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Wednesday, April 19, 2023

Original COVID-19 shots no longer authorized

 

Judge tentatively OKs $725M Facebook settlement: How to apply for a payout

 A massive $725 million settlement involving Facebook’s parent company Meta was tentatively approved by a judge last month, paving the way for users of the social media platform to apply for a chunk of the payout.

Meta has agreed to the payment to settle a lawsuit claiming Facebook allowed users’ personal data to be shared with third parties, the most famous being Cambridge Analytica, a consulting firm that supported Donald Trump’s 2016 presidential campaign. The firm harvested the data of as many as 87 million Facebook users, the Associated Press reported.

Final approval of the settlement isn’t expected until September, but Facebook users don’t need to wait to file their claim.

Who qualifies for a payment?

You don’t need to know if your data was accessed by a third-party app to get a piece of the settlement. Anyone who was a Facebook user between May 24, 2007, and Dec. 22, 2022, is eligible, per the settlement page.

That means a lot of people are eligible — Facebook reports 2 billion users globally, including about 200 million in the United States and Canada.

Only U.S. users are eligible for a payment.

How do I apply?

There are two ways to submit a claim: online or by mail.

To file online, you’ll need to click here, answer a few questions about yourself, and then decide how you’d like to be paid (prepaid gift card, direct deposit, PayPal, etc.).

To file by mail, you’ll need to print some forms and send them in to the settlement administrator in Philadelphia.

You need to submit the form by August 25 in order to qualify.

How much will I get?

As with many class action lawsuits, the size of each individual’s payout depends on how many claims come in. How long you were a Facebook user will also determine the size of your payment — the longer you had an active account, the larger your payment will be. (You need to disclose if you’ve deleted your Facebook account when submitting a claim.)

And before any money lands in your bank account, attorneys’ fees and administrative expenses will be deducted from the $725 million pot.

When will I get paid?

The final settlement hearing is set for Sept. 7, 2023, so any approved payments definitely wouldn’t be sent out before then. “Settlement payments will be distributed as soon as possible if the Court grants Final Approval of the Settlement and after any appeals are resolved,” the claim site’s FAQ explains.

The date of the hearing is also subject to change.

https://thehill.com/homenews/nexstar_media_wire/3956560-judge-tentatively-oks-725m-facebook-settlement-how-to-apply-for-a-payout/

Oversight panel holds hearing on Biden’s handling of Afghan withdrawal

 


The House Oversight and Accountability Committee is holding a hearing Wednesday to review the Biden administration’s actions surrounding the withdrawal of U.S. troops from Afghanistan in 2021.

Committee Chairman James Comer (R-Ky.) and other GOP lawmakers have criticized President Biden’s handling of the chaotic exit, which was marked by a deadly bombing that killed 13 U.S. service members and the Taliban’s takeover of the country.

The Biden administration has argued that former President Trump’s policies and initial plans for a withdrawal created especially difficult conditions.

The hearing is scheduled to begin at 10 a.m. ET.

Watch the live video above.

https://thehill.com/homenews/house/3958331-watch-live-house-oversight-panel-holds-hearing-on-biden-handling-of-afghanistan-withdrawal/

Robert F. Kennedy Jr. presidential bid backed by 14 percent of Biden voters: survey

 Robert F. Kennedy Jr. is set to announce his bid as a 2024 Democratic presidential nominee on Wednesday in Boston, and he already appears to have sizable support from voters who cast their ballot for President Biden in 2020. 

In a USA Today/Suffolk University poll, 14 percent of surveyed voters who backed President Biden in 2020 said they would support Kennedy in 2024.

Biden’s support among his own 2020 voters stands at 67 percent, according to the survey. Additionally, 5 percent of voters said they would support self-help author Marianne Williamson and 13 percent remained undecided.  

According to the poll, Kennedy — the nephew of former President Kennedy and son of the late Sen. Robert F. Kennedy — drew support from “self-identified conservatives, younger voters, and those who don’t have a college degree.”

