U.S. FDA accepted Bristol Myers Squibb and 2seventy bio’s supplemental Biologics License Application and has assigned a target action date of December 16, 2023
European Medicines Agency has validated Bristol Myers Squibb’s Type II variation application for Abecma
Bristol Myers Squibb’s supplemental New Drug Application for Abecma has also been accepted by Japan's Ministry of Health, Labour and Welfare
Applications based on interim results of Phase 3 KarMMa-3 study, the first and only randomized, controlled study designed to evaluate a CAR T cell therapy in triple-class exposed relapsed and refractory multiple myeloma, in which Abecma significantly reduced the risk of disease progression or death versus standard regimens
The Washington state House approved a bill that would authorize state agencies to hide children seeking transgender medical intervention from parents.
On April 12, House lawmakers debated Senate Bill 5599 (pdf), which creates an exemption for the state that grants it the right to not be required to notify parents of minors who have left their homes because their parents wouldn’t let them pursue gender transition medical procedures.
In a video statement after the vote, Republican state Rep. Chris Corry said the bill “erodes parental rights in the state of Washington.”
“Essentially what the bill would do would be if a child left a parents’ home for certain medical care and went to a shelter or host family, that shelter or host family would not be required to notify the parents of their child’s whereabouts,” Corry said. “This is obviously a fundamental violation of parental rights and something that’s deeply concerning for parents across Washington state.”
State Rep. Peter Abbarno, a Republican, said the crux of the debate over the bill was whether the state be permitted to “essentially hide where the child is.”
Most parents, Corry said, would “go to the ends of the earth to find their child” if they disappeared after an argument.
“And the fact that we have a bill that may become law that would say, ‘we’re not going to tell you,’ was really just a bridge too far for us,” Corry said.
Corry told The Epoch Times that, under the bill, a disagreement between a child and parents over the child’s desire for a medical transition constitutes “abuse and neglect,” only because the parent hasn’t “properly affirmed what the child wants.”
Corry said there are already laws that protect children from abuse and neglect in the state that require “solid and compelling reasons” why children would need to be removed from their homes.
“What’s frustrating is even in those cases, the parents still have a right to know where their kids are after they’ve been removed,” Corry said. “In this case, parents would have no idea.”
House Debate
Republican state Rep. Travis Couture spoke on the House floor in a debate over amendments to the bill, stating that the U.S. Constitution, based on the precedent set by previous Supreme Court rulings, permits the state to interfere with the right of parents only to prevent harm to a child “and any legislation that goes further fails that standard.”
“The Constitution doesn’t tell us what we can do; it tells us what we can’t do to people,” Couture said. “And multiple times our U.S. Supreme Court has ruled in favor of parental rights.”
The Due Process clause of the Fourteenth Amendment “gives parents the right to parent” through the educating and rearing “as they see fit.”
“I think it’s important as we embark on this bill tonight to recognize the very important and critical role parents have not only in our society, and not only with their families and their children but in our law as well,” Couture said.
State Rep. Julio Cortes, a Democrat, said though having a supportive family environment is critical, it doesn’t always determine the best outcome for the success of a child’s well-being.
“But family dynamics as I’m sure a lot of us can agree at times be let’s say complicated,” Cortes said. “Positive mental health outcomes are possible even when a family dynamic is negative, and on the other side negative outcomes are possible even when a family is supportive. This bill is about providing housing security for our trans youth.”
While not addressing parental consent, Cortes shared an anecdotal story about a trans child he said he helped while working with homeless youth.
The child, he said, ran away to protect his family who was being attacked by community members over the child’s decision.
“I had the privilege of working with this youth and through case management and our prevention program we were able to get that youth back home, but we got him back home with the skills and the tools that they needed and that their family needed to make sure that they could be safer,” he said. “Supporting our trans youth is a collective effort, Mr. Speaker, and while families play a critical role, they are not the only support system that these youth need. It takes, as they say, a village."
