Ivantis has secured approval from the FDA for its Hydrus Microstent, designed to be used in conjunction with cataract surgery for the treatment of mild to moderate primary open-angle glaucoma. The approval was backed by results from a 556-patient trial, which showed improved outcomes for patients who underwent cataract surgery with the device at 24 months, compared with use of surgery alone.
EKF Diagnostics Holdings and McKesson Medical-Surgical have entered a US distribution agreement for EKF's DiaSpect Tm reagent-free hemoglobin analyzer. The device will be offered under the McKesson Consult Hb brand.
Clinical laboratories could provide help in different models of home-based health care programs, such as performing laboratory testing, advising on pre-analytical factors, certifying operators, choosing and validating the appropriate devices, guiding integration of results into the electronic medical record, managing IT connectivity, maintaining appropriate quality control and quality assurance procedures, and performing regular reviews of standard operating procedures.
A gene-based risk-scoring system for coronary artery disease could also be used to evaluate the risk for breast cancer, inflammatory bowel disease, type 2 diabetes and atrial fibrillation in people of European ancestry, researchers report in Nature Genetics. The researchers analyzed previous genetic studies, identified minor genetic variations associated with any of the five diseases, and developed an algorithm to determine cumulative effects and generate a "polygenic risk score."
More treatments for neglected tropical diseases were developed after Congress enacted legislation allowing priority review vouchers; however, the program has had a much larger effect on development of malaria and tuberculosis drugs, compared with drugs for other tropical diseases, according to a study in PLOS. High development costs and failure rates along with declining prices for priority review vouchers might reduce research and development of these drugs, the researchers wrote.
Sekar Kathiresan, director of the Cardiovascular Disease Initiative at the Broad Institute, wants to make a system for evaluating heart attack risk freely available. The risk-scoring system is based on 6.6 million single-letter genetic mutations often found in people who have had a heart attack at a relatively young age, and Kathiresan wants people who have already used direct-to-consumer genotyping services to submit their data to a portal he is building.
The first patient was dosed in a late-stage trial of BeiGene's tislelizumab in combination with chemotherapy, being assessed in China as a treatment of stage IIIB or stage IV squamous non-small cell lung cancer. The study will evaluate progression-free survival as assessed by the Independent Review Committee.
The FDA has extended the deadline for the submission of unique device identifier data into the Global Unique Device Identification Database by manufacturers of biologic-device or drug-device combination products that go through the Center for Drug Evaluation and Research to Sept. 24, 2019. The agency said more time is needed to update the database system, although these products still have to adopt UDI on their labeling by Sept. 24. of this year.
Researchers in Switzerland and the UK found that type 2 diabetes patients who used an artificial pancreas had significantly better blood glucose levels, 8.6 mmol/L on average, compared with 10.4 mmol/L among those in the control group. The findings in The New England Journal of Medicine, based on 136 adult diabetes patients, revealed no severe hypoglycemia episodes and no significant differences for hypoglycemia between the two groups.
FDA Commissioner Scott Gottlieb said on Twitter the agency will release more detailed information on the meaning of food packaging terms to help consumers better understand them. A recent op-ed article in The Wall Street Journal discussed the roughly $47 billion-a-year organic industry, claiming the FDA purportedly allows "blatantly false and deceptive advertising claims."