scholarly journals Industry update May 2019

2019 ◽  
Vol 10 (10) ◽  
pp. 613-620
Author(s):  
Elaine Harris
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Balloon Catheter ◽  
Sources Of Information ◽  
Press Releases ◽  
News Websites ◽  
The Us ◽  
Us Fda ◽  
Clinical Trial Results ◽  
Drug Coated Balloon

The present industry update covers the period 1–31 May 2019. Sources of information included company press releases, regulatory and patent agencies notices, and various news websites. This month saw the announcement that world-renowned MIT scientist, Robert Langer is to be awarded the 2019 Dreyfus Prize for Chemistry for his contribution to drug delivery. Several notable collaborations were announced this month including Intec to partner with Merck on development of products using Intec's ‘Accordion Pill’ and Zylö Therapeutics to use its Nanopods™ in a partnership with Hoth Therapeutics to develop a treatment for lupus. Approvals this month include concept receiving ‘Breakthrough Device designation’ from the US FDA for its CE-marked sirolimus drug-coated balloon catheter, MagicTouch. Tocsagen and Insmed released positive late stage clinical trial results for products employing advanced delivery technologies.

scholarly journals Fidaxomicin for the treatment of Clostridioides difficile in children

2020 ◽  
Vol 15 (11) ◽  
pp. 967-979
Author(s):  
Andrew M Skinner ◽  
Tonya Scardina ◽  
Larry K Kociolek
Keyword(s):  
Clinical Trial ◽  
Efficacy And Safety ◽  
Narrow Spectrum ◽  
Clostridioides Difficile ◽  
Macrocyclic Antibiotic ◽  
The Us ◽  
Us Fda ◽  
Multinational Clinical Trial

Fidaxomicin is an oral narrow-spectrum novel 18-membered macrocyclic antibiotic that was initially approved in 2011 by the US FDA for the treatment of Clostridioides difficile infections (CDI) in adults. In February 2020, the FDA approved fidaxomicin for the treatment of CDI in children age >6 months. In adults, fidaxomicin is as efficacious as vancomycin in treating CDI and reduces the risk of recurrent CDI. An investigator-blinded, randomized, multicenter, multinational clinical trial comparing the efficacy and safety of fidaxomicin with vancomycin in children was recently published confirming similar findings as previously reported in adults. Fidaxomicin is the first FDA-approved treatment for CDI in children and offers a promising option for reducing recurrent CDI in this population.

Development and validation of a UPLC–MS/MS method for simultaneous determination of LBPT and its metabolites in human plasma

Bioanalysis ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 211-220
Author(s):  
Mengyi Wu ◽  
Aijing Liu ◽  
Quankun Zhuang ◽  
Ranran Jia ◽  
Yinping Zhou ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Plasma ◽  
Tandem Mass ◽  
Plasma Samples ◽  
Triple Quadrupole ◽  
Multiple Reactions ◽  
The Us ◽  
Us Fda ◽  
Development And Validation

Aim: A UPLC–MS/MS method was developed to determine LBPT as well as its four metabolites in human plasma to support the clinical study aiming to evaluate the efficacy of LBPT tablet in patients undergoing hip/knee replacement. Methodology: Plasma samples were prepared by protein precipitation and then separated on a C18 analytical column using (A) acetonitrile (B) 0.1% formic acid and 10 mM ammonium formate in water. The detection was performed on a triple quadrupole tandem mass spectrometer in positive electrospray ionization using multiple reactions monitoring mode. Results & conclusion: The method has been validated in accordance with the US FDA guidelines and was applied to the measurement of five analytes in human plasma samples from a Phase II clinical trial.

Cambia® (Diclofenac Potassium for Oral Solution) in the Management of Acute Migraine

US Neurology ◽  
2011 ◽  
Vol 07 (02) ◽  
pp. 139 ◽  
Author(s):  
Kevin Kahn ◽  
Keyword(s):  
Clinical Trial ◽  
Real World ◽  
Clinical Trial Data ◽  
Oral Solution ◽  
Comparable Efficacy ◽  
Migraine Treatment ◽  
The Past ◽  
The Us ◽  
Clinical Trial Results ◽  
Favorable Side Effect Profile

Migraine is a prevalent and disabling disorder involving central and peripheral neurologic processes that generate inflammatory mediated pain. Cambia® (diclofenac potassium for oral solution), a novel patented form of the anti-inflammatory medication diclofenac potassium, has been approved by the US Food and Drug Administration for the acute treatment of migraine. Clinical trial data have demonstrated that this formulation offers a four-fold decrease in time of onset of relief compared with conventional diclofenac, which has comparable efficacy to triptan medication. It has also proven effective in a real-world setting. Over the past few years, it has been established that migraine treatment that is administered early may prevent central sensitization and improve treatment outcomes. Given the importance of early intervention in migraine treatment, this medication offers rapid, convenient, and effective relief with a favorable side-effect profile. This review describes migraine pathophysiology, treatment rationale, clinical trial results, and real-world experience with the use of this new medication.

Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems

2012 ◽  
Vol 3 (12) ◽  
pp. 1383-1394 ◽  
Author(s):  
Kim E Sapsford ◽  
Kristina Lauritsen ◽  
Katherine M Tyner
Keyword(s):  
Drug Delivery ◽  
Drug Delivery Systems ◽  
Delivery Systems ◽  
Regulatory Framework ◽  
The Us ◽  
Us Fda

INSIDE INDUSTRY

2017 ◽  
Vol 21 (11) ◽  
pp. 32-43
Keyword(s):  
Drug Delivery ◽  
Clinical Trial ◽  
Fragility Fractures ◽  
Asia Pacific ◽  
European Patent ◽  
Medical Cannabis ◽  
The Us ◽  
Long Acting ◽  
Drug Delivery Devices ◽  
Delivery Technology

APAC drug delivery devices market to reach $5.4 billion in 2023. Mergermarket released Global Pharma, Medical & Biotech trend report for Q3 2017. Global BioLife develops breakthrough modified sugar. Breakthrough noodle formula with low-glycemic score of 38. Aphria ships first medical cannabis oil to Australia’s Medlab for clinical trial. Envirotainer doubles e-technology capacity across Asia. Genesis CancerCare Queensland is first in Asia-Pacific to use Elekta’s Venezia Brachytherapy Applicator. iX Biopharma secures European patent for WaferiX drug delivery technology. Shingrix approved in the US for prevention of shingles in adults aged 50 and over. First three-monthly long-acting treatment for schizophrenia patients in Singapore. China, Brazil and Russia named by healthcare companies as riskiest markets for compliance and regulation. New survey shows patients in Asia Pacific fail to recognize their fragility fracture is due to osteoporosis. Healthcare community join forces to fight growing epidemic of fragility fractures caused by osteoporosis.

Critical appraisal of the recent US FDA approval for earlier DBS intervention

Neurology ◽  
2018 ◽  
Vol 91 (3) ◽  
pp. 133-136 ◽  
Author(s):  
Laura Y. Cabrera ◽  
John Goudreau ◽  
Christos Sidiropoulos
Keyword(s):  
Clinical Trial ◽  
Critical Appraisal ◽  
Disease Course ◽  
Motor Complications ◽  
Recent Onset ◽  
Fda Approval ◽  
Parallel Group ◽  
The Us ◽  
Us Fda ◽  
Deep Brain

In November 2015, Medtronic announced the US Food and Drug Administration (FDA) approval for the use of deep brain stimulation (DBS) therapy in people with Parkinson disease (PD) “of at least 4 years duration and with recent onset motor complications, or motor complications of longer-standing duration that are not adequately controlled with medication.” The approval was based on data from the EARLYSTIM clinical trial, a randomized, prospective, multicenter, parallel-group clinical trial in Germany and France involving 251 patients with PD. While others have reviewed the application of DBS earlier in the disease course and the results from EARLYSTIM, we focus on the conceptual, scientific, clinical, ethical, and policy issues that arise regarding the recent FDA approval.

Histone Deacetylase Inhibitors: A Review on Class-I Specific Inhibition

2015 ◽  
Vol 15 (9) ◽  
pp. 731-750 ◽  
Author(s):  
Jagannath Behera ◽  
Venkatesan Jayaprakash ◽  
Barij Nayan Sinha
Keyword(s):  
Clinical Trial ◽  
Histone Deacetylase ◽  
Anticancer Agents ◽  
Histone Deacetylase Inhibitors ◽  
Hdac Inhibitors ◽  
Class I ◽  
Specific Inhibition ◽  
Comprehensive Review ◽  
The Us ◽  
Us Fda

Histone Deacetylase (HDAC) is an established and validated target for the treatment of cancer. It has been attempted to present a comprehensive review on the inhibitors for Class-I Histone Deacetylase enzyme family, reported during the period from 2002 to 2012. This review has summarized the inhibitors, based on their specificity towards different isoforms within this class. Further various recent United State (US) patents and the HDAC inhibitors, used singly or in combination undergoing clinical trial as anticancer agents have been reviewed. Three such inhibitors SAHA, Romidepsin and Belinostat have already been approved by the US-FDA for the treatment of cancer.

STUDY OF DIFFERENT PROPERTIES AND APPLICATIONS OF POLY LACTIC-CO-GLYCOLIC ACID (PLGA) NANOTECHNOLOGY: AN OVERVIEW

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 5-22
Author(s):  
A.P Gadad ◽  
◽  
G Vannuruswamy ◽  
Chandra P. Sharath ◽  
P.M. Dandagi ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Drug Delivery ◽  
Particle Size ◽  
Drug Release ◽  
Glycolic Acid ◽  
Science Research ◽  
Factors Affecting ◽  
Wide Range ◽  
The Us ◽  
Us Fda

In past decades poly lactic-co-glycolic acid (PLGA) has been one of the most attractive polymeric candidates used to fabricate devices for diagnostics and other applications of clinical and basic science research, including vaccine, cancer, cardiovascular disease, and tissue engineering. In addition, PLGA and its co-polymers are important in designing nanoparticles with desired characteristics such as biocompatibility, biodegradation, particle size, surface properties, drug release and target ability and exhibit a wide range of erosion times. PLGA has been approved by the US FDA for use in drug delivery. This article represents the more recent successes of applying PLGA-based nanotechnologies and tools in these medicine-related applications, and factors affecting their degradation and drug release. It focuses on the possible mechanisms, diagnosis and treatment effects of PLGA preparations and devices.

Sign in / Sign up

Export Citation Format

Share Document