But not everyone is sitting idly by, letting this trend continue. Led by First Lady Casey DeSantis, Florida is taking steps to replace a broken mental-health-care system with one based on resilient prevention instead of reactive passivity.
Progressives howl about Gov. Ron DeSantis’ various moves, but this should not be a partisan issue.
I hope Democrats who care about saving lives get on board.
Rachel’s Challenge, a nonprofit the father of the first Columbine victim founded, teaches millions of schoolchildren, reportedly preventing numerous suicides and school shootings through anti-bullying and empathy training.
But as a standalone nonprofit, this and similar efforts need broader, systemic support, and Florida is stepping up.
Florida aims to no longer teach to mental disorders — it’s equipping kids with the skills to learn how to overcome challenges and prevent these disorders.
Casey DeSantis, who launched her Resiliency Florida Initiative in February 2021, last month nudged the Board of Education to revise the state’s academic standards and update its mental-health education and character education in grades 6 through 12 to reflect a resiliency approach.
These resiliency standards include a focus on volunteerism, problem-solving, critical thinking, compassion and grit.
Grit is that character trait so often lacking in today’s culture, which breeds victimhood, divisiveness and hyperfocus on microaggressions.
Florida’s mandated civics education and volunteerism help counter the self-absorption and isolation barraging our kids in social media.
Ron DeSantis and Florid is trying to take steps to replace a broken mental-health-care system.Scott Eisen/Getty Images
Today’s parenting too often veers into two extreme ditches.
Either overprotective helicopter overlords never let children experience failures and disappointments — or neglectful, absentee guardians let electronic devices or the streets raise these precious young ones.
Both extremes produce children with difficulty operating in life, lacking the mental stamina to respond to stress in healthy, positive ways.
In my case, my overbearing parents sheltered me and my seven siblings with extreme tactics, to the point that child-protective authorities almost took us away under suspicion of child abuse.
This hyper-controlling upbringing yielded depression, anxiety, PTSD and fibromyalgia in me as an adult.
It took many painful years to relearn basic notions of stress management and mitigating fight-or-flight responses to everyday situations.
It’s no wonder slavery abolitionist and statesman Frederick Douglass said, “It is easier to build strong children than fix broken men.”
Florida’s efforts are important and a shining example, but ultimately children’s mental-health success rests with parents.
Casey DeSantis launched her Resiliency Florida Initiative in February 2021.Ivy Ceballo/Tampa Bay Times
Casey DeSantis spearheaded this education initiative with input from conversations with students and parents across the state, as well as school-district mental-health coordinators, teachers and faculty.
The initiative is meant to “reframe and rethink the way we’re approaching mental health,” she said last month. “It’s not about being a victim relegated to a set of circumstances you cannot overcome.”
Sports is an excellent vehicle for teaching grit and resilience to students. The first lady partnered with professional sports teams and athletes to lend their voices and personal stories, including the Orlando Magic, Tampa Bay Buccaneers, Tampa Bay Rays, Miami Heat, Miami Dolphins, NASCAR and LPGA. Athletes endorsing this effort include Tom Brady, David Beckham, Peyton Manning and Lou Holtz.
The Resiliency Florida Initiative offers a free curriculum to educators and tools created specifically for parents interested in learning what resources are available to help their children.
Dr. Chloe Carmichael, clinical psychologist and author of “Nervous Energy: Harness the Power of Your Anxiety,” told me she supports Casey DeSantis’ efforts.
“As a psychologist, I like that the initiative normalizes the fact that life has challenges and takes a solution-focused approach,” Carmichael said.
“The emphasis on personal efficacy and an internal locus of control may help students to guard against a sense of helplessness, which is one of the hallmark features of depression. The proactive approach may also help equip students to better engage with the healthy function of anxiety, which is to stimulate preparation behaviors.”
