Baloxavir Marboxil: An Original New Drug against Influenza

Baloxavir marboxil is a new drug developed in Japan by Shionogi to treat seasonal flu infection. This cap-dependent endonuclease inhibitor is a prodrug that releases the biologically active baloxavir acid. This new medicine has been marketed in Japan, the USA and Europe. It is well tolerated (more than 1% of the patients experienced diarrhea, bronchitis, nausea, nasopharyngitis, and headache), and both influenza A and B viruses are sensitive, although the B strain is more resistant due to variations in the amino acid residues in the binding site. The drug is now in post-marketing pharmacovigilance phase, and its interest will be especially re-evaluated in the future during the annual flu outbreaks. It has been also introduced in a recent clinical trial against COVID-19 with favipiravir.

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Effect of new dietary supplement on sperm quality

Orvosi Hetilap ◽

10.1556/oh.2012.29468 ◽

2012 ◽

Vol 153 (45) ◽

pp. 1787-1792 ◽

Cited By ~ 1

Author(s):

Mária Horváth ◽

Endre Czeizel

Keyword(s):

Adverse Effect ◽

Clinical Trial ◽

Dietary Supplement ◽

Male Fertility ◽

Sperm Quality ◽

Sperm Count ◽

Before And After ◽

The Usa ◽

New Treatments

Introduction: There is a decline in male fertility thus new treatments are needed. Aims: To test the efficacy of a new dietary supplement developed in the USA and registered as a curing drug in Hungary (OGYI). Methods: In a clinical trial 100 men with low sperm quality (spermium count 5–20 M/ml, good motility 10–40%, and adverse shape 30–50%) were examined. Results: Sperm parameters were measured before and after a 3-month treatment and after another 3-month without treatment. This dietary supplement statistically and clinically significantly improved sperm count and motility. In 74 cases this dietary supplement demonstrated a beneficial effect on sperm quality (more than 10% increase in sperm count, or quality of motility, or shape); in 16 cases the improvement exceeded 30%. No adverse effect could be accounted for this treatment. Conclusions: This new dietary supplement may contribute to the treatment of male infertility. Orv. Hetil., 2012, 153, 1787–1792.

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Faculty Opinions recommendation of Association between Guillain-Barré syndrome and influenza A (H1N1) 2009 monovalent inactivated vaccines in the USA: a meta-analysis.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717995526.793476164 ◽

2013 ◽

Author(s):

Sari Kiuru-Enari ◽

Mari Auranen

Keyword(s):

Influenza A ◽

Meta Analysis ◽

Guillain Barre Syndrome ◽

Influenza A H1n1 ◽

Guillain Barré Syndrome ◽

The Usa ◽

Inactivated Vaccines ◽

Guillain Barré

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Analogues of the cholecystokinin octapeptide modified in the central part of the molecule

Collection of Czechoslovak Chemical Communications ◽

10.1135/cccc19911963 ◽

1991 ◽

Vol 56 (9) ◽

pp. 1963-1970 ◽

Cited By ~ 3

Author(s):

Jan Hlaváček ◽

Václav Čeřovský ◽

Jana Pírková ◽

Pavel Majer ◽

Lenka Maletínská ◽

...

Keyword(s):

Amino Acid ◽

Biological Activities ◽

Point Of View ◽

Biologically Active ◽

Side Chain ◽

Amino Acid Residues ◽

Cholecystokinin Octapeptide ◽

Biological Tests ◽

Biological Potency ◽

Biologically Active Conformation

In a series of analogues of the cholecystokinin octapeptide (CCK-8) the amino acid residues were gradually modified by substituting Gly by Pro in position 4, Trp by His in position 5, Met by Cle in position 6, or the Gly residue was inserted between Tyr and Met in positions 2 and 3 of the peptide chain, and in the case of the cholecystokinin heptapeptide (CCK-7) the Met residues were substituted by Nle or Aib. These peptides were investigated from the point of view of their biological potency in the peripheral and central region. From the results of the biological tests it follows that the modifications carried out in these analogues and in their Nα-Boc derivatives mean a suppression of the investigated biological activities by 2-3 orders of magnitude (at a maximum dose of the tested substance of 2 . 10-2 mg per animal).This means that a disturbance of the assumed biologically active conformation of CCK-8, connected with a considerable decrease of the biological potency of the molecule, takes place not only after introduction of the side chain into its centre (substitution of Gly4), but also after the modification of the side chains of the amino acids or by extension of the backbone in further positions around this central amino acid.

