Category: Cancer & Oncology Tags: Review Article Source Type: research

Cough and cold products—still in use despite the FDA advisory
On January 17, 2008, the US Food and Drug Administration issued a Public Health Advisory recommending that over-the-counter cough and cold products not be used to treat infants and children less than 2 years of age, citing “serious and potentially life-threatening side effects.” O'Donnell et al took advantage of two large cohort studies of children in this age range with bronchiolitis, one from 2004-2006 and the other from 2007-2010. In each cohort, caregivers were asked about the use of “decongestant or cough medicine.” Reassuringly, use decreased from 25% of children to 7% after the advisory, although in the olde...
Source: The Journal of Pediatrics - June 26, 2015 Category: Pediatrics Authors: Denise M. Goodman Tags: The Editors' Perspective Source Type: research

Sildenafil in pediatric pulmonary arterial hypertension
This article provides a review of the use of sildenafil in the treatment of PAH in children. (Source: Journal of Postgraduate Medicine)
Source: Journal of Postgraduate Medicine - June 26, 2015 Category: Internal Medicine Authors: AK DhariwalSB Bavdekar Source Type: research

The Role of Topical Brimonidine Tartrate Gel as a Novel Therapeutic Option for Persistent Facial Erythema Associated with Rosacea
Abstract Rosacea is a chronic inflammatory skin condition that commonly presents with persistent facial erythema with or without the coincident presence of flushing, telangiectasias, inflammatory papules or pustules, phymatous changes, or ocular involvement. Patients often present with a constellation of various signs and symptoms of the disease, and an individualized treatment plan should be tailored to a patient’s unique clinical presentation. Previously available medications for rosacea have all targeted the inflammatory erythematous papules and pustules frequently associated with the disease, leaving a thera...
Source: Dermatology and Therapy - June 26, 2015 Category: Dermatology Source Type: research

Training the Mind, and the Food and Drug Administration, on Droperidol
Publication date: Available online 24 June 2015 Source:Annals of Emergency Medicine Author(s): David H. Newman (Source: Annals of Emergency Medicine)
Source: Annals of Emergency Medicine - June 26, 2015 Category: Emergency Medicine Source Type: research

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices
Abstract Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals. Now, with the first biosimilar approval in the USA and many biosimilars expected to be launched glo...
Source: Drug Safety - June 25, 2015 Category: Drugs & Pharmacology Source Type: research

Conditionally Increased Acoustic Pressures in Nonfetal Diagnostic Ultrasound Examinations Without Contrast Agents: A Preliminary Assessment
The mechanical index (MI) has been used by the US Food and Drug Administration (FDA) since 1992 for regulatory decisions regarding the acoustic output of diagnostic ultrasound equipment. Its formula is based on predictions of acoustic cavitation under specific conditions. Since its implementation over 2 decades ago, new imaging modes have been developed that employ unique beam sequences exploiting higher-order acoustic phenomena, and, concurrently, studies of the bioeffects of ultrasound under a range of imaging scenarios have been conducted. In 2012, the American Institute of Ultrasound in Medicine Technical Standards Com...
Source: Journal of Ultrasound in Medicine - June 25, 2015 Category: Radiology Authors: Nightingale, K. R., Church, C. C., Harris, G., Wear, K. A., Bailey, M. R., Carson, P. L., Jiang, H., Sandstrom, K. L., Szabo, T. L., Ziskin, M. C. Tags: Online Only Source Type: research

Seeing is believing: Good graphic design principles for medical research
Have you noticed when you browse a book, journal, study report, or product label how your eye is drawn to figures more than to words and tables? Statistical graphs are powerful ways to transparently and succinctly communicate the key points of medical research. Furthermore, the graphic design itself adds to the clarity of the messages in the data. The goal of this paper is to provide a mechanism for selecting the appropriate graph to thoughtfully construct quality deliverables using good graphic design principles. Examples are motivated by the efforts of a Safety Graphics Working Group that consisted of scientists from the...
Source: Statistics in Medicine - June 25, 2015 Category: Statistics Authors: Susan P. Duke, Fabrice Bancken, Brenda Crowe, Mat Soukup, Taxiarchis Botsis, Richard Forshee Tags: Special Issue Paper Source Type: research

