BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
- The document is a corporate presentation by Roberto Bellini, President and CEO of BELLUS Health Inc., discussing the company's lead product candidate KIACTA for treating AA amyloidosis.
- KIACTA is currently in a Phase 3 confirmatory study expected to report results in mid-2016. It has shown strong results in reducing kidney worsening events in a prior Phase 2/3 study.
- BELLUS has a partnership with Auven Therapeutics to fully fund the KIACTA development program. Auven will fund 100% of costs with proceeds from any future KIACTA deal or commercialization to be shared 50-50.
- BELLUS is also exploring
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
BioVie Inc. (OTCQB: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Visit BIVIinfo.com to learn more.
- The document is a corporate presentation by Roberto Bellini, President and CEO of BELLUS Health Inc., discussing the company's lead product candidate KIACTA for treating AA amyloidosis.
- KIACTA is currently in a Phase 3 confirmatory study expected to report results in mid-2016. It has shown strong results in reducing kidney worsening events in a prior Phase 2/3 study.
- BELLUS has a partnership with Auven Therapeutics to fully fund the KIACTA development program. Auven will fund 100% of costs with proceeds from any future KIACTA deal or commercialization to be shared 50-50.
- BELLUS is also exploring
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Schedule Y outlines the regulatory requirements for conducting clinical trials in India. It provides guidelines on applying for trial approval, sponsor and investigator responsibilities, informed consent, trial phases and types of studies. The document discusses amendments made to Schedule Y over time to align it more closely with ICH-GCP guidelines. It also describes the 11 appendices that provide details on topics like pre-clinical data submission, animal studies, ethics committee composition, serious adverse event reporting, and stability testing. The goal of Schedule Y is to improve clinical trial quality and ensure data standards are globally accepted.
New drugs and Clinical Trials Rule in india 2019Arya V Devi
The document discusses new rules for conducting clinical trials in India. Some key points:
- The new rules aim to promote clinical research by making the approval process more transparent and speedy. Applications for clinical trials will be approved within 30 days.
- Foreign drugs that are approved and marketed for over two years in countries like the US, UK, and Europe can now be considered for clinical trials in India without additional trials.
- The rules provide clearer compensation guidelines for injuries during clinical trials, with subjects set to receive 60% of compensation immediately.
Corporate Presentation TiGenix - September 2014TiGenix
This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company.
This document may contain forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of TiGenix and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this document and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
The document summarizes the key changes to clinical trial regulations in India in 2019. Some of the major changes include shorter approval timelines for clinical trials (45 days from 100 days previously), increased application fees, stricter timelines for reporting serious adverse events, and new pre-submission and post-submission meetings with regulators. The new rules aim to streamline processes, ensure patient safety, and align certain aspects of regulation with international guidelines like ICH. Overall, the changes brought greater clarity and transparency to various aspects of conducting clinical trials in India.
This corporate presentation discusses BELLUS Health's focus on developing drugs for rare diseases. Their lead product candidate, KIACTA, is in Phase 3 trials for AA amyloidosis, a rare and deadly kidney disease with no existing treatment. Positive results from a previous Phase 3 trial showed KIACTA slowed kidney function decline. If successful, KIACTA could achieve premium pricing compared to other orphan drugs. BELLUS is also developing treatments for other rare diseases including sHUS and AL amyloidosis through clinical trials and partnerships.
The document outlines new rules for drugs and clinical trials in India established by the Ministry of Health and Family Welfare in 2019. Key aspects include:
- Establishing authorities like the Central Licensing Authority to oversee drug approval and clinical trials.
- Requiring Ethics Committee approval and registration for clinical trials and bioavailability/bioequivalence studies.
- Detailing processes for approval and oversight of clinical trials, including applications, inspections, and suspending trials.
- Establishing compensation amounts in cases of injury or death in clinical trials based on risk factors and disability percentages.
The document discusses Subsequent Entry Biologics (SEBs), which are copies of previously approved biological products in Canada. It provides definitions of biologics and SEBs, and describes the regulatory pathway and requirements for approval of SEBs, including demonstrating similarity to the reference biological product through analytical, nonclinical, and clinical studies. Health Canada regulates SEBs to verify their quality, safety, and efficacy are equivalent to the original product.
The document discusses Thailand's drug registration and control system. It provides details on:
1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance.
2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality.
3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues.
4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and
The FDA revoked the EUA for chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19 based on new clinical trial data. New data showed the suggested dosages were unlikely to produce an antiviral effect and a large randomized controlled trial found no evidence of benefit for mortality or other outcomes. Based on this new information, the FDA determined the criteria for issuing the EUA were no longer met and revoked the authorization to protect public health and safety.
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
PDUFA has had a significant role in modern drug review at FDA. Before PDUFA, FDA's review process was understaffed, unpredictable and slow. FDA lacked sufficient staff to perform timely reviews or develop procedures and standards to make the process more rigorous, consistent, and predictable. FDA lacked the funds to provide computers to all FDA reviewers.
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...Thelansis
This document provides epidemiological data on primary biliary cholangitis (PBC) in China from 2018 to 2030. It estimates that the number of new PBC cases diagnosed annually in China will increase from 20,145 in 2018 to 21,108 in 2030. The total number of prevalent PBC cases in China is estimated to increase from 105,542 cases in 2018 to 110,588 cases in 2030. The document also summarizes the current treatment landscape and pipeline for PBC in China and other major markets.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
This document provides an overview of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to regulatory agencies for drug approval. It describes the key differences between NDAs which are for new drugs and require clinical trials, and ANDAs which are for generic drugs and require bioequivalence testing. The document outlines the contents and review process for both NDAs and ANDAs and the steps involved in submitting and reviewing each type of application.
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The new Drugs and Clinical Trials Rules 2019 introduced by the Ministry of Health and Family Welfare in India came into effect on March 25, 2019. Key changes include new definitions, shorter timelines for approval of clinical trials and bioequivalence studies, compensation processes in case of injury or death during trials, and increased oversight of ethics committees. The new rules aim to strengthen and streamline the clinical research approval process in India.
New drugs and clinical trials rules, 2019_ Dilip KawaneDilip Kawane
The new Drugs and Clinical Trials Rules 2019 aim to promote clinical research in India by making the regulation of clinical trials more predictable, transparent and effective. Key features include reduced timelines for approving clinical trial applications to 30 days for drugs developed in India and 90 days for foreign drugs. The rules also provide for automatic approval if no communication is received within these timelines. They mandate medical management of subjects injured during trials as determined by investigators and allow waiver of local clinical trials for drugs approved in specified foreign countries. However, some criticize that the rules do not adequately address issues like ensuring drug suitability for India's diverse populations through bridging trials.
