Ranbaxy Laboratories has received US FDA approval for the manufacture and marketing of cefuroxime axetil for oral suspension USP

2008 ◽  
Vol &NA; (1625) ◽  
pp. 22
Author(s):  
&NA;
Keyword(s):  
Cefuroxime Axetil ◽  
Oral Suspension ◽  
Fda Approval ◽  
Us Fda

Single-arm oncology trials and the nature of external controls arms

2021 ◽  
Author(s):  
Mustafa Hashmi ◽  
Jeremy Rassen ◽  
Sebastian Schneeweiss
Keyword(s):  
Secondary Data ◽  
Outcome Data ◽  
Aggregate Data ◽  
Primary Data ◽  
External Control ◽  
Calendar Time ◽  
Convenience Sample ◽  
Fda Approval ◽  
Baseline Characteristics ◽  
Us Fda

Aim: Single-arm trials with external control arms (ECAs) have gained popularity in oncology. ECAs may consist of primary data from previous trials, electronic health records (EHRs) or aggregate data from the literature. We sought to provide a description of how such studies achieve similarity of patients, comparability of data quality and outcome assessment. Materials & methods: In a stratified convenience sample of 15 studies, five used primary data from trials as ECAs, five used secondary data from EHRs and five used aggregate data from the literature. Data were collected from the published literature and public web resources, blinded to the eventual approval decision. Results: Studies using ECAs from primary data and EHR data displayed methods to achieve comparability of information, including matched baseline characteristics. Aggregate data from published studies did not attempt to match covariates. The EHR controls often showed calendar time overlap for collecting information while trial data were mostly historic. Outcome data were not consistently reported across studies. US FDA approval was only seen when primary data from trials or EHR data were used as the ECA, however no ECA in this sample directly contributed to approval. Discussion: In this nonsystematic review of ECAs for single-arm trials, the ECAs derived from primary data collected by other trials or EHRs show patterns of patient comparability, time overlap, and realistic methodological approaches to achieving balance between treatment arms. They are often submitted to regulators while literature-derived aggregate findings as ECA may serve as benchmarks for pipeline decisions.

Luspatercept in the treatment of lower-risk myelodysplastic syndromes

2021 ◽  
Author(s):  
Onyee Chan ◽  
Rami S Komrokji
Keyword(s):  
Clinical Trials ◽  
Myelodysplastic Syndromes ◽  
Transforming Growth Factor Beta ◽  
Transforming Growth Factor ◽  
Safety Data ◽  
Erythroid Differentiation ◽  
Fda Approval ◽  
The Us ◽  
Us Fda ◽  
Terminal Erythroid Differentiation

Transforming growth factor beta (TGF-β) signaling pathway is key to hematopoiesis regulation. Increased activation of this pathway contributes to ineffective terminal erythroid differentiation in myelodysplastic syndromes (MDS). Luspatercept is a novel fusion protein that traps TGF-β ligands preventing them from binding to Type II TGF-β receptors, thereby decreasing phosphorylated SMAD2/3 resulting in the downstream effect of promoting erythropoiesis. Seminal clinical trials using luspatercept, PACE-MD and MEDALIST, demonstrated impressive efficacy in the treatment of transfusion-dependent anemia in intermediate risk or lower MDS had led to the US FDA approval for this indication. This review summarizes luspatercept mechanisms of action, efficacy/safety data supporting its use and ongoing clinical trials in MDS.

Industry Watch

2003 ◽  
Vol 07 (22) ◽  
pp. 1391-1406
Keyword(s):  
Drug Discovery ◽  
Animal Health ◽  
Biotech Company ◽  
Discovery Research ◽  
Fda Approval ◽  
Drug Discovery Research ◽  
Medical Facilities ◽  
Us Government ◽  
Health Products ◽  
Us Fda

Alliance between AGT Biosciences and Starpharma. First Australian Biotech Company to List on HKSE. Breakthrough in Transdermal Drug Discovery Technology. Acrux Licenses MDTS Technology to Eli Lilly got Animal Health Products. Biota Secures SARS Testing Agreement with US Government Research Agencies. SysArris in Bio Partnering Europe 2003. Shantha Bio to Launch Streptokinase by Year-end. Lupin Receives US FDA Approval to Launch Ceftriaxone. MerLion Pharma Collaborates with Schering-Plough in Drug Discovery Research. Quest Pharmaceutical Sets up Taiwanese Subsidiary. BenQ to Invest in Nanjing's Medical Facilities.

