Industry News

Report: Poor physician/nurse engagement contributes to low patient recruitment rates

Centerwatch - Tue, 2017-01-17 09:13

Although physicians and nurses are familiar with, and comfortable discussing, clinical trials, they refer a mere fraction of their patients for these studies, reflecting, in part, a failure by sponsors, CROs and investigative site personnel to engage health care providers as partners in the clinical research process, according to a recently completed analysis conducted by […]

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FDA extends review period for rheumatoid arthritis treatment Baricitinib

Centerwatch - Tue, 2017-01-17 09:09

Eli Lilly and Incyte announced that the FDA has extended the review period for the new drug application (NDA) for investigational baricitinib, a once-daily oral medication for the treatment of moderate to severe rheumatoid arthritis (RA). The NDA for baricitinib was submitted to the FDA in January 2016. The FDA extended the action date to allow […]

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MRC Technology Centre relocates to expand diagnostics research capability

Centerwatch - Tue, 2017-01-17 09:02

MRC Technology, an independent medical research charity, has announced the relocation of its Centre for Diagnostics Development (CDD) to Nine, Edinburgh BioQuarter, in the U.K. The move forms part of the charity’s investment of over £7 million over the next five years to further its work accelerating diagnostic research into the clinic. CDD will potentially […]

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Exco InTouch receives privacy shield framework self-certification

Centerwatch - Tue, 2017-01-17 08:57

ERT company Exco InTouch, a provider of digital patient engagement and data capture solutions for clinical research and healthcare providers, has formally received EU-U.S. Privacy Shield Framework Self-Certification status by the U.S. Department of Commerce’s International Trade Administration (ITA). The designation certifies that Exco InTouch’s practices meet or exceed the data privacy and security principles […]

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Malecare launches trial accrual system Cancergraph

Centerwatch - Tue, 2017-01-17 08:36

Malecare, a U.S. men’s cancer survivor support and advocacy national nonprofit organization, launched Cancergraph, a mobile application that tracks cancer symptoms, disease states and quality of life reports in real time and quickly identified its primary value as a clinical trial accrual system. Cancergraph distills each users’ health data to provide, in real time, only […]

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Chi-Med appoints Paul Carter to board of directors

Centerwatch - Mon, 2017-01-16 15:04

Hutchison China MediTech (Chi-Med) has announced, effective from February 1, Paul Rutherford Carter has been appointed as senior independent non-executive director and member of the audit committee, Remuneration Committee and Technical Committee of Chi-Med; and Shigeru Endo tendered his resignation as non-executive director and Christopher Nash tendered his resignation as senior independent non-executive director and […]

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Columbia U, NewYork-Presbyterian and The Life Raft partner

Centerwatch - Mon, 2017-01-16 14:28

Columbia University Medical Center, New York-Presbyterian and the Life Raft Group (LRG), a patient advocacy organization specializing in gastrointestinal stromal tumors (GIST) cancer, announced that they have entered into a collaborative research project to investigate the efficacy of a novel system biology approach for identifying the best treatment options for patients with advanced GIST. The […]

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NY proposal aimed at prescription drug prices

Centerwatch - Mon, 2017-01-16 14:01

Governor Andrew M. Cuomo has announced a new proposal to protect New Yorkers from the soaring prices of prescription drugs in New York State.  The Governor’s plan consists of a three-pronged approach that will: Insulate taxpayers by preventing prescription drug price gouging in the Medicaid program; Impose a surcharge on drug manufacturers that charge exorbitant […]

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Biogen presents SPINRAZA data for infant spinal muscular atrophy

Centerwatch - Mon, 2017-01-16 13:47

Biogen presented new data from the phase III ENDEAR study of SPINRAZA (nusinersen), which demonstrated a statistically significant reduction in the risk of death or permanent ventilation in SPINRAZA-treated infants with spinal muscular atrophy (SMA) compared to untreated infants. In August 2016, Biogen reported that ENDEAR met its pre-specified primary endpoint at the interim analysis, […]

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Nivalis Therapeutics restructures