He also polled well among the 33 percent of respondents who disapprove of Biden’s job in the White House and the 35 percent who said his policies have been “too liberal.”

Kennedy has become a controversial figure in recent years for promoting claims that falsely link vaccines to autism and crusading against COVID-19 vaccines. He founded the anti-vaccine organization Children’s Health Defense. 

Kennedy’s stances have, at times, caused his family to denounce his views, including over his support for the release of Sirhan Sirhan, the man who assassinated his father in 1968. 

https://thehill.com/homenews/campaign/3958414-robert-f-kennedy-jr-presidential-bid-backed-by-14-percent-of-biden-voters-survey/

Suit seeks to force Archives to get DOJ help in finding missing Secret Service texts

 A suit filed in federal court Wednesday seeks to compel the National Archives to seek assistance from the Department of Justice (DOJ) in recovering text messages from both the Secret Service and leadership of the Department of Homeland Security (DHS) that were apparently lost in days following the 2020 election.

The suit, filed on behalf of Ken Klippenstein, a reporter for The Intercept, turns to a provision of the Federal Records Act that requires the head of the Archives to request assistance from the attorney general if an agency does not act to recover the records.

Lawmakers were notified in July by DHS Inspector General Joseph Cuffari that the Secret Service had “erased” text messages from Jan. 6, 2021, something the agency said occurred as a result of a migration to a new phone software that took place just weeks after the attack on the Capitol.

Text messages from then-Acting Secretary of Homeland Security Chad Wolf and his deputy, Ken Cuccinelli, were also lost in a “reset” of government phones during the transmission to the Biden administration.

Together, the erasures represent a major loss for those reviewing the effort to block the transition of power after the 2020 election, both in terms of reviewing discussions around former President Trump’s movements that day, as well as his efforts to have DHS seize voting machines.

The National Archives, also known as NARA, did request the Secret Service look into the matter, but the suit alleges the agency stopped short of requesting any assistance from the Justice Department.

Kel McClanahan, the attorney in the case and the executive director of nonprofit law firm National Security Counselors, said the duty to do so under law would bring the technical resources of the FBI and DOJ to the matter.

“All NARA can really do is ask questions and wag their finger. The FBI and DOJ can subpoena and can compel answers,” he said.

“The goal of this entire regime is not just to punish people who break it, but to recover records and to recover information.”

In July, Klippenstein filed a request with the Archives, pushing the agency to seek DOJ assistance and saying the Secret Service had engaged in “obfuscation and obstruction” about the nature of the loss of records.

“Viewed through the lens most favorable to the agency, these claims demonstrate that [the Secret Service] is, at best, out of its depth, and that prompt action needs to be taken by a more competent forensic agency,” he wrote at the time. 

McClanahan said it’s now been almost a year since Klippenstein filed the request, and “by any stretch of the imagination, that’s a reasonable amount of time. And now the archivist needs to do something.”

For its part, the Secret Service has denied there was anything nefarious about the loss of the messages, maintaining that for security reasons it advises agents against texting.

Cuffari had asked for the text messages of 24 agents for his own investigation into Jan. 6, but the Secret Service produced just one responsive text — a message from the then-chief of the Capitol Police asking for assistance.

The agency ultimately turned over thousands of documents to the House Committee investigating the attack on the Capitol, including other emails and communications from that day but did not provide any additional texts. It was a response members of the panel described as an overwhelming amount of information to sift through.

But the efforts to recover the messages are made all the more complex by a battle with Cuffari, who has faced numerous calls to step aside from the investigation into the missing texts.

Cuffari launched a criminal probe into the missing texts a few weeks after his letter to lawmakers. 

But the inspector general may have violated protocol by failing to swiftly notify Congress that the records were lost, as there are multiple provisions in the Inspector General Act that require notifying agency heads or Congress about “particularly serious or flagrant problems,” in some cases within seven days.

