September 2015

Teva buys Mexican co Rimsa for $2.3b. Teva CEO: This acquisition delivers on our strategy of increasing our presence in key emerging markets. Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) is acquiring Mexican pharmaceutical manufacturing and distribution company Representaciones e Investigaciones Médicas, S.A. de C.V. (Rimsa). The deal also includes a portfolio of products and companies, intellectual property, assets and pharmaceutical patents in Latin America and Europe in a debt-free, cash free set of transactions, for an aggregate $2.3 billion. Through this acquisition, Teva will become a leading pharmaceutical company in Mexico. Teva expects the deal will yield substantial and achievable synergies and offer a platform for growth in the region.
 
HeartWare buys Israeli co Valtech Cardio for $800mHeartWare International Inc. announced that it has entered into a definitive agreement to acquire Valtech Cardio Inc. in a share and milestone payments deal that could reach $857 million. Valtech is a privately held company that specializes in the development of innovative, non-invasive surgical and transcatheter valve repair and replacement devices for the treatment of the most prevalent heart valve diseases mitral valve regurgitation (MR) and tricuspid valve regurgitation (TR).
 
The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register.  seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015, when the docket will be open for submitting public comments. 
A brief summary of the proposed changes can be accessed at the following HHS website: http://www.hhs.gov/ohrp/humansubjects/regulations/nprm2015summary.html.
 
Strengthening the Clinical Trial Enterprise for Medical Devices: An FDA/CDRH Strategic Priority Update. Every day, millions of Americans rely on FDA approved or cleared medical devices to save, sustain, or improve the quality of their lives. At the Center for Devices and Radiological Health (CDRH), we are committed to patients having access to high-quality, safe, and effective medical devices–as quickly as possible. Innovation is key to both speed and excellence in that endeavor. And as we discussed in our blog earlier this year, clinical trials are a key component to the device innovation process.  As part of our 2014-2015 Strategic Priorities, CDRH committed to reducing the time and cost of regulatory and non-regulatory aspects of the U.S. clinical trial enterprise, while assuring the protection of human subjects and the generation of robust data.
 
Biotech China Sept.21-23 NanjingThe Biotech China Conference & Exhibition was held on Sept.21-23 at the Nanjing International Expo Center. The event is sponsored by the Nanjing Municipal Peoples’ Government Exhibition Office and China Quality Association for Pharmaceuticals. It represents the top level of China’s bio industry.
 
Ctrials is holding a seminar: GCP Audits - Why should I take to heart? Audits are a significant learning tool for improving all clinical development stages. The audit contributes to the level of certainty regarding the quality of data and the rights protection of the participants. During the seminar, experienced professionals will share their experience about the rationale and offer practical tools for work. The seminar will be held on  28 October 2015, 9:00 to 13:30 at the Rambam Medical Center, Haifa.
 
The Israeli Ministry of Health will hold a workshop on regulations of clinical trials in advanced therapy. The conference is sponsored by the EU TAIEX program. The lectures will be given by guest lecturers from abroad and will discuss all aspects of the field from the perspective of European regulations. The workshop will take place on October 12-13 in Jerusalem.
 
Israel best investment after Silicon Valley - DeloitteIsraeli high tech has been breaking records in recent years, with venture capital funds raising huge sums and startups enjoying generous valuations. This is a worldwide trend, but investors have greater confidence in certain countries. Global firm Deloitte conducted a survey to find in which country venture capital investors prefer to invest their money.

                       
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