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Thursday, May 4, 2023

'Markey introduces bill to improve climate-related mental health services'

 Sen. Ed Markey (D-Mass.) announced bipartisan legislation Thursday aimed at improving mental health services for the impacts of climate change and natural disasters.

The legislation, the Community Mental Wellness and Resilience Act, would establish a $36 million pilot program through the Centers for Disease Control and Prevention (CDC) for mental health care specifically for communities on the frontlines of climate change.

Markey has distinguished himself as a leader of the progressive wing of the Democratic Party on climate and environmental issues, co-sponsoring the sweeping Green New Deal resolution with Rep. Alexandria Ocasio-Cortez (D-N.Y.). However, his co-sponsors include two Republicans, Reps. Brian Fitzpatrick (Pa.) and Don Bacon (Neb.), as well as Rep. Mary Sattler Peltola (D-Alaska), who joined her state’s Republican senators in lobbying heavily for the approval of a massive oil drilling project in Alaska in recent months.

Other co-sponsors on the legislation include Reps. Paul Tonko (D-N.Y.) and Kathy Castor (D-Fla.), as well as Sens. Richard Blumenthal (D-Conn.) and Sheldon Whitehouse (D-R.I.).

“Environmental justice communities are bearing the brunt of compounded climate and mental health crises fueled by climate disasters that level homes, break apart communities, and leave people with visible and invisible scars,” Markey said in a statement. “This legislation will give communities the resources they need to build defenses to these dual crises and ensure a healthier, more sustainable future for all.”

Markey, Tonko and Fitzpatrick introduced similar legislation in 2022, but Bacon, a moderate Republican whose district voted for President Biden in 2020, is a new addition.

Climate anxiety is a particular concern among Americans 16-25, according to research published in The Lancet in 2021, which found 59 percent worldwide describe themselves as very or extremely worried about the climate crisis and 45 percent saying it is a detriment to their daily life. A plurality of American youth — 46 percent — said they are either extremely or very worried.

https://thehill.com/policy/energy-environment/3988179-markey-introduces-bipartisan-bill-to-improve-climate-related-mental-health-services/

'Active shooter drills may be traumatizing millions of students'

 Schools are desperate to protect their students from the rising threat of mass shootings, but experts say the very measures being deployed for safety are in fact traumatizing entire generations of American youth.

There were 51 school shootings in 2022, according to a tracker from Education Week, directly impacting thousands of students.

By comparison, 95 percent of U.S. schools have shooter lockdown practice, according to Everytown for Gun Safety, affecting millions of students each year.

Sarah Burd-Sharps, senior director of research at Everytown, said, “active shooter drills are actually harmful” for students.

“The cumulative impact of shooter drills, lockdowns, metal detectors, armed teachers, and other school-hardening measures is an environment that feels inherently unsafe for America’s schoolchildren,” Burd-Sharps said. 

In 2020, Everytown analyzed millions of tweets and 1,000 Reddit posts using machine-learning psychological affect classifiers, studying posts from both before and after school lockdown drills. Based on the use of words such as “afraid,” “suicidal” and “irritability,” they said there was a 42 percent increase in anxiety around the drills and a 39 percent increase in depression.

The situation is coming to a head in New York, where schools are required to do four lockdown drills a year. Lawmakers want to drop that requirement down to one, with parents given the option to opt their child out of the drill entirely due to mental health concerns.

“If you enter the school system as a 3-year-old, and you exit as an 18-year-old, you will have done 60 lockdown drills,” Robert Murtfeld, a parent in New York advocating for the new law, told Chalkbeat New York in an interview published last week. “This is not about making anyone less safe — this is about being smart about what is the best mediated solution.”

The issue is not only the drills themselves but the way many schools conduct them.

Nancy Rappaport, a board certified child and adolescent psychiatrist and an associate professor of psychiatry at Harvard Medical School, says lockdown practices are “conducted in a pretty poor, chaotic way.”

Schools often do not do a debriefing of high-risk students, such as those previously involved in shootings or trauma in that area, causing further damage, Rappaport said. There have even been incidents where schools did not tell students the situation was only a drill until after it was over. 

“I’ve had several kids who have been involved with school shootings […] and then they have to do lockdowns. And that’s really, really hard. Talk about a triggering event when you’ve been in a school that might have had a school shooting and then you return to school and you’d have to keep practicing these drills,” Rappaport said. 