These preparation behaviors train young people to have already-ingrained healthy cognitive patterns to use when they’re triggered by external stimuli. Despite our recent headwinds, resilient mental health is achievable and necessary for an American turnaround.
Carrie Sheffield is a senior fellow at Independent Women’s Voice andTony Blankley Fellow for American Exceptionalism at The Steamboat Institute.
Six more members of the Biden clan may have benefitted from the family’s various business schemes, bringing the total number of kin implicated up to nine, House Oversight Committee Chairman James Comer revealed Monday.
The findings come after the Kentucky GOP congressman and other lawmakers on the panel examined suspicious activity reports sent by banks to the Treasury Department alerting of potential criminal activity in transactions involving President Biden’s family.
“Thousands of pages of financial records related to the Biden family, their companies, and associates’ business schemes were made available to members of the House Committee on Oversight and Accountability, which confirm the importance of this investigation,” Comer said in a statement.
“The Biden family enterprise is centered on Joe Biden’s political career and connections, and it has generated an exorbitant amount of money for the Biden family. We’ve identified six additional members of Joe Biden’s family who may have benefited from the Biden family’s businesses that we are investigating, bringing the total number of those involved or benefiting to nine,” he said.
Rep. James Comer and other lawmakers reviewed suspicious activity reports related to the Biden family Monday.The Washington Post via Getty Images
Last month, Comer announced his committee had found evidence that at least three Biden family members and two associates received payments that originated from China in 2017, fewer than two months after Joe Biden left office as Barack Obama’s vice president.
Bank records subpoenaed by the committee show that State Energy HK Limited, a firm affiliated with Chinese Communist Party-backed energy company CEFC China Energy, wired $3 million to Biden family associate Rob Walker in March 2017, who then divvied it up over a period of about three months, Comer said.
It appears that first son Hunter Biden received about $610,000 in payments as part of the 2017 deal, while first brother James Biden got roughly $360,000, and the president’s daughter-in-law, Hallie Biden, received $25,000.
The panel’s March memo also listed an “Unknown Biden” who received four payments in 2017 totaling $70,000.
On Monday, Comer did not provide any clues as to who the six new Biden family members identified by the committee were.
At least nine members of the president’s family may have benefitted from the family’s business dealings, according to Comer.REUTERS
“The Oversight Committee will continue to pursue additional bank records to follow the Bidens’ tangled web of financial transactions to determine if the Biden family has been targeted by foreign actors and if there is a national security threat,” Comer said. “We will soon provide the public with more information about what we’ve uncovered to date. The American people need transparency and accountability, and the Oversight Committee will deliver much needed answers.”
Rep. Nancy Mace (R-SC), who reviewed the 100 or so suspicious activity reports alongside Comer, said in a tweet Monday that “it’s wild the amount of [Biden] family members involved” and hinted that evidence has been uncovered pointing to “prostitution rings.
“I have to tell you, there are more Biden’s involved than we knew previously. And every time you look under a stone, there’s so much more you have to investigate because it’s wild the number of family members involved,” Mace said in a video posted on Twitter.
“And it’s even – the amount of money that we’re talking about in these suspicious activity reports is astronomical. And the accusations therein, the source of the funding, where the money’s going, the shell companies, prostitution rings, etc. It’s insanity to me that it’s not been investigated in the way that it should be,” she added.
Nine states, including Michigan and Nebraska, have joined a U.S. Department of Justice lawsuit against Alphabet's Google which alleges the search and advertising company broke antitrust law in running its digital advertising business, the department said on Monday.
The states joining the lawsuit were Arizona, Illinois, Michigan, Minnesota, Nebraska, New Hampshire, North Carolina, Washington and West Virginia, the department said.
The government, which filed the ad tech lawsuit in January along with eight states, had argued that Google should be forced to sell its ad manager suite because it illegally abused its dominance of online advertising. Google has denied any wrongdoing and has asked Judge Leonie Brinkema in the Eastern District of Virginia to dismiss the lawsuit.