FDA introduces 'final rule' on use of antibiotics in feed
THE Food and Drug Administration (FDA) in the USA has taken a further step in its strategy to ensure judicious use of antibiotics in food-producing animals in the USA. On June 2, the FDA announced the introduction of the Veterinary Feed Directive (VFD) ‘final rule’, which outlines the process for authorising the use of VFD drugs (ie, animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian). The FDA said that the rule would provide veterinarians in all US states with a framework for authorising the use of medically important antimicrobials in feed when needed fo...
Source: Veterinary Record - June 25, 2015 Category: Veterinary Research Tags: News and Reports Source Type: research

A Call to Action to Bring Safer Parenteral Micronutrient Products to the U.S. Market.
e Parenteral Vitamin and Trace Element Working Group and the American Society for Parenteral and Enteral Nutrition A S P E N Abstract The American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.) started an intensive review of commercially available parenteral vitamin and trace element (TE) products in 2009. The chief findings were that adult multi-TE products currently available in the United States (U.S.) provide potentially toxic amounts of manganese, copper, and chromium, and neonatal/pediatric multi-TE products provide potentially toxic amounts of manganese and chromium. The multivitamin products appe...
Source: Nutrition in Clinical Practice - June 25, 2015 Category: Nutrition Authors: Vanek VW, Borum P, Buchman A, Fessler TA, Howard L, Shenkin A, Valentine CJ, Novel Nutrient Task Force, Parenteral Vitamin and Trace Element Working Group; and the American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.), Novel Nutrient Task For Tags: Nutr Clin Pract Source Type: research

Committee Opinion: Human Papillomavirus Vaccination.
Authors: Abstract Human papillomavirus (HPV) is associated with the development of anogenital cancer (including cervical, vaginal, vulvar, penile, and anal), oropharyngeal cancer, and genital warts. Human papillomavirus vaccination can significantly reduce the incidence of anogenital cancer and genital warts. Despite the benefits of HPV vaccines, only approximately one third of girls in the recommended age group have received all three vaccines. Compared with other vaccines recommended in the same age bracket, HPV vaccination rates in the United States are unacceptably low. It is crucial that obstetrician-gynecolo...
Source: Obstetrics and Gynecology - June 25, 2015 Category: OBGYN Tags: Obstet Gynecol Source Type: research

Kv7 channels in the nucleus accumbens are altered by chronic drinking and are targets for reducing alcohol consumption
Abstract Alcohol use disorders (AUDs) are a major public health issue and produce enormous societal and economic burdens. Current Food and Drug Administration (FDA)‐approved pharmacotherapies for treating AUDs suffer from deleterious side effects and are only effective in a subset of individuals. It is therefore essential to find improved medications for the management of AUDs. Emerging evidence suggests that anticonvulsants are a promising class of drugs for treating individuals with AUDs. In these studies, we used integrative functional genomics to demonstrate that genes that encode Kv7 channels (i.e. Kcnq2/3) are rela...
Source: Addiction Biology - June 24, 2015 Category: Addiction Authors: Natalie S. McGuier, William C. Griffin, Justin T. Gass, Audrey E. Padula, Elissa J. Chesler, Patrick J. Mulholland Tags: Original Article Source Type: research

How a patient advocacy group developed the first proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration
Among the challenges confronting patients with rare diseases is a dearth of treatment options. The development of safe and effective new therapies is hampered by challenges associated with conducting clinical trials in small populations. In this article, we describe how the Duchenne muscular dystrophy community–led by Parent Project Muscular Dystrophy–created a proposed draft guidance document for industry for submission to the U.S. Food and Drug Administration. This unprecedented undertaking involved a broad coalition of more than 80 stakeholders collaborating across nine time zones to produce a document in only 6 mo...
Source: Orphanet Journal of Rare Diseases - June 24, 2015 Category: Internal Medicine Authors: Pat FurlongJohn BridgesLawrence CharnasJustin FallonRyan FischerKevin FlaniganTimothy FransonNeera GulatiCraig McDonaldHolly PeayH. Sweeney Source Type: research