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Tuberculosis and viral hepatitis in patients treated with certolizumab pegol in Asia-Pacific countries and worldwide: real-world and clinical trial data

Clinical Rheumatology ◽

10.1007/s10067-020-05248-4 ◽

2020 ◽

Author(s):

Chak Sing Lau ◽

Yi-Hsing Chen ◽

Keith Lim ◽

Marc de Longueville ◽

Catherine Arendt ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Viral Hepatitis ◽

Central Europe ◽

Real World ◽

Certolizumab Pegol ◽

Safety Data ◽

Asia Pacific ◽

Hbv Reactivation ◽

Post Marketing

Abstract Introduction/objectives To evaluate the incidence rate (IR) of tuberculosis (TB) and viral hepatitis B and C (HBV/HCV) during certolizumab pegol (CZP) treatment, worldwide and in Asia-Pacific countries, across clinical trials and post-marketing reports (non-interventional studies and real-world practice). Method CZP safety data were pooled across 49 clinical trials from 1998 to June 2017. Post-marketing reports were from initial commercialization until March 2015 (TB)/February 2017 (HBV/HCV). All suspected TB and HBV/HCV cases underwent centralized retrospective review by external experts. Incidence rates (IRs) were calculated per 100 patient-years (PY) of CZP exposure. Results Among 11,317 clinical trial patients (21,695 PY), 62 TB cases were confirmed (IR 0.29/100 PY) including 2 in Japan (0.10/100 PY) and 3 in other Asia-Pacific countries (0.58/100 PY). From > 238,000 PY estimated post-marketing CZP exposure, there were 31 confirmed TB cases (0.01/100 PY): 5 in Japan (0.05/100 PY), 1 in other Asia-Pacific countries (0.03/100 PY). Reported regional TB IRs were highest in eastern Europe (0.17/100 PY), central Europe (0.09/100 PY), and Mexico (0.16/100 PY). Across clinical trials, there was 1 confirmed HBV reactivation and no HCV cases. From > 420,000 PY estimated post-marketing CZP exposure, 5 HBV/HCV cases were confirmed (0.001/100 PY): 2 HCV reactivations; 1 new HCV; plus 2 HBV reactivations in Japan (0.008/100 PY). Conclusions CZP TB risk is aligned with nationwide TB rates, being slightly higher in Asia-Pacific countries excluding Japan. Overall, TB and HBV/HCV risk with CZP treatment is currently relatively low, as risk can be minimized with patient/physician education, screening, and vigilant treatment, according to international guidelines. Key Points:• TB rates were highest in eastern/central Europe, Mexico, and Asia-Pacific regions.• With the implementation of stricter TB screening and risk evaluations in 2007, especially in high TB incidence countries, there was a notable reduction TB occurrence.• Safety profile of biologics in real-world settings complements controlled studies.• TB and hepatitis (HBV/HCV) risk with certolizumab pegol (CZP) treatment is low.

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A bivariate Bayesian framework for simultaneous evaluation of two candidate companion diagnostic assays in a new drug clinical trial

Biostatistics & Epidemiology ◽

10.1080/24709360.2021.1913705 ◽

2021 ◽

pp. 1-11

Author(s):

Richard M. Simon ◽

Songbai Wang

Keyword(s):

Clinical Trial ◽

Bayesian Framework ◽

Diagnostic Assays ◽

New Drug ◽

Simultaneous Evaluation ◽

Drug Clinical Trial ◽

Companion Diagnostic

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Synthesis of a Biologically Active Nonadecapeptide Corresponding to the First Nineteen Amino Acid Residues of Adrenocorticotropins1a

Journal of the American Chemical Society ◽

10.1021/ja01482a035 ◽

1961 ◽

Vol 83 (21) ◽

pp. 4449-4457 ◽

Cited By ~ 46

Author(s):

Choh Hao Li ◽

Johannes Meienhofer ◽

Eugen Schnabel ◽

David Chung ◽

Tung-Bin Lo ◽

...

