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1. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens : REVIVE-1

Author

Huang, David B., O’Riordan, William, Overcash, J. Scott, Heller, Barry, Amin, Faisal, File, Thomas M., Wilcox, Mark H., Torres, Antoni, Dryden, Matthew, Holland, Thomas L., McLeroth, Patrick, Shukla, Rajesh, and Corey, G. Ralph

Published
2018

7. A Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load

Author

Dougan, Michael, primary, Azizad, Masoud, additional, Mocherla, Bharat, additional, Gottlieb, Robert L, additional, Chen, Peter, additional, Hebert, Corey, additional, Perry, Russell, additional, Boscia, Joseph, additional, Heller, Barry, additional, Morris, Jason, additional, Crystal, Chad, additional, Igbinadolor, Awawu, additional, Huhn, Gregory, additional, Cardona, Jose, additional, Shawa, Imad, additional, Kumar, Princy, additional, Blomkalns, Andra, additional, Adams, Andrew C, additional, Van Naarden, Jacob, additional, Custer, Kenneth L, additional, Knorr, Jack, additional, Oakley, Gerard, additional, Schade, Andrew E, additional, Holzer, Timothy R, additional, Ebert, Philip J, additional, Higgs, Richard E, additional, Sabo, Janelle, additional, Patel, Dipak R, additional, Dabora, Matan C, additional, Williams, Mark, additional, Klekotka, Paul, additional, Shen, Lei, additional, Skovronsky, Daniel M, additional, and Nirula, Ajay, additional

Published
2021
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8. Bamlanivimab plus Etesevimab in Mild or Moderate Covid-19

Author

Dougan, Michael, primary, Nirula, Ajay, additional, Azizad, Masoud, additional, Mocherla, Bharat, additional, Gottlieb, Robert L., additional, Chen, Peter, additional, Hebert, Corey, additional, Perry, Russell, additional, Boscia, Joseph, additional, Heller, Barry, additional, Morris, Jason, additional, Crystal, Chad, additional, Igbinadolor, Awawu, additional, Huhn, Gregory, additional, Cardona, Jose, additional, Shawa, Imad, additional, Kumar, Princy, additional, Adams, Andrew C., additional, Van Naarden, Jacob, additional, Custer, Kenneth L., additional, Durante, Michael, additional, Oakley, Gerard, additional, Schade, Andrew E., additional, Holzer, Timothy R., additional, Ebert, Philip J., additional, Higgs, Richard E., additional, Kallewaard, Nicole L., additional, Sabo, Janelle, additional, Patel, Dipak R., additional, Dabora, Matan C., additional, Klekotka, Paul, additional, Shen, Lei, additional, and Skovronsky, Daniel M., additional

Published
2021
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9. Effect of Bamlanivimab as Monotherapy or in Combination With Etesevimab on Viral Load in Patients With Mild to Moderate COVID-19

Author

Gottlieb, Robert L., Nirula, Ajay, Chen, Peter, Boscia, Joseph, Heller, Barry, Morris, Jason, Huhn, Gregory, Cardona, Jose, Mocherla, Bharat, Stosor, Valentina, Shawa, Imad, Kumar, Princy, Adams, Andrew C., Van Naarden, Jacob, Custer, Kenneth L., Durante, Michael, Oakley, Gerard, Schade, Andrew E., Holzer, Timothy R., Ebert, Philip J., Higgs, Richard E., Kallewaard, Nicole L., Sabo, Janelle, Patel, Dipak R., Klekotka, Paul, Shen, Lei, and Skovronsky, Daniel M.

Subjects
General Medicine
Published
2021
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10. Randomized, Placebo-Controlled Clinical Trial of Bamlanivimab and Etesevimab Together in High-Risk Ambulatory Patients With COVID-19 and Validation of the Prognostic Value of Persistently High Viral Load.

