PubMed Journals Articles About "Pfizer Score Approval Orthopedic Drug" RSS

10:12 EDT 24th March 2018 | BioPortfolio

Pfizer Score Approval Orthopedic Drug PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest Pfizer Score Approval Orthopedic Drug articles that have been published worldwide.

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Showing "Pfizer Score Approval Orthopedic Drug" PubMed Articles 1–25 of 11,000+

Is patient exposure preapproval and postapproval a determinant of the timing and frequency of occurrence of safety issues?

The amount of drug exposure, pre and post approval, is considered to be a direct determinant of knowledge about the safety of a drug. A larger pre-approval exposed population is supposed to reduce the risk of unanticipated safety issues post-approval. The amount of use in the postapproval population is also expected to influence the occurrence and timing of safety issues. We investigated how the amount of pre and post approval exposure influences the detection of post-approval safety issues.

A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

Accelerated approval (AA) is a US Food and Drug Administration (FDA) expedited program intended to speed the approval of drugs and biologics that may demonstrate a meaningful advantage over available therapies for diseases that are serious or life-threatening.

Contact Dermatitis Reaction to 2-Octyl Cyanoacrylate Following 3 Orthopedic Procedures.

Two-octyl cyanoacrylate is a popular skin adhesive used for closing surgical incisions. Since Food and Drug Administration approval in 1998, the few reports of adverse reactions following its use have primarily been limited to the nonorthopedic literature. The authors present a case series of contact dermatitis associated with 2-octyl cyanoacrylate following orthopedic surgery and a review of the literature on the diagnosis and treatment of this complication. All 3 patients presented with blistering around ...

Transparency and Dermatologic Device Approval by the US Food and Drug Administration.

The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting measures and can cause understudied changes that lead to drift from a device's original design.

The Educational Opportunities Provided by a Pediatric Orthopedic Urgent Case Review Conference: Keep Score to Provide a Better Experience.

To evaluate the distribution of conditions presented at a case conference to assess resident educational exposure to acute pediatric orthopedic conditions.

Ertugliflozin: First Global Approval.

Ertugliflozin (Steglatro™) is an orally active sodium glucose co-transporter type 2 inhibitor being developed by Merck and Pfizer as a treatment for type 2 diabetes mellitus (T2DM). Ertugliflozin as monotherapy and in combination with various other antidiabetic drugs was associated with improvements in glycaemic control and secondary outcome measures in the VERTIS phase III clinical trial program. Ertugliflozin and fixed-dose combinations of ertugliflozin and metformin (Segluromet™) and ertugliflozin an...

Edaravone: A new drug approved for ALS.

Amyotrophic lateral sclerosis (ALS) is a progressive, adult onset neurodegenerative disease that is always fatal. The history of ALS drug discovery is fraught with many stops and starts. It took 22 years after the FDA approval of the anti-excitotoxic drug Riluzole before another drug was found to be effective in altering ALS progression: the anti-oxidant Edaravone.

The role of targeted therapy in the management of patients with AML.

Drug therapy for acute myeloid leukemia (AML) is finally undergoing major changes in 2017. This is due to the US Food and Drug Administration's approval of several new, targeted agents (midostaurin, enasidenib, and gemtuzumab ozogamicin). Paired with the recent approval of a novel liposomal formulation of daunorubicin/cytarabine (CPX-351/Vyxeos), the standard of care is changing rapidly in AML for subgroups. This review will focus on currently approved agents and promising novel agents in development and wi...

The value and pitfalls of biologics registries for psoriasis.

We are pleased that our initial perspective article in the BJD have sparked discussions. As indicated in our initial paper, our main critical point is the exponential growth in publications relating to drug survival as an efficacy assessment based on non-randomized registry data (Figure 1). Indeed, we ourselves have performed such drug survival analyses.(1) While we agree that methods such as propensity score matching could even out some of the between-drug variations in patient characteristics, propensity ...

New and Incremental FDA Black Box Warnings from 2008 to 2015.

The boxed warning (also known as "black box warning [BBW]") is one of the strongest drug safety actions that the U.S. Food & Drug Administration (FDA) can implement, and often warns of serious risks. The objective of this study was to comprehensively characterize BBWs issued for drugs after FDA approval.

First new drug approval for AML in 15 years.

Drug approval needs a helping hand.

Sunlight and Other Disinfectants: Disclosure Obligations under the Federal Securities and Drug Regulatory Regimes.

Drug development requires patience. Beyond the inherent uncertainty of the development process itself, U.S. drug developers must comply with the regulatory approval process overseen by the U.S. Food and Drug Administration (FDA). Because this process takes time, drug development also costs money. Drug companies seeking to raise funds in U.S. capital markets must navigate the securities regime governed by the Securities & Exchange Commission (SEC). Despite their similar roles as protectors of consumers and p...

Seeking a better landscape for therapy development in neuromuscular disorders.

