February 15, 2018 In their petition, representatives from the Association of State and Territorial Health Officials, National Safety Council, Physicians for Responsible Opioid Prescribing, American College of Medical Toxicology and Coalition to End the Opioid Epidemic urged the FDA that the risks of ultra-high dose opioids (UHDU) aren’t worth “modest” benefits. Citing potential for misuse … Read more
February 13, 2018 The app, dubbed BilliScreen, uses computer vision algorithms and machine learning algorithms to detect jaundice in a photo of a person’s eyes. Specifically, it measures elevated levels of bilirubin in the sclera, the white part of the eye. Jaundice, an early symptom of pancreatic cancer and a number of other diseases, is … Read more
February 08, 2018 Sixty-five percent (65%) of girls and 56% of boys received at least one dose of the HPV shot in 2016, according to the CDC. However, only 43% of teens completed the schedule. The Agency maintains more work needs to be done to further boost HPV vaccination rates. Rates lagged in rural areas … Read more
February 01, 2018 U.S. Marshals seized five (5) vials of the vaccine, a controlled substance known as ACAM2000, which contains live virus. The drug regulator said the vaccine, in “excess amounts,” was mixed with stem cells derived from body fat to create a potentially dangerous treatment. The unapproved therapy was marketed by San Diego-based StemImmune … Read more
January 30, 2018 A team of researchers at the University of California San Diego School of Medicine has discovered an existing drug that does just that. The drug is cyclosporine, which is typically prescribed to organ transplant patients to prevent rejection. Cyclosporine tips the balance in favor of memory CD8+ T cells by activating the … Read more
January 25, 2018 Mutations in the MECP2 gene can cause abnormal expression of the MeCP2 protein. Instead of attacking the gene mutation, a team led by Laura Lombardi, a postdoctoral researcher at Baylor College of Medicine, tried to indirectly influence the abundance of the protein in nerve cells. Using a cell culture-based method, the team … Read more
January 18, 2018 He resorted to Twitter in August 2017 to take a clear stand after press reports revisited President Donald Trump’s plans for a vaccine safety commission, which vaccine skeptic Robert F. Kennedy Jr. supported early on in the Trump administration. Top FDA officials had met with Kennedy, just not Gottlieb himself. Lyndsay Meyer, an FDA spokeswoman, … Read more
January 16, 2018 In a new report, the financial news service found that biotech deals in 2017 “are on pace for almost half the yearly totals of the past two years,” with just $11.5 billion in takeovers made by August 2017, half the total over the 24 months prior. And Bloomberg adds that global biotech … Read more
January 11, 2018 “At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using its Emergency Use Authorization authorities,” said FDA Commissioner Scott Gottlieb, M.D. “By providing … Read more
January 09, 2018 The study, details of which were published in the Journal of the American Medical Association, looked at the 22 drugs that won accelerated approvals in 24 indications between 2009 and 2013. About two-thirds (2/3) of the trials that generated data to support these approvals lacked control arms, reflecting the FDA’s then-emerging willingness … Read more