In 2022, National Center for Education Statistics (NCES) found school shootings were at their highest in 20 years, though still a tiny fraction of U.S. gun deaths — less than 1 percent, according to the 2020 report from Everytown for Gun Safety.

So far this year, there have been 21 school shootings, according to a Washington Post database. Among them, eight children were killed, six of them at the Nashville Christian school shooting in April. 

Meanwhile, preparations for potential mass shooter events can make students feel unsafe in a building that is a safe space for youth. And younger children may not always be able to tell that they aren’t in real danger.

“Their idea of what’s reality and what’s pretend-play are pretty close together,” Rappaport said. 

“So when you’re having kids practice a lockdown, what they start to do is called repetitive play, where they repeat the idea that there’s a lockdown happening and that people have to hide and things are unsafe, and that’s another kind of trauma reaction,” she added. 

And the evidence is not clear whether these drills are actually useful in a real situation, nor whether other school safety measures will help students more than hurt them. 

“I think if that’s used as an opportunity to get a lot more police in schools, more dogs to sniff students, more metal detectors, more video cameras to surveil students, more guns that teachers or other people carry on, that’ll be a mistake in my mind,” said Ron Avi Astor, professor at the Luskin School of Public Affairs at UCLA, adding that “people will feel justified in really fortifying our schools into little mini prisons.”

Experts have been pushing for a more trauma-informed approach to school safety issues and addressing concerns about school shootings.

Rappaport advocates for schools to have a threat assessment team that can speak to the plans for evacuation in an emergency, but says actual drills are unnecessary. 

“I’ve heard some people talk about every time you get on a plane people give you warnings about how to manage if there’s a plane crash, but they don’t do a simulated crash,” she said. 

https://thehill.com/homenews/education/3983963-active-shooter-drills-may-be-traumatizing-millions-of-students/

'Biden lightens his White House schedule, lets Harris take lead in AI meeting'

 President Biden assigned himself a light schedule this week with no public events from Tuesday through Thursday, and let Vice President Kamala Harris take the lead on a meeting with companies on artificial intelligence.

The only listed activity from Biden today was a private briefing with Harris, who will then meet with tech executives on AI and then depart to Richmond, Virginia, for an event on small businesses. The president is not listed as an attendee for either event.

Also today, first lady Jill Biden will fly to the United Kingdom for King Charles III's coronation — an invitation the president declined to attend.

Biden spoke at an event Monday on Small Business Week then had a meeting with the president of the Philippines. He spent Saturday at festivities for the White House Correspondents’ Association Dinner.

The lightened work load for Biden, 80, comes one week after he announced his bid for re-election.

Kamala Harris VP

Vice President Kamala Harris on Thursday will meet with tech executives on the issue of artificial intelligence, then depart to Richmond, Virginia, for an event on small business. (Mario Tama)

No White House immigration events were scheduled this week as Title 42 is set to expire next week. The Biden administration will reportedly send 1,500 US troops to the Mexico border in response.

White House press secretary Karine Jean-Pierre on Wednesday responded to a question about Biden's lightened schedule.

"He’s been meeting with — having internal meetings in the Oval Office," Jean-Pierre said. "I had a meeting with him earlier today with… senior advisors, senior staff, talking about the issues that matter to the American people."

The White House did not respond to questions on why Biden deferred to Harris on the artificial intelligence event Thursday.

Harris will be joined Thursday by senior White House officials in her meeting with tech executives at Microsoft, Google and OpenAI. The officials, CNBC reported, include Biden Chief of Staff Jeff Zients, National Security Advisor Jake Sullivan, Secretary of Commerce Gina Raimondo and Director of Science and Technology Policy Arati Prabhakar.

https://www.foxnews.com/politics/biden-lightens-white-house-schedule-harris-take-lead-ai-meeting

Protara Q1 Results and Business Update

 

  • Favorable tolerability and anti-tumor activity observed in NMIBC patients treated with TARA-002 in ADVANCED-1 trial
     
  • Company plans to initiate ADVANCED-2 trial in BCG-naïve CIS patients and BCG-unresponsive CIS patients in 2H23
     
  • Regulatory clearance received from FDA to commence Phase 2 trial of TARA-002 in Lymphatic Malformations; trial expected to initiate in Q423
     
  • Continue to expect cash, cash equivalents and investments of $90M as of March 31, 2023 to fund operations into 2025

TD-First Horizon Collapse Points to Merger-Arbitrage Traders’ Biggest Fear

 

  • Traders previously bet on price cut near end-of-May walk date
  • First Horizon sinks 40% on merger failure, regional bank woes

Merger arbitrage traders were expecting hiccups in Toronto-Dominion Bank’s proposed takeover of First Horizon Corp., but they were unprepared for what happened Thursday when the $13.4 billion transaction melted down.

