The FDA approved RiVive, an over-the-counter version of naloxone nasal spray from Harm Reduction Therapeutics. It’s the second such approval from the FDA this year, following an affirmative decision in March for OTC Narcan.
More restrictive opioid prescribing guidelines were put in place in a rightful effort to stop a devastating crisis. But this sudden and dramatic change negatively impacted chronic pain patients who were managing their pain through prescription opioids given few other effective options.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
As the pandemic rages on, the other major public health crisis in recent history has not ebbed. The opioid epidemic is worsening, but providers have kept their eye on the ball and are continuing their efforts to treat opioid use disorder and curb unnecessary prescriptions. Here is a snapshot of those efforts.
Covid-19 may have hampered investigations and led authorities to shift resources to more obvious frauds, attorneys said. But the pandemic also created new targets to investigate, including telemedicine and CARES Act funding.
Practice Fusion will pay $145 million to resolve criminal and civil allegations that it received kickbacks from an unnamed pharmaceutical company in exchange for building a clinical decision support system that could influence opioid prescriptions. The system generated more than 230 million alerts between 2016 and 2019, according to court documents.
The Israeli drugmaker, plus AmerisourceBergen, Cardinal Health and McKesson, reached the settlement with Ohio's Cuyahoga and Summit counties. Walgreens did not manage to reach an agreement.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Shares of the company fell 40 percent Thursday following a story late Wednesday afternoon by Bloomberg, which reported that a bankruptcy filing was a potential option.
In a regulatory filing, the company said that the postponement was not unique to NKTR-181, though it may result in a delay in the FDA's approval decision for the drug.
Reuters reported Monday that the maker of OxyContin was considering the filing so that it could negotiate claims with plaintiffs in about 2,000 lawsuits regarding the drug.
The Boston-based company said it would not pursue a planned IPO, citing "market conditions." Nasdaq had agreed to its listing on Tuesday.
We will highlight Build My Health's revenue practice management tools, which could help physician practices add up to $250,000 to their practices.
Briefing documents from the Psychopharmacologic Drugs Advisory Committee earlier this week had cast doubt on the chances of a positive vote.
The Psychopharmacologic Drugs Advisory Committee will meet on Thursday to vote on whether to recommend the FDA approve the drug, ALKS 5461, an opioid for major depressive disorder.
The $50,000 challenge was sponsered by the Robert Wood Johnson Foundation to help find a tech-enabled approach to addressing substance abuse of opioids.
In the past, organs exposed to hepatitis C were typically discarded or given only to patients who already had the illness. Using them in patients who don’t have the virus could shorten the transplant wait time for hundreds of patients each year.
New research of more than 800 clinicians found those who knew about a patient's overdose death cut the overall volume of opioids they prescribed by almost 10 percent over three months.