Schedule y under drugs and cosmetic act 1945neelotpal31
This document provides information about Schedule Y of the Drugs and Cosmetics Rules 1945 in India, which describes the data required for permission to import or manufacture new drugs. Some key points include: Schedule Y provides requirements for clinical trial phases I-III; responsibilities of sponsors, investigators, and ethics committees; application process and fees; and considerations around human clinical pharmacology trials, draft labeling, and bioequivalence studies.
This document provides guidelines for conducting clinical trials and obtaining regulatory approval for new drugs in India. It outlines the requirements and process for importing or manufacturing new drugs, including application forms, fees, pre-clinical and clinical data requirements, and responsibilities of sponsors, investigators and ethics committees. Key points covered include Schedule Y which provides Good Clinical Practice guidelines; types of clinical trials and special population studies; and the roles of regulatory authorities like the Drug Controller General of India.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
NE3107 is a small molecule in Phase 3 clinical trials for Alzheimer's disease and Parkinson's disease. It works by inhibiting neuroinflammation and insulin resistance, two key drivers of cognitive decline. A Phase 3 trial for Alzheimer's is underway testing NE3107's ability to slow cognitive decline compared to placebo. Preclinical studies show NE3107 reduces inflammation, enhances insulin sensitivity, and has neuroprotective effects, supporting its potential in neurodegenerative diseases. A Phase 2 trial will assess NE3107's activity and safety when combined with L-dopa for Parkinson's disease.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
Schedule Y outlines the regulatory requirements for conducting clinical trials in India. It provides guidelines on applying for trial approval, sponsor and investigator responsibilities, informed consent, trial phases and types of studies. The document discusses amendments made to Schedule Y over time to align it more closely with ICH-GCP guidelines. It also describes the 11 appendices that provide details on topics like pre-clinical data submission, animal studies, ethics committee composition, serious adverse event reporting, and stability testing. The goal of Schedule Y is to improve clinical trial quality and ensure data standards are globally accepted.
New drugs and Clinical Trials Rule in india 2019Arya V Devi
The document discusses new rules for conducting clinical trials in India. Some key points:
- The new rules aim to promote clinical research by making the approval process more transparent and speedy. Applications for clinical trials will be approved within 30 days.
- Foreign drugs that are approved and marketed for over two years in countries like the US, UK, and Europe can now be considered for clinical trials in India without additional trials.
- The rules provide clearer compensation guidelines for injuries during clinical trials, with subjects set to receive 60% of compensation immediately.
Corporate Presentation TiGenix - September 2014TiGenix
This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of its distribution form part of or be relied on in connection with any contract or investment decision relating thereto, nor does it constitute a recommendation regarding the securities of the Company.
This document may contain forward-looking statements and estimates made by the Company, including with respect to the anticipated future performance of TiGenix and the market in which it operates. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only speak as of the date of this document and no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based.
This document provides guidelines for conducting clinical trials and importing or manufacturing new drugs for sale according to Schedule Y of the Drugs and Cosmetics Act of 1940 in India. It outlines the application process and required data to be submitted, including chemical/pharmaceutical information, pre-clinical toxicology and pharmacology studies in animals, protocols for human clinical trials through various phases, and post-marketing surveillance requirements. Ethics committee approval and informed consent of participants are necessary. Manufacturers must establish the drug's quality, safety, and efficacy primarily through clinical trials conducted in India.
The document summarizes the key changes to clinical trial regulations in India in 2019. Some of the major changes include shorter approval timelines for clinical trials (45 days from 100 days previously), increased application fees, stricter timelines for reporting serious adverse events, and new pre-submission and post-submission meetings with regulators. The new rules aim to streamline processes, ensure patient safety, and align certain aspects of regulation with international guidelines like ICH. Overall, the changes brought greater clarity and transparency to various aspects of conducting clinical trials in India.
This corporate presentation discusses BELLUS Health's focus on developing drugs for rare diseases. Their lead product candidate, KIACTA, is in Phase 3 trials for AA amyloidosis, a rare and deadly kidney disease with no existing treatment. Positive results from a previous Phase 3 trial showed KIACTA slowed kidney function decline. If successful, KIACTA could achieve premium pricing compared to other orphan drugs. BELLUS is also developing treatments for other rare diseases including sHUS and AL amyloidosis through clinical trials and partnerships.
The document outlines new rules for drugs and clinical trials in India established by the Ministry of Health and Family Welfare in 2019. Key aspects include:
- Establishing authorities like the Central Licensing Authority to oversee drug approval and clinical trials.
- Requiring Ethics Committee approval and registration for clinical trials and bioavailability/bioequivalence studies.
- Detailing processes for approval and oversight of clinical trials, including applications, inspections, and suspending trials.
- Establishing compensation amounts in cases of injury or death in clinical trials based on risk factors and disability percentages.
The document discusses Subsequent Entry Biologics (SEBs), which are copies of previously approved biological products in Canada. It provides definitions of biologics and SEBs, and describes the regulatory pathway and requirements for approval of SEBs, including demonstrating similarity to the reference biological product through analytical, nonclinical, and clinical studies. Health Canada regulates SEBs to verify their quality, safety, and efficacy are equivalent to the original product.
The document discusses Thailand's drug registration and control system. It provides details on:
1) The organizational structure of Thailand's Food and Drug Administration (FDA) and its drug control divisions that are responsible for pre-and post-marketing activities like inspections, monitoring, and surveillance.
2) Thailand's drug registration process which requires licensees to obtain licenses before selling, manufacturing, or importing drugs. The registration ensures safety, efficacy and quality.
3) Different categories of drugs and their registration processes, timelines, and requirements. Priority review is given to drugs addressing public health issues.
4) Ongoing efforts to strengthen regulatory capacity, encourage compliance, and facilitate access through various initiatives and
The FDA revoked the EUA for chloroquine phosphate and hydroxychloroquine sulfate to treat COVID-19 based on new clinical trial data. New data showed the suggested dosages were unlikely to produce an antiviral effect and a large randomized controlled trial found no evidence of benefit for mortality or other outcomes. Based on this new information, the FDA determined the criteria for issuing the EUA were no longer met and revoked the authorization to protect public health and safety.
The Prescription Drug User Fee Act (PDUFA) was a law passed by the United States Congress in1992 which allowed the Food and Drug Administration (FDA) to collect fees from drug manufacturers to fund the new drug approval process.
PDUFA has had a significant role in modern drug review at FDA. Before PDUFA, FDA's review process was understaffed, unpredictable and slow. FDA lacked sufficient staff to perform timely reviews or develop procedures and standards to make the process more rigorous, consistent, and predictable. FDA lacked the funds to provide computers to all FDA reviewers.