SAPHRIS approved for pediatric manic or mixed bipolar I
The Food and Drug Administration in March approved the supplemental new drug application of Actavis for SAPHRIS (asenapine) as a monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10–17). SAPHRIS is the only atypical antipsychotic treatment option with a sublingual (under the tongue) formulation. (Source: The Brown University Child and Adolescent Psychopharmacology Update)
Source: The Brown University Child and Adolescent Psychopharmacology Update - June 24, 2015 Category: Psychiatry Tags: From the FDA Source Type: research

The impact of initiating rivaroxaban versus low-molecular weight heparin plus warfarin in patients admitted to the hospital for venous thromboembolism
Rivaroxaban, a direct factor Xa inhibitor, is the first target-specific oral anticoagulant (TSOAC) to gain Food and Drug Administration approval for the treatment of venous thromboembolism (VTE) [1]. A rapid onset of action and predictable pharmacokinetics obviate the need for bridging or routine monitoring with rivaroxaban, overcoming challenges imposed by traditional warfarin therapy. These advantages are desirable in the hospital setting where discharge may be prolonged due to the time to reach a therapeutic international normalized ratio (INR) in patients treated with warfarin, leading to a longer length of stay (LOS) ...
Source: International Journal of Cardiology - June 24, 2015 Category: Cardiology Authors: Lindsay Hom, Diana M. Sobieraj Tags: Letter to the editor Source Type: research

Magnetic resonance elastography and transient elastography as non‐invasive analyses for liver fibrosis: can they obviate the need for liver biopsy in psoriasis patients treated with methotrexate?
Abstract The liver biopsy has been regarded as the reference standard method of monitoring hepatic fibrosis in psoriasis patients treated with methotrexate. It has also been subject to concerns over sampling error, internal and external variability, and potential for morbidity and mortality. During the past two decades, two imaging techniques, magnetic resonance elastography and transient elastography, have been developed and approved by the US Food and Drug Administration (FDA) for the assessment of hepatic fibrosis. Although high‐quality, psoriasis‐specific data are lacking, both methods have been shown to have outst...
Source: International Journal of Dermatology - June 24, 2015 Category: Dermatology Authors: Benjamin H. Kaffenberger, Jessica A. Kaffenberger, Henry Wong, Wael Jarjour, Douglas Levin, Mark A. Bechtel Tags: Review Source Type: research

Product-Specific Regulatory Pathways to Approve Generic Drugs: The Need for Follow-up Studies to Ensure Safety and Effectiveness
Abstract Generic drugs possessing the same active ingredients, dosage form, strength, route of administration, and labeling can be approved by the US Food and Drug Administration (FDA) as interchangeable with a brand-name drug without needing to repeat the formal Phase I, II, and III clinical trials conducted by the original manufacturers. In recent years, the FDA has approved several generic drugs using product-specific testing to determine therapeutic equivalence in accordance with the unique features of the particular drug. These have been used in two primary situations: (1) cases for which certain bioequivalen...
Source: Drug Safety - June 24, 2015 Category: Drugs & Pharmacology Source Type: research

Infant formula: the addition of minimum and maximum levels of selenium to infant formula and related labeling requirements. Final rule.
Abstract The Food and Drug Administration (FDA or we) is amending the regulations on nutrient specifications and labeling for infant formula to add the mineral selenium to the list of required nutrients and to establish minimum and maximum levels of selenium in infant formula. PMID: 26103741 [PubMed - in process] (Source: Fed Regist)
Source: Fed Regist - June 23, 2015 Category: American Health Authors: Food and Drug Administration, HHS Tags: Fed Regist Source Type: research

