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Drugs Approvals and Trials

NIH Begins Early Human Clinical Trial of VSV Ebola Vaccine

​ Human testing of a second investigational Ebola vaccine candidate is under way at the National Institutes of Health’s Clinical Center in ...

Drug for Rare Blood Disorder Developed at Penn Receives Orphan Drug Status from European Union

PHILADELPHIA — A Penn Medicine-developed drug has received orphan status in Europe this week for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), ...

FDA approves U-M-invented drug for Gaucher disease

ANN ARBOR, Mich. — Cerdelga, a treatment for Gaucher disease type 1 developed at the University of Michigan Medical School and licensed to Genzyme Corp., has been approved by the U.S. Food and Drug Administration. ... Full story

Patient at Royal Manchester Children’s Hospital first to take part in trial of new treatment for rare inherited disease

Researchers at The Royal Manchester Children’s Hospital and The University of Manchester have recruited the first child into a new study, which aims to evaluate the clinical effectiveness of a treatment developed in Manchester. Funded by charity, The Society for Mucopolysaccharide Diseases (The MPS Society)*, the study could alter the lives of patients with Sanfilippo Disease – a fatal inherited condition which causes progressive dementia in children. ... Full story

FDA expands approved use of Imbruvica for chronic lymphocytic leukemia

The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. ... Full story

Study to investigate whether ibuprofen can reverse the effects of emphysema

Temple University Hospital (TUH) is participating in a nationwide phase II clinical trial that is testing the possibility that ibuprofen can reverse the effects of emphysema. ... Full story

New Technologies Fuel Patient Participation and Data Collection in Research

By Duke Medicine News and Communications - DURHAM, N.C. – The changing dynamic of health studies driven by “big data” research projects will empower patients to become active participants who provide real-time information such as symptoms, side effects and clinical outcomes, according to researchers at Duke Medicine. ... Full story

Vulnerable need pre-trial counselling, say experts

Counsellors need more support to ensure they feel able to give victims of sexual abuse pre-trial counselling, experts will say at an event at The University of Manchester on July 8. ... Full story

FDA approves Beleodaq to treat rare, aggressive form of non-Hodgkin lymphoma

The U.S. Food and Drug Administration today approved Beleodaq (belinostat) for the treatment of patients with peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL). The action was taken under the agency’s accelerated approval program. ... Full story

Sickle cell drug passes early phase trial

(SACRAMENTO, Calif.) - A potentially groundbreaking investigational drug designed to treat the painful vaso-occlusive crises that are the hallmark of sickle cell disease has been found to be safe following a clinical trial at UC Davis. ... Full story

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