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. (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. (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.
- 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. (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. (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.
- 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
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
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.
This white paper focuses on the 505(b)(2) New Drug Approval (NDA) regulatory pathway, which relies on the public literature of clinical studies and/or the FDA's filing of safety and efficacy data for a previously approved drug.
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.
- 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.
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.
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.
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.
Wyeth reported strong financial results for the 1st quarter of 2007, with net revenue increasing 11% and operating profit growing 22%. Several key products such as Enbrel, Prevnar, and Zosyn saw significant revenue growth. Wyeth provided updates on several pipeline products, including positive late-stage trial results for Pristiq, Viviant, and Aprela, and anticipated regulatory actions and filings in 2007. While working to resolve issues at its Guayama manufacturing facility, Wyeth does not expect any pipeline delays and remains focused on new product launches.
Fast track drug development is a process designed to expedite FDA review of drugs for serious conditions with unmet medical needs. Drugs approved through this process treat life-threatening diseases like AIDS, cancer, and Alzheimer's. The process provides sponsors with more frequent guidance from the FDA, accelerated approval if certain criteria are met, and priority review to receive approval more quickly if all requirements are satisfied.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Regulations, guidelines & ethics in clinical researchDr. Harisha S
This document provides an overview of regulations, guidelines, and ethics regarding clinical research. It discusses regulations established by organizations like the FDA, CDSCO, and ICH that govern clinical trials. Guidelines like ICH GCP and CIOMS provide standards for conducting research ethically and credibly. Ethics committees ensure research complies with moral principles to protect human subjects. The document outlines regulations like Schedule Y of India's Drugs and Cosmetics Act that provide rules for approving clinical trials and new drugs.
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
Gerry Jeffcott, of 360 Public Affairs, gave a presentation for the CCSN on the drug approval process in Canada on March 27, 2014. He outlines the divide between public and private networks, cost management, as well as the review and approval process for pharmaceuticals in Canada.
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.
The document discusses FDA acceptance of foreign clinical trial data for regulatory submissions. It provides an overview of current regulations and considerations for both IND and non-IND studies conducted abroad. Key points include that foreign data is acceptable if studies meet good clinical practices and are applicable to the US population. While IND studies must follow all US rules, non-IND studies require proof of GCP compliance and complete documentation for FDA to consider acceptance. Practical and scientific issues in extrapolating results from foreign to US populations are also addressed.
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
Are you ready to hit 2021 running regarding CMS audit protocol changes? If not, you might find this webinar the most insightful event of 2020.
Discover how to sustain compliance with CMS regulations by accessing Inovaare’s webinar, CMS 2021 Audit Protocol Changes: Forewarned Is Forearmed. Join Brenda Wade and Judi Mason, industry experts in health plan compliance, to ensure you don’t enter the new year unprepared.
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 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.
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
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.
This white paper focuses on the 505(b)(2) New Drug Approval (NDA) regulatory pathway, which relies on the public literature of clinical studies and/or the FDA's filing of safety and efficacy data for a previously approved drug.
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.
- 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.
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.
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.
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.
Wyeth reported strong financial results for the 1st quarter of 2007, with net revenue increasing 11% and operating profit growing 22%. Several key products such as Enbrel, Prevnar, and Zosyn saw significant revenue growth. Wyeth provided updates on several pipeline products, including positive late-stage trial results for Pristiq, Viviant, and Aprela, and anticipated regulatory actions and filings in 2007. While working to resolve issues at its Guayama manufacturing facility, Wyeth does not expect any pipeline delays and remains focused on new product launches.
Fast track drug development is a process designed to expedite FDA review of drugs for serious conditions with unmet medical needs. Drugs approved through this process treat life-threatening diseases like AIDS, cancer, and Alzheimer's. The process provides sponsors with more frequent guidance from the FDA, accelerated approval if certain criteria are met, and priority review to receive approval more quickly if all requirements are satisfied.