Primary biliary cholangitis (PBC) Epidemiology and Compitive landscape_Thelan...Thelansis
This document provides epidemiological data on primary biliary cholangitis (PBC) in China from 2018 to 2030. It estimates that the number of new PBC cases diagnosed annually in China will increase from 20,145 in 2018 to 21,108 in 2030. The total number of prevalent PBC cases in China is estimated to increase from 105,542 cases in 2018 to 110,588 cases in 2030. The document also summarizes the current treatment landscape and pipeline for PBC in China and other major markets.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
drug registrastion requirements in china ...sonali mishraSonaliMishra64
The document discusses regulatory highlights and drug development in China. It provides an overview of the Chinese regulatory authority, currently called the National Medical Products Administration (NMPA), which oversees drug registration and clinical trials. It also summarizes the drug registration process in China, including requirements for imported drugs. This involves submitting clinical trial applications, conducting clinical trials, and obtaining an imported drug license. The document outlines categories for drug registration and review timelines, as well as opportunities for accelerated approval in China.
This document provides an overview of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) submitted to regulatory agencies for drug approval. It describes the key differences between NDAs which are for new drugs and require clinical trials, and ANDAs which are for generic drugs and require bioequivalence testing. The document outlines the contents and review process for both NDAs and ANDAs and the steps involved in submitting and reviewing each type of application.
Tabular summary of New Drugs & Clinical Trials Rules, 2019 [INDIA]Vikas Dhiman
The new Drugs and Clinical Trials Rules 2019 introduced by the Ministry of Health and Family Welfare in India came into effect on March 25, 2019. Key changes include new definitions, shorter timelines for approval of clinical trials and bioequivalence studies, compensation processes in case of injury or death during trials, and increased oversight of ethics committees. The new rules aim to strengthen and streamline the clinical research approval process in India.
New drugs and clinical trials rules, 2019_ Dilip KawaneDilip Kawane
The new Drugs and Clinical Trials Rules 2019 aim to promote clinical research in India by making the regulation of clinical trials more predictable, transparent and effective. Key features include reduced timelines for approving clinical trial applications to 30 days for drugs developed in India and 90 days for foreign drugs. The rules also provide for automatic approval if no communication is received within these timelines. They mandate medical management of subjects injured during trials as determined by investigators and allow waiver of local clinical trials for drugs approved in specified foreign countries. However, some criticize that the rules do not adequately address issues like ensuring drug suitability for India's diverse populations through bridging trials.
Schedule y under drugs and cosmetic act 1945neelotpal31
This document provides information about Schedule Y of the Drugs and Cosmetics Rules 1945 in India, which describes the data required for permission to import or manufacture new drugs. Some key points include: Schedule Y provides requirements for clinical trial phases I-III; responsibilities of sponsors, investigators, and ethics committees; application process and fees; and considerations around human clinical pharmacology trials, draft labeling, and bioequivalence studies.
This document provides guidelines for conducting clinical trials and obtaining regulatory approval for new drugs in India. It outlines the requirements and process for importing or manufacturing new drugs, including application forms, fees, pre-clinical and clinical data requirements, and responsibilities of sponsors, investigators and ethics committees. Key points covered include Schedule Y which provides Good Clinical Practice guidelines; types of clinical trials and special population studies; and the roles of regulatory authorities like the Drug Controller General of India.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for liver disease. The Company’s drug candidate, BIV201 (continuous infusion terlipressin), has an Orphan Drug designation for the treatment of refractory ascites, FDA Fast Track status, and US patent pending. BIV201 also has an Orphan Drug designation for the treatment of hepatorenal syndrome (HRS). The active agent in BIV201, terlipressin, is approved for use in about 40 countries for the treatment of related complications of advanced liver cirrhosis but is not available in the US or Japan. The FDA has never approved terlipressin. BioVie is targeting this landmark achievement.
NE3107 is a small molecule in Phase 3 clinical trials for Alzheimer's disease and Parkinson's disease. It works by inhibiting neuroinflammation and insulin resistance, two key drivers of cognitive decline. A Phase 3 trial for Alzheimer's is underway testing NE3107's ability to slow cognitive decline compared to placebo. Preclinical studies show NE3107 reduces inflammation, enhances insulin sensitivity, and has neuroprotective effects, supporting its potential in neurodegenerative diseases. A Phase 2 trial will assess NE3107's activity and safety when combined with L-dopa for Parkinson's disease.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing what it believes will be transformative therapies to overcome unmet medical needs in neurodegeneration and liver disease. The Company is developing NE3107 for Alzheimer’s (AD) and Parkinson’s (PD) and BIV201 for refractory ascites and HRS-AKI.
This document discusses a pharmaceutical company focused on developing drugs for gastrointestinal disorders. It provides estimates and forward-looking statements about 3 late-stage clinical trials investigating treatments for hemorrhoids, anal fissures, and fecal incontinence. It notes risks and uncertainties that could influence projections, and that actual results may differ from estimates. Key company leadership and development team members are also summarized.
This document discusses estimates and forward-looking statements regarding a pharmaceutical company focused on developing products for gastrointestinal disorders. It contains 3 late-stage clinical trials, including Phase III trials for hemorrhoids and anal fissures. The document outlines risks and uncertainties that could impact projections, including regulatory approval, clinical trial results, funding, and competition. It also provides details on management experience and the development plans and milestones for the company's lead product candidates.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
- Sanofi is building a leading rare blood disorder franchise through the acquisitions of Bioverativ and Ablynx which expand their portfolio of therapies for rare diseases like hemophilia and acquired thrombotic thrombocytopenic purpura (aTTP).
- Bioverativ strengthens Sanofi's position in hemophilia with therapies like Eloctate and Alprolix and the investigational fitusiran. Caplacizumab shows strong results for aTTP and was filed for approval in the EU and U.S.
- The global hemophilia market is approximately $10 billion and growing at 7% annually, driven by reliable extended half-life factor therapies and broader
- Sanofi's CEO Olivier Brandicourt presented at a healthcare conference on September 14, 2018.
- He discussed Sanofi's continued progress on its strategic transformation including acquiring new assets, driving simplification through restructuring, reshaping its portfolio, and executing new product launches.
- Brandicourt highlighted several potentially significant drug approvals and trial results for new drugs and indications expected over the next 12 months that could further advance Sanofi's growth.
- He concluded that while Sanofi saw impacts from recent drug losses of exclusivity in the first half of 2018, performance was otherwise in line with expectations and several factors position Sanofi for a new growth phase in the second half of
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Rheumatoid Arthritis and Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Visit CANFinfo.com to learn more.
