FDA halts use of 2 treatments found to be ineffective against omicron
WASHINGTON — U.S. regulators restricted the use of a pair of COVID-19 monoclonal antibody therapies after scientific evidence suggested they are unlikely to be effective against the omicron variant.
The Food and Drug Administration said in a statement on Monday that it had decided to limit access to the treatments, which are made by Eli Lilly & Co. and Regeneron Pharmaceuticals Inc., amid the recent surge in omicron infections. The variant, which was first detected last year in southern Africa, now accounts for nearly all new cases of COVID-19 in the U.S.
“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
As a result of the FDA’s decision, the federal government will pause shipments of the drugs.
Monoclonal antibody therapies at one time were considered a pandemic-fighting breakthrough and characterized by top health officials as a bridge to vaccines before shots were available. Regeneron’s drug was given to former President Donald Trump when he contracted COVID-19 in October 2020.
—Bloomberg News
Opening statements forecast trial of 3 ex-cops implicated in George Floyd's death
MINNEAPOLIS — Attorneys on both sides laid out opening arguments Monday morning in the civil rights case of three former Minneapolis officers, forecasting a trial that will hinge on what the men thought and saw as Derek Chauvin knelt on George Floyd's neck for more than nine minutes.
In St. Paul's federal courthouse, Assistant U.S. Attorney Samantha Trepel described how Tou Thao, Thomas Lane and J. Alexander Kueng ignored signs of grave distress in the man who they'd taken into custody. They in turn neglected their training and legal obligation to render medical aid as the window to save Floyd's life "slammed shut."
"Here, on May 25, Memorial Day 2020, for second after second, minute after minute, these three CPR-trained defendants stood or knelt next to officer Chauvin as he slowly killed George Floyd right in front of them," said Trepel.
The opening remarks offered for the first time a window into the defense attorneys' arguments for their respective clients, and a revelation that at least Lane plans to testify. In separate opening arguments, the attorneys described a hectic and at times scary situation in which the officers encountered an erratic suspect who ignored or resisted their commands.
Thomas Plunkett, attorney for Kueng, described his client as a "rookie officer" who was failed by the Minneapolis Police Department's inadequate training. He said Kueng saw only what was right in front of him, rather than in the wide-view of bystander video. "That video is not what Alex Kueng saw," said Plunkett. "It's not what Alex Kueng perceived and it's not what he experienced on May 25, 2020."
Signaling a contentious trial ahead, Plunkett called for a mistrial within the first 90 minutes of court, saying Trepel inserted inappropriate argumentative remarks in her opening. Judge Paul Magnson rejected Plunkett's request.
—Star Tribune
San Jose to take final vote on first-of-its-kind gun control measures
SAN JOSE, Calif. — San Jose is on the verge of becoming the first city in the nation to require gun owners to carry liability insurance and pay a fee aimed at reducing gun violence.
More than two years after Mayor Sam Liccardo introduced his proposal for these novel gun control measures, the San Jose City Council on Tuesday night will take a final vote on the controversial regulations.
“Anyone hoping that Congress will act to better protect Americans from the scourge of gun violence will be waiting a very long time,” Liccardo said in an interview. “It’s incumbent on local communities to deploy new approaches to tackle this problem because it’s not getting solved by the current approach.”
If approved, the measures — which include substantial revisions from the mayor’s initial proposals — are set to take effect at the end of August. However, that could be delayed by legal challenges, which Second Amendment advocacy organizations have been threatening from the start.
—The Mercury News
Pope Emeritus Benedict XVI admits false statement in abuse probe
MUNICH, Germany — Pope Emeritus Benedict XVI has admitted that he made a false statement during an investigation into child sexual abuse in the German Catholic Church that accused several current and former priests of misconduct.
In a statement released via his private secretary Georg Gänswein on Monday, Benedict admitted that he had taken part in a meeting in 1980 at which a priest was discussed who had abused boys in the diocese of Essen in western Germany and was being transferred to Bavaria.
Benedict, at the time archbishop of Munich and Freising, had repeatedly claimed that he had not attended the meeting with the priest, who was later reinstated as a pastor.
However, the law firm which prepared the report, Westpfahl Spilker Wastl (WSW), obtained minutes confirming his presence at the meeting.
The mistake was "not made with bad intentions" but was the "result of an oversight in the editing of his statement," said the statement from the office of Joseph Ratzinger, which is the retired pope's birth name and how he was called during the period covered by the report.
He was "very sorry" for the mistake and said he hoped that it could be forgiven, said the statement, which was published on the Vatican News website.
—dpa