The Justice Department's ad tech lawsuit followed a separate lawsuit filed in 2020, at the end of the Trump administration, that accused Google of violating antitrust law to maintain its dominance in search. That case goes to trial in September.
The administration of President Joe Biden has sought to toughen antitrust enforcement. Alongside the Google lawsuit, it is also challenging multiple proposed mergers.
Wall Street may be ripping a page out of the post-WWII era.
According to RBC Capital Markets’ Lori Calvasina, stocks may be ignoring all signs of a recession.
“If you go all the way back to 1945, that was the recession coming out of World War II, the stock market just marched through it,” the firm’s head of U.S. equity strategy told CNBC’s “Fast Money” on Monday. “It is the only recession where it’s essentially been ignored.”
In a research note out this week, Calvasina tackled the S&P 500′s performance during recessions going back to 1937. She found the 1945 recession was the only one with no market pullback.
She listed the resemblance between the government war funding in 1945 to 2020′s massive Covid relief and the Fed’s rate hikes as a few examples.
“I actually found some interesting terms that were similar. It was described as a technical recession, just being driven by the fact that the wartime economy was shutting down, and we were pivoting to a peacetime economy,” said Calvasina. ”[This] idea of a manufactured recession that we were all talking about last year, you actually had it back then.”
However, she also acknowledged that there are differences between the two time periods and noted that she isn’t a believer of the bull case.
“I actually think that we priced in a recession back at the October lows, but I think people are tired of hearing that,” noted Calvasina.
Her S&P 500 year-end price target is 4,100. She adjusted her S&P EPS forecast last week to $200 from $199. The S&P closed at 4,135.32 today and is up more than eight percent year-to-date.
Coming off its success in getting archrivals Iran and Saudi Arabia to restore ties, China is now trying its hand at Israel-Palestine peace, after weeks of sporadic clashes between Palestinians and Israeli police in the West Bank and Jerusalem's Al-Aqsa Mosque.
China's foreign minister Qin Gang on Monday said Beijing is ready and willing to "play a constructive role" in promoting peace in the region. He also said he is "very concerned" over ratcheting tensions and violence, also after recent brief flare-ups of rocket fire from Gaza and Israeli return airstrikes.
During prior clashes at al-Aqsa this month, the Chinese foreign ministry issued a statement saying, "We call on all parties, Israel in particular, to show calm and restraint and immediately stop all words and deeds that might heighten tensions." This followed viral video showing police beating Muslim worshipers inside the mosque for defying a strict curfew at the Temple Mount.
Qin Gang's Monday statements were conveyed in a phone call to Israeli Foreign Minister Eli Cohen, the first such call since the Chinese FM took office. The Israelis and Palestinian Authority were urged to resume peace talks as soon as possible in the call.
As for the Israeli side, it's still nervous over Iran-Saudi rapprochement:
"I spoke with the Chinese Foreign Minister, Qin Gang, about the danger we see in the Iranian nuclear program, a danger that is shared by many countries in the region, including countries that have diplomatic relations with Iran. The international community must act immediately to To prevent the Ayatollah regime in Tehran from obtaining nuclear capabilities," Cohen said, according to the foreign ministry's statement.
The Israelis have been chiefly concerned that the pressure and spotlight will be taken off of Iranian malfeasance in the region, which could in turn be a threat to Israel's security.
As Reuters points out, after Washington spent decades trying to find a solution to the conflict, there's been no progress. "U.S.-brokered peace talks aimed at establishing a Palestinian state in the West Bank, East Jerusalem and Gaza -territories Israel captured in a 1967 war - have stalled for almost a decade and show no sign of revival," Reuters writes.
Some have seen China's recent efforts at stronger diplomacy in the Middle East as a sign of waning US influence; however, the Biden administration has said it welcomes opportunities to forge greater peace and stability.