Therapeutic transdermal drug innovation from 2000 to 2014: current status and outlook.
Abstract The US Food and Drug Administration (FDA) approved the first transdermal drug over 35 years ago. Today, transdermal products represent a growing, multibillion dollar market. From 2000 to 2014, an average of 2.6 new transdermal drug approvals occurred each year. However, only two of these approvals represented new molecular entities (NMEs). Furthermore, the FDA designated none of these approvals for priority review. Currently, transdermal drugs are limited in scope to fewer than 20 clinical indications. The past decade has seen significant safety, performance, and cost issues surrounding multiple transderma...
Source: Drug Discovery Today - June 23, 2015 Category: Drugs & Pharmacology Authors: Walter JR, Xu S Tags: Drug Discov Today Source Type: research

Strengthening Medical Device Postmarket Safety Surveillance
The system by which the US Food and Drug Administration engages in medical device postmarket safety surveillance needs strengthening. Efforts are limited by reliance on passively aggregated adverse events through the Manufacturer and User Facility Device Experience (MAUDE) database, investigated adverse events at select clinical sites within the Medical Product Safety Network (MedSun), and select active surveillance efforts using Post-Approval Studies and Postmarket Surveillance Studies (also known as the 522 Postmarket Surveillance Studies Program). While these efforts have successfully detected potential safety issues an...
Source: JAMA Internal Medicine - June 22, 2015 Category: Internal Medicine Source Type: research

Romidepsin for the Treatment of Peripheral T-Cell Lymphoma.
Abstract Peripheral T-cell lymphoma (PTCL) is a heterogeneous group of non-Hodgkin lymphomas associated with poor prognosis in most subtypes. Diagnosis of this rare disease by expert hematopathologists improves accuracy of subtyping, and referral to academic or specialty centers is recommended. Many patients, however, will receive treatment in the community, and knowledge of approved agents is key to optimizing therapeutic approaches for all patients. There is no current standard of care for patients with PTCL and no approved therapies for first-line treatment. Although many patients initially respond to induction ...
Source: The Oncologist - June 22, 2015 Category: Cancer & Oncology Authors: Iyer SP, Foss FF Tags: Oncologist Source Type: research

An analysis of original research contributions toward FDA-approved drugs.
Abstract Academic researchers shaped the landscape of drug discovery for nearly two centuries, and their efforts initiated programs for more than half of the US Food and Drug Administration (FDA)-approved new molecular entities (NMEs). During the first 50 years of the 20th century, contributions from industry-based discovery programs steadily increased, stabilizing near half of all first publications for NMEs. Although academia and industry have made similar contributions to the discovery of FDA-approved NMEs, there remains a substantial difference in the gap-to-approval; on average, industry NMEs are 12 years clos...
Source: Drug Discovery Today - June 22, 2015 Category: Drugs & Pharmacology Authors: Patridge EV, Gareiss PC, Kinch MS, Hoyer DW Tags: Drug Discov Today Source Type: research

Case report: MR imaging features of disseminated uterine leiomyosarcoma presenting after hysterectomy with morcellation
Abstract A 53-year-old woman underwent elective hysterectomy for symptomatic anemia secondary to abnormal uterine bleeding. She presented 15 months later with complaints of abdominal fullness. Abdominopelvic magnetic resonance imaging demonstrated multiple confluent enhancing solid masses centered in the pelvis and extending cranially to the level of the umbilicus. Additional separate nodules also were visible along the peritoneum. Biopsy demonstrated leiomyosarcoma. Additional clinical information was obtained, which revealed that the patient’s prior hysterectomy was performed with morcellation. In November 20...
Source: Abdominal Imaging - June 21, 2015 Category: Radiology Source Type: research

