Important industry news and company updates
TransCelerate Biopharma Inc. released a free training on Risk-Based-Monitoring
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Published - 31.Jul.2014

Since 1996 ICH-GCP has proven to regulators considerable advances in technology. Monitoring and identifying risk has justified all efforts to accomplish safety and compliance of clinical trials, which makes it both beneficial- pharma industry and patients. Looking at the future of the clinical research world, TransCelerate Biopharma Inc., an independent non-profit organization focused on accelerating the development of new medicines and solving fundamental issues pharmaceutical companies face in bringing new therapeutics to market, believes that their Risk-Based Monitoring (RBM) methodology...MORE >

Astra Nova and ACRES Partner on Quality and Access of Training for Research Professionals
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Published - 24.Jul.2014

ACRES Alliance broadens to include Astra Nova’s international network of more than 140 global experts and accessible online training courses for clinical research professionals. Cambridge, MA (PRWEB) July 23, 2014 Astra Nova Training, a global provider of innovative and comprehensive consultancy and pharma training services, and the Alliance for Clinical Research Excellence and Safety (ACRES), a non-profit integrating the expertise and investments of research stakeholders worldwide to build and maintain a global system for clinical trials, are pleased to announce a...MORE >

Brand New GCP Training Coming Soon
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Published - 24.Sep.2013

Astra Nova has started working on a brand new GCP training.   The many people who have already used the company’s popular online GCP training provided Astra Nova with useful feedback on course needs. And this valuable feedback is the main purpose that pushed Astra Nova towards developing a brand new training course.   The course not only reviews GCP regulations, but also provides an approach of how those regulations are being applied in professionals’ day-to-day activities. A number of case studies will help...MORE >

Update Your Knowledge about Good Distribution Practices and Regulations with the GDP Free Training Course
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Published - 09.Sep.2013

New GDP (Good Distribution Practice) Training has just been released by Astra Nova. The new course is now available in the online learning management system of the company and is completely free. The training is fully interactive and is prepared to cover all newly applied Guidelines for GDP. It is also a guide about all the important aspects of keeping up to the terms and regulations coming into place from the 8th of September 2013. The new and completely free GDP...MORE >

FDA Accepts Eliquis® (apixaban) Supplemental New Drug Application
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Published - 11.Jul.2013

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Supplemental New Drug Application (sNDA) for Eliquis® (apixaban), for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in adult patients who have undergone hip or knee replacement surgery. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is March 15, 2014. The submission is...MORE >

Roche halts investigation of aleglitazar
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Published - 10.Jul.2013

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that following the results of a regular safety review of the aleglitazar AleCardio phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended to halt the trial due to safety signals and lack of efficacy. Based on this recommendation, Roche has decided to terminate the AleCardio trial and all other trials involving aleglitazar.   “The safety of patients is our first priority. Roche is working with investigators to support the management...MORE >

Astra Nova Assembles Interactiveness and Updated Information in the GMP Training Course
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Published - 03.Jul.2013

Astra Nova has released a new, fully interactive and up-to-date GMP (Good Manufacturing Practice) training course. The training is entirely web-based and is designed as a comprehensive learning tool for everyone that wants to learn about the GMP regulations and requirements and latest legislation updates, which came into effect on 31 January 2013. The GMP Training is developed as a refresher course which focuses mainly on the latest GMP legislation changes.  It is intended to help professionals get up to date...MORE >

INC Research Strengthens Therapeutic Expertise with Appointment of Ian Braithwaite
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Published - 02.Jul.2013

INC Research LLC, a therapeutically focused global clinical research organization (CRO) with a Trusted Process® for delivering reliable results, today announced the appointment of Ian M. Braithwaite, PhD, as Executive Vice President and General Manager, General Medicine. Dr. Braithwaite brings extensive experience both in the CRO and biopharmaceutical industries to this key role providing global leadership for the Company's General Medicine business unit, which specializes in conducting clinical trials in areas ranging from infectious disease, respiratory disease, women's health, immunology...MORE >

Quintiles Named a Best Workplace in Europe
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Published - 28.Jun.2013

Quintiles announced today that it has been recognized as one of Europe’s Best Workplaces by the Great Place to Work® Institute, finishing in 8th place in the Best “Multinational Large” Workplace category. Quintiles was also recognized this year in several individual European countries including Germany, Ireland, Italy, the Netherlands, Scotland, Spain and the United Kingdom.   The Great Place to Work Institute annual ranking is the most comprehensive study in organizational culture in the world. More than 2,100 companies representing 1 million...MORE >

Ad hoc: MorphoSys and Celgene Create Strategic Alliance to Advance CD38 Cancer Program
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Published - 26.Jun.2013

MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Celgene Corporation (NASDAQ: CELG) today announced an agreement to jointly develop MOR202 globally and to co-promote MOR202 in Europe. MOR202 is a fully human monoclonal antibody targeting CD38 to treat patients with multiple myeloma (MM) and certain leukemias. MOR202 is currently being evaluated in a phase 1/2a trial in patients with relapsed/refractory myeloma. MorphoSys and Celgene will collaborate on the development of MOR202 in multiple myeloma and other indications and share...MORE >

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