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

02:39 EDT 20th September 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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We have published hundreds of Pfizer Score Approval Orthopedic Drug news stories on BioPortfolio along with dozens of Pfizer Score Approval Orthopedic Drug Clinical Trials and PubMed Articles about Pfizer Score Approval Orthopedic Drug for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of Pfizer Score Approval Orthopedic Drug Companies in our database. You can also find out about relevant Pfizer Score Approval Orthopedic Drug Drugs and Medications on this site too.

Showing "Pfizer Score Approval Orthopedic Drug" PubMed Articles 1–25 of 12,000+

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.


The importance of greater speed in drug development for advanced malignancies.

It takes on average 6-12 years to develop new anticancer drugs from discovery to approval. Effective new agents prolong survival. To demonstrate the importance of rapid drug approval, we calculated life-years potentially saved if selected agents were approved more rapidly. As illustrative examples, we used 27 trials documenting improvements in survival. We multiplied improvement in median survival by numbers of patients dying annually and multiplied this by number of years from drug discovery until approva...

First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.

The Food and Drug Administration (FDA) initiated the Expedited Access Pathway (EAP) to accelerate approval of novel therapies targeting unmet needs for life-threatening conditions. EAP allows for the possibility of initial FDA approval using intermediate end points with postapproval demonstration of improved outcomes.


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...

Is the pharmaceutical industry's preoccupation with the monotherapy drug model stifling the development of effective new drug therapies?

Drug discovery and development is heavily biased towards the development of monotherapies. Screening, testing, and evaluation of mono-entity drugs are generally much simpler than drug combinations, and are generally easier to get approval from the regulatory authorities for their clinical use. However, monotherapy drugs may not have optimal activity, may have associated toxicities, or may lose activity over time as their target develops resistance. Drug combinations, often developed from existing monotherap...

Generalized fixed drug eruption to piperacillin/tazobactam and review of literature.

Fixed drug eruption (FDE) is an adverse drug reaction characterized by the development of well-circumscribed, round, dusky erythematous macules and plaques on cutaneous or mucosal surfaces. The reaction occurs on the same mucosal or cutaneous site with subsequent exposures to the offending drug. Although FDE usually manifests as a single lesion, in rare instances, more than one lesion may arise and this is referred to as a generalized eruption. Herein, we present a 31year-old man with history of cystic fibr...

Japan-Specific Key Regulatory Aspects for Development of New Biopharmaceutical Drug Products.

Japan represents the third largest pharmaceutical market in the world. Developing a new biopharmaceutical drug product for the Japanese market is a top business priority for global pharmaceutical companies while aligning with ethical drivers to treat more patients in need. Understanding Japan-specific key regulatory requirements is essential to achieve successful approvals. Understanding the full context of Japan-specific regulatory requirements/expectations is challenging to global pharmaceutical companies...

The Correlation Between PROMIS Pain Interference and VAS Pain in Ambulatory Orthopedic Patients.

The purpose of this study was to investigate the correlation of Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) score with traditionally collected visual analog scale (VAS) scores and to determine the influence of patient demographics on PROMIS PI and VAS scores. Patient demographics were collected, and PROMIS PI, PROMIS Physical Function (PF), and VAS questionnaires were distributed to 215 patients in orthopedic ambulatory clinics. The primary outcome was correlatio...

Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings.

The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA whe...

Perspective: Regulation of Pest and Disease Control Strategies and Why (Many) Economists are Concerned.

Pests and diseases are a continuous challenge in agriculture production. A wide range of control strategies have been and will continue to be developed. New control strategies are in almost all countries around the world assessed prior to approval for use in farmers' fields. This is rightly so to avoid and even reduce negative effects for human health and the environment. Over the past decades the approval processes have become increasingly politicized resulting in an increase in the direct approval costs a...

Assessment of return to play in professional overhead athletes subjected to arthroscopic repair of rotator cuff tears and associated labral injuries using the Italian version of the Kerlan-Jobe Orthopedic Clinic Shoulder and Elbow score.