Can-Fite is a clinical stage drug development company developing oral small molecule drugs for inflammatory and cancer indications. Their lead drugs, Piclidenoson and Namodenoson, have shown efficacy and safety in Phase II/III studies for psoriasis, liver cancer, and NASH. Piclidenoson has commenced a Phase II study in COVID-19 patients. Can-Fite has outlicensed their drugs in select territories, receiving $20M to date with potential for $130M more in milestones and royalties. They are well positioned financially to advance their clinical programs targeting multi-billion dollar markets.
Mastering Regulatory Approval in New Orphan Drug MarketsLewis Lau
Presented at DIA 2015 Annual Meeting. A symposum titled "A Global Update on Orphan Drug" chaired by Mr Noriaki Murao
http://www.diaglobal.org/en-US/Flagship-Meetings/DIA-Annual-Meeting/Meeting-Program/Find-Sessions-and-Presentations/Event-Details.aspx?productID=3803687&eventType=Symposium&title=A%20Global%20Update%20on%20Orphan%20Drugs
This symposium addresses the current status and forthcoming activities related to orphan drugs in North America, EU and Japan. Orphan drug development is considered essential in these regions, and the various provisions to accelerate the development of orphan drugs have been implemented. However, some challenges still remain for the companies and the agencies wishing to pursue development and approval of orphan drugs in these regions.
Impact of Real world data in Pharmacovigilance and Regulatory Decision MakingClinosolIndia
Real-world data (RWD) has emerged as a transformative force in the field of pharmacovigilance, significantly influencing regulatory decision-making processes. Unlike data generated in controlled clinical trials, RWD reflects the everyday clinical experiences and outcomes of patients in real-world settings. The impact of integrating RWD into pharmacovigilance and regulatory decision-making is multifaceted and has profound implications for patient safety, drug development, and healthcare policymaking
This presentation contains an overview of the scientific and business update provided by management during Critical Outcome Technologies' 2017 Annual General and Special Meeting of Shareholders on December 20, 2017.
- The document discusses Sanofi's performance at the Cowen Healthcare Conference on March 12, 2018.
- It highlights Sanofi's building of a leadership position in rare blood disorders through recent acquisitions including Bioverativ and planned acquisition of Ablynx.
- Clinical trial results for investigational drugs like caplacizumab for aTTP and fitusiran for hemophilia are presented as enhancing Sanofi's pipeline.
- Growth of Sanofi's immunology franchise including Dupixent is discussed as an emerging driver of specialty care sales.
OneMedForum New York Company Presentation: Soligenix, Inc., a late-stage biopharmaceutical company, focuses on the development of products to treat life-threatening side effects of cancer treatments. Learn More at: http://www.onemedplace.com/database/list/cid/14016
The development & approval of Novoeight, a case studyAllen Che
The FDA approved Novoeight, a recombinant Factor VIII treatment for hemophilia A, in October 2013 based on positive results from clinical trials. Novoeight was found to effectively control and prevent bleeding episodes in adults and children with hemophilia A. The approval process involved reviewing manufacturing, clinical data, and inspections to ensure safety and efficacy. This approval expands treatment options for hemophilia A patients and represents continued innovation in the development of safer recombinant clotting factor therapies.
Bellus corporate presentation january 2014 v finalBellusHealth
BELLUS Health is developing therapies for rare diseases starting with conditions affecting the kidneys. Its lead product KIACTA is in Phase III trials for AA amyloidosis, a rare kidney disease with no approved treatments. It has executed a partnership for KIACTA's development and aims to complete enrollment in 2014. BELLUS' pipeline also includes Shigamab for STEC-HUS and a research program in AL amyloidosis. The company expects key milestones in 2014 to progress these programs and generate long-term value.
Global Regulatory Pathways for COVID-19 Therapies and VaccinesMridula Shukla
This document summarizes global regulatory pathways for COVID-19 therapies and vaccines. It outlines the key challenges to developing vaccines and treatments, including time, costs, safety testing and manufacturing constraints. Significant research is underway, with over 145 vaccine candidates and 224 treatment candidates in development. The FDA and EMA have implemented expedited pathways like Emergency Use Authorization and rolling reviews to accelerate approval timelines while ensuring safety and effectiveness. These pathways could reduce approval times from 10-15 years to as little as 6 months.
Better Choice Company (OTCQB: BTTR) is a rapidly growing animal health and wellness company committed to leading the industry shift toward pet products and services that help dogs and cats live healthier, happier and longer lives. Better Choice takes an alternative, nutrition-based approach to animal health relative to conventional dog and cat food offerings, and positions its portfolio of brands to benefit from the mainstream trends of growing pet humanization and consumer focus on health and wellness. The Company has a demonstrated, multi-decade track record of success selling trusted animal health and wellness products, and leverage its established digital footprint to provide pet parents with the knowledge to make informed decisions about their pet’s health. Better Choice sells the majority of its dog food, cat food and treats under the Halo and TruDog brands, which are focused, respectively, on providing sustainably sourced kibble and canned food derived from real whole meat, and minimally processed raw-diet dog food and treats.
Annovis Bio (NYSE American: ANVS) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (AD-DS). Annovis is believed to be the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. The company expects its treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. Annovis has an ongoing Phase 2a study in AD patients and plans to commence a second Phase 2a study in PD patients. Learn more at ANVSinfo.com.
Tiziana Life Sciences (NASDAQ: TLSA) Investor Presentation - July 20th 2020RedChip Companies, Inc.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Tiziana Life Sciences (NASDAQ: TLSA) is a dual-listed clinical stage company developing targeted therapeutics to transform treatment of liver diseases, inflammatory diseases, and cancer. Our clinical pipeline includes drug assets for Crohn's, and hepatocellular carcinoma. Tiziana’s two lead drug candidates, Foralumab and Milciclib, uniquely target the root cause of diseases with large unmet needs in multibillion-dollar markets. Tiziana is accelerating development of anti-IL6 receptor monoclonal antibody (mAb) for treatment of COVID-19 lung inflammation. Tiziana is a market leader in the invention of proprietary technology for oral, nasal and inhaled formulation to transform immunotherapies with Monoclonal Antibodies currently administered intravenously. Also, Tiziana has a robust and growing patent portfolio.
Recruiter.com Group Inc. (OTCQB: RCRT) is disrupting the recruiting and staffing industry by aggregating the small and independent recruiters under a common platform, giving them access to large enterprise customers and advanced technologies.
Creating alcohol-free environments to increase productivity and save lives. That is the mission of Boulder, CO-based SOBRSafe, Inc. The company is integrating a preventative detection technology platform through partnership, licensing and acquisitions, and is in protype phase with its launch product: the patented, proprietary SOBRSafe® device - a non-invasive, touch-based identity verification and alcohol detection solution.