Author

Dougan, Michael, Azizad, Masoud, Mocherla, Bharat, Gottlieb, Robert L, Chen, Peter, Hebert, Corey, Perry, Russell, Boscia, Joseph, Heller, Barry, Morris, Jason, Crystal, Chad, Igbinadolor, Awawu, Huhn, Gregory, Cardona, Jose, Shawa, Imad, Kumar, Princy, Blomkalns, Andra, Adams, Andrew C, Naarden, Jacob Van, and Custer, Kenneth L

Subjects
THERAPEUTIC use of monoclonal antibodies, COVID-19, COMBINATION drug therapy, OUTPATIENT medical care, CONFIDENCE intervals, VIRAL load, MONOCLONAL antibodies, RANDOMIZED controlled trials, BLIND experiment, DESCRIPTIVE statistics, HOSPITAL care, STATISTICAL sampling, DEATH, PATIENT safety
Abstract

Background Based on interim analyses and modeling data, lower doses of bamlanivimab and etesevimab together (700/1400 mg) were investigated to determine optimal dose and expand availability of treatment. Methods This Phase 3 portion of the BLAZE-1 trial characterized the effect of bamlanivimab with etesevimab on overall patient clinical status and virologic outcomes in ambulatory patients ≥12 years old, with mild-to-moderate coronavirus disease 2019 (COVID-19), and ≥1 risk factor for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab and etesevimab together (700/1400 mg) or placebo were infused intravenously within 3 days of patients' first positive COVID-19 test. Results In total, 769 patients were infused (median age [range]; 56.0 years [12, 93], 30.3% of patients ≥65 years of age and median duration of symptoms; 4 days). By day 29, 4/511 patients (0.8%) in the antibody treatment group had a COVID-19-related hospitalization or any-cause death, as compared with 15/258 patients (5.8%) in the placebo group (Δ[95% confidence interval {CI}] = −5.0 [−8.0, −2.1], P  < .001). No deaths occurred in the bamlanivimab and etesevimab group compared with 4 deaths (all COVID-19-related) in the placebo group. Patients receiving antibody treatment had a greater mean reduction in viral load from baseline to Day 7 (Δ[95% CI] = −0.99 [−1.33, −.66], P  < .0001) compared with those receiving placebo. Persistently high viral load at Day 7 correlated with COVID-19-related hospitalization or any-cause death by Day 29 in all BLAZE-1 cohorts investigated. Conclusions These data support the use of bamlanivimab and etesevimab (700/1400 mg) for ambulatory patients at high risk for severe COVID-19. Evolution of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants will require continued monitoring to determine the applicability of this treatment. Clinical Trials Registration NCT04427501. [ABSTRACT FROM AUTHOR]

Published
2022
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11. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19

Author

Chen, Peter, primary, Nirula, Ajay, additional, Heller, Barry, additional, Gottlieb, Robert L., additional, Boscia, Joseph, additional, Morris, Jason, additional, Huhn, Gregory, additional, Cardona, Jose, additional, Mocherla, Bharat, additional, Stosor, Valentina, additional, Shawa, Imad, additional, Adams, Andrew C., additional, Van Naarden, Jacob, additional, Custer, Kenneth L., additional, Shen, Lei, additional, Durante, Michael, additional, Oakley, Gerard, additional, Schade, Andrew E., additional, Sabo, Janelle, additional, Patel, Dipak R., additional, Klekotka, Paul, additional, and Skovronsky, Daniel M., additional

Published
2021
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14. Mechanism of Action of Vibrant Capsule for the Treatment of Chronic Idiopathic Constipation: Pooled Results of 2 Different Studies

Author

Rao, Satish S.C., primary, Lembo, Anthony, additional, Chey, William D., additional, Friedenberg, Keith, additional, Loredo, Jorge, additional, Kelly, Kathleen, additional, Hazan, Lydie, additional, Huilgol, Viv, additional, Lindenberg, Daniel, additional, Straga, Jeanette, additional, Lillo, Joseph, additional, Nguyen, Hai, additional, Dennis, Patrick, additional, Fisher, Chester, additional, Lane, Paula, additional, Peterson, Dena, additional, Anderson, Duane, additional, Aazami, Hessam, additional, Heller, Barry, additional, Su, Sean, additional, Paliwal, Amit, additional, Quigley, Eamonn M.M., additional, and Block, Bradley, additional

Published
2018
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15. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim Vs Vancomycin for the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens: REVIVE-1

Author

Huang, David B, primary, O’Riordan, William, additional, Overcash, J Scott, additional, Heller, Barry, additional, Amin, Faisal, additional, File, Thomas M, additional, Wilcox, Mark H, additional, Torres, Antoni, additional, Dryden, Matthew, additional, Holland, Thomas L, additional, McLeroth, Patrick, additional, Shukla, Rajesh, additional, and Corey, G Ralph, additional

Published
2017
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16. Important decisions in 2014.