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
Regulations, guidelines & ethics in clinical researchDr. Harisha S
This document provides an overview of regulations, guidelines, and ethics regarding clinical research. It discusses regulations established by organizations like the FDA, CDSCO, and ICH that govern clinical trials. Guidelines like ICH GCP and CIOMS provide standards for conducting research ethically and credibly. Ethics committees ensure research complies with moral principles to protect human subjects. The document outlines regulations like Schedule Y of India's Drugs and Cosmetics Act that provide rules for approving clinical trials and new drugs.
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
Gerry Jeffcott, of 360 Public Affairs, gave a presentation for the CCSN on the drug approval process in Canada on March 27, 2014. He outlines the divide between public and private networks, cost management, as well as the review and approval process for pharmaceuticals in Canada.
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.
The document discusses FDA acceptance of foreign clinical trial data for regulatory submissions. It provides an overview of current regulations and considerations for both IND and non-IND studies conducted abroad. Key points include that foreign data is acceptable if studies meet good clinical practices and are applicable to the US population. While IND studies must follow all US rules, non-IND studies require proof of GCP compliance and complete documentation for FDA to consider acceptance. Practical and scientific issues in extrapolating results from foreign to US populations are also addressed.
Fast track Designation is a designation for accelerated approval of drugs and medicines in US. Presentation contains brief view of this expedite program.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
Are you ready to hit 2021 running regarding CMS audit protocol changes? If not, you might find this webinar the most insightful event of 2020.
Discover how to sustain compliance with CMS regulations by accessing Inovaare’s webinar, CMS 2021 Audit Protocol Changes: Forewarned Is Forearmed. Join Brenda Wade and Judi Mason, industry experts in health plan compliance, to ensure you don’t enter the new year unprepared.
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 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.
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.
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.
- 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
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.
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.
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.
This document discusses hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome. It provides details on the epidemiology, clinical presentation, risk factors, pathophysiology, prevention, and treatment of VOD. VOD is a serious complication of hematopoietic stem cell transplantation that results from liver cell necrosis and vascular congestion. It most commonly occurs within the first month after transplantation. Prevention strategies include heparin, ursodeoxycholic acid, defibrotide, and controlling risk factors. Treatment focuses on managing symptoms, with defibrotide showing promise for improving outcomes in severe cases. The prognosis depends on the severity of the VOD, with mild cases having low mortality
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.
- 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.
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.
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.
Palisade Bio, Inc. (PALI) is developing novel therapeutics designed to improve human health through therapeutic protection of the gastrointestinal (GI) mucosal barrier. PALI’s initial focus is combatting the interruption of GI function (ileus) following major surgery in order to accelerate recovery times and shorten the duration of patient hospital stays. Additionally, PALI believes that its investigational therapies have the potential to prevent the formation of post-surgical adhesions (reducing hospital re-admissions and additional surgeries), as well as to address health conditions and complications associated with disruption of the gastrointestinal mucosal barrier.
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'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
Bellus Health Corporate Presentation June 2016BellusHealth
- The document is a corporate presentation for Bellus Health Inc. discussing their rare disease drug pipeline and lead product candidate KIACTA for AA amyloidosis.
- KIACTA showed positive results in a Phase 2/3 trial, reducing risk of worsening kidney events. A Phase 3 confirmatory study has completed enrollment with results expected in Q2 2016.
- If successful, KIACTA has the potential for regulatory approval and commercialization through a partnership, as Bellus' partner Auven Therapeutics is funding the entire development program.
Ventrus Biosciences is a Phase 3 biopharmaceutical company focused on developing products for gastrointestinal disorders. It has two late-stage products targeting large underserved markets: VEN 309, a topical treatment for hemorrhoids entering Phase 3 trials in 2011; and VEN 307, a topical treatment for anal fissures which recently initiated a Phase 3 trial in Europe. Near-term milestones include Phase 3 trial initiations and data readouts in 2012, as well as patent actions, which could position the company for strategic partnerships or independent commercialization.
Ventrus BioSciences, Inc. (Nasdaq: VTUS; Twitter: $VTUS) hosted a conference call this morning about Friday's press release (see Friday's ProActive write-up) on the revised protocol. The U.S. Food and Drug Administration (FDA) recommended, under a Special Protocol Assessment (SPA), new and more robust definitions for efficacy endpoints.