The document provides an investor overview of SPI Energy Co., Ltd., a solar energy company that operates solar project development, electricity production, residential solar solutions, and solar industry investments businesses around the world. It outlines SPI's business segments and assets, financial information, management team, and presents SPI as an undervalued investment opportunity in the growing solar industry given its large portfolio of solar assets.
Can-Fite is developing small molecule drugs that target the A3 adenosine receptor, including Piclidenoson for rheumatoid arthritis and psoriasis, and Namodenoson for liver cancer and NASH. Piclidenoson has shown efficacy in Phase II trials for rheumatoid arthritis and is currently in Phase III trials for rheumatoid arthritis and psoriasis. Namodenoson has shown efficacy in Phase II trials for liver cancer and is preparing for Phase III trials. Can-Fite is also exploring using Piclidenoson for COVID-19 given its anti-inflammatory and potential anti-viral properties.
SPI Energy (NASDAQ: SPI) is an established green energy player with global operations in key markets in Australia, Europe, Japan and the United States. It is leveraging its sizable solar platform and industry expertise to make strategic investment opportunities in green industries with significant growth and earnings potential and/or industries than can benefit from green power. Learn more at www.SpiGroupsInfo.com.
Creating alcohol-free environments to increase productivity and save lives. That is the mission of Boulder, CO-based SOBRSafe, Inc. The company is integrating a preventative detection technology platform through partnership, licensing and acquisitions, and is in protype phase with its launch product: the patented, proprietary SOBRSafe® device - a non-invasive, touch-based identity verification and alcohol detection solution.
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE), a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products. Learn more at GENETechinfo.com.
Annovis Bio (NYSE American: ANVS) is a clinical-stage, drug platform company addressing neurodegeneration, such as Alzheimer’s disease (AD), Parkinson’s disease (PD) and Alzheimer’s in Down Syndrome (AD-DS). Annovis is believed to be the only company developing a drug for AD, PD and AD-DS that inhibits more than one neurotoxic protein and improves the information highway of the nerve cell, known as axonal transport. When this information flow is impaired, the nerve cell gets sick and dies. The company expects its treatment to improve memory loss and dementia associated with AD and AD-DS, as well as body and brain function in PD. Annovis has an ongoing Phase 2a study in AD patients and plans to commence a second Phase 2a study in PD patients. Learn more at ANVSinfo.com.
Nemaura Medical is developing non-invasive and minimally invasive wearable diagnostic devices,
coupled with artificial intelligence capabilities for digital healthcare. The company’s first product,
which is CE approved and undergoing commercial launch, is the sugarBEAT® non-invasive
continuous glucose monitoring device and BEAT®diabetes digital healthcare platform.
sugarBEAT® is a non-invasive and flexible continuous glucose monitor (CGM) providing
actionable insights derived from real-time glucose measurements and daily glucose trend data,
which help people with Type 1 or Type 2 diabetes and prediabetes respectively to better manage,
reverse and prevent the onset of diabetes. BEAT®diabetes is a health subscription service
providing 1-on-1 lifestyle coaching and behavior change recommendations driven by personalized
data provided by sugarBEAT®. Insulin users can also adjunctively use sugarBEAT® for insulin
dosage purposes when calibrated by a finger stick reading. sugarBEAT® is intended to be worn
during waking hours and consists of a daily disposable adhesive skin-patch connected to a
rechargeable transmitter, with an app displaying glucose readings at five-minute intervals.
Recruiter.com Group Inc. (OTCQB: RCRT) is disrupting the recruiting and staffing industry by aggregating the small and independent recruiters under a common platform, giving them access to large enterprise
customers and advanced technologies.
Creating alcohol-free environments to increase productivity and save lives. That is the mission of Boulder, CO-based SOBRSafe, Inc. The company is integrating a preventative detection technology platform through partnership, licensing and acquisitions, and is in protype phase with its launch product: the patented, proprietary SOBRSafe® device - a non-invasive, touch-based identity verification and alcohol detection solution.
COMSovereign Holding Corp. has assembled a portfolio of US-based communications technology companies whose combined capabilities enable connectivity across the entire data transmission spectrum. Through strategic acquisitions and organic research and development efforts, COMSovereign is seeking to become a U.S.-based pure-play communications provider able to provide LTE Advanced and 5G-NR telecom solutions to network operators and enterprises worldwide.
Better Choice Company (OTCQB: BTTR) is a rapidly growing animal health and wellness company committed to leading the industry shift toward pet products and services that help dogs and cats live healthier, happier and longer lives. Better Choice takes an alternative, nutrition-based approach to animal health relative to conventional dog and cat food offerings, and positions its portfolio of brands to benefit from the mainstream trends of growing pet humanization and consumer focus on health and wellness. The Company has a demonstrated, multi-decade track record of success selling trusted animal health and wellness products, and leverage its established digital footprint to provide pet parents with the knowledge to make informed decisions about their pet’s health. Better Choice sells the majority of its dog food, cat food and treats under the Halo and TruDog brands, which are focused, respectively, on providing sustainably sourced kibble and canned food derived from real whole meat, and minimally processed raw-diet dog food and treats.
Cuentas provides innovative mobile banking, mobility, and telecommunications solutions to underserved, unbanked, and emerging markets. The Company’s portfolio of fintech solutions meet the highest-volume services demand of the estimated 70 million underbanked and unbanked consumers in the US. ‘Underbanked’ refers to those who have limited or restricted access to banking services, due to poor credit or their international/resident status, and represent more than $1 trillion in total purchasing power.
Can coffee help me lose weight? Yes, 25,422 users in the USA use it for that ...nirahealhty
The South Beach Coffee Java Diet is a variation of the popular South Beach Diet, which was developed by cardiologist Dr. Arthur Agatston. The original South Beach Diet focuses on consuming lean proteins, healthy fats, and low-glycemic index carbohydrates. The South Beach Coffee Java Diet adds the element of coffee, specifically caffeine, to enhance weight loss and improve energy levels.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
Michigan HealthTech Market Map 2024. Includes 7 categories: Policy Makers, Academic Innovation Centers, Digital Health Providers, Healthcare Providers, Payers / Insurance, Device Companies, Life Science Companies, Innovation Accelerators. Developed by the Michigan-Israel Business Accelerator
Let's Talk About It: Breast Cancer (What is Mindset and Does it Really Matter?)bkling
Your mindset is the way you make sense of the world around you. This lens influences the way you think, the way you feel, and how you might behave in certain situations. Let's talk about mindset myths that can get us into trouble and ways to cultivate a mindset to support your cancer survivorship in authentic ways. Let’s Talk About It!
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
DECODING THE RISKS - ALCOHOL, TOBACCO & DRUGS.pdfDr Rachana Gujar
Introduction: Substance use education is crucial due to its prevalence and societal impact.