Dietary supplements: international legal framework and adulteration profiles, and characteristics of products on the Brazilian clandestine market.
The objectives of this work were to evaluate current legislation on dietary supplements in the United States, the European Union and Brazil, and the profile of adulterated and/or irregular products on these markets. Due to a less restrictive legal framework, a supplement product that is freely available in the US may be considered a drug or even be proscribed in the EU and Brazil, thus giving rise to a clandestine market based on smuggling. From 2007 to 2014, the United States Food and Drug Administration reported 572 cases of supplement adulterations in the country, mainly products for sexual enhancement (41.6%). Data fro...
Source: Regulatory Toxicology and Pharmacology : RTP - June 21, 2015 Category: Toxicology Authors: Justa Neves DB, Caldas ED Tags: Regul Toxicol Pharmacol Source Type: research

Preclinical Assessment of Abuse Liability of Biologics: In Defense of Current Regulatory Control Policies.
Abstract Current regulatory policies of both the US Food and Drug Administration and Drug Enforcement Administration do not delineate automatic exceptions for biologics with respect to preclinical assessments for abuse liability of all new entities. As defined in current guidance documents and drug control policies, an exception may be given upon thorough review of available data, therapeutic target and in consultation with the Controlled Substances Staff within the Center for Drug Evaluation and Research of the FDA, but a blanket exception for all biological entities is not currently available. We review the abuse...
Source: Regulatory Toxicology and Pharmacology : RTP - June 21, 2015 Category: Toxicology Authors: Gauvin DV, Zimmermann ZJ, Baird TJ Tags: Regul Toxicol Pharmacol Source Type: research

Therapeutic Area Data Standards for Autosomal Dominant Polycystic Kidney Disease: A Report From the Polycystic Kidney Disease Outcomes Consortium (PKDOC)
We describe the process for development of the first-ever Clinical Data Interchange Standards Consortium (CDISC) data standard for autosomal dominant polycystic kidney disease (ADPKD) by the Polycystic Kidney Disease Outcomes Consortium (PKDOC). Definition of common data elements and creation of ADPKD-specific data standards from case report forms used in long-term ADPKD registries, an observational cohort (Consortium for Radiologic Imaging Studies of Polycystic Kidney Disease [CRISP] 1 and 2), and a randomized clinical trial (Halt Progression of Polycystic Kidney Disease [HALT-PKD]) are described in detail. This data stan...
Source: American Journal of Kidney Diseases - June 20, 2015 Category: Urology & Nephrology Source Type: research

Definition and Classification of Generic Drugs Across the World
Abstract Our aim was to systematically identify and compare how generic medications, as defined by the US Food and Drug Administration (FDA), World Health Organization (WHO), and European Medicines Agency (EMA), are classified and defined by regulatory agencies around the world. We focused on emerging markets and selected the most populated countries in each of the WHO regions: Africa, the Americas, Eastern Mediterranean, Europe, Southeast Asia, and Western Pacific. A structured review of published literature was performed through December 2013. Direct information from regulatory agencies and Ministries of Hea...
Source: Applied Health Economics and Health Policy - June 20, 2015 Category: Health Management Source Type: research

The iontophoretic transdermal system formulation of sumatriptan as a new option in the acute treatment of migraine: a perspective
An iontophoretic transdermal system (ITS) (skin patch) formulation of sumatriptan for the acute treatment of migraine attacks was approved by the US Food and Drug Administration in January 2013. This transdermal system bypasses the gastrointestinal tract, as it uses low electrical current to move sumatriptan transdermally into the subcutaneous tissue. Randomized, double-blind, controlled clinical trials have demonstrated minimal triptan-related side effects and superior efficacy versus placebo, comparable with other sumatriptan formulations. Sumatriptan ITS can be applied successfully during a mild or severe migraine attac...
Source: Therapeutic Advances in Neurological Disorders - June 19, 2015 Category: Neurology Authors: Vikelis, M., Spingos, K. C., Rapoport, A. M. Tags: Reviews Source Type: research