Centerwatch - Mon, 2017-01-16 13:39

Nivalis Therapeutics, a clinical stage pharmaceutical company focused on developing innovative solutions for people with cystic fibrosis (CF), has announced that its board of directors has approved a restructuring plan as part of the company’s initiative to explore strategic alternatives focused on maximizing stockholder value from its clinical assets and cash resources. The company intends […]

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Merck KGaA, Palantir partnership on healthcare acceleration

Centerwatch - Mon, 2017-01-16 13:35

Merck KGaA, a science and technology company, has announced a partnership with Palantir Technologies, developer of data integration and analysis software, at Palantir’s headquarters in Palo Alto, California. The partnership will leverage Palantir’s advanced data analytics capabilities to help Merck better and more rapidly develop and deliver medicines to patients, commercialize new products and improve patient […]

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DermCare runs fully electronic clinical research center

Centerwatch - Mon, 2017-01-16 13:28

At the heart of Quincy Center, DermCare is a medical and cosmetic dermatology practice conducting clinical trial operations. The practice is one of only a small number nationwide that uses full-fledged electronic data collection for research trials. Pushed by the government, doctor’s offices started adopting electronic medical records years ago, but physicians managing FDA trials […]

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Report: Biopharmaceutical M&A expected to soar in 2017

Centerwatch - Mon, 2017-01-16 13:23

The biopharmaceutical industry’s desire for inorganic growth is expected to intensify an already heated mergers and acquisitions (M&A) environment in 2017. This is according to the EY M&A Outlook and Firepower Report 2017. With new regulatory and tax environments expected following the changing geopolitical landscape, most notably in the post-election U.S., expectations are that the industry may […]

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Use and adoption of site-facing technology

Centerwatch - Mon, 2017-01-16 08:00

EDC, RBM, SSO, etc.—These three-letter acronyms related to technology are enough to make your head spin. Everyone’s talking about the latest site-facing technology and how it could improve clinical trial operations efficiency, but I thought I would start off the new year (and the new Pulse on Technology column) by setting the record straight on […]

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The CenterWatch Weekly, January 16, 2016

Centerwatch - Mon, 2017-01-16 08:00

St. Jude cybersecurity vulnerabilities spark medical device hacking debate A recent cybersecurity scandal involv­ing St. Jude’s Merlin@home device sparked a renewed discussion within the medical device industry about the best way to address security flaws discovered by independent security experts, sometimes called “white hat” hackers. As medical devices become increasingly vulnerable to cyber attack, the […]

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Harrington Discovery, ADDF expand collaboration

Centerwatch - Fri, 2017-01-13 10:01

Harrington Discovery Institute at University Hospitals in Cleveland, Ohio, and the Alzheimer’s Drug Discovery Foundation (ADDF) have expanded their collaboration to accelerate translation of innovative research efforts for Alzheimer’s disease. Together, the two organizations will jointly market and administer a new award program for academic researchers. By leveraging their combined expertise, investment, and resources, Harrington […]

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Parexel to restructure

Centerwatch - Fri, 2017-01-13 09:54

Chairman, CEO and the Corporate Vice President and Interim CFO of Parexel International has approved a plan to restructure its operations to improve the productivity and efficiency of the company, simplify the organization and streamline decision-making, thereby enhancing client engagement. The restructuring initiative is company-wide. These actions are expected to result in pre-tax charges in […]

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Additions/Deletions for Prescription and OTC Drug Product Lists

FDA News - Thu, 2017-01-12 15:08
The list has been updated through November 2016.
Categories: Industry News

Julian Adams joins Vedantra Pharmaceuticals as executive chairman

Centerwatch - Thu, 2017-01-12 09:29

Vedantra Pharmaceuticals, an immunotherapy company focused on developing products for cancer and infectious disease, has announced the appointment of Julian Adams, Ph.D., as executive chairman. Dr. Adams, who recently stepped down as president of Research and Development at Infinity Pharmaceuticals, will oversee strategic and operational responsibilities, fund raising and drive R&D program development for the […]

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