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The Academy of Medical Royal Colleges has released a statement on the proposed Medical Innovation Bill.
Array BioPharma, based in Boulder, Colo., has reached a definitive agreement with Novartis Pharma to acquire worldwide rights to encorafenib (LGX818), a BRAF inhibitor currently in phase III development. This agreement is conditional on the closing of transactions announced by Novartis and GlaxoSmithKline on April 22, 2014, which are expected to close in the first half of 2015, and the agreement remains subject to the receipt of regulatory approvals.
Status: Not yet recruiting, Condition Summary: Alzheimer's Disease
Study of the Safety and Effectiveness of Two Doses of Investigational Study Drug EVP-6124 in Subjects With Alzheimer's Disease
Status: Recruiting, Condition Summary: Alzheimer's Disease; Dementia
Labeling for Bronchodilators: Cold, Cough, Allergy, Bronchodilator, And Antiasthmatic Drug Products for Over-the-Counter Human Use (Small Entity Compliance Guide)
Over-the-Counter; Small Entity Compliance Guide
CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has removed the partial clinical hold on the company's aldoxorubicin clinical trials. Enrollment and dosing of new patients now is permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.
VolitionRx, a Belgium-based life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has signed an agreement to commence a pilot ovarian cancer study in collaboration with Singapore General Hospital (SGH). Blood and tissue samples collected from 40 patients will be assessed to establish the feasibility of VolitionRx's proprietary NuQ assays in detecting ovarian cancer. If this test proves to be accurate, it could offer hope as an early-stage screening tool.
The list has been updated through December 2014.
The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).
INC Research Holdings, a, global phase I to IV CRO based in Raleigh, N.C., has announced the promotions of Alistair Macdonald and Michael Gibertini, Ph.D., to key roles within the C-suite.
The Dr. Paul Janssen Award for Biomedical Research has opened its 2015 call for nominations. This prestigious award recognizes individuals whose scientific research has made, or has the potential to make, significant contributions toward the improvement of human health.
Continuum Clinical, a healthcare research and communications company, has added U.K.-based industry veteran Elaine Ferguson to its leadership team as the global practice lead, medical communications. The move expands Continuum Clinical’s Medical Communications practice, while also adding to the company’s global presence.
med fusion, an integrated Molecular Center of Excellence and clinical trials service organization headquartered in Lewisville, Texas, has released its solid tumor molecular profiling testing services (SEQ) enhanced by next generation sequencing (NGS) technology. The introduction of NGS will further enable physicians to interrogate their patient’s tumor at the molecular level in order to develop a personalized treatment plan according to the genetic makeup of their specific tumor.
AbbVie, a global research-based biopharmaceutical company based in North Chicago, Ill., has opened the AbbVie Innovation Center on campus at the University of Illinois Research Park in Urbana-Champaign.
Silicon Valley Biosystems (SV Bio) has changed its name to Lifecode. The new name is consistent with the company's mission to improve the lives of patients by providing concise, accurate and actionable molecular information. Lifecode also has released its flagship next generation sequencing (NGS)-based oncology assay, the Pan Cancer Somatic Panel (PCSP), to a select group of physicians nationwide in advance of a broad launch later this spring.
Curis, a Lexington, Mass.-based biotechnology company focused on the development and commercialization of innovative drug candidates for the treatment of human cancers, and Aurigene Discovery Technologies, a Bangalore, India-based, specialized, discovery stage biotechnology company developing novel therapies to treat cancer and inflammatory diseases, have entered into an exclusive collaboration agreement focused on immuno-oncology and selected precision oncology targets.
Zymeworks, a privately held biotherapeutics company based in Vancouver, has formed a collaboration and licensing agreement with Celgene for the research, development and commercialization of bi-specific antibody therapeutics enabled using Zymeworks’ proprietary Azymetric platform.
The public consultation on how the transparency rules of the European Clinical Trial Regulation will be applied in the new clinical trial database has been launched by the EMA. Stakeholders are invited to send their comments before Feb. 18.
The EMA has published a guide to support the implementation of a new international standard for the safety monitoring of medicines in the E.U. The so-called ISO ICSR standard improves the reporting of suspected side effects of medicines in Individual Case Safety Reports (ICSRs). The use of the new international standard will take effect on July 1, 2016.
Status: Recruiting, Condition Summary: Alzheimer's Disease