A review of the efficacy and safety of eslicarbazepine acetate in the management of partial-onset seizures
Eslicarbazepine acetate is a is a once-daily antiepileptic drug (AED) that was approved in 2009 by the European Medicines Agency (EMA) (Zebinix™), and in 2013 by the US Food and Drug Administration (FDA) (Aptiom™) as adjunctive therapy in adults with refractory partial-onset seizures, with or without secondary generalization. It is a third-generation member of the dibenzazepine family of AEDs with distinctive mechanism of action, posology and tolerability profile. The eslicarbazepine acetate development program included an initial phase II study (study BIA 2-093) and three subsequent phase III, multicentre, ran...
Source: Therapeutic Advances in Neurological Disorders - June 19, 2015 Category: Neurology Authors: Rocamora, R. Tags: Reviews Source Type: research

2014 in review: FDA approval of new drugs.
Abstract The year 2014 witnessed the approval by the US Food and Drug Administration (FDA) of 42 new molecular entities (NMEs), which is well above recent averages. These molecules targeted a range of molecular pathways and clinical indications, although the latter was skewed towards hepatitis c virus infection and diabetes. By contrast, a single drug was approved for cardiovascular diseases and none for neurological indications (excepting sleeping disorders). Of note is a continued trend towards consolidation because the net number of biotechnology companies has reached its lowest point in over 25 years, raising q...
Source: Drug Discovery Today - June 19, 2015 Category: Drugs & Pharmacology Authors: Kinch MS Tags: Drug Discov Today Source Type: research

and fosfomycin: past, present and future
Treatment of multidrug-resistant (MDR) organisms has become a major concern over the past decade. There have been a limited number of novel antimicrobial agents approved by the US Food and Drug Administration (FDA) or the European Medicines Agency for the treatment of Gram-negative bacterial infections [1,2]. Given the limited antibiotic armamentarium, clinicians are often forced to use combination therapy or existing, often more toxic, antimicrobial agents to treat these MDR infections [3,4]. In light of dwindling treatment options and increasing resistance, the US Centers for Disease Control and Prevention (CDC) has prio...
Source: International Journal of Antimicrobial Agents - June 18, 2015 Category: Drugs & Pharmacology Authors: Lauren D. Tesh, Kristy M. Shaeer, Jonathan C. Cho, Sandy J. Estrada, Vanthida Huang, Christopher M. Bland, V. Paul DiMondi, Alicia Potter, Gamal Hussein, P. Brandon Bookstaver Tags: Review Source Type: research

Re: Testosterone Products: Drug Safety Communication - FDA Cautions about Using Testosterone Products for Low Testosterone due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack and Stroke
U.S. Food and Drug Administration (Source: The Journal of Urology)
Source: The Journal of Urology - June 17, 2015 Category: Urology & Nephrology Authors: Allen D. Seftel Tags: Urological Survey Source Type: research

Assessment of Consumer Knowledge of New Sunscreen Labels
UV-A radiation is associated with accelerated skin aging, while UV-B exposure is associated with sunburns. Exposure to both types of radiation is a major risk factor for the development of skin cancer. By protecting the skin from UV light, sunscreen protects against these negative sequelae of sun exposure. In 2011, the US Food and Drug Administration announced new regulations for sunscreen labels to emphasize the importance of protection against both UV-A and UV-B radiation, now known as broad-spectrum protection. In this survey study, we assessed consumer comprehension of sunscreen labels and knowledge of general sun prot...
Source: JAMA Dermatology - June 17, 2015 Category: Dermatology Source Type: research

Should self-destructive behavior affect a patient's access to scarce medical resources?
Although the Food and Drug Administration approved tumor necrosis factor (TNF)-α inhibitors for psoriatic arthritis and plaque psoriasis in 2002 and 2004, respectively, MTX remains the first-line systemic therapy for these disorders. Biologics are reserved for patients with psoriasis who are poorly controlled on MTX or when there are contraindications to its use. Heavy alcohol consumption (>100 g/wk) while taking MTX increases the risk of MTX hepatotoxicity1 and there is no reliable test for monitoring hepatic fibrosis or progression to cirrhosis. (Source: Journal of the American Academy of Dermatology)
Source: Journal of the American Academy of Dermatology - June 16, 2015 Category: Dermatology Authors: Catherine S. Yang, George Kroumpouzos, Lionel Bercovitch Tags: Dermatoethics consultation Source Type: research