The deal spread had been widening in recent months, as some traders were anticipating a price cut. But a total collapse weeks ahead of the May 27 deadline was not in the cards. Now, these traders are desperately seeking protection in a market that’s reluctant to give it as First Horizon shares nosedive.

https://www.bloomberg.com/news/articles/2023-05-04/td-first-horizon-collapse-points-to-arb-traders-biggest-fear

Neurocrine upped to Buy from Neutral by Guggenheim

 Target $145

https://finviz.com/quote.ashx?t=NBIX&p=d

The quiet resurgence of Cellular Biomedicine

 Cellular Biomedicine Group once made a bold bid to enter China’s Car-T market, listing its shares on Nasdaq and courting controversy in the process, but in 2021 it went private and entered obscurity. That lasted until this week.

A licensing deal with Johnson & Johnson on Tuesday gave it an immediate $245m cash injection in return for two clinical-stage Car-T projects that do not, on the face of it, look spectacular. This is not the first time CBMG has received big pharma endorsement – a 2018 tie-up featured none other than Novartis – but it is the most lucrative.

J&J’s own Car-T breakthrough came through a deal with another China-focused group, Legend Biotech, and yielded Carvykti. The US company has now gained ex-China rights to CBMG’s C-CAR039 and C-CAR066, which are in trials for non-Hodgkin’s lymphoma at City of Hope and the Mayo Clinic respectively; responsibility for these studies now passes to J&J.

Both assets are autologous and both hit CD20, the target of successful drugs like Rituxan and Gazyva, but that has so far yielded little promising data for cell therapy approaches. C-CAR039 also hits the well-known CD19, the idea being that relapse by antigen escape can be avoided; Miltenyi Biotec is clinically studying a project that, while very similar, is unrelated.

While CMBG calls the assets novel it is unclear in what way they might differ from current-generation Car-T therapies. At Ash 2020 the company profiled a separate pipeline asset, the BCMA-targeting C-CAR088, which it said was a second-generation Car; however, apart from its humanised binding domain, this uses a fairly standard Car construct.

Major China push

CBMG had burst onto the cell therapy scene in 2015 when it bought rights to Chinese PLA General Hospital’s Car-T assets, making an instant bid to become a major local cell therapy player. Among the assets were Cars against CD19 and CD20, so it is possible that the projects licensed to J&J are based on this work.

It made other small acquisitions, and struck deals with the NCI and Novartis, becoming the latter’s China manufacturer for Kymriah as well as giving the Swiss firm rights to undisclosed tech. However, many of these efforts no longer appear in CBMG’s pipeline, which now also includes TILs and a Car therapy against autoimmune disease.

In August 2020 CBMG’s management took the group private at a valuation of around $385m, with cash secured from several funds, and little has been heard from the company since then. This week’s J&J deal is CBMG’s first serious cash injection since a $120m series A round closed in September 2021.

It will not go unnoticed that cash that has come into the business in the past two years is almost equal to its take-private valuation. It will be interesting to see what valuation CBMG might attract at IPO, if indeed it now chooses to pursue the public path again.


https://www.evaluate.com/vantage/articles/news/deals/quiet-resurgence-cellular-biomedicine

A short history of Cellular Biomedicine Group (CBMG)
May 2023Deal with Johnson & Johnson$245m up front for C-CAR039 & C-CAR066
Sep 2021Series A financingRaises $120m
Feb 2021Management takes company private$19.75/share, $385m valuation
Dec 2020C-CAR088 data at Ash
Mar 2019Secondary equity offering$17.5m raised
Oct 2018Licensing deal with NCI (NIH)TIL projects still in pipeline
Sep 2018Deal with NovartisKymriah manufacturing + tech
Jun 2015Company buys Blackbird Bio for $2.5mCD40LGVAX vaccine since discontinued
Feb 2015Licenses in Chinese PLA General Hospital Car-T portfolio (followed acquisition of Agreen Immune)Some PLA assets still in the pipeline
Jun 2014Company starts trading on NasdaqPreviously traded OTC