Mackenziealvarado1623
This work describes the late-stage product portfolios of the biotechnology companies that completed initial public offerings (IPOs) from 1997 to 2016. We asked whether these emerging companies continue to develop innovative, biologic products and produce the innovation promised by the early biotechnology industry.
We identified therapeutic products that reached Phase III development from 1997 to 2016, the characteristics of the products, the dates of the initiation of Phase III and product approval, proxy indicators of the innovativeness of each product, and the contribution of each biotechnology company. Companies were characterized by IPO window and clinical status of the most advanced product at IPO. Time from IPO to Phase III or approval, and the estimated probability of a company having a product advance to these milestones, were examined using Kaplan-Meier analysis.
A total of 319 biotechnology companies completed IPOs from 1997 to 2016. These companies contributed to the development of 367 producpresented 16% of all NMEs and 28% of biologics approved between 1997 and 2016. Seven products achieved per-annum sales of >$1 billion during the study period.
The majority of emerging publicly owned biotechnology companies contribute to products that advance to Phase III development and approval, although these companies are no longer distinctively focused on biologic products.
The majority of emerging publicly owned biotechnology companies contribute to products that advance to Phase III development and approval, although these companies are no longer distinctively focused on biologic products.
Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody therapeutic in development for patients with severe, uncontrolled asthma. In ongoing Phase III studies, tezepelumab is administered via subcutaneous (SC) injections using a vial-and-syringe (V-S). This study compared the pharmacokinetic (PK) parameters, safety, and tolerability of tezepelumab administered subcutaneously via V-S versus via an accessorized prefilled syringe (APFS) or autoinjector (AI).
This single-center, randomized, open-label, parallel-group study was conducted in healthy volunteers aged 18-65 years. Participants, stratified according to weight (50 to <70kg, 70 to <80kg, or 80-90kg), were randomized evenly to 9 groups representing injections to the abdomen, thigh, or upper arm via V-S, APFS, or AI. Tezepelumab PK parameters over 113 days were evaluated after a single 210-mg SC dose. The primary end points were comparison of C
and AUC
between device groups. Further PK parameters, immunogenicity, safety (incluAPFS, and AI groups. Median visual analog scale pain score (0-100mm scale) was 2mm immediately after injection and was 0mmat 30min for all groups.
Tezepelumab PK parameters after a single 210-mg SC dose were comparable when administered via V-S, APFS, or AI. In all groups, immunogenicity rate and injection site pain were low, and ISRs were uncommon. These findings support administration of tezepelumab via APFS or AI, in addition to V-S, providing patients and physicians with greater choice and the potential convenience of at-home use. ClinicalTrials.gov identifier NCT03989544.
Tezepelumab PK parameters after a single 210-mg SC dose were comparable when administered via V-S, APFS, or AI. In all groups, immunogenicity rate and injection site pain were low, and ISRs were uncommon. These findings support administration of tezepelumab via APFS or AI, in addition to V-S, providing patients and physicians with greater choice and the potential convenience of at-home use. ClinicalTrials.gov identifier NCT03989544.
Mexico has reported high death and case fatality rates due to COVID-19. Several comorbidities have been related to mortality in COVID-19, as hypertension, diabetes, coronary heart disease, chronic obstructive lung disease and chronic kidney disease.
To describe the main clinical characteristics of COVID-19 in the major social security institution in Mexico, as well as the contribution of chronic comorbidities and the population attributable fraction related to them.
Data for all patients with a positive test for SARS-CoV-2 in the institutional database was included for analysis. Demographic information, the presence of pneumonia and whether the patient was hospitalized or treated at home as an outpatient as well as comorbidities were analyzed. Case fatality rate was estimated for different groups. Odds ratios with 95% confidence intervals from a logistic regression model were estimated, as well as the population attributable fraction.
By November 13, 2020, 323,671 subjects with COVID-19 infection have been identified. Case fatality rate is higher in males (20.2%), than in females (13.0%), and increases with age. Case fatality rate increased with the presence of obesity, hypertension and/or diabetes. Age and sex were major independent risk factors for mortality, as well as the presence of pneumonia, diabetes, hypertension, obesity, immunosuppression, and end-stage kidney disease. The population attributable fraction due to obesity in outpatients was 16.8%.
Major cardiovascular risk factors and other comorbidities increase the risk of dying in patients with COVID-19. Identification of populations with high fatality in COVID-19, provides insight to deal with this pandemic by health services in Mexico.
Major cardiovascular risk factors and other comorbidities increase the risk of dying in patients with COVID-19. Identification of populations with high fatality in COVID-19, provides insight to deal with this pandemic by health services in Mexico.
Lipoprotein(a) [Lp(a)] is an independent cardiovascular risk factor. We present real-life characteristics of patients with increased Lp(a) levels attending a University Lipid Clinic.