Lawmakers complained the delay compounded the difficulty of recovering the messages and were confused why months passed before they were alerted. In an anonymous letter, employees of the DHS IG office also asked President Biden to remove Cuffari.

The Council of the Inspectors General on Integrity and Efficiency (CIGIE), a federal entity with oversight of inspectors general, has an ongoing investigation into Cuffari’s office.

Cuffari last week launched a suit against the CIGIE, noting that its Integrity Committee filed another request for information from Cuffari’s staff as recently as earlier this month.

Attorney General Merrick Garland has largely dodged questions about whether the Justice Department would get involved in the investigation into the texts.

“As a general matter, any allegations of wrongdoing about inspector generals are handled by what we call CIGIE,” he said at an August press conference, noting the review of Cuffari.

“That’s the way those kind of allegations are handled. And without commenting on this particular case, needless to say, the Justice Department’s job is to investigate allegations of violations of the criminal law, including allegations regarding matters involving the scope of inspector generals.”

Several lawmakers have made clear, however, their preference for DOJ involvement.

“I don’t know whether the failure to preserve these critical government texts from January 6 is the result of bad faith or stunning incompetence,” Senate Judiciary Chair Dick Durbin (D-Ill.) said last August.  

“But I do know that the man who has overseen the investigation of this fiasco is not the right person to continue leading it. [Cuffari] has lost whatever credibility he may have once had on this matter.  That is why I’ve asked Attorney General Merrick Garland to step in and take control of this investigation into the missing texts.”

https://thehill.com/regulation/court-battles/3957429-lawsuit-archives-doj-missing-secret-service-texts/

Cancer vaccines come to the fore at AACR

 This year’s American Association of Cancer Research (AACR) annual meeting saw a clutch of new studies on therapeutic vaccines that suggest the approach is starting to gain traction, after years of mostly futile effort.

It’s been 13 years since the FDA approved its first therapeutic vaccine – Dendreon Pharma’s Provenge (sipuleucel-T) for prostate cancer, which was not a commercial success – and since then it has been joined by only a handful of others, including Ferring Pharma’s bladder cancer shot Adstiladrin (nadofaragene firadenovec) and Amgen’s Imlygic (talimogene laherparepvec) for melanoma.

There are signs that the floodgates may be starting to open, fuelled by new technologies such as mRNA, for example Moderna and Merck & Co’s mRNA-4157 shot for melanoma, which showed encouraging results in a phase 3 trial alongside cancer immunotherapy Keytruda (pembrolizumab) – see our coverage here.

Clinical data on several other experimental candidates is being presented at AACR, many targeting so-called ‘neoantigens’, protein antigens that result from genetic mutations in cancer cells. Here are some of the highlights:

Emeryville, California-based start-up Gritstone bio presented updated results from a phase 1/2 trial of GRANITE, its personalised neoantigen vaccine candidate, generated from a patient biopsy, which has now started a randomised phase 2/3 study as a first-line therapy for microsatellite-stable colorectal cancer (MSS-CRC).

The study has shown that the vaccine stimulates the priming and boosting of antigen-specific T-cell populations associated with conversion of ‘cold’ to ‘hot’ tumours – in other words, vulnerable to immunological attack. CRC is a notoriously cold tumour type, which is why treatment with immunotherapies like checkpoint inhibitors have shown limited efficacy in this type of cancer. The first efficacy data from the study is due later this year.

Danish biotech Evaxion reported a readout from its phase 1/2a trial of EVX-02, a personalised DNA-based neoantigen vaccine, in combination with Bristol-Myers Squibb’s immunotherapy drug Opdivo (nivolumab).

All 10 patients with late-stage melanoma who completed the full eight-dose regimen of EVX-02 showed treatment-specific immune responses and were relapse-free at their last assessment, with nine who completed the trial relapse-free at 12 months. That showed “clear signs of a protective cancer vaccination effect,” said the biotech’s CEO, Per Norlén.

France’s Transgene and partner NEC Corp presented results from a phase 1 trial of their individualised neoantigen cancer vaccine TG4050 in patients with human papillomavirus (HPV) negative head and neck cancer, and ovarian cancer.