The Alone Rangers and Silver
In this issue of the Journal, Gabriels et al.1 report what appears to be the first randomized clinical trial of therapeutic horse riding for children with autism. The result looks encouraging: a significant medium benefit compared with a randomly assigned control condition (a non-equine barn activity of equal duration and frequency) using an outcome measurement acceptable to the Food and Drug Administration for drug indications in autism (the Irritability subscale of the Aberrant Behavior Checklist). (Source: Journal of the American Academy of Child and Adolescent Psychiatry)
Source: Journal of the American Academy of Child and Adolescent Psychiatry - June 16, 2015 Category: Psychiatry Authors: L. Eugene Arnold Tags: Editorial Source Type: research

Tumor immunology and cancer immunotherapy: summary of the 2014 SITC primer
Abstract The pioneers of tumor immunology and cancer immunotherapy, including the late William B. Coley and Lloyd J. Old, have championed the potential for immunotherapy for over a century. Finally, advances in our understanding of the fundamentals of tumor immunology are translating into clinical success, with recent US Food and Drug Administration approval of several immunotherapies that improve clinical outcomes across prostate cancer, metastatic melanoma, non-small cell lung cancer and lymphocytic leukemia. In tandem with these clinical successes, new technologies such as high-throughput DNA/RNA sequencing, g...
Source: Journal for Immunotherapy of Cancer - June 16, 2015 Category: Cancer & Oncology Source Type: research

Treatment of ALK -Rearranged Non-Small Cell Lung Cancer: Recent Progress and Future Directions
Abstract Rearrangements of the anaplastic lymphoma kinase (ALK) gene originally discovered nearly 20 years ago in the context of anaplastic large cell lymphoma were identified as oncogenic drivers in a subset of non-small cell lung cancers (NSCLCs) in 2007. These ALK gene rearrangements are present in 3–5 % of NSCLC patients, typically younger, never or light smokers with adenocarcinomas. Crizotinib is a first-in-class ALK tyrosine kinase inhibitor with significant activity in ALK-positive NSCLC that received accelerated US Food and Drug Administration approval for treatment of ALK-positive NSCLC in 2011, just...
Source: Drugs - June 16, 2015 Category: Drugs & Pharmacology Source Type: research

Extent and content of data for regulatory submissions: First-in-human and marketing authorization – Viewpoint of US industry
Publication date: Available online 15 June 2015 Source:Biologicals Author(s): Ian Ross Harris The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committe...
Source: Biologicals - June 16, 2015 Category: Biology Source Type: research

Margaret A. Hamburg, MD, Reflects on 6 Years as FDA Commissioner
Margaret A. Hamburg, MD, the second woman nominated to be commissioner of the Food and Drug Administration (FDA), stepped down from the post in late March, just shy of 6 years on the job. (Source: JAMA)
Source: JAMA - June 16, 2015 Category: Journals (General) Source Type: research

Are PCSK9 Inhibitors the Next Breakthrough in the Cardiovascular Field?
Proprotein convertase subtilisin/kexin type 9 (PCSK9) binds to the low-density lipoprotein receptor, escorting it to its destruction in the lysosome and thereby preventing the recirculation of the low-density lipoprotein receptor to the hepatocyte cell surface. Both gain-of-function mutations in PCSK9 (causing marked increases in low-density lipoprotein cholesterol [LDL-C] concentration and premature atherosclerosis) and loss-of-function mutations (causing modest LDL-C reduction with low rates of coronary heart disease) have been described. Several monoclonal antibodies to PCSK9 have achieved LDL-C reductions of 50% to 7...
Source: Journal of the American College of Cardiology - June 15, 2015 Category: Cardiology Source Type: research

