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First Patient Enrolled in BioVie Phase 2a Clinical Trial of BIV201 for Ascites

By |2018-08-18T16:51:07+00:00September 14th, 2017|

First Patient Enrolled in BioVie Phase 2a Clinical Trial of BIV201 for Ascites September 14, 2017 BEVERLY, MA–(Marketwired – September 14, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today confirmed enrollment of the first patient in the Company’s mid-stage (Phase 2a) clinical trial of BIV201 for the treatment of patients with refractory ascites due to liver cirrhosis. The initial trial is being led by Jasmohan Bajaj, MD, MS, study site principal investigator (PI) at the McGuire Research Institute in Richmond, VA.The study titled Safety and pharmacodynamic activity of low-dose terlipressin delivered by continuous intravenous infusion in patients with cirrhosis and refractory ascites requiring recurrent large volume paracentesis is an open-label prospective study in a cohort of 6 patients who are refractory to, or intolerant of, diuretic therapy. In addition to examining the [...]

BioVie Files Patent Application in Japan for BIV201 for the Treatment of Ascites Due to Liver Cirrhosis

By |2018-08-18T16:50:18+00:00July 26th, 2017|

BioVie Files Patent Application in Japan for BIV201 for the Treatment of Ascites Due to Liver Cirrhosis July 26, 2017 BEVERLY, MA–(Marketwired – July 26, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today the filing of an application in Japan for patent coverage of the Company’s new drug candidate BIV201 for the treatment of ascites in patients with advanced liver cirrhosis. This follows the recent issuance of US Patent No. 9,655,945 for the use of BIV201 to treat this medical condition. The Company is pursuing an approach known as the “patent prosecution highway” in order to seek an expedited patent approval in Japan, which may take less than one year.BioVie is an emerging leader in the development of drug therapies for ascites and other life-threatening complications of advanced liver [...]

Hari Kuma Joins BioVie Board

By |2018-08-18T16:51:28+00:00May 10th, 2017|

Distinguished BioPharma Executive Hari Kumar Joins BioVie Board of Directors and Purchases Company Stock May 10, 2017 BEVERLY, MA–(Marketwired – May 10, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today welcomed Dr. Hari Kumar, a highly accomplished biopharmaceutical industry executive, to its Board of Directors as an independent director. In addition, Dr. Kumar purchased common shares of BioVie stock through a private placement.After earning a PhD in immunology in 1984, Dr. Kumar embarked upon a successful career in the biopharmaceutical industry. He held positions of increasing responsibility at Roche Pharma culminating in serving as Global Business Development Director, and in 2007 assumed the role of Chief Business Officer for Amira Pharmaceuticals. He led the sale of Amira to Bristol-Myers Squibb in 2011 for $475 million. He then served as Chief [...]

BioVie Signs Cooperative Research and Development Agreement (CRADA) to Conduct a Phase 2a Clinical Trial

By |2018-08-18T16:52:06+00:00April 25th, 2017|

BioVie Signs Cooperative Research and Development Agreement (CRADA) to Conduct a Phase 2a Clinical Trial of BIV201 in Refractory Ascites Patients April 25, 2017 BEVERLY, MA–(Marketwired – April 25, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, today announced the signing of a Cooperative Research and Development Agreement (CRADA) to conduct a Phase 2a clinical trial of BIV201 in patients with refractory or intractable ascites due to advanced liver cirrhosis. The study is titled: Safety and pharmacodynamic activity of low-dose terlipressin delivered by continuous intravenous infusion in patients with cirrhosis and refractory ascites requiring recurrent large volume paracentesis.”BIV201 is a continuous infusion of the peptide terlipressin, initially being developed for the treatment of refractory ascites. Terlipressin, dosed differently, is approved in about 40 countries for other complications of liver cirrhosis arising from [...]

BioVie Receives FDA Clearance for Phase 2a Clinical Trial and Attains Patent Allowance, Satisfies Conditions to Commence Funding Under the $12m Aspire Agreement

By |2018-08-18T16:52:50+00:00April 3rd, 2017|

BioVie Receives FDA Clearance for Phase 2a Clinical Trial and Attains Patent Allowance, Satisfies Conditions to Commence Funding Under the $12m Aspire Agreement April 3, 2017 BEVERLY, MA–(Marketwired – April 03, 2017) – BioVie Inc. (OTCQB: BIVI), a clinical-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce that it has received notice from the US Food and Drug Administration (FDA) that the planned Phase 2a clinical trial of its new drug candidate BIV201 may be initiated. This was based on the Company’s Investigational New Drug Application (IND) to conduct a study in patients with refractory or intractable ascites due to advanced liver cirrhosis.A second key milestone was achieved when BioVie was notified by the US Patent and Trademark Office (USPTO) that its application for a core patent covering the use of BIV201 to reduce ascites [...]

