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Biologics, Volume 2, Issue 3 (September 2022) – 4 articles

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2 pages, 180 KiB  
Editorial
Why Are We Still Talking about Ivermectin? Editorial Note on Stone et al. Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment
by Seth H. Pincus
Biologics 2022, 2(3), 211-212; https://doi.org/10.3390/biologics2030016 - 31 Aug 2022
Viewed by 2756
Abstract
In this issue of Biologics, we publish an article describing a surprising clinical effect of the anti-helminthic drug ivermectin on patients with COVID-19 [...] Full article
15 pages, 4818 KiB  
Article
Changes in SpO2 on Room Air for 34 Severe COVID-19 Patients after Ivermectin-Based Combination Treatment: 62% Normalization within 24 Hours
by Jaqueline C. Stone, Pisirai Ndarukwa, David E. Scheim, Barry M. Dancis, Jerome Dancis, Martin G. Gill and Colleen Aldous
Biologics 2022, 2(3), 196-210; https://doi.org/10.3390/biologics2030015 - 31 Aug 2022
Cited by 7 | Viewed by 19549
Abstract
The emergence of COVID-19 in March 2020 challenged Zimbabwe to respond with limited medical facilities and therapeutic options. Based on early clinical indications of efficacy for the macrocyclic lactone, Ivermectin (IVM), against COVID-19, IVM-based combination treatments were deployed to treat it. Oxygen saturation [...] Read more.
The emergence of COVID-19 in March 2020 challenged Zimbabwe to respond with limited medical facilities and therapeutic options. Based on early clinical indications of efficacy for the macrocyclic lactone, Ivermectin (IVM), against COVID-19, IVM-based combination treatments were deployed to treat it. Oxygen saturation (SpO2) data were retrospectively analyzed for 34 severe, hypoxic COVID-19 patients all on room air (without supplemental oxygen). The patients, median age 56.5, were treated at clinics or at home between August 2020 and May 2021. All but three of these 34 patients had significantly increased SpO2 values within 24 h after the first IVM dose. The mean increase in SpO2 as a percentage of full normalization to SpO2 = 97 was 55.1% at +12 h and 62.3% at +24 h after the first IVM dose (paired t-test, p < 0.0000001). These results parallel similar sharp, rapid increases in SpO2, all on room air, for 24 mostly severe COVID-19 patients in the USA (California) who were given an IVM-based combination treatment. All patients in both of these critical series recovered. These rapid increases in SpO2 values after IVM treatment stand in sharp contrast to declines in SpO2 and associated pulmonary function through the second week following the onset of moderate or severe COVID-19 symptoms under standard care. Full article
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25 pages, 383 KiB  
Review
Biosimilars: Harmonizing the Approval Guidelines
by Sarfaraz K. Niazi
Biologics 2022, 2(3), 171-195; https://doi.org/10.3390/biologics2030014 - 28 Jul 2022
Cited by 14 | Viewed by 7835
Abstract
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products [...] Read more.
Biosimilar approval guidelines need rationalization and harmonization to remove the inconsistencies and misconceptions to enable faster, safer, and more cost-effective biosimilars. This paper proposes a platform for a model guideline based on the scientific evaluation of the regulatory filings of the 130+ products approved in the US, UK, and EU and hundreds more in the WHO member countries. Extensive literature survey of clinical data published and reported, including Clinicaltrials.gov, a review of all current guidelines in the US, UK and EU, and WHO, and detailed discussions with the FDA have confirmed that removing the animal and clinical efficacy testing and fixing other minor approaches will enable the creation of a harmonized guideline that will best suit an ICH designation. Full article
6 pages, 1070 KiB  
Editorial
Aged Population and Immunocompromised Patients: Impact on SARS-CoV-2 Variants and Treatment Outcomes
by Vivek P. Chavda, Mahesh T. Chhabria and Vasso Apostolopoulos
Biologics 2022, 2(3), 165-170; https://doi.org/10.3390/biologics2030013 - 22 Jul 2022
Cited by 2 | Viewed by 3013
Abstract
Patients with an immunocompromised state are at risk of developing a long-term infection from the coronavirus 2 that causes severe acute respiratory syndrome (SARS-CoV-2) [...] Full article
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