While the neuromuscular field has seen accelerated approval of a drug for Duchenne muscular dystrophy (DMD) and full approval of one for spinal muscular atrophy, these experiences have shown that objective data and an adequate level of effect are essential for drug approval and reimbursement. The appropriateness and validity of biomarkers and clinically meaningful endpoints, and an understanding of disease progression rates, all played essential roles in the levels of evidence for these drugs. Such tools ar...

The emerging role of immunotherapy in advanced urothelial cancers.

Recent Food and Drug Administration (FDA) approval of five new immune checkpoint inhibitors for the treatment of metastatic urothelial cancer represents the first major treatment breakthrough for this disease since the introduction of combination chemotherapy over 30 years ago. This review examines the recent clinical trials leading to FDA approval of these agents, the current challenges facing immunotherapy and areas that require further research.

Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval.

A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is $2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication.

Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot.

Communication with orthopedic trauma patients is traditionally problematic with low response rates (RRs). The purpose of this investigation was to (1) evaluate the feasibility of communicating with orthopedic trauma patients postoperatively, utilizing an automated mobile phone messaging platform; and (2) assess the first 2 weeks of postoperative patient-reported pain and opioid use after lower extremity orthopedic trauma procedures.

Validation of the DAPT score in patients randomized to 6 or 12 months clopidogrel after predominantly second-generation drug-eluting stents.

The DAPT score is a recently-proposed decision tool for guiding optimal duration of dual antiplatelet therapy (DAPT). It showed modest accuracy in prior derivation and validation cohorts of patients with ≥12 months DAPT. This study was aimed to evaluate the validity of the DAPT score in a cohort of patients with 6 or 12 months DAPT after implantation of predominantly second-generation drug-eluting stents. We analyzed data of patients enrolled in the ISAR-SAFE trial. Patients were classified into low (

Effects of alteplase for acute stroke according to criteria defining the European Union and United States marketing authorizations: Individual-patient-data meta-analysis of randomized trials.

Background The recommended maximum age and time window for intravenous alteplase treatment of acute ischemic stroke differs between the Europe Union and United States. Aims We compared the effects of alteplase in cohorts defined by the current Europe Union or United States marketing approval labels, and by hypothetical revisions of the labels that would remove the Europe Union upper age limit or extend the United States treatment time window to 4.5 h. Methods We assessed outcomes in an individual-patient-...

3D gait analysis with and without an orthopedic walking boot.

Orthopedic walking boots have been widely used in place of traditional fiberglass casts for a variety of orthopedic injuries and post-surgical interventions. These walking boots create a leg length discrepancy (LLD). LLD has been shown to alter the kinematics and kinetics of gait and are associated with lumbar and lower limb conditions such as: foot over pronation, low back pain, scoliosis, and osteoarthritis of the hip and knee joints. Past gait analyses research with orthopedic boots is limited to finding...

The Treatment Landscape of Myelofibrosis Before and After Ruxolitinib Approval.

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm that presents with a heterogeneous clinical phenotype and prognosis. Before the US Food and Drug Administration approval of ruxolitinib, treatment options were varied and had limited effect. The increased use of ruxolitinib has drastically altered the MF treatment landscape. In this study, we aimed to clarify the clinical situations in which ruxolitinib is being used and analyze its effect on this landscape.

Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan.

Multiregional clinical trials (MRCT) are a standard strategy used to improve global drug approval efficiency and the feasibility of clinical trials. Japan is the world's third largest drug market with a unique health care system, making it a key inclusion as an operational region for MRCT (MRCT-JP) for global drug development. We aimed to identify the factors required for efficient drug development by comprehensively reviewing the clinical trials of drugs approved in Japan to identify the factors associated...

The US Food and Drug Administration's Approval of Adjuvant Sunitinib for Renal Cell Cancer: A Case of Regulatory Capture?

An update on new and unique uses of botulinum toxin in movement disorders.

The therapeutic applications of botulinum toxin (BoNT) have grown manifold since its initial approval in 1989 by the US Food and Drug Administration (FDA) for the treatment of strabismus, blepharospasm, and other facial spasms. Although it is the most potent biologic toxin known to man, long-term studies have established its safety in the treatment of a variety of neurologic and non-neurologic disorders. This review focuses on some novel and uncommon uses of BoNT in the treatment of movement disorders, such...

A comparative study of the calcaneal closing-wedge calcaneal osteotomy versus posterior-superior prominence removal in both sides with Haglund syndrome.

Objective: To compare the clinical outcome of removal of calcaneal posterior-superior prominence and that of calcaneal closing-wedge osteotomy for Haglund syndrome. Methods: From February 2009 to July 2014, 36 patients with Haglund syndrome were included.They were divided into two groups, and each group included 18 patients and underwent removal of calcaneal posterior-superior prominence and calcaneal closing-wedge osteotomy respectively.They were evaluated preoperatively and after 6 , 12 months and 24 mont...

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