Based in Ann Arbor, Michigan, Zomedica is a veterinary health company creating diagnostic and therapeutic products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. With modest cash burn and a strong balance sheet, including $142.4 million cash and cash equivalents as of June 30, 2023, Zomedica is well-positioned to fund both organic growth and acquisitions.
Docola has developed a healthcare communication platform that utilizes asynchronous telehealth to deliver patient education and support. Their proprietary platform currently has over 55,000 patient users and over 1,100 clinician users. Docola seeks to raise up to $500,000 through a convertible note to fund working capital, research and development, and costs associated with an upcoming IPO.
- INNO Holdings is presenting an IPO investor presentation for an initial public offering on the NASDAQ Capital Market.
- The company manufactures prefabricated steel building components and systems using proprietary technology to reduce construction costs and environmental impact.
- INNO Holdings has four initial product lines - metal studs, prefabricated housing units, modular apartment buildings, and a mobile factory system. It aims to disrupt the construction industry through standardized, sustainable construction methods.
Everything Blockchain builds platforms of trust for the modern enterprise and is on a mission to ensure every organization has access to the tools and platforms that enable them to manage, store, and protect data without the cost and complexity that holds them back today. The Company’s patented advances in engineering deliver the essential elements needed for real-world business use: speed, security, and efficiency. Everything Blockchain’s current business lines include: EB Advise, Build DB and EB Control.
ASP Isotope is an isotope enrichment company utilizing technology developed in South Africa over the past 20 years to enrich isotopes of elements or molecules with low atomic masses. Many of these elements are unsuitable for enrichment using traditional methods such as centrifuges. The Company’s initial focus is on producing and commercializing highly enriched isotopes for the healthcare and technology industries.
MDNA Life Sciences is a pioneer in the science of mitochondrial DNA. It’s our mission to create an extensive portfolio of proprietary tests that dramatically improve diagnosis, treatment, prognosis and monitoring. Putting an end to the unnecessary surgical procedures, pain and uncertainty that affect patients across the world.
Digital Ally, Inc. is a diversified holding company with operations in video solution technology, human and animal health protection products, healthcare revenue cycle management, ticket brokering and marketing, and event production. The Company pursues an acquisition strategy that targets organizations with positive earnings, strong growth potential, innovation, and operational synergies. To maximize long-term shareholder value, Digital Ally intends to spin-off its ticketing and entertainment business lines into a separate public company in 2023. The spin-off will create two optimized, tech-driven public companies with strong growth opportunities and operating metrics.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
Aditxt is a biotech company developing immune monitoring and immune modulation platforms. Its AditxtScore platform can provide comprehensive immune profiles to monitor responses to pathogens, vaccines, drugs and transplants. Its Adimune platform aims to modulate the immune system to treat conditions like psoriasis, type 1 diabetes, and increase skin allograft survival. The company is working to develop, operate and commercialize these platforms. It currently generates revenue from immune monitoring tests and expects revenue from licensing deals for immune modulation programs as they advance in clinical trials towards commercialization.
1847 Holdings LLC, a publicly traded diversified acquisition holding company, was founded by Ellery W. Roberts, a former partner of Parallel Investment Partners, Saunders Karp & Megrue and Principal of Lazard Freres Strategic Realty Investors. EFSH's investment thesis is that capital market inefficiencies have left the founders and/or stakeholders of many small business enterprises and lower-middle market businesses with limited exit options, despite the intrinsic value of their business. Given this dynamic, EFSH can consistently acquire "solid" businesses for reasonable multiples of cash flow and then deploy resources to strengthen the infrastructure and systems to improve operations. These improvements may lead to a sale or IPO of an operating subsidiary at considerably higher valuations than the purchase price (as successfully demonstrated with the mid-2020 IPO of 1847 Goedeker on the NYSE American) and/or alternatively, an operating subsidiary may be held in perpetuity and contribute to EFSH's ability to pay regular and special dividends to shareholders.