Alcohol Use: Immediate and long-term risks include impaired judgment, health issues, and social consequences.
Tobacco Use: Immediate effects include increased heart rate, while long-term risks encompass cancer and heart disease.
Drug Use: Risks vary depending on the drug type, including health and psychological implications.
Prevention Strategies: Education, healthy coping mechanisms, community support, and policies are vital in preventing substance use.
Harm Reduction Strategies: Safe use practices, medication-assisted treatment, and naloxone availability aim to reduce harm.
Seeking Help for Addiction: Recognizing signs, available treatments, support systems, and resources are essential for recovery.
Personal Stories: Real stories of recovery emphasize hope and resilience.
Interactive Q&A: Engage the audience and encourage discussion.
Conclusion: Recap key points and emphasize the importance of awareness, prevention, and seeking help.
Resources: Provide contact information and links for further support.
Hypertension and it's role of physiotherapy in it.Vishal kr Thakur
This particular slides consist of- what is hypertension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is summary of hypertension -
Hypertension, also known as high blood pressure, is a serious medical condition that occurs when blood pressure in the body's arteries is consistently too high. Blood pressure is the force of blood pushing against the walls of blood vessels as the heart pumps it. Hypertension can increase the risk of heart disease, brain disease, kidney disease, and premature death.
International Cancer Survivors Day is celebrated during June, placing the spotlight not only on cancer survivors, but also their caregivers.
CANSA has compiled a list of tips and guidelines of support:
https://cansa.org.za/who-cares-for-cancer-patients-caregivers/
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardso...rightmanforbloodline
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
TEST BANK For Accounting Information Systems, 3rd Edition by Vernon Richardson, Verified Chapters 1 - 18, Complete Newest Version
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
DR SHAMIN EABENSON - JOURNAL CLUB - NEEDLE STICK INJURY
BioVie Investor Deck, June 2020
1. 1
Pioneering therapies for patients
suffering from advanced liver cirrhosis
Corporate Presentation | June 2020
2. 2
Forward-looking statements
This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause BioVie’s
actual results and experience to differ materially from anticipated results and expectations expressed in these forward-
looking statements. BioVie has in some cases identified forward-looking statements by using words such as
"anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may,"
"suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those
expressed in forward-looking statements are BioVie’s need for, and the availability of, substantial capital in the future
to fund its operations and research and development. Other risks are that BioVie’s compounds may not successfully
complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United
States or elsewhere. BioVie cannot guarantee the effectiveness of its patents or Orphan Drug designations. A more
complete description of these risk factors is included in BioVie’s filings with the Securities and Exchange Commission.
In addition to the risks described above and in BioVie’s filings with the Securities and Exchange Commission, other
unknown or unpredictable factors also could affect BioVie’s results. No forward-looking statements can be guaranteed
and actual results may differ materially from such statements. You should not place undue reliance on any forward-
looking statements. BioVie undertakes no obligation to release publicly the results of any revisions to any such
forward-looking statements that may be made to reflect events or circumstances after the date of that these slides are
posted to BioVie’s website or to reflect the occurrence of unanticipated events, except as required by applicable law or
regulation.
3. 33
$600M 20,000
US patients
targeted for
BIV201 therapy
0/0
Number of FDA-
approved drugs to
specifically treat
ascites; Number of
direct competitors
Phase 2;
Ph3 in 2021
Mid-stage Phase 2
Orphan drug
candidate; FDA
Fast Track and will
seek Breakthrough
Therapy status
Orphan
Drug
Orphan Drug designations
for ascites and HRS with
potential 7 years market
exclusivity**; Patent-
pending liquid
formulations
BioVie Overview
Addressable US
ascites market size*;
Projected BIV201 US
peak sales of $400 M
with 67% penetration
Sources/Notes:
* D'Amico 2014; Gines 2004; Third party market assessment, published 2015; US Patient Hospital
Discharge Data, 2005; Assumes three 28-day treatment regimens annually.
** If first to market.
4. 4
Our initial target is ascites due to advanced
liver cirrhosis
• Cirrhosis is the 8th leading
cause of death in the US1
• Resulted in 49,500 US deaths in
20101
• Ascites is the most common
major complication2
• For refractory ascites the mean
one-year survival rate is only 50%3
Our first disease
target is ascites,
the accumulation
of 5+ liters of fluid
in the abdomen.
Fluid in the
peritoneal cavity
(ASCITES)
1Burden of Disease Collaborators 2013
2Ge and Runyon 20161US
3Bureau et al. 2017
5. 5
No effective medication options:
Primed for disruption
No drugs approved by FDA specifically for
treating ascites
Refractory ascites patients have frequent
paracentesis procedures:
• Withdrawal of ~5–10L of ascites fluid from
abdomen every week to 10 days with a large bore
needle*
• Provides short-term relief, but the kidneys will
eventually “burn out”
• Patients worsen with life-threatening
complications
• No remaining options except for TIPS** surgery
or liver transplant
* Wong 2012
** TIPS = transjugular intrahepatic portosystemic shunt to
channel blood flow around the liver
6. 6
Ascites patients incur $5 billion+ in annual
treatment costs
Source: HCUP Nationwide Readmissions Database 2016. Average length of stay and charges for patients requiring paracentesis.
7. 7
How our therapy is intended to
work:
• Vasoconstricts the central region,
forcing blood flow through the liver
• This restores effective blood volume
in the arteries, which
• Shuts down the RAAS signaling
pathway, so the kidneys no longer
retain excessive salt and water
• Thereby halting ascites fluid
production
Therapeutic goal: Halt the downward spiral
Adapted from: Wong 2012
8. 8
Exploring the potential for terlipressin
Terlipressin is approved in 40+ countries for
treating two related complications of liver cirrhosis:
HRS & BEV1
• Used for decades in hospitals dosed by IV bolus injection (1-2 mg
every 4-6 hours)
• Well understood mechanism of action2 with hundreds of
publications
• Not approved in the US or Japan
• Not yet approved to treat ascites in any country
BioVie advisor Dr. Paolo Angeli invented a new dosing
method as a continuous infusion in the outpatient setting
1. HRS = Hepatorenal syndrome; BEV = Bleeding esophageal varices
2. Ding 2013
9. 9
BIV201 clinical development program
BIV201 key clinical objectives are to:
• Deliver terlipressin safely via continuous infusion with a portable pump and
novel patent-pending liquid formulation in a pre-filled syringe
• Reduce ascites fluid accumulation
• Reduce ascites-related complications requiring hospitalization
• Enable at-home therapy
• Long-term bridge to liver transplant, or potentially avoid the need for
transplant*
Continuous infusion dosing: a new treatment paradigm
“Terlipressin given by continuous infusion is better tolerated than intravenous boluses
in the treatment of type 1 HRS. Moreover, it is effective at lower doses**”
BIV201 is an investigational therapy
BIV201
** HEPATOLOGY 2016;63:983-992.
* Based on Australian study results; will require US clinical trials to support this use.