Author

Heller, Barry, Verhey, John, and Hughes, John

Abstract

A couple of significant decisions regarding franchising were decided in 2014. Their developments and implications to the industry are summarized below. In Patterson v. Domino's Pizza, LLC [60 Cal.4th 474 [...]

Published
2015

17. A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Iclaprim vs. Vancomycin in the Treatment of Acute Bacterial Skin and Skin Structure Infections Suspected or Confirmed to be Due to Gram-Positive Pathogens (REVIVE-1)

Author

Huang, David, primary, Mcleroth, Patrick, additional, Shukla, Rajesh, additional, File, Thomas M, additional, Wilcox, Mark, additional, Torres, Antoni, additional, Liu, Alyssa, additional, O’riordan, William, additional, Overcash, Scott, additional, Dryden, Matthew, additional, Corey, G Ralph, additional, and Heller, Barry, additional

Published
2017
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19. Single-Dose Oritavancin Versus 7–10 Days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study

Author

Corey, G. Ralph, primary, Good, Samantha, additional, Jiang, Hai, additional, Moeck, Greg, additional, Wikler, Matthew, additional, Green, Sinikka, additional, Manos, Paul, additional, Keech, Richard, additional, Singh, Rajesh, additional, Heller, Barry, additional, Bubnova, Natalia, additional, and O'Riordan, William, additional

Published
2014
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20. Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients

Author

Ison, Michael G, primary, Fraiz, Joseph, additional, Heller, Barry, additional, Jauregui, Luis, additional, Mills, Graham, additional, O'Riordan, William, additional, O'Neil, Brian, additional, Playford, E Geoffrey, additional, Rolf, J Douglass, additional, Sada-Diaz, Eduardo, additional, Elder, Jenna, additional, Collis, Phil, additional, Hernandez, Jaime E, additional, and Sheridan, William P, additional

Published
2013
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21. Single-Dose Oritavancin Versus 7–10 Days of Vancomycin in the Treatment of Gram-Positive Acute Bacterial Skin and Skin Structure Infections: The SOLO II Noninferiority Study.

Author

Corey, G. Ralph, Good, Samantha, Jiang, Hai, Moeck, Greg, Wikler, Matthew, Green, Sinikka, Manos, Paul, Keech, Richard, Singh, Rajesh, Heller, Barry, Bubnova, Natalia, and O'Riordan, William

Subjects
GRAM-positive bacterial infections, METHICILLIN-resistant staphylococcus aureus treatment, VANCOMYCIN, TREATMENT effectiveness, PHARMACOKINETICS, BACTERIAL disease treatment
Abstract

A single 1200-mg dose of oritavancin was noninferior to 7–10 days of vancomycin for treatment of acute bacterial skin and skin structure infections (ABSSSIs) caused by gram-positive pathogens. Oritavancin provides a single-dose alternative to multi-dose therapies for ABSSSI.Background. Oritavancin is a lipoglycopeptide antibiotic with rapid bactericidal activity against gram-positive bacteria. Its concentration-dependent activity and long half-life allow for single-dose treatment.Methods. In a randomized, double-blind trial, adults with acute bacterial skin and skin structure infections (ABSSSIs) received either a single intravenous 1200-mg dose of oritavancin or 7–10 days of twice-daily vancomycin. Three efficacy endpoints were tested for noninferiority: (1) primary composite endpoint at 48–72 hours (cessation of spreading or reduction in lesion size, absence of fever, and no rescue antibiotic); (2) investigator-assessed clinical cure 7–14 days after end of treatment; and (3) ≥20% reduction in lesion area at 48–72 hours.Results. A total of 503 and 502 patients comprised the modified intent-to-treat population for oritavancin and vancomycin, respectively. All 3 efficacy endpoints met the 10% noninferiority margin: the primary composite endpoint (80.1% vs 82.9%; 95% confidence interval [CI], −7.5 to 2.0), investigator-assessed clinical cure (82.7% vs 80.5%; 95% CI, −2.6 to 7.0), and proportion of patients attaining ≥20% reduction in lesion area (85.9% vs 85.3%; 95% CI, −3.7 to 5.0) for oritavancin vs vancomycin, respectively. Efficacy outcomes by pathogen, including methicillin-resistant Staphylococcus aureus and the frequency of adverse events, were similar between treatment groups.Conclusions. A single 1200-mg dose of oritavancin was noninferior to 7–10 days of vancomycin in treating ABSSSIs caused by gram-positive pathogens, and was well tolerated. Oritavancin provides a single-dose alternative to multidose therapies for the treatment of ABSSSIs.Clinical Trials Registration. NCT01252732. [ABSTRACT FROM PUBLISHER]