We retrospectively studied patients attending the University of Ioannina Hospital Lipid Clinic with Lp(a) levels ≥30mg/dL who were followed-up for a median of 22months.
One hundred eight patients (median age 59years, 49% females) were included with median Lp(a) levels 67mg/dL (30-320). Of patients, 25.1% had established atherosclerotic cardiovascular disease (ASCVD) 11.1 and 5.6% positive personal history of myocardial infarction (MI) and stroke, respectively, 6.5% carotid artery disease and 1.9% lower extremities arterial disease (LEAD). In addition, 35.2% of participants had heterozygous familial hypercholesterolemia (heFH), 37.9% positive family history of premature ASCVD, 29.6% hypertension, 12.0% diabetes and 5.5% chronic kidney disease (CKD). Of patients, 67.6% were receiving statin therapy and 16.6% additional ezetimibe at baseline visit, and 83 and 35% were receiving statin treatment and additional ezetimibe, respectively, during follow-up. Low-density cholesterol (LDL-C) levels and LDL-C
levels were significantly reduced in lipid-lowering therapy naive patients by 37 and 40% (p <0.05), in lipid-lowering therapy intensified patients by 31 and 36% (p <0.05), and in patients on stable lipid-lowering treatment by 15% (p <0.05) and 10% (p >0.05), respectively, during follow-up. THZ531 Lp(a) levels increased by 9% (p <0.05).
Our data confirm the high prevalence of established ASCVD, hFH and positive familial history of premature ASCVD in patients with elevated Lp(a) levels. Lp(a) levels slightly increased during follow-up.
Our data confirm the high prevalence of established ASCVD, hFH and positive familial history of premature ASCVD in patients with elevated Lp(a) levels. Lp(a) levels slightly increased during follow-up.
Iron is an essential trace element to almost all organism, and the delicate balance between host defend system and viral proliferation plays an important role in infective conditions. While the association of the iron metabolism with the prognosis of COVID-19 remains poorly understood. We aimed to estimate the associations of systemic iron metabolism parameters with the severity and risks of adverse outcomes in COVID-19.
In this retrospective cohort study, we included 158 confirmed COVID-19 patients in Tongji Hospital, Wuhan, China (27 January to 5 April, 2020). Demographic data, comorbidities, laboratory examinations, treatments, and clinical outcomes were all collected. Multivariable Poisson regression was used to estimate the association of iron parameter levels with the severity and risks of adverse outcomes in COVID-19 patients.
We identified 60 (38%) severe cases in 158 COVID-19 patients. The median age was 63 years (interquartile range [IQR] 54-73) and the median length of hospital stay was 28 days (IQR 17-40). After adjusting for age, sex, IL-6, and pre-existing comorbidities, all iron parameters were associated with the severity of COVID-19 with adjusted risk ratio of 0.42 [95% CI 0.22-0.83], 4.38 [95% CI 1.86-10.33], 0.19 [95% CI 0.08-0.48], and 0.25 [95% CI 0.10-0.58] for serum iron, ferritin, transferrin, and total iron-binding capacity, respectively. These iron indices were also related to the risk of ARDS, coagulopathy, acute cardiac injury, acute liver injury, and acute kidney injury in COVID-19 patients and high cytokine concentrations.
Patients with low serum iron status likely suffered from severe condition and multiple-organ injury in COVID-19. The iron metabolism parameters might be risk factors and clinical biomarkers for COVID-19 prognosis.
Patients with low serum iron status likely suffered from severe condition and multiple-organ injury in COVID-19. The iron metabolism parameters might be risk factors and clinical biomarkers for COVID-19 prognosis.Cultured Epithelial Autografts (CEAs), developed at the end of the 1970s from in vitro culture amplification of keratinocytes, have led to a therapeutic revolution in the treatment of major burns. The areas of improvement of the cultures initially involved the manufacturing processes (culture media, support matrices, etc.) and then clinical applications (use of a largely expanded allogeneic or autologous dermal bed). These advances have enabled burn centers (BC) using CEAs to obtain very satisfactory percentages of graft integration and survival of major burns patients. However, since CEAs are not without major drawbacks (fragility, high rate of infection, high cost, unstable scars), these pitfalls have restricted their use worldwide. As of 2014, CEAs produced by Genyzme Tissue Repair are no longer available in Europe, which has considerably reduced an indispensable therapeutic arsenal for severe and extensive burns. To overcome these therapeutic limitations, current research is focusing on techniques combining surgery, tissue engineering and cell therapy. The advent of regenerative medicine, based on the use of stem cells, in particular mesenchymal stem cells (MSC), can contribute to an improvement in the management of these massively burned patients (optimization of the environmental medium, attenuation of the systemic inflammatory response and the immunosuppressive effects of the burn, acceleration of tissue regeneration, etc.). Cell therapy, therefore, offers alternatives to CEAs, which must imperatively retain their place in the therapeutic arsenal, namely an effective emergency coverage technique that can be improved.