The data showed that all evaluable patients developed a specific immune response after treatment with TG4050 against multiple cancer neoantigens, even in patients with poor immune function. All 16 patients who received TG4050 remained disease-free, with a median follow-up time of 9.2 months, and the partners plan to move ahead with a phase 2 trial in the second half of this year.

Anixa, meanwhile, reported new data from a phase 1a trial of its α-lactalbumin-targeting breast cancer vaccine carried out at the Cleveland Clinic, conducted in women who had triple-negative breast cancer (TNBC) within the last three years and received treatment with the aim of curing the disease. At the time of vaccination, all participants were tumour-free, but at high risk of recurrence.

The US biotech reported that T-cell responses specific to α-lactalbumin were reported across all dose levels with the vaccine, which is also in an investigator-led phase 1b study that is due to complete within the next few months. The maximum-tolerated dose (MTD) of the shot was established, but lead investigator Thomas Budd of Cleveland’s Taussig Cancer Institute told AACR delegates that the study is not designed to determine whether the responses are sufficient to prevent recurrence.

Finally, Mendus unveiled new data from its phase 1 ALISON trial of vididencel (DCP-001) – an off-the-shelf allogeneic dendritic cell-based vaccine – in high-grade serous ovarian cancer (HGSOC) patients, a population that has a higher risk of resistance to chemotherapy and disease relapse.

The data at AACR showed that the vaccine was safe and well-tolerated and induces durable T-cell responses to tumour associated antigens when administered after chemo and surgical removal of the tumour. At a week 22 visit, four out of six patients had no clinical signs of progressive disease, while two patients had progressed during the treatment.

The Sweden and Netherlands-based company said the trial will continue to follow patients over a two-year period, looking at recurrence free survival (RFS) and overall survival (OS).

https://pharmaphorum.com/news/cancer-vaccines-come-fore-aacr

"Freight Recession" Highlighted By Largest Cargo Drop Since Pandemic

 J.B. Hunt Transport Services Inc., the fourth largest trucking company in the US, reported Monday first-quarter profit and revenue that missed expectations, as it explained volumes and revenue per truckload fell amid fears of a "freight recession." 

"To start, we're in a challenging freight environment where there is deflationary price pressure for an industry that continues to face inflationary cost pressures," President Shelley Simpson told investors in a post-earnings conference call.

Cargo demand has been softening as consumers spend more money on services than goods. Inflation and soaring credit card rates also hurt consumer demand. We recently asked: Is a second trucking bloodbath on the horizon? 

According to Bloomberg, the latest data from American Trucking Association shows the truck tonnage index dropped 5.4% in March versus February, the largest decline since Aug. 2012. 

"Falling home construction, decreasing factory output and soft retail sales all hurt contract freight tonnage," said Bob Costello, chief economist for the ATA.

"The freight market is one of the most volatile markets on the planet. Hot markets can turn ice cold in a flash, particularly after the federal government and central bankers flooded our economy with so much liquidity and then proceeded to institute the fastest monetary tightening cycle in history," supply chain data firm FreightWaves said. 

FreightWaves pointed out, "The freight market downturn is a thing of the past. The freight recession has come, and carriers, regardless of whether they operate in the contract or spot markets, are having to contend with it." 

FreightWaves' data also shows spot rates of truck hauls have plunged over the last 12 months, tender volumes are sliding, and there's a trucking overcapacity issue. 

Despite all the gloom, Ravi Shanker, Morgan Stanley transportation equity analyst, recently told clients besides "all the bad headlines and mixed data points on macro, our latest quarterly Shipper Survey keeps showing signs of improvement under the surface." 

Well, that depends if the consumer can survive even more tightening of monetary conditions as the Fed is expected to increase interest rates by 25bps next month to around 500bps. 

https://www.zerohedge.com/markets/freight-recession-highlighted-largest-cargo-drop-pandemic