Knocked back by a complete response letter (CRL) in late 2018, Trevena Inc. dusted itself off, resubmitted its NDA for oliceridine and found satisfaction as the FDA has approved the opioid agonist.
Tony McKinney, the founder and CEO of Ethismos Research Inc., has worked with the small molecule he plans to take into the clinic this year for the past 10 years. All the while he’s used the same support group of personnel to develop the molecule. Sometimes that group works and sometimes it’s on hiatus.
What with the lawsuits, declining prescriptions and approval hurdles that seem to be the U.S. answer to a nationwide opioid epidemic, drug companies have to think long and hard before spending the resources to develop yet another opioid drug. And patients are paying the price.
The hormone prolactin is known for and named after its role in breastfeeding. But that is far from its only role. There are more than 300 identified functions of prolactin, which is present in both men and women, though women have higher levels, and extremely high levels late in pregnancy and during breastfeeding. Now, scientists at the University of Arizona have identified another function of prolactin signaling.
As a word to the wise in a week filled with FDA advisory committee meetings on potential new opioid drugs, the state of Oklahoma filed a lawsuit Monday against three distributors, reminding everyone in the U.S. opioid prescription supply chain of the risk of litigation and hefty penalties.
Saluda Medical Pty. Ltd., of Artarmon, Australia, made waves in 2019, winning the CE mark for its Evoke closed-loop spinal cord stimulation (SCS) system. The good news kept coming following the publication of results from a pivotal study in The Lancet Neurology.
PERTH, Australia – Australia’s Therapeutic Goods Administration is putting in place a number of opioid reforms to clamp down on the use of opioids to deal with increasing deaths and hospitalizations from the use of those drugs.
For biopharma, 2019 can be described as a terrific year – with a few asterisks. The financial markets were flourishing, with venture capital dollars, in particular, flowing to the sector, while dealmaking reached historic proportions. Meanwhile, scientific breakthroughs led the way as cell and gene therapies gained ground, the first signs of success emerged with new technologies like CRISPR and the long-awaited promise of genomics found its way to the front lines of health care.
With little more than a month to go before a trial begins in a multidistrict litigation (MDL) against several opioid manufacturers, privately owned Purdue Pharma LP is continuing its efforts to settle with all the plaintiffs involved.
Telehealth and telemedicine have been slow to catch on for a number of reasons, but the U.S. Federal Communications Commission (FCC) has proposed a pilot program to increase the use of telemedicine for low-income Americans and military veterans. While access to broadband services is still an issue for many, the so-called Connected Care Pilot drew support from a range of stakeholders, who argued that telehealth is critical to managing public health crises, such as diabetes and the opioid epidemic.