Sharps Technology is a medical device and pharmaceutical packaging company specializing in the development and manufacturing of innovative drug delivery systems. The Company’s product lines focus on low waste and ultra-low waste syringe technologies that incorporate both passive and active safety features. These features protect front line healthcare workers from life-threatening needle stick injuries and protect the public from needle re-use. Sharps Technology has extensive expertise in specialized prefilled syringe systems and is on track to launch this new product line in Q4 2023. The Company has a manufacturing facility in Hungary and has partnered with Nephron Pharmaceuticals to expand its manufacturing capacity in the US.
SPI Energy is a global renewable energy company and provider of solar storage and electric vehicle (EV) solutions that was founded in 2006 in Roseville, California and is headquartered in McClellan Park, California. The Company has three core divisions: SolarJuice which has solar wholesale distribution, as well as residential solar and roofing installation and solar module manufacturing (Solar4America & SEM Wafertech), SPI Solar and Orange Power which operates a commercial & utility solar division, and the EdisonFuture/Phoenix Motor EV division. SolarJuice is the leader in renewable energy system solutions for residential and small commercial markets and has extensive operations in the Asia Pacific and North America markets. The SPI Solar commercial & utility solar division provides a full spectrum of EPC services to third party project developers, and develops, owns and operates solar projects that sell electricity to the grid in multiple regions, including the U.S., U.K., and Europe. Phoenix Motor is a leader in medium-duty commercial electric vehicles, and is developing EV charger solutions, electric pickup trucks, electric forklifts, and other EV products. SPI maintains global operations in North America, Australia, Asia and Europe and is also targeting strategic investment opportunities in fast growing green energy industries such as battery storage, charging stations, and other EVs which leverage the Company's expertise and substantial solar cash flow.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BullFrog AI is a technology enabled drug development company using machine learning to usher in a new era of precision medicine. Through its collaborations with leading research institutions, including Johns Hopkins University and J. Craig Venter Institute, BullFrog AI is at the forefront of AI-driven drug development. Using its proprietary bfLEAP™ artificial intelligence platform, BullFrog AI aims to enable the successful development of pharmaceuticals and biologics by predicting which patients will respond to therapies in development. BullFrog AI is deploying bfLEAP™ for use at several critical stages of development with the intention of streamlining data analytics in therapeutics development, decreasing the overall development costs by decreasing failure rates for new therapeutics, and impacting the lives of countless patients that may have otherwise not received the therapies they need.
BioVie 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.
Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 25 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of therapies including eleven cancer indications and an antibody-drug conjugate (ADC) program. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2-3 years and at approximately $1.0-2.0 million per program.
Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
Splash Beverage Group, an innovator in the beverage industry, owns a growing portfolio of alcoholic and non-alcoholic beverage brands including Copa di Vino wines by the glass, SALT naturally flavored tequilas, Pulpoloco Sangria, and TapouT performance hydration and recovery drinks and TapouT Cognitive Energy Drink. Splash’s strategy is to rapidly develop early-stage brands already in its portfolio as well as acquire and then accelerate brands that have high visibility or are innovators in their categories. Led by a management team that has built and managed some of the top brands in the beverage industry and led sales from product launch into the billions, Splash is rapidly expanding its brand portfolio and global distribution.
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
English Drug and Alcohol Commissioners June 2024.pptxMatSouthwell1
Presentation made by Mat Southwell to the Harm Reduction Working Group of the English Drug and Alcohol Commissioners. Discuss stimulants, OAMT, NSP coverage and community-led approach to DCRs. Focussing on active drug user perspectives and interests
This particular slides consist of- what is Pneumothorax,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 a summary of Pneumothorax:
Pneumothorax, also known as a collapsed lung, is a condition that occurs when air leaks into the space between the lung and chest wall. This air buildup puts pressure on the lung, preventing it from expanding fully when you breathe. A pneumothorax can cause a complete or partial collapse of the lung.
CHAPTER 1 SEMESTER V COMMUNICATION TECHNIQUES FOR CHILDREN.pdfSachin Sharma
Here are some key objectives of communication with children:
Build Trust and Security:
Establish a safe and supportive environment where children feel comfortable expressing themselves.
Encourage Expression:
Enable children to articulate their thoughts, feelings, and experiences.
Promote Emotional Understanding:
Help children identify and understand their own emotions and the emotions of others.
Enhance Listening Skills:
Develop children’s ability to listen attentively and respond appropriately.
