Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 33 n° 244

Posts Tagged ‘promethera’

cGMP Compliance Status for Promethera Biosciences’ Production Site in Durham, NC Confirmed by Health Canada

Posted by fidest press agency su sabato, 1 settembre 2018

Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, today announced that Health Canada has confirmed a cGMP compliance status for the company’s production facility in Durham, North Carolina. The Durham facility will be focused on achieving the goals of Promethera’s current strategic focus, developing and producing the starting material of HepaStem as a treatment for chronic liver disorders such as Non-alcoholic steatohepatitis (NASH) and Acute-on-chronic liver failure (ACLF). As part of this strategy, the company has decided on a full out-licensing of the Heparesc program to a commercial partner, and hence cancelled its New Drug Submission (NDS) before a final decision was reached by Health Canada in order to keep full negotiation flexibility with a future partner. “The confirmation of our Durham factory’s cGMP compliance status brings us a step closer to commercial capabilities for the production of our HepaStem treatment,” says John Tchelingerian, PhD, President & CEO of Promethera Biosciences SA. “HepaStem’s multiple mechanisms of action could be a potential alternative to reverse the NASH disease process forming a possible solution for the damage inflicted by advanced NASH or other chronic liver diseases that can lead to ACLF. With our new focus, we decided the time was right to bring in a commercial partner that would carry the Heparesc technology across the regulatory finish line.”“Our experienced manufacturing and quality teams in the US continue to work in line with very high-quality standards, as evident in our cGMP status confirmation, helping the site continue to play an important role in the overall group structure,” said Mark Johnston, Managing Director, Promethera Biosciences LLC.

Posted in Estero/world news | Contrassegnato da tag: , , | Leave a Comment »

Promethera Biosciences Appoints Mutsuki Takano as General Manager of its Branch Office in Tokyo

Posted by fidest press agency su giovedì, 2 agosto 2018

Promethera Biosciences SA, a global innovator in cell-based medicines and liver diseases, announced the appointment of Mutsuki Takano as Branch General Manager of Promethera Biosciences Japan Branch and Member of the Management Team of Promethera Biosciences SA. As announced in May 2018, Promethera’s branch office in Tokyo marks the starting point for building a strong presence of Promethera in Japan and additional Asian markets.Mutsuki Takano joins Promethera from Mitsui & Co., Ltd, one of the biggest Japanese conglomerate where he was influential in international business activities such as new company launches, the set-up of joint ventures, foreign company operations and restructuring projects in the US, UK, India, China, and other Asian countries. Most recently, his work focused on private equity transactions in the biotechnology sector for Mitsui Global Investment, the venture capital arm of Mitsui & Co. Ltd. Mutsuki has contributed to the successful development of more than 10 portfolio companies as a board observer. He received a Bachelor of Science in Politics and Economics from the Waseda University, Tokyo, Japan and did his EMBA at Sun Yat-Sen University, Guangzhou, China.“In looking to fill this new position, the ideal candidate had to offer a strong network in Japan and the wider Asian region, combined with a strong biopharma investment and corporate development expertise. Mutsuki fulfilled all this and more and we are thus very pleased to present him as the new head of our recently established branch office in Tokyo and to welcome him in our Management team,” said John Tchelingerian, PhD, President & CEO of Promethera Biosciences SA.“The positive climate and regulatory environment for cell therapy and regenerative medicine in Japan represent a special opportunity for Promethera as we drive product and corporate development activities in the region. I am excited and very much looking forward to contributing to the continued success of Promethera in Japan/Asia and worldwide,” commented Mutsuki Takano, Branch General Manager of Promethera Biosciences Japan Branch.

Posted in Estero/world news | Contrassegnato da tag: , , | Leave a Comment »