The self-administered Kerlan-Jobe Orthopedic Clinic (KJOC) Shoulder and Elbow questionnaire is a reliable and sensitive outcome tool to assess upper extremity athletic performance and functional changes affecting return to play in overhead athletes. We report the results of a study of return to sport in professional overhead athletes at a mean follow-up of 2 years after arthroscopic repair of rotator cuff tears and associated labral injuries using the Italian version of the score.

Information Transparency in the Drug Approval Process.

Streamlining nonclinical drug development using the FDA 505(b)(2) new drug application regulatory pathway.

In the USA, drugs are approved by the FDA by three main regulatory pathways: (i) 505(b)(1) new drug applications (NDAs); (ii) 505(b)(2) NDAs; and (iii) 505(j) abbreviated NDAs (ANDAs). The appropriate pathway depends on the active ingredient, already approved drug products, drug formulation, clinical indication, route of exposure, among other factors. The 505(b)(2) NDA pathway is a regulatory approval pathway that allows sponsors to use existing public data in lieu of conducting studies; thus, potentially o...

Postmarketing Modifications of Drug Labels for Cancer Drugs Approved by the US Food and Drug Administration Between 2006 and 2016 With and Without Supporting Randomized Controlled Trials.

Purpose Modifications in cancer drug indications, dosing, and related toxicities after Food and Drug Administration approval are common. It is unclear whether drug approval without a supporting randomized controlled trial (RCT) influences the probability of such modifications. Methods We searched the Drugs@FDA Web site for new drug indications for solid tumors approved between January 2006 and December 2016. Study characteristics, regulatory pathways, and label modifications from approval to October 2017 we...

Chinese approval for Ascletis' HCV drug is first homegrown success.

Information Transparency in the Drug Approval Process-Reply.

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.

US Food and Drug Administration's Approval of Aripiprazole Tablets With Sensor: Our Perspective.

Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety.

FDA Approval Summary: Pembrolizumab for Recurrent Locally Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing PD-L1.

On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda, Merck & Co., Inc., Whitehouse Station, NJ) for the treatment of patients with recurrent, locally advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after two or more systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy, and whose tumors express p...

Ethical approval for multicenter cohort studies on drug exposure during pregnancy: a survey among members of the European Network of Teratology Information Services (ENTIS).

The European Network of Teratology Information Services (ENTIS) is in a privileged position to perform independent post-marketing surveillance of drugs in pregnancy. The aim of this survey was to describe the legal requirements and procedures involved in obtaining ethical approval for collaborative cohort studies. We sent a survey questionnaire to all 28 Teratology Information Services (TIS), of which 25 (89%) in 18 countries completed our questionnaire. For 15 TIS, specific research ethical approval was ma...

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

US Food and Drug Administration Approval of Whole Slide Imaging for Primary Diagnosis: A Key Milestone Is Reached and New Questions Are Raised.

April 12, 2017, marked a significant day in the evolution of digital pathology in the United States, when the US Food and Drug Administration announced its approval of the Philips IntelliSite Pathology Solution for primary diagnosis in surgical pathology. Although this event is expected to facilitate more widespread adoption of whole slide imaging for clinical applications in the United States, it also raises a number of questions as to the means by which pathologists might choose to incorporate this techno...

The A-Z of Zika drug discovery.

Despite the recent outbreak of Zika virus (ZIKV), there are still no approved treatments, and early-stage compounds are probably many years away from approval. A comprehensive A-Z review of the recent advances in ZIKV drug discovery efforts is presented, highlighting drug repositioning and computationally guided compounds, including discovered viral and host cell inhibitors. Promising ZIKV molecular targets are also described and discussed, as well as targets belonging to the host cell, as new opportunities...

3D printed drug delivery and testing systems - a passing fad or the future?

The US Food and Drug Administration approval of the first 3D printed tablet in 2015 has ignited growing interest in 3D printing, or additive manufacturing (AM), for drug delivery and testing systems. Beyond just a novel method for rapid prototyping, AM provides key advantages over traditional manufacturing of drug delivery and testing systems. These includes the ability to fabricate complex geometries to achieve variable drug release kinetics; ease of personalising pharmacotherapy for patient and lowering t...


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