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DBV Technologies, a clinical-stage specialty biopharmaceutical company, has announced the completion of its End-of-Phase II meeting with the FDA. The outcome of this meeting on the clinical development plan for Viaskin Peanut is consistent with the previously announced positive opinion of the Pediatric Committee of the EMA on Viaskin Peanut’s Pediatric Investigation Plan (PIP).
The EMA has granted Orphan Drug designation to a gene transfer therapeutic currently in clinical development in the U.S. for the treatment of type 1 spinal muscular atrophy (SMA). AveXis, a gene therapy company developing treatments for rare and life-threatening genetic diseases, received Orphan Drug designation for SMA in the U.S. in Oct. 2014.
Pfizer has announced that the first patient has been enrolled in the RESET (Rivipansel: Evaluating Safety, Efficacy and Time to Discharge) study—a phase III clinical trial assessing the efficacy and safety of rivipansel for the treatment of vaso-occlusive crisis in hospitalized individuals with sickle cell disease who are 6 years of age or older.
Broad Institute of MIT and Harvard is teaming up with Google Genomics to explore how to break down major technical barriers that increasingly hinder biomedical research by addressing the need for computing infrastructure to store and process enormous datasets, and by creating tools to analyze such data and unravel long-standing mysteries about human health.
Caladrius Biosciences, a cell therapy company with a late-stage clinical program for immuno-oncology, has finalized its corporate name change from NeoStem to Caladrius.
Huntingdon Life Sciences (HLS) and Harlan Laboratories, a U.K. CRO, have announced that the combined companies will be called Envigo.
Claritas Genomics, a Cambridge, Mass.-based genetic diagnostic laboratory, and Genetic Alliance, a nonprofit health advocacy organization based in Wash. D.C., announced a partnership to help patients and families find and participate in relevant research opportunities that will advance understanding of individual genetic disorders and development of new therapies.
The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.
PrimeGen Biotech, a privately-held research firm, has opened a new 10,000 square-foot research facility located in Santa Ana, Calif. Founded by co-founder of AST Computers and former CEO of SRS Labs, Thomas C.K. Yuen plans to utilize PrimeGen's new research facility and his experience in marketing technologies to lead PrimeGen's team of research scientists in the discovery of new breakthroughs in stem cell science, and bringing advanced treatments of degenerative and aging related diseases to market.
The Society for Clinical Research Sites (SCRS), a global trade organization representing the interests of clinical research sites, has announced an invigorated, solution-driven program for the 10th Annual Global Site Solutions Summit. The Summit will be Oct. 8-11, in Amelia Island, Fla. The annual meeting, which attracts investigators, site executives and industry executives from around the globe, is inclusive of interactive sessions, knowledge and best practice sharing, and networking opportunities, centered around the collaboration-focused theme “Better Together.”
Juniper Pharma Services, a contract development and manufacturing organization (CDMO) subsidiary of Juniper Pharmaceuticals, has entered into a long-term collaboration with OxSonics to support the development, scale-up and GMP manufacturing of OxSonics' proprietary "sono-sensitive particles." OxSonics was established in July 2013 to develop and commercialize therapeutic ultrasound advancements invented at the University of Oxford's Institute of Biomedical Engineering.
Roche has launched a new Africa Strategy in an effort to expand its footprint in parts of the continent.
The National Institutes of Health has announced the appointment of eight individuals to the NIH Council of Councils. The council was established to advise the NIH director on policies and activities of the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), including making recommendations on research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis or would otherwise benefit from strategic planning and coordination.
The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced the election of five of its newest members to its board of directors.
CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service CRO, is collaborating with Cincinnati, Ohio-based Xavier University on a new Master’s program.
ZEISS is participating in a new public-private partnership with University of California Berkeley as part of the Brain Microscopy Innovation Center (BrainMIC), a component of the Berkeley BRAIN Initiative. The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative was launched by President Obama in 2013 and is focused on revolutionizing understanding of the human brain, with the goal of helping researchers uncover the mysteries of such brain disorders as Alzheimer’s and Parkinson’s diseases, depression and traumatic brain injury.
FDA Drug Safety Communication: FDA determines 2013 labeling adequate to manage risk of retinal abnormalities, potential vision loss, and skin discoloration with anti-seizure drug Potiga (ezogabine); requires additional study
[06-16-2015] Based on reviews of additional safety reports from patients treated with the anti-seizure drug Potiga (ezogabine), the U.S. Food and Drug Administration (FDA) has determined that the potential risks of vision loss due to pigment changes in the retina and of skin discoloration can be adequately managed by following the current recommendations in the Potiga labeling.
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA aprueba los cambios en la etiqueta para el medicamento anticonvulsivo Potiga (ezogabine) que describen el riesgo de anormalidades de la retina, pérdida potencial de la visión y decoloración
[15-06-2015] En base a las revisiones de informes adicionales de seguridad de pacientes tratados con el medicamento anticonvulsivo Potiga (erzogabine), la Administración de Alimentos y Medicamentos de Estados Unidos (FDA, por sus siglas en inglés) ha determinado que los riesgos potenciales de pérdida de visión debido a cambios en la pigmentación de la retina y decoloración de la piel pueden ser manejados adecuadamente siguiendo las recomendaciones actuales en la etiqueta de Potiga.
Teva Pharmaceutical Industries and Microchips Biotech, a Lexington, Mass.-based provider of microchip-based implants, have entered into a partnership to explore innovative ways to apply Microchips Biotech’s implantable drug delivery device to Teva’s portfolio of products with the goal of enhancing clinical outcomes for patients on chronic drug therapies.