Johnson & Johnson

NIH partners with 11 biopharmaceutical companies on cancer immunotherapy strategies

Friday, October 13, 2017

The NIH and 11 biopharmaceutical companies launched the Partnership for Accelerating Cancer Therapies (PACT), a five-year public-private research collaboration totaling $215 million as part of the Cancer Moonshot. PACT will initially focus on efforts to identify, develop and validate robust biomarkers—standardized biological markers of disease and treatment response—to advance new immunotherapy treatments that harness the immune system to attack cancer. The partnership will be managed by the Foundation for the National Institutes of Health (FNIH), with the Food and Drug Administration serving in an advisory role. 

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FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

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Conflicts of interest and the clinical investigator

Tuesday, August 1, 2017

A conflict of interest (COI) can erode the judgment of clinical research professionals, leading to questions about their professionalism and integrity. Every professional has a COI. It could be an interest in a promotion, a financial collaboration, or a need to gain more research funding or be published in a medical journal. The May 2, 2017, issue of the Journal of the American Medical Association (JAMA) looked at the issue of COI; one topic addressed biomedical researchers and the difference between financial and nonfinancial possible biases.

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Resolving the conflict between feasibility and relevance

Monday, May 15, 2017

Multi-disciplinary teams tasked with the design of phase III clinical trials face a series of challenges. These include: determining the number of subjects required for statistically meaningful results, the time to complete the trial, budget and regulatory hurdles and guideline implications of the trial design.

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Alexion appoints Ludwig Hantson chief executive officer

Tuesday, March 28, 2017

Alexion Pharmaceuticals announced that its board of directors has appointed Ludwig N. Hantson, Ph.D., as chief executive officer and member of the board of directors, effective immediately. Dr. Hantson most recently served as president and CEO of Baxalta, a spin-off as a public company from Baxter, and a developer of therapies for orphan and underserved diseases in hematology, immunology and oncology. Dr. Hantson brings to Alexion a strong record of developing diverse rare disease pipelines and commercializing innovative and life-transformative therapies at industry-leading companies.

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Califf launches People-Centered Clinical Research Foundation

Wednesday, March 22, 2017

Dr. Robert Califf has launched the People-Centered Research Foundation (PCRF), a new nonprofit organization committed to accelerating people-driven research. PCRF has been created to sustain and expand a national network for clinical research that originated with funding from the Patient-Centered Outcomes Research Institute (PCORI) and studies conducted by the National Patient-Centered Clinical Research Network (PCORnet).

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Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

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Integra LifeSciences to acquire the Codman Neurosurgery Business for $1.04B in Cash

Thursday, February 16, 2017

Integra LifeSciences, a global provider of medical technology, has made a binding offer to acquire the Johnson & Johnson Codman Neurosurgery business for a price of $1.045 billion in cash. Codman Neurosurgery offers a portfolio of devices focused on advanced hydrocephalus, neuro-critical care and operative neurosurgery. If the binding offer is accepted, upon closing, Integra will be a global provider of neurosurgical products.

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