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Wednesday, September 4, 2019
Allergan: FDA OKs Juvederm VOLUMA XC for Mid-Face Injection via Cannula
Allergan plc (NYSE: AGN) announced today it received U.S. Food and Drug Administration (FDA) approval for the use of Juvederm VOLUMA XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDE cannula for cheek augmentation to correct age-related volume deficit in the mid-face in adults over 21.
A cannula is a thin, flexible tube with a rounded tip that can serve as an effective delivery system. Use of a cannula allows for injection of Juvederm VOLUMA XC in the cheek area. The TSK STERiGLIDE has a unique design compared to other cannulas available on the market and features a patented tip design with a near-tip delivery port for precise product placement.
Walmart ban on some ammunition fills vacuum left by lack of state, federal laws
Weeks after a gunman killed 22 people at a Walmart in Texas, the company announced that it would stop selling handgun ammunition and wind down its sales of handguns.
The company introduced this new policy on firearms while state lawmakers have stalled on the issue of gun control, despite the multiple mass shootings in recent months.
“It’s clear to us that the status quo is unacceptable,” Walmart CEO Doug McMillon wrote Tuesday, days after a separate shooting Saturday in Odessa and Midland, Texas that killed seven people.
“We encourage our nation’s leaders to move forward and strengthen background checks and to remove weapons from those who have been determined to pose an imminent danger,” he said.
‘A mass shooting roughly doubles the number of laws enacted in a year that loosen gun restrictions in states with Republican-controlled legislatures.’
State-level firearm bills between 1990 and 2014 have a passage rate of just 15.6%, according to researchers at Harvard Business School and University of California, Los Angeles.
Researchers looking into the impacts of mass shootings said there were 20,409 firearm bills introduced in state legislatures between 1990 and 2014, but only 3,199 became laws.
One mass shooting leads to a 15% increase in state-level firearm bills within a year of the event, they said. The study counted a mass shooting as an attack that kills at least four people.
Republicans, tending towards loosened rules, introduced 48% more firearm-related bills in the year after a mass shooting, according to the study. Democrats, tending towards tighter rules, introduced 11% more bills researchers said.
In fact, “a mass shooting roughly doubles the number of laws enacted in a year that loosen gun restrictions in states with Republican-controlled legislatures.”
There wasn’t any statistically significant spike in new gun laws in Democrat-controlled statehouses, according to the study, which was distributed this week by the National Bureau of Economic Research.
There are more than 30,000 gun fatalities a year, the study said. More than half (56%) are suicides and 40% are homicides, the researchers said. Between 1989 and 2014, mass shootings accounted for 0.13% of all gun deaths, they added.
Given those numbers, mass shootings appear to have “outsized influence,” on when lawmakers have decided when to act during that lengthy span from 1990 to 2014, the researchers wrote.
In addition to taking handgun ammunition off its shelves and stopping handgun sales in Alaska — which close out the retailer’s sales of handguns — Walmart is also asking shoppers not to bring their guns into stores even if state laws allow “open carry.”
With bellwether opioid trial nearing, Ohio attorney general pushes for delay
Many inside and outside the pharma industry are anticipating an October bellwether trial testing claims against opioid drugmakers and distributors, but Ohio’s attorney general Dave Yost is seeking to put a hold on that trial.
In a new court filing (PDF), Yost argues the lawsuits that are set to be tried—brought by Ohio’s Cuyahoga and Summit counties—ignore the needs of the rest of the state. He’s asking the court to halt the trial until the state’s own opioid lawsuits go to trial, and he says Supreme Court precedent backs his argument.
Ohio sued opioid drugmakers and distributors in 2017 and 2018, respectively, in state courts, Yost writes. The counties sued several months after the state’s lawsuit, but now the counties’ claims are set to be tried first in a federal court.
Yost listed a number of issues with the way the proceedings are playing out, including that “the hardest-hit counties of Appalachia and the vast majority of the state are being asked to take a number and wait—and that wait could delay or prevent justice.”
Yost argues his lawsuits are “poised to bring comprehensive statewide relief, accountability, and remediation to the citizens of Ohio for their past, present, and future injuries.” On the contrary, the counties “advance claims that belong to the State in an effort to commandeer moneys that rightfully should be distributed across the state by Ohio,” the attorney general writes.
Aside from those arguments, Yost writes that the trial would fragment claims and could result in inconsistent verdicts, duplicate or overlapping damages and misallocated funds.
As it stands, Cuyahoga and Summit counties are set to be the first localities to air their arguments against opioid drugmakers and distributors in a seven-week trial scheduled for Oct. 21. The counties are asking for $8 billion in damages.
Yost’s filing comes after Endo and Allergan inked deals worth $11 million and $5 million, respectively, to resolve the claims from the counties. After those deals, Yost said the companies would still face claims from the state.
In all, about 2,000 cities, counties and other localities have sued opioid drugmakers and distributors, arguing drug companies oversold opioids’ benefits for treating chronic pain and downplayed their risks. Distributors didn’t monitor suspicious orders, plaintiffs say. Together, the conduct helped create a national opioid and addiction crisis, they add.
Separately, Oklahoma sued Johnson & Johnson, Teva and Purdue over a claim their opioid marketing led to a public nuisance. The state secured $355 million in settlements from Purdue Pharma and Teva and a $572 million verdict against J&J. J&J said it’ll appeal.
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