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.’

—Newly released study, ‘The Impact of Mass Shootings on Gun Policy’

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.”

https://www.marketwatch.com/story/walmarts-decision-to-ban-certain-ammunition-fills-vacuum-left-by-lack-of-state-and-federal-laws-2019-09-04?siteid=rss&rss=1

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.

https://www.fiercepharma.com/pharma/bellwether-opioid-trial-nearing-ohio-ag-pushes-for-delay

Daiichi Sankyo Reports Non-Inferiority in Lixiana Clinical Trial for AFib

Daiichi Sankyo announced results from ENTRUST-AF PCI, a trial of its Lixiana (edoxaban) plus a P2Y12 inhibitor compared to vitamin K agonist (VKA) plus P2Y12 inhibitor and acetyl salicylic acid (ASA), or aspirin. The trial was conducted in atrial fibrillation (AF) patients after successful percutaneous coronary intervention (PCI).

The composite endpoint was major or clinically-relevant non-major bleeding over 12 months. AF is an irregular and rapid heartbeat. When this occurs, blood pools and thickens in the chambers of the heart. This causes a greater risk of blood clots, which can break off and travel to the brain and potentially trigger a stroke. It is the most common type of heart rhythm disorder.

ENTRUST-AF PCI enrolled 1,506 patients with AF after a successful stent replacement for ACS or stable CAD. They were randomized to receive either once-a-day Lixiana plus a P2Y12 inhibitor for a year or a VKA in combination with a P2Y12 inhibitor and 100 mg of aspirin.

Major or clinically relevant non-major bleeding occurred in 128 patients in the Lixiana group and 152 in the VKA group. Basically, this showed non-inferiority for the Lixiana combination therapy for this patient population. The company indicates there was “a trend toward less bleeding with edoxaban, though, results did not show statistical superiority.”

“For patients with atrial fibrillation receiving PCI, an antithrombotic treatment strategy that prevents both bleeding and potential coronary events is critical,” said Andreas Goette, Chief Physician, St. Vincez-Hospital Paderborn, Germany, Department of Cardiology and Intensive Care Medicine and the study’s principal investigator.

Goette added, “These results from the ENTRUST-AF PCI study support the use of a dual antithrombotic therapy with edoxaban plus a P2Y12 inhibitor as an alternative option with an equivalent safety profile compared to VKA-based triple therapy, including a P2Y12 inhibitor, plus risk adapted ASA for a duration of one to 12 months.”

Brand name P2Y12 inhibitors include Bristol-Myers Squibb’s Plavix (clopidogrel), Daiichi-Sanyko and Eli Lilly’s Effient (prasugrel), AstraZeneca’s Brilinta (ticagrelor) and Chiesi Farmaceutici’s Kengreal (cangrelor).

All bleeding events observed in the study were consistent across all common bleeding definitions. There were four cases of intracranial hemorrhage in patients receiving Lixiana and nine in the VKA-treated cohort. One patient died from bleeding in the Lixiana group and seven died in the VKA cohort.

ENTRUST-AF PCI is one of more than 10 clinical trials that are part of the Edoxaban Clinical Research Programme. All told, more than 100,000 patients globally are expected to participate in these programs.

“These results reinforce the value of the approved regimen of edoxaban for AF treatment in post-PCI patients, providing the potential for less bleeding compared to current standard-of-care VKA-based triple therapies without significant differences in ischemic events,” stated Hans Lanz, vice president, Global Medical Affairs Specialty & Value Products for Daiichi Sankyo. “ENTRUST-AF PCI is part of the Edoxaban Clinical Research Programme, which is designed to address a broad range of cardiovascular conditions and patient types including the elderly. We are encouraged by these results which represent an important advancement in our understanding of how to best manage AF patients post-PCI.”

https://www.biospace.com/article/daiichi-sankyo-s-lixiana-effective-for-atrial-fibrillation-patients/

Ultragenyx up on positive DTX401 data

Ultragenyx Pharmaceutical (NASDAQ:RARE) is up 10% premarket on light volume in reaction to positive data from the second cohort in its Phase 1/2 clinical trial evaluating gene therapy DTX401 in patients with glycogen storage disease type Ia. The data were presented at SSIEM in Rotterdam.

All three patients responded with improvements in glucose control and other metabolic measures compared to baseline.

Participants in the first cohort (lower dose) continue to experience sustained responses.

The estimated completion date is September 2020.

https://seekingalpha.com/news/3496756-ultragenyx-10-percent-premarket-positive-dtx401-data

FDA gives advanced tag for Magenta cell therapy for inherited metabolic disorders

The FDA designates Magenta Therapeutics’ (MGTA +1.3%) one-time cell therapy MGTA-456 a Regenerative Medicine Advance Therapy (RMAT) for the treatment of multiple inherited metabolic disorders.

RMAT is akin to Breakthrough Therapy status for drugs/biologics. It provides for the accelerated review of the marketing application and more intensive guidance on development.

Phase 2-stage MGTA-456 is designed to stop the progress of the metabolic disorders by providing a high dose of stem cells that regenerate a new immune system in the patient.

https://seekingalpha.com/news/3496769-fda-grants-rmat-tag-magenta-cell-therapy-inherited-metabolic-disorders

Biohaven up 7% on accelerated rimegepant timeline

Biohaven Pharmaceutical Holding Company (BHVN +7.3%) is up, albeit on light volume, in reaction its corporate update that includes an expected FDA nod for migraine med rimegepant in Q1 2020 under Priority Review status.

The company recently filed U.S. applications for Zydis ODT and tablet formulations along with a Priority Review Voucher. The FDA does not intend to hold an advisory committee meeting on the filings so the company expects an action date in Q1 2020 (slide #6).

https://seekingalpha.com/news/3496786-biohaven-7-percent-accelerated-rimegepant-timeline

Merck Gets Euro OK for Keytruda/Inlyta Combo in Renal Cell Carcinoma

Merck & Co. (MRK) on Wednesday said the European Commission approved the company’s cancer drug Keytruda in combination with Pfizer Inlyta for the first-line treatment of patients with advanced renal cell carcinoma, the most common type of kidney cancer.

The Kenilworth, N.J., drug maker said the approval includes patients in all IMDC risk groups.

The European Medicines Agency’s Committee for Medicinal Products for Human Use in July recommended EC approval of the combination, which received clearance from the U.S. Food and Drug Administration in April.

https://www.marketscreener.com/MERCK-AND-COMPANY-13611/news/Merck-and-Gets-Europe-OK-for-Keytruda-Inlyta-Combo-in-Renal-Cell-Carcinoma-29155985/