News Wire

Alirocumab injection (Praluent, Regeneron Pharmaceuticals/Sanofi) reduced the risk of major cardiac events by 15% among patients who had suffered heart attacks and other coronary events in the ODYSSEY OUTCOMES trial. The two companies have announced that they are willing to offer price breaks on the…
Disappointing results in the phase 3 RESULT trial have led Anthera Pharmaceuticals, Inc., to discontinue development of its drug candidate Sollpura for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis. Sollpura failed to meet the trial’s primary endpoint: noninferiority in…
Canagliflozin (Invokana, Janssen Pharmaceutical) significantly reduced the risk of cardiovascular death or hospitalization for heart failure in patients with type-2 diabetes at high cardiovascular risk in an exploratory analysis from the CANVAS clinical program, according to a presentation at the American…
The FDA has  issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. As part of an ongoing effort to prevent…
The FDA has approved a new type of antiretroviral medication for adults living with human immunodeficiency virus (HIV) who have tried multiple medications that are no longer controlling their disease.  Ibalizumab-uiyk (Trogarzo, TaiMed Biologics USA Corp.) is indicated for heavily treatment-experienced…
The FDA has approved the world’s smallest mechanical heart valve to aid in the treatment of congenital defects in newborns. The 15-mm valve size was added to the existing Masters Series Mechanical Heart Valve with Hemodynamic Plus Sewing Cuff (St. Jude Medical). “While larger replacement heart valves…
The FDA has approved the first direct-to-consumer test that can warn users of their increased risk of breast, ovarian, or prostate cancer, but only a small percentage of Americans can reap any benefit. The Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), marketed…
The alarmingly high number of pediatric deaths so far during the 2017–2018 flu season reinforce the need to shift away from the traditional chicken-egg-based approach to mass production of commercial influenza vaccines, according to consultant GlobalData. The egg-based vaccines commonly induce a suboptimal…
FDA Commissioner Scott Gottlieb, MD, criticized pharmacy benefit managers, health insurers, and drug-makers Wednesday for “Kabuki drug-pricing constructs” that profit the industry at the expense of consumers, Reuters reported. The comments, made at a conference organized by a leading U.S. health…
The American College of Physicians (ACP) has issued new guidance that adults with type-2 diabetes can aim for an easier-to-achieve blood sugar target than what’s been used to guide treatment in the past, according to a Reuters report. But that advice is already controversial. Based on its review of…
The FDA has approved a supplemental biologics license application updating the dosing schedule of nivolumab (Opdivo, Bristol-Myers Squibb) to include 480 mg infused every four weeks (Q4W) for a majority of approved indications. This approval will give health care professionals the flexibility to customize…
Researchers have found that temporarily increasing the dosage of inhaled steroids when asthma symptoms begin to worsen does not effectively prevent severe flare-ups and may be associated with slowing a child’s growth, challenging a common medical practice involving children with mild-to-moderate asthma.…
A one-month antibiotic regimen to prevent active tuberculosis (TB) disease was at least as safe and effective as the standard nine-month therapy for people living with human immunodeficiency virus (HIV) infection, according to the results of a large international clinical trial. Adults and adolescents…
Newly released phase 3 results have shown that lanadelumab, Shire plc’s experimental hereditary angioedema (HAE) drug, reduced monthly attack rates and improved quality of life compared with placebo. Recently presented at the 2018 American Academy of Allergy, Asthma, and Immunology meeting, the data…
A federal judge in New York on Monday ordered Martin Shkreli, the former drug company executive convicted of defrauding investors, to forfeit $7.36 million in assets, which could include a Picasso painting and a one-of-a-kind album by the Wu-Tang Clan. U.S. District Judge Kiyo Matsumoto in Brooklyn…

Pages