Industry News

Survey: Sponsors 62% more likely to engage CROs that 5 years ago

Centerwatch - Thu, 2016-07-21 12:31

A recent survey by Worldwide Clinical Trials reveals that 62% of respondents are more likely to engage a CRO partner for clinical research than they were five years ago, demonstrating the increasingly vital role that CROs are playing in modern drug development, and the importance of partnering with a CRO that offers medical and scientific […]

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Report: Global regenerative medicine market poised for strong growth

Centerwatch - Thu, 2016-07-21 11:21

A strong development pipeline for regenerative medicine (RM) therapies aimed at treating a broad range of unmet medical needs signals rapid growth in global RM product sales that could have significant and positive impacts on public health, according to a newly completed analysis by the Tufts Center for the Study of Drug Development. Today, there […]

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iPug launches as global digital health company

Centerwatch - Wed, 2016-07-20 11:05

A network of New Zealand angel investors has helped launch iPug, a digital health company that is transforming the way research and public health campaigns are delivered, into the U.S. market at the BIO International Convention in San Francisco. The investors, led by Hamilton-based property developer and investor, Zane Beckett, have provided seed capital and […]

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Medidata, Memorial-Sloan Kettering to expand oncology mHealth use

Centerwatch - Wed, 2016-07-20 09:39

Medidata, a global provider of cloud-based solutions for clinical research in life sciences, is collaborating with Memorial Sloan-Kettering Cancer Center (MSK) to expand the use of mobile health (mHealth) technology in oncology treatment. Through the collaboration, Medidata and MSK will assess the viability of deploying wearable sensors and mobile technology to evaluate quality of life during cancer […]

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Mitsubishi Tanabe joins Certara’s Simcyp Consortium

Centerwatch - Wed, 2016-07-20 09:34

Certara, a provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, has announced that Mitsubishi Tanabe joined its Simcyp Consortium and licensed its proprietary Simcyp Population-based Simulator. Mitsubishi Tanabe is the 34th biopharmaceutical company and the 10th Japanese pharmaceutical company to join the Consortium. In addition to its […]

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Exco InTouch successful completes HIPAA Privacy audit for NIST guidelines

Centerwatch - Wed, 2016-07-20 08:00

Exco InTouch, a provider of patient engagement and data capture solutions for clinical research and healthcare providers, has announced that it has successfully undergone and completed an independent audit to assess compliance utilizing the National Institute of Standards and Technology (NIST) guidelines for Health Insurance Portability and Accountability Act (HIPAA), formally completing the independent auditing process […]

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A Study of LY3314814 in Participants With Mild Alzheimer's Disease Dementia

Alzheimers - Tue, 2016-07-19 20:00
Status: Recruiting, Condition Summary: Alzheimer's Disease
Categories: Industry News

Roivant Sciences, Plexcera form Enzyvant Sciences

Centerwatch - Tue, 2016-07-19 14:14

Roivant Sciences and Plexcera Therapeutics have announced the formation of Enzyvant Sciences, a new biopharmaceutical company focused on the development of recombinant human acid ceramidase (rhAC), an enzyme replacement therapy for the treatment of patients with Farber disease. Developed in the lab of Professor Edward Schuchman, Ph.D., at the Icahn School of Medicine at Mount Sinai, […]

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EMD Serono to open $115M life science campus in Massachusetts

Centerwatch - Tue, 2016-07-19 14:05

EMD Serono, known as Merck outside of the U.S. and Canada, a science and technology company, has announced plans to build a new campus in Burlington, Massachusetts, that will serve as a major hub for the North American life science business of Merck. The 280,000-square-foot facility will include a customer collaboration laboratory and training center […]

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PhRMA adds five new member companies

Centerwatch - Tue, 2016-07-19 13:58

The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced three biopharmaceutical research companies joined the association as members and two transitioned from research associates to full members. The new members are Alexion Pharmaceuticals, New Haven, Connecticut; Jazz Pharmaceuticals, Palo Alto, California; and Teva Pharmaceutical Industries, North Wales, Pennsylvania. AMAG Pharmaceuticals, Waltham, Massachusetts, and Horizon Pharma, Lake Forest, Illinois, transitioned […]

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How to Report a Shortage or Supply Issue

FDA News - Tue, 2016-07-19 10:26
Updated
Categories: Industry News

Medidata launches new payment technology

Centerwatch - Tue, 2016-07-19 08:28

Medidata, a global provider of cloud-based solutions for clinical research in life sciences, has announced the launch of Medidata Payments. A new component of the industry-leading Medidata Clinical Cloud, Medidata Payments enables clinical trial sponsors and CROs to calculate reimbursements to investigative sites in real time and automatically disburse payments, eliminating a key operational pain […]

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Study: Mentorship programs build long-term research careers

Centerwatch - Tue, 2016-07-19 08:23

A public-private mentored research program based at the NIH called the NIH Clinical Research Training Program (CRTP) has helped foster the careers of research-oriented medical and dental students, and similar programs may help bolster the dwindling pipeline of biomedical researchers and clinician-scientists, according to a study now available electronically in Academic Medicine. The NIH CRTP, which […]

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NIH expands investment in HIV cure research

Centerwatch - Tue, 2016-07-19 08:07

The NIH has awarded approximately $30 million in annual funding over the next five years to six research collaborations working to advance basic medical science toward an HIV cure. The awards comprise the second iteration of the Martin Delaney Collaboratory: Towards an HIV-1 Cure program and are a part of President Barack Obama’s pledge to invest in HIV cure […]

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Boehringer Ingelheim, University of Dundee collaborate to develop new class of medicines

Centerwatch - Tue, 2016-07-19 07:55

Boehringer Ingelheim and the University of Dundee will join forces in an exciting collaboration with the aim to develop a novel class of medicines that target disease causing proteins for degradation. The collaboration brings together the expertise of Dr Alessio Ciulli, one of the pioneers in the field of PROTACs and based in the School of Life […]

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Dr. Andreas Rummelt joins supervisory board of Leukocare

Centerwatch - Tue, 2016-07-19 07:51

Leukocare, a provider of stabilizing and protecting formulation technologies for biopharmaceuticals like biologics and vaccines, announced the election of Dr. Andreas Rummelt as new member of its supervisory board. Together with Dr. Jean-Paul Prieels, who held various executive positions at GlaxoSmithKline, former Sandoz CEO Dr. Rummelt is the second former executive from big pharma on […]

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FDA Adverse Event Reporting System (FAERS): Latest Quarterly Data Files

FDA News - Mon, 2016-07-18 13:54
Third quarter 2015 FAERS data files have been added.
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Newly Added Guidance Documents

FDA News - Mon, 2016-07-18 09:24
Categories: Industry News

The CenterWatch Weekly, July 18, 2016

Centerwatch - Mon, 2016-07-18 08:00

Alliance for Multispecialty Research launches new business model The Alliance for Multispecialty Research (AMR), which includes some of the most experienced indepen­dent clinical research centers in the U.S., has established a new business model that fully integrates its 17-member network and better positions the organization to collaborate with sponsors and CROs in preferred provider site networks […]

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The importance of the monitoring visit report

Centerwatch - Mon, 2016-07-18 08:00

The monitoring visit report serves a spectrum of integral purposes specific to each monitoring visit type. It is the medium by which all findings identified at monitoring visits, and the status of findings from previous monitoring visits, are documented. It provides conceptual proof of training delivery for initiation visit conduct, and a logistical, clinical and […]

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