Foster Positive Relationships:
Strengthen the bond between children and caregivers, peers, and other adults.
Support Learning and Development:
Aid cognitive and language development through engaging and meaningful conversations.
Teach Social Skills:
Encourage polite, respectful, and empathetic interactions with others.
Resolve Conflicts:
Provide tools and guidance for children to handle disagreements constructively.
Encourage Independence:
Support children in making decisions and solving problems on their own.
Provide Reassurance and Comfort:
Offer comfort and understanding during times of distress or uncertainty.
Reinforce Positive Behavior:
Acknowledge and encourage positive actions and behaviors.
Guide and Educate:
Offer clear instructions and explanations to help children understand expectations and learn new concepts.
By focusing on these objectives, communication with children can be both effective and nurturing, supporting their overall growth and well-being.
NURSING MANAGEMENT OF PATIENT WITH EMPHYSEMA .PPTblessyjannu21
Prepared by Prof. BLESSY THOMAS, VICE PRINCIPAL, FNCON, SPN.
Emphysema is a disease condition of respiratory system.
Emphysema is an abnormal permanent enlargement of the air spaces distal to terminal bronchioles, accompanied by destruction of their walls and without obvious fibrosis.
Emphysema of lung is defined as hyper inflation of the lung ais spaces due to obstruction of non respiratory bronchioles as due to loss of elasticity of alveoli.
It is a type of chronic obstructive
pulmonary disease.
It is a progressive disease of lungs.
Mental Health and well-being Presentation. Exploring innovative approaches and strategies for enhancing mental well-being. Discover cutting-edge research, effective strategies, and practical methods for fostering mental well-being.
This particular slides consist of- what is hypotension,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 the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
VEDANTA AIR AMBULANCE SERVICES IN REWA AT A COST-EFFECTIVE PRICE.pdfVedanta A
Air Ambulance Services In Rewa works in close coordination with ground-based emergency services, including local Emergency Medical Services, fire departments, and law enforcement agencies.
More@: https://tinyurl.com/2shrryhx
More@: https://tinyurl.com/5n8h3wp8
nursing management of patient with Empyema pptblessyjannu21
prepared by Prof. BLESSY THOMAS, SPN
Empyema is a disease of respiratory system It is defines as the accumulation of thick, purulent fluid within the pleural space, often with fibrin development.
Empyema is also called pyothorax or purulent pleuritis.
It’s a condition in which pus gathers in the area between the lungs and the inner surface of the chest wall. This area is known as the pleural space.
Pus is a fluid that’s filled with immune cells, dead cells, and bacteria.
Pus in the pleural space can’t be coughed out. Instead, it needs to be drained by a needle or surgery.
Empyema usually develops after pneumonia, which is an infection of the lung tissue. it is mainly caused due in infectious micro-organisms. It can be treated with medications and other measures.
Enhancing Hip and Knee Arthroplasty Precision with Preoperative CT and MRI Im...Pristyn Care Reviews
Precision becomes a byword, most especially in such procedures as hip and knee arthroplasty. The success of these surgeries is not just dependent on the skill and experience of the surgeons but is extremely dependent on preoperative planning. Recognizing this important need, Pristyn Care commits itself to the integration of advanced imaging technologies like CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) into the surgical planning process.
1. 1
Pioneering therapies for patients
suffering from advanced liver cirrhosis
Corporate Presentation | March 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
$500M+ 20,000
US patients
targeted for
BIV201 therapy
0/0
Number of FDA-
approved drugs to
specifically treat
ascites; Number of
direct competitors
Ph2b/3
Submitted Phase
2b/3 protocol; 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
market size*;
Projected BIV201 US
sales of $250 M with
50% penetration
Sources/Notes:
* D'Amico 2014; Gines 2004; Third party market assessment, published 2015; US Patient Hospital
Discharge Data, 2005; Ascites & BEV: Assumes three 21-day treatment regimens annually; CRH:
Assumes 3 days of therapy (Auchet, 2017) & HRS: Assumes 10 days of therapy.
