Shire plc (LSE: SHP, NASDAQ: SHPG), the global biotechnology leader in rare diseases, announced the U.S. Food and Drug Administration (FDA) awarded Orphan Drug Designation(ODD) to Shire`s gene therapy candidate SHP654 (also designated as BAX 888), an investigational factor VIII (FVIII) gene therapy for the treatment of hemophilia A. The regulatory agency also granted Shire investigational new drug (IND) status for SHP654.
The NIH has amended its definition of clinical trials to include brain studies, introducing new regulations considered unnecessary by many researchers.
Researchers at the University of Illinois at Urbana-Champaign have developed technology that enables a smartphone to perform lab-grade medical diagnostic tests that typically require large, expensive instruments. Costing only $550, the spectral transmission-reflectance-intensity (TRI)-Analyzer from Bioengineering and Electrical & Computer Engineering Professor Brian Cunningham’s lab attaches to a smartphone and analyzes patient blood, urine, or saliva samples as reliably as clinic-based instruments that cost thousands of dollars.
The NHS will fund gene therapy for the first time, with a £500,000 treatment for “bubble baby syndrome”.
Researchers are one step closer to a new drug that could lower blood glucose levels in patients with insulin resistance, but without the potentially harmful side effects.
New research published in the European Heart Journal suggests that blood-thinning drugs such as warfarin may protect not only against stroke, but also against dementia in people who have atrial fibrillation.
The FDA this week released a warning letter it sent to UVLrx Therapeutics over issues with an unapproved study of an intravascular catheter, citing failures to obtain approval for the trial alongside a number of other violations.
Now, in a new study published today in Nature, UNC researchers report a breakthrough. They have used single cell RNA sequencing technology in combination with mathematical modeling and genetic and chemical approaches to delineate the step-by-step molecular changes that occur during cell fate conversion from fibroblast to cardiomyocyte.
AbbVie (ABBV), a global biopharmaceutical company, and Alector, a privately owned biotechnology company, announced a global strategic collaboration to develop and commercialize medicines to treat Alzheimer's disease and other neurodegenerative disorders.
The FDA has cleared Abbott’s smartphone-compatible insertable cardiac monitor (ICM), the first and only device of its kind in the U.S. This provides patients and physicians with another way to monitor and diagnose abnormal heart rhythms.
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