Company News

2001 ◽  
Vol 05 (13) ◽  
pp. 259-269
Keyword(s):  
Combinatorial Chemistry ◽  
Blood Test ◽  
Tumor Necrosis ◽  
Generic Version ◽  
Mainland China ◽  
Cancer Drug ◽  
Fda Approval ◽  
Tumor Necrosis Therapy ◽  
Us Fda ◽  
Medical Glass

US-based Peregrine to Continue With Tumor Necrosis Therapy in China. CardioDynamics' Proprietary Technology Available in Taiwan. Gilead Initiates Phase I Clinical Trial for Hepatitis B Drug in China. China's Medical Glass Manufacturer Imports Production Line from US-based EM. Japan's Kyowa Hakko Aims to be Top Bio-pharmaceutical Company by 2010. Australian Biotech Company Invests US$2.65 million in US Firm. Qugen — Singapore's First Gene Therapy Company. Roche Launches Cancer Drug in Japan. ChemBridge Corporation Forms Combinatorial Chemistry Alliance with Sumitomo Pharmaceuticals. Indian Pharma Company Receives US FDA Approval for Pentoxifyline. Dr. Reddy's to Launch Generic Version of Prisolec in US. US Patent Granted for Heparanese Gene. Taiwan Tobacco and Wine Board to Collaborate with Mainland China. Taiwan Company Develops Rapid Blood Test for Enterovirus. Ranbaxy Laboratories: An Update.

Lasers for Onychomycosis

2016 ◽  
Vol 21 (2) ◽  
pp. 114-116 ◽  
Author(s):  
Aditya K. Gupta ◽  
Kelly A. Foley ◽  
Sarah G. Versteeg
Keyword(s):  
Laser Treatment ◽  
Clinical Trial Design ◽  
Temporary Increase ◽  
Drug Trials ◽  
Mycological Cure ◽  
Treatment Regimens ◽  
Fda Approval ◽  
The Us ◽  
Current Article ◽  
Us Fda

Many studies that have been recently published investigate the efficacy of laser treatment for onychomycosis. These studies support the current US Food and Drug Administration (FDA) approval of lasers for the ‘temporary increase in clear nail’. Clear nail growth is an important treatment goal for patients; however, many do not realise that laser treatment is not a cure for onychomycosis. The current article briefly reviews why lasers may be theoretically effective in treating onychomycosis and critically reviews published laser studies for onychomycosis in light of the standards employed in drug trials. Treatment regimens, efficacy endpoints, and the unit of analysis (nails vs patients) vary widely among published laser studies. Complete cure, mycological cure, and clinical improvement rates in laser studies are not reported or use such disparate criteria that comparison among studies is not possible. The US FDA has recently published guidelines for the use of medical devices in clinical trial design for onychomycosis. Future laser studies should adopt the FDA’s guidelines to allow for more consistency within the field and focus on the efficacy of lasers as monotherapy for onychomycosis.

scholarly journals Brodalumab: a promising option in the management of psoriasis

2020 ◽  
Vol 9 (7) ◽  
pp. 1153
Author(s):  
Melina Infenta Sahay ◽  
Roshini Ravindranath ◽  
Snehalatha Krishnamoorthy ◽  
Damal Kandadai Sriram ◽  
Melvin George
Keyword(s):  
Monoclonal Antibody ◽  
Biological Therapy ◽  
Clinical Symptoms ◽  
Human Monoclonal Antibody ◽  
Boxed Warning ◽  
Current Status ◽  
European Medicines Agency ◽  
Safety And Efficacy ◽  
Fda Approval ◽  
Us Fda

Brodalumab, a human monoclonal antibody approved as a biological therapy for treating psoriasis. Due to its consistent results across several clinical studies in treating patients with plaque psoriasis, in 2016 it was first approved worldwide in Japan followed by US FDA approval in 2017 and the European medicines agency. Brodalumab, selectively binds with higher affinity to IL-17RA, thereby blocking the actions of IL-17A, E and F. This act as a novel mechanism to inhibit the inflammation, hyperproliferation, skin thickening and other clinical symptoms associated with psoriasis. The safety and adverse effects of Brodalumab were similar to other IL-17 inhibitors, frequently reported adverse events were nasopharyngitis, neutropenia, and candidiasis. The FDA has recommended a boxed warning for the suicidal tendencies that could occur among Brodalumab users. This review is an endeavor to depict the drug's mode of action, pharmacokinetics, safety, and efficacy as well as its current status among other drugs targeting IL-17.

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