** 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 US
• Ascites is the most common
major complication
• 15% of patients diagnosed with
ascites succumb within 1 year;
44% die within 5 years
Our first disease
target is ascites,
the accumulation
of 5+ liters of fluid
in the abdomen.
Fluid in the
peritoneal cavity
(ASCITES)
Source: Ge and Runyon 2016
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 serious 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. 1111
Prospective clinical study results from Gow and colleagues (Australia 2016)
Continuous infusion terlipressin
in 5 refractory ascites patients
Source: AJ GASTRO Vol. 111 July2016.
No serious adverse events were reported in this study.
Terlipressin is not available in the US
12. 1212
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
13. 13
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 were to assess safety, tolerability and pharmacokinetics (PK)
Results1:
• BIV201 therapy maintained for 28 days in 3 of 6 patients
• Pharmacokinetics (PK) of continuous terlipressin infusion matched our predicted model2
• Adverse events observed: bacteremia3, recurrence of moderate HE4, asymptomatic
hyponatremia, abdominal pain, headache, diarrhea, dizziness
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).
4. Possibly due to dehydration in conjunction with terlipressin response (one patient).
14. 14
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
15. 15
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
16. 16
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
‒ FDA written response expected within 45 days
A Phase 2b/3 Randomized Study of BIV201 Continuous Infusion in Addition to Standard
of Care Compared to Standard of Care to Reduce the Recurrence of Ascites in Patients
with Refractory Ascites Secondary to Decompensated Liver Cirrhosis
(Clinicaltrials.gov NCT identifier 04112199)
17. 17
Phase 2b/3 clinical trial design
• 2 open-label phases:
‒ Lead-in (12 patients): treatment with BIV201 plus standard of care (SOC)
‒ Randomized (120 patients): BIV201+SOC treatment group compared to control group
receiving SOC only
• Dosing: 3 mg/day for 28 days
• Multi-center (US study sites TBD)
• Primary endpoints:
1. Time to recurrence of large volume paracentesis (removal of >5 liters from abdomen)
2. Cumulative increase in ascites fluid removed over 28 days
Source: clinicaltrials.gov (identifier: NCT04112199). The FDA discussed trial design with the Company in
June 2019 but has not provided final guidance; certain risks associated with yet to be validated quality
of life measures may still need to be addressed.
18. 18
Novel BIV201 delivery system for Ph2b/3 trial
BIV201 Premixed/
Prefilled Syringe
Needle-free
Connector
50 mL bag of saline for
insertion into pump
Portable pump
(carried in small satchel)
20. 20
Will seek patent coverage
in 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
21. 21
Estimated US
Patients
(000s)
Total Addressable
Market (TAM)
Peak US Sales
@ 50% Market
Penetration
Refractory Ascites 19.81 $500 M $250 M
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: $442 MSources/Notes:
1. D'Amico 2014; Gines 2004
2. Third party market assessment, published 2015
3. US Patient Hospital Discharge Data, 2016
4. Ascites & BEV: Assumes three 21-day treatment regimens annually; CRH: Assumes 3 days
of therapy (Auchet, 2017) & HRS: Assumes 10 days of therapy
BIV201 revenue potential – US only
22. 22
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)
✓
✓
✓
23. 23
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.
24. 24
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.
25. 25
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.
26. 26
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
27. 2727
Capitalization table
Capital structure as of 2/28/2020
Common shares outstanding
(Ticker: BIVI)
5,199,346
Warrants (WAEP: $4.52) 1,374,666
Options (WAEP: $10.53) 67,600
Fully-diluted shares 6,641,612
28. 2828
Company highlights
• BIV201 is a novel therapeutic approach to a severe unmet medical need
• Only late-stage drug candidate in development for ascites (no drugs ever approved
by FDA for ascites)
– The same therapy is currently in practice in Australia*
• High cost of patient care creates a strong economic rationale for drug therapy
• Planning to commence late-stage (Phase 2b/3) clinical trial this year
• Planning to submit NDA for US marketing approval in 2021
• IP estate includes two Orphan drug designations
• Up to $500 million US ascites sales opportunity
• Additional revenue opportunities for related conditions and global expansion
• High profit margins anticipated
* Source: ABC News Australia, March 5, 2018