10. 1010
Retrospective study results from P.Angeli, MD (Italy 2015)
Continuous infusion terlipressin
in 6 refractory ascites/HRS patients
Source: Adapted from BioVie US Patent application 16/379,446 Angeli et al.
No drug-related side effects were reported in this study.
Terlipressin is not available in the US
11. 1112
Prospective study by Chapman et al. (Australia 2018)
Continuous infusion terlipressin
in 19 refractory ascites/HRS patients
Pre-therapy:
• 70% of patients required weekly large volume
paracentesis (LVP)
• 70% poor muscle strength
Results:
• Median duration of CI terlipressin treatment: 51
days
• 43% average reduction in frequency of paracentesis
• Significantly improved nutritional intake and muscle
strength
• No complications directly attributable to terlipressin
Decreased Need for Paracentesis
Change in frequency of paracentesis procedures
Source: JHEP 2019.
Terlipressin is not available in the US
12. 12
BIV201 Phase 2a study results in 6 refractory
ascites patients (completed April 2019)
Principal Investigator: Jasmohan Bajaj, MD at McGuire VA in Richmond, VA
Primary objectives to assess safety, tolerability and pharmacokinetics (PK)
Results1:
• Pharmacokinetics (PK) of continuous terlipressin infusion matched our predicted model2
• Serious complications observed over 2-month period during/after BIV201 therapy:
• Recurrence of hepatic encephalopathy (HE): 1 patient – possibly due to dehydration in conjunction with
strong response to terlipressin in conjunction with diuretics (protocol modified to avoid this)
• Leaking umbilical hernia: 1 patient (pre-existing) – not drug-related
• Other adverse events observed: bacteremia3, asymptomatic hyponatremia, abdominal
pain, headache, diarrhea, dizziness
• BIV201 therapy maintained for 28 days in 3 of 6 patients
1. Large-scale clinical trial(s) will be required to confirm results.
2. Source: BioVie poster presentation at AASLD 2019.
3. On day 28 possibly related to a chronic non-healing leg ulcer wound (one patient).
13. 13
BioVie Phase 2a trial results:
Timing of next paracenteses procedure
4 of 6 patients achieved
≥ 50% increase in days
until next ascites fluid
withdrawal
(paracentesis) after
starting BIV201 therapy
Source: BioVie poster presentation at
AASLD 2019.
BIV201 is an investigational therapy
14. 14
BioVie Phase 2a trial results:
Change in serum creatinine
4 of 6 patients
experienced a reduction
in serum creatinine
(clearance of SCr is an
indicator of kidney
function)
Source: BioVie poster presentation at
AASLD 2019.
BIV201 is an investigational therapy
15. 15
Advancing the BIV201 clinical program
• June 2019: Type C Guidance Meeting with FDA
• July: FDA meeting minutes received
• October: Submitted Phase 2b/3 Clinical Trial Protocol to FDA
• February 2020: Submitted FDA pre-meeting information package
• April 2020: FDA feedback received and trial design finalized
• Clinical study planned this summer:
A Phase 2 Randomized, Controlled, Dose-Titration, Open-Label Study Evaluating the Safety
and Efficacy of BIV201 in Addition to Standard of Care Compared to Standard of Care to
Reduce the Recurrence of Ascites and Complications in Patients with Refractory Ascites
Secondary to Decompensated Liver Cirrhosis (Clinicaltrials.gov NCT identifier 04112199)
16. 16
Phase 2 & 3 clinical trial plan
• US Phase 2 trial with 24 refractory ascites patients:
‒ 16 will receive BIV201 + standard of care (SOC); 8 receive SOC only (control group)
• Primary composite endpoint: Incidence of ascites-related complications, at least grade 2, over
180 days following randomization
• Secondary endpoint: Ascites fluid removed over 90 days
‒ Dosing: start at 3 mg/day for 28 days (titrate between 1-6 mg/day if needed)
‒ Enrollment: ~6 sites enrolling ~4 subjects on average
‒ Timeframe: 2 cycles BIV201 within 4 months and follow for 60 days; long-term follow-up
• Following completion of Phase 2, conduct a single pivotal Phase 3
randomized, controlled trial at ~20 US study sites
Source: clinicaltrials.gov (identifier: NCT04112199). The FDA provided additional guidance in April 2020;
certain risks associated with yet to be validated quality of life measures will be explored in Phase 2 trial.
17. 17 BIV201 is an investigational therapy
BIV201 projected clinical timeline
Phase 2a
Trial + PK Analysis
Completed
April 2019
Phase 2/3 Clinical Trials
YE/2018 YE/2020 YE/2021
Dose
1st Patient
Target
NDA*Filing
2022
* New Drug Application
YE/2019
BIV201 is an investigational therapy
18. 18
Novel BIV201 home care delivery system
BIV201 Premixed/
Prefilled Syringe
Needle-free
Connector
50 mL bag of saline for
insertion into pump
Portable pump
(carried in small satchel)
19. 19
Filed formulation PCT &
will apply for patent
coverage in US, Japan,
Europe, and China
US Orphan Drug
designations for both
ascites (Sept ‘16) and HRS
(Nov ‘18) to enable up to 7
years of market exclusivity
FDA Fast Track status;
will seek Breakthrough
Therapy designation
FDA
Creating global patent
estate to cover
proprietary liquid
terlipressin formulations
USPTO
IP protection and FDA Fast Track status
20. 20
Estimated US
Patients
(000s)
Total Addressable
Market (TAM)
Projected
Peak US Sales
Refractory Ascites 19.81 $600 M $ 400M*
Bleeding Esophageal Varices
(BEV)
6.63 $166 M $83 M
Catecholamine-Resistant
Hypotension/Shock
125,0002 $150 M $75 M
Hepatorenal Syndrome (HRS) 16.83 $67 M $34 M
TOTAL: $792 MSources/Notes:
* Planned US sales force: 30 reps/mgrs targeting 3,000 US liver disease specialists @$200K
full cost per person = $6M per year
1. D'Amico 2014; Gines 2004
2. Third party market assessment, published 2015
3. US Patient Hospital Discharge Data, 2016
Note: Ascites & BEV assumes three 28-day treatment regimens annually; CRH assumes 3 days of
therapy (Auchet, 2017); HRS Assumes 10 days of therapy
BIV201 revenue potential – US only
21. 21
Will Seek
Patent
Coverage
Patients
Diagnosed
with Cirrhosis
Estimated
Ascites
Patients
(000s)
Est’d Refractory/
Intractable
Ascites (000s)
Japan 270,0001 541 10.8
Europe 800,0002 164 33
China 2 million3 500 100
Sources/Notes:
1. Third party market assessment, published 2013
2. BioVie assessment based on multiple sources
3. Minimum based on reported prevalence rates of cirrhosis in US/EU (China has
highest prevalence of Hepatitis B worldwide)
BIV201 international ascites treatment opportunity
Potential to increase BIV201 revenues by >2X (excluding China)
✓
✓
✓
22. 22
Experienced and effective management team
Terren Peizer, Chief Executive Officer, Chairman of the Board
Mr. Peizer is an entrepreneur, investor, and financier with a particular interest in healthcare, having founded and
successfully commercialized several healthcare companies. Mr. Peizer is the founder of Catasys, Inc., a leader in
behavioral and mental health management services. He has served as the Chairman of the Board of Directors and CEO
of Catasys since inception in 2004. Mr. Peizer is the Founder, Chairman, CEO and majority shareholder of NeurMedix,
Inc., a biotechnology company with a focus on inflammatory, neurological and neuro-degenerative diseases. He is also
the Chairman of Acuitas Group Holdings, LLC, his personal holding company that owns all his portfolio company
interests, including BioVie, NeurMedix and Catasys. Acuitas is an industry leader in investing in micro and small
capitalization public equities, having invested over $1.2 billion directly into portfolio companies. Previously he was
Chairman of Cray, Inc., the leading supercomputing company, and held senior executive positions with the investment
banking firms Goldman Sachs, First Boston, and Drexel Burnham Lambert. He received his B.S.E. in finance from The
Wharton School of Finance and Commerce.
