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FDA Drug Safety Communication: FDA warns of serious skin reactions with the anti-seizure drug Onfi (clobazam) and has approved label changes
The U.S. Food and Drug Administration (FDA) is warning the public that the anti-seizure drug Onfi (clobazam) can cause rare but serious skin reactions that can result in permanent harm and death.
Proteostasis Therapeutics, developing novel therapeutics that regulate protein homeostasis aimed at helping to improve outcomes for patients with orphan and neurodegenerative diseases, has entered into a worldwide collaboration with Biogen Idec to research and develop therapeutic candidates based on the inhibition of Usp14.
The Jain Foundation, a nonprofit organization whose mission is to cure muscular dystrophies caused by dysferlin protein deficiency, has signed a Master Service Agreement with Cellular Dynamics International (CDI), a developer of next-generation stem cell technologies for drug development, cell therapy, tissue engineering and organ regeneration.
The Biomedical Research Alliance of New York (BRANY), a national organization providing expedited end-to-end solutions for clinical trials support to sponsors and investigators, and the nonprofit Alliance for Clinical Research Excellence and Safety (ACRES), have announced a strategic alliance.
European CRO Venn Life Sciences has acquired Medevol, a CRO based in Northern Ireland, for a total maximum consideration of $1.1 million.
Certara, a provider of software and scientific consulting services to improve productivity and decision-making from drug discovery through drug development, has partnered with LabLogic Systems, an instrument and software provider supporting PET/nuclear medicine facilities, pharmaceutical companies, agrochemical research, universities and CROs, to integrate Certara’s Phoenix WinNonlin pharmacokinetic (PK)/pharmacodynamic (PD) modeling and non-compartmental analysis product with LabLogic’s Debra Laboratory Information Management System (LIMS).
Johnson & Johnson Innovation is collaborating with two Canadian early-stage drug technology development centers to identify and advance biopharmaceutical technologies: Montreal-based NEOMED, a nonprofit, public-private pharma alliance dedicated to drug discovery and development; and Toronto-based MaRS Innovation, the commercialization agent for Ontario’s discovery pipeline from 16 academic institutions,
CRO Algorithme Pharma has partnered with Hôpital Maisonneuve-Rosemont (HMR). The HMR clinical research team includes over 60 clinicians and is supported by 75 employees and 75 graduate students and postgraduates. Together, they form an experienced network working in hematology, oncology, nephrology, ophthalmology and metabolic diseases.
Centro Ricerche Cliniche di Verona (CRC), an early phase CRO, has become the first organization to be accredited under a new scheme of quality certification conducted by the European CROs Federation (EUCROF).
Forest Laboratories, a specialty pharmaceutical company focused on the U.S., has announced appointments to its executive leadership team as part of its plans to flatten and broaden the organization during Project Rejuvenate.
Comunicado de la FDA sobre la seguridad de los medicamentos: FDA advierte de graves reacciones de la piel con el medicamento anticonvulsivo Onfi (clobazam) y ha aprobado cambios a la etiqueta
La tercera de diciembre, 2013, La Administración de Alimentos y Medicamentos de Estados Unidos (FDA por sus siglas en inglés) le advirtió al público que el medicamento anticonvulsivo Onfi (clobazam) puede causar graves reacciones de la piel que son poco comunes y que pueden resultar en daño permanente y muerte.
Covidien, a global healthcare products company, will acquire all of the outstanding shares of Given Imaging, a provider of technology platforms for visualizing, diagnosing and monitoring the digestive system, for $30 per share in cash, for a total of approximately $860 million. Covidien intends to finance the transaction through cash on hand.
New England-based CRO Agilux Laboratories, a provider of drug metabolism and pharmacokinetics (DMPK) services to sponsors, has expanded its in vivo pharmacokinetics services to support clients' demands and increased service requirements. The space expansion will allow Agilux to significantly increase its capacity and volume, while maintaining fast study starts.
Johnson & Johnson Innovation, London, has formed a network of partnering offices across U.K. life science clusters. The offices function as extensions of its London Innovation Center, to work with academics and entrepreneurs throughout the U.K. to identify early stage innovation and support the translation of research into new products for patients.
Policy, medical training and clinical practice have failed to adapt to a significant increase in the number of patients taking multiple prescription drugs, according to a new report on taking numerous prescription drugs (polypharmacy) and medicines optimization by The King’s Fund.
AstraZeneca will donate its Environmental Laboratory in Brixham to Plymouth University to ensure the lab continues to serve scientific and research purposes.
The National Institute for Health Research (NIHR) Clinical Research Network has decreased the time it takes for studies funded by non-commercial organizations, such as charitable organizations and academic institutions, to be included in the NIHR Portfolio of research.
The Medicines Company has acquired Rempex Pharmaceuticals, a company with multiple potential new therapies focused on multi-drug resistant gram-negative bacteria.