Keyword(s):

Amino Acid ◽

Biologically Active ◽

Amino Acid Residues

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Global publication trends and hotspots of molecular biomarkers in DILI from 1991 to 2020: A 30-year bibliometric analysis

Science Progress ◽

10.1177/00368504211000535 ◽

2021 ◽

Vol 104 (1) ◽

pp. 003685042110005

Author(s):

Mingnan Cao ◽

Li Wang ◽

Lin Zhang ◽

Jingli Duan

Keyword(s):

Bibliometric Analysis ◽

Research Collaboration ◽

Citation Networks ◽

Publication Trends ◽

Drug Induced ◽

Topic Area ◽

The Past ◽

Black Box Warnings ◽

The Usa ◽

Post Marketing

Drug-induced liver injury (DILI) is one of the common adverse drug reactions and the leading cause of drug development attritions, black box warnings, and post-marketing withdrawals. Current biomarkers are suboptimal in detecting DILI and predicting its outcome. This study aimed to quantitatively and qualitatively investigate the research trends on DILI biomarkers using bibliometric analysis. All relevant publications were extracted from the Web of Science database. An online analysis platform of literature metrology, bibliographic item co-occurrence matrix builder, and CiteSpace software were used to analyze the publication trends. CitNetExplorer was used to construct direct citation networks and VOSviewer was used to analyze the keywords and research hotspots. We found a total of 485 publications related to DILI biomarkers published from 1991 to 2020. Toxicological Sciences had been the most popular journal in this field over the past 30 years. The USA maintained a top position worldwide and provided a pivotal influence, followed by China. Among all the institutions, the University of Liverpool was regarded as a leader for research collaboration. Moreover, Professors Paul B. Watkins and Tsuyoshi Yokoi made great achievements in topic area. We analyzed the citation networks and keywords, therefore identified five and six research hotspot clusters, respectively. We considered the publication information regarding different countries/regions, organizations, authors, journals, et al. by summarizing the literature on DILI biomarkers over the past 30 years. Notably, the subject of DILI biomarkers is an active area of research. In addition, the investigation and discovery of novel promising biomarkers such as microRNAs, keratin18, and bile acids will be future developing hotspots.

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Analytical detection of influenza A(H3N2)v and other A variant viruses from the USA by rapid influenza diagnostic tests

Influenza and Other Respiratory Viruses ◽

10.1111/irv.12017 ◽

2012 ◽

Vol 7 (4) ◽

pp. 491-496 ◽

Cited By ~ 17

Author(s):

Amanda Balish ◽

Rebecca Garten ◽

Alexander Klimov ◽

Julie Villanueva

Keyword(s):

Diagnostic Tests ◽

Influenza A ◽

The Usa ◽

Analytical Detection

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Industry Watch

Asia-Pacific Biotech News ◽

10.1142/s0219030304001673 ◽

2004 ◽

Vol 08 (20) ◽

pp. 1099-1111

Keyword(s):

Clinical Trial ◽

Phase I ◽

Stock Exchange ◽

Medical Industry ◽

Phase I Clinical Trial ◽

New Drug ◽

Global Companies ◽

Japan Tobacco ◽

New Entry

New Entry to Australian Stock Exchange: Acrux. Peplin's Phase I Clinical Trial Completed. Prima BioMed & AstraZeneca in Licensing Agreement. Ultratech India Restrained from Tampering with Pfizer's Viagra Trademarks. India Offers Competitive New Drug Solutions. Rofecoxib Formulation Discontinued after Health Ministry's Ban. GSK Focuses on In-licensing for Other Global Companies in India. Forthcoming Pharmaceutical Hub in Bengal. Upcoming Medical Industry Zone in Japan. Roche and Japan Tobacco in Licensing Collaboration for Potential Dyslipidemia Therapy. Tapping on Nature for Drugs.

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