Anaplastic Lymphoma Kinase Inhibitors in Non-Small Cell Lung Cancer: A Review of the Literature.
Abstract Lung cancer is the leading cause of cancer death among both sexes in the United States and non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Over the last several decades, there have been many advances in both surgical approaches and systemic therapies for the treatment of NSCLC, but the prognosis for advanced disease remains poor. New research, however, is exploring the use of targeted therapies for the treatment of NSCLC. The anaplastic lymphoma kinase (ALK) is involved in normal mammalian central nervous system development. A novel fusion gene involving ALK and the echinoderm mi...
Source: Current Drug Targets - June 15, 2015 Category: Drugs & Pharmacology Authors: Straughan DM, Azoury SC, Shukla V Tags: Curr Drug Targets Source Type: research

Anti-VEGF therapy for retinal vein occlusions.
Abstract Retinal vein occlusion (RVO) is the second most common cause of visual loss in the Western World. RVO is usually classified into branch RVO (BRVO) and central RVO (CRVO) according to the anatomical site of the vascular occlusion. The pathogenesis of RVO is not yet fully understood, however an important event is the intraluminal thrombus formation, which is usually secondary to several conditions such as hypertension, hyperlipidemia, diabetes and thrombophilia. The blockage of venous circulation causes an elevation of intraluminal pressure in the capillaries, leading to hemorrhages and leakage of fluid with...
Source: Current Drug Targets - June 15, 2015 Category: Drugs & Pharmacology Authors: Campa C, Alivernini G, Bolletta E, Battaglia MP, Perri P Tags: Curr Drug Targets Source Type: research

Susceptibility Profile of Ceftolozane/Tazobactam and Other Parenteral Antimicrobials Against Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa From US Hospitals.
Abstract PURPOSE: Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa are frequently isolated pathogens in the hospital setting, and antimicrobial resistance among these organisms is on the rise. In an attempt to meet the challenge of gram-negative resistance, new therapies, including ceftolozane/tazobactam (C/T), were recently approved by the Food and Drug Administration, and others are in late-stage development. The purpose of this study is to describe the in vitro potency of C/T and other parenteral antimicrobials against a geographically diverse population of E coli, K pneumoniae, and P aerugino...
Source: Clinical Therapeutics - June 15, 2015 Category: Drugs & Pharmacology Authors: Sutherland CA, Nicolau DP Tags: Clin Ther Source Type: research

Extent and content of data for regulatory submissions: First-in-human and marketing authorization - Viewpoint of US industry.
Abstract The amount and type of data in regulatory submissions increases dramatically from the first-in-human clinical trials application through to the extensive dossier that is required for marketing authorization. The Pharmaceuticals and Biotechnology industries are very familiar with the requirements and expectations of Health Authorities for small molecule and biologics, but have limited experience for cell-based therapies. Fortunately, the United States Food and Drug Administration (FDA) and European Medicines agency (EMA) Committee for Advanced Therapies (CAT) have considerable experience in regulating cell ...
Source: Biologicals : Journal of the International Association of Biological Standardization - June 15, 2015 Category: Biotechnology Authors: Harris IR Tags: Biologicals Source Type: research

Nanotechnology: A Successful Approach to Improve Oral Bioavailability of Phytochemicals.
Authors: Shakeri A, Sahebkar A Abstract Phytochemicals have gained significant recognition for their potential therapeutic uses against a variety of human diseases. However, the poor water solubility, limited intestinal absorption and low water stability of phytochemicals generally prevent from achieving a high oral bioavailability and even detectable plasma levels of the parent compound. Dose escalation is not always a solution to address limited oral bioavailability, and may increase the risk of adverse events, most frequently in the gastrointestinal system [1]. Low water solubility is a common reason for the lim...
Source: Recent Patents on Drug Delivery and Formulation - June 14, 2015 Category: Drugs & Pharmacology Tags: Recent Pat Drug Deliv Formul Source Type: research