Julie G. Anderson Joins BioVie as Independent Director

By |2018-08-18T16:53:26+00:00March 15th, 2017|

Julie G. Anderson Joins BioVie as Independent Director and Investor March 15, 2017 BEVERLY, MA–(Marketwired – March 15, 2017) – BioVie Inc. (OTCQB: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Julie G. Anderson as an independent member of the Company’s Board of Directors. Ms. Anderson brings an impressive experience base in the pharma/biotech industry to BioVie. She also invested personally in the Company.Ms. Anderson most recently served Catheter Connections, Inc. as its Vice President of Marketing until the company was sold last month. Previously she was Senior Director of Marketing for Durata Therapeutics, Inc., playing a key role in helping build the infrastructure and commercialization plan necessary to launch the novel antibiotic Dalvance. The team’s efforts led to an acquisition of the company in 2014 by Actavis (now [...]

BioVie Announces Uplisting to OTCQB Market

By |2018-08-18T16:54:19+00:00March 6th, 2017|

BioVie Announces Uplisting to OTCQB Market  March 6, 2017 BEVERLY, MA–(Marketwired – March 06, 2017) – BioVie Inc. (OTCQB: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today that its stock has commenced trading on the OTCQB market after successfully uplisting from the OTC Pink market.OTCQB membership provides enhanced investor benefits including higher reporting standards, increased analyst coverage and access to news services, and more comprehensive compliance requirements. “We anticipate that trading on the OTCQB will raise BioVie visibility in the investment community and broaden our shareholder base,” commented CEO Jonathan Adams. “It’s an important step towards building BioVie into a larger company.”BioVie recently submitted a complete response to the U.S. Food and Drug Administration (FDA), addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by the Company in [...]

BioVie Submits Additional Information to FDA for BIV201 Clinical Trial in Ascites Patients

By |2018-08-18T16:54:56+00:00February 22nd, 2017|

BioVie Submits Additional Information to FDA for BIV201 Clinical Trial in Ascites Patients February 22, 2017 BEVERLY, MA–(Marketwired – February 22, 2017) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, announced today that it has submitted a complete response to the U.S. Food and Drug Administration (FDA) addressing the issues identified in the Investigational New Drug Application (IND) clinical hold letter received by BioVie last month.“The FDA requested more information about the ambulatory pumps to be used in our clinical study. We have provided this information and conducted 3 bench studies, all with supportive results. Additionally, we incorporated the Agency’s suggestions to improve the quality of our planned clinical study,” commented CEO Jonathan Adams. “I also want to thank our talented IND team and research partners for their fast work in [...]

BioVie Enters Into A $12 Million Common Stock Purchase Agreement With Aspire Capital Fund

By |2018-08-18T16:55:28+00:00January 5th, 2017|

BIV201 Clinical Trial May Begin This Spring January 5, 2017 BEVERLY, MA–(Marketwired – January 05, 2017) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the completion of a Common Stock Purchase Agreement with Aspire Capital Fund, LLC, a Chicago-based institutional investor, to purchase up to $12 million of BioVie common stock over a 30-month period. Upon entering into the Agreement, Aspire made an initial purchase $200,000 of BioVie’s common stock at $0.20 per share and received warrants to purchase an additional 500,000 shares at a $0.50 exercise price within five years. After a registration statement related to the transaction has been filed and declared effective by the U.S. Securities and Exchange Commission, BioVie will have the right to sell up to $11.8 million of additional common stock to [...]

Accomplished Healthcare Executive Jim Lang Invests and Joins BioVie’s Board of Directors

By |2018-08-14T22:11:17+00:00December 7th, 2016|

Accomplished Healthcare Executive Jim Lang Invests and Joins BioVie’s Board of Directors – December 07, 2016 December 7, 2016 BEVERLY, MA–(Marketwired – December 07, 2016) – BioVie Inc. (OTC PINK: BIVI), a development-stage company focused on the discovery, development, and commercialization of innovative drug therapies for liver disease, is pleased to announce the appointment of Mr. James Lang as an independent member of the Company’s Board of Directors. Mr. Lang is an active investor in emerging healthcare companies, and recently invested in BioVie.Mr. Lang was formerly the Chief Executive Officer of Decision Resources Group (DRG), a leading healthcare research and consulting company. During his tenure there, Mr. Lang helped to transform the company into an industry leader, achieving robust revenue and profit growth. Previously Mr. Lang was the CEO of Strategic Decisions Group, a premier global strategy consultancy, where he expanded the life sciences practice and [...]

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