Published
2015
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22. When Franchisee Counsel Goes Too Far

Author

Heller, Barry M. and McIntosh, Scott

Subjects
Franchises -- Laws, regulations and rules, Franchises -- Cases, Company legal issue, Government regulation, Business, international
Abstract

By Barry M. Heller and Scott McIntosh The vast majority of franchisors have seen their share of complaints filed by franchisees that are anything but the 'short and plain statement [...]

Published
2003

25. Intravenous Peramivir for Treatment of Influenza in Hospitalized Patients

Author

Ison, Michael G, Fraiz, Joseph, Heller, Barry, Jauregui, Luis, Mills, Graham, O'Riordan, William, O'Neil, Brian, Playford, E Geoffrey, Rolf, J Douglass, Sada-Diaz, Eduardo, Elder, Jenna, Collis, Phil, Hernandez, Jaime E, and Sheridan, William P

Abstract

Background Influenza causes over 200,000 hospitalizations a year in the United States, but few antiviral treatment studies have focused on patients hospitalized with influenza. This open-label, randomized study was initiated during the 2009 H1N1 pandemic to help assess the antiviral activity, safety and tolerability of 5–10 days treatment with two different dosing regimens of the intravenous neuraminidase inhibitor, peramivir, in hospitalized subjects with influenza.Methods Quantitative virology was done on nasopharyngeal swab specimens from subjects =6 years of age to measure change from baseline in tissue culture infective dose (primary end point) and quantitative viral RNA levels by real-time PCR. Clinical end points included time to clinical resolution, a composite end point of four vital signs and oxygen saturation.Results A total of 234 hospitalized patients were randomized to peramivir 300 mg twice daily or 600 mg once daily; 127 had laboratory confirmed influenza. In those with detectable virus at baseline, viral titres declined without differences between regimens. There were no significant differences in clinical or virological end points between treatment arms, and apparent differences were explained by baseline disease severity differences in the groups. Peramivir was generally safe and well tolerated for treated patients hospitalized with pandemic influenza with outcomes similar to those described in the literature.Conclusions This open-label trial of intravenous peramivir in subjects hospitalized predominantly with 2009 influenza A (H1N1) demonstrated that once- or twice-daily administration was associated with decreases in viral shedding and clinical improvement. ClinicalTrials.gov number NCT00957996.

Published
2014
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27. The FDA's new menu labeling rules.

Author

Heller, Barry M.

Subjects
MENUS, RESTAURANT menus, CALORIC content of foods, CALORIC content of convenience foods, OBESITY, FOOD safety policy, GOVERNMENT policy, LAW
Abstract

The article provides the new brief on the issue of rule by The Food and Drug Administration (FDA) so that calorie information be listed on menus of chains which has 20 units operating under the same. The new rules are part of the federal government's effort to fight obesity. The article details the types of establishments covered under this rule, type of food covered under this rule, exception in labeling, information to be labelled and the format of labeling and Substantiation requirement.

Published
2015

28. Franchising faces a major threat.

Author

Heller, Barry M.

Subjects
RETAIL franchises, EMPLOYERS, FRANCHISOR-franchisee relationships, EMPLOYEES
Abstract

The article reports that the basic structure of the franchise relationship faces a threat in the form of the joint employer theory in which franchisors would become joint employers of the employees who work under the franchisees. Topics mentioned include the urge for the U.S. National Labor Relations Board to abandon its existing joint-employer standard, concept of fissuring in the franchise industry, and the need for franchisors to consider making changes to their franchise agreements.

Published
2015

29. The legal issues when a franchisor operates competing systems.

Author

Heller, Barry M.

Subjects
FRANCHISOR-franchisee relationships, COMMERCIAL law, RISK management in business, CONTRACTS, MERGERS & acquisitions
Abstract

The article offers suggestions on avoiding legal complications for the franchisors operating multiple competing systems. Topics include assessment of the business changes to avoid violation of the rights of any of the system, assessing legal risks of a proposed business change such as rights to the franchisor in the agreement and permission to impose system changes, consideration of non-contractual claims like fraud, and requirement of due diligence in case of acquisition of franchise system.

Published
2015

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