Jonathan Adams, President & Chief Operating Officer, Director
In 2007 founded the predecessor company to BioVie with over 29 years of biopharma industry experience including
finance, M&A and licensing deals, technology commercialization, global product launches, drug marketing and sales
force management. Mr. Adams was a member of Searle Pharma’s global launch team for Celebrex and worked on the
commercialization of follow-on COX-2 inhibitors. After Searle was acquired, he was a vice president/account supervisor
for healthcare advertising agencies and developed expertise covering a wide range of drugs and medical devices.
Subsequently he became a leader of Mission Pharmacal’s urology division. Mr. Adams earned a BS at Cornell University
and an MBA at the Tuck School at Dartmouth.
23. 23
Accomplished Board of Directors
Chairman of the Board: Terren Peizer Director: Jonathan Adams
Cuong Do
President, Samsung Global Strategy Group;
former Chief Strategy Officer at Merck; former
partner at McKinsey who led their healthcare
practice.
Michael Sherman
Former managing director at Barclays and
Lehman Brothers; significant experience in health
care finance; previously a securities attorney.
Richard J Berman
Former Chairman of National Investment Managers
with $12 billion pension administration assets;
director of Catasys, Inc., Advaxis, Inc., Cryoport Inc.
and Immuron Ltd. Previously started the M&A and
Leveraged Buyout Departments for Bankers Trust
Company.
Jim Lang
CEO of Eversana, and health services company.
Former CEO of healthcare analytics firm Decision
Resources Group; active investor and advisor to
several healthcare companies.
24. 24
Experienced and effective clinical & financial team
Penelope Markham, PhD, Chief Scientific Officer
Dr. Markham led the development of modified terlipressin compounds for LAT Pharma LLC, the predecessor company
to BioVie, for 7 years prior to its acquisition by BioVie. Previously, she spent 15 years in immunology, infectious
disease, bacteriology and drug discovery research. Dr. Markham was a co-founder and Research Director for Influx,
Inc. engaged in antibiotic drug discovery. She has been a member of NIH grant review panels and consulted in a
variety of therapeutic areas including Orphan drug development. Dr. Markham has more than 20 publications in peer-
reviewed journals and three patents.
Patrick Yeramian, MD, Chief Medical Officer
Dr. Yeramian brings over three decades of drug research and medical device experience to BioVie. He has served as a
medical director for multiple organizations including Searle Pharmaceuticals (now Pfizer) and TapImmune Inc. During
his career, he has helped companies to file more than 20 investigational new drug and device applications
(IND/CTX/CTAs), and won regulatory approvals for five new drugs and devices.
J. Wendy Kim, CPA, Chief Financial Officer
Over 25 years of experience in accounting and finance. As a CFO she managed corporate finance and operational
groups, closed M&A transactions and secured bank financings.
Denise Smith, MS, Vice President of Manufacturing
Managed the development laboratory for a large CMO, including analytical development and validation, and
established manufacturing processes for parenteral products (liquid, lyophilized, liposomes, emulsions) for new
chemical entities for the National Cancer Institute and other contract customers.
Leslie Koehler, RAC, MBA, Vice President of Regulatory Affairs
Former Director, Global Regulatory Affairs for Baxter Healthcare’s pharmaceuticals division. Serves as a regulatory
consultant for several pharmaceutical companies.
25. 25
World-leading medical advisory team
Paolo Angeli, MD
Head of the Unit of Hepatic Emergencies and Liver Transplantation at the University of Padova, Italy. He has
participated in more than 15 clinical trials (Phase II – IV) in the treatment of clinical complications of portal
hypertension and liver transplant. Currently he is Secretary of the International Ascites Club and, as a member
of EASL, has participated in drafting guidelines for the management of patients with cirrhosis and ascites. Dr.
Angeli has pioneered the use of continuous infusion terlipressin as a safer alternative to the traditional
approach of intermitted IV bolus dosing in the treatment of hepatorenal syndrome. He is a frequent speaker
on liver disease and has been widely published.
Lead medical advisor
26. 2628
Company highlights
• BIV201 is a novel therapeutic approach to a severe unmet medical need
• Mid-stage drug candidate in US development for ascites
- No drugs ever approved by FDA to treat ascites
- Similar therapy currently in practice in Australia*
• Clinical development plan:
- Commence Phase 2 clinical study this summer
- Commence pivotal Phase 3 trial in 2021
- Submit NDA for US marketing approval in 2022
• IP estate includes two Orphan drug designations and formulation patent application
• High cost of patient care creates strong economic rationale for drug therapy
• $400 million sales opportunity for ascites in US alone
• Additional revenue opportunities for related conditions and global expansion
* Source: ABC News Australia, March 5, 2018
27. 2727
Capitalization table
Capital structure as of June 1, 2020
Common shares outstanding
(Ticker: BIVI)
5,199,346
Warrants (WAEP: $4.52) 1,374,666
Options (WAEP: $10.50) 68,400
Fully-diluted shares 6,642,412