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Saturday, December 3, 2022

Now-Dominant BQ COVID Strains Are Cause for Concern

 The latest circulating COVID-19 variants have shown greater immune escape, which will likely lead to increasing cases over the coming months, experts said.

New Omicron subvariants BQ.1 and BQ.1.1 together now make up more than half of all COVID cases in the U.S. (30.9% and 31.9%, respectively), according to the CDC's COVID Data Tracker, representing a rapid rise from early November when they represented about a quarter of all cases.

David Weber, MD, MPH, of the UNC Medical Center in Chapel Hill, North Carolina, said the rising prevalence of these variants is likely attributed to ineffective immune responses from prior infections and vaccination, but healthcare providers should still rely on tried-and-true approaches, such as boosters, antivirals, and masking.

"The bottom line is those variants, BQ.1 and BQ.1.1, because they escaped immunity from natural infection ... we'll expect to see increasing proportions of them over the next couple of months," Weber told MedPage Today.

"A model from Europe suggested that by December 1, [the variants] would be more than 50%, and they were correct," he added. "And they suggest by January 1, more than 80% of the circulating variants will be BQ.1 and BQ.1.1."

In response to the increasing prevalence of these variants, the FDA announced this week that bebtelovimab, the monoclonal antibody found to be effective against earlier variants, would no longer be authorized for emergency use.

The FDA recommends that healthcare providers consider treatment options that are effective against these new variants, including ritonavir-nirmatrelvir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio). The agency also highlighted the potential efficacy of bivalent COVID-19 boosters and the use of convalescent plasma for immunosuppressed patients.

Weber stressed that the best line of defense is the bivalent booster.

"Nothing is more important than a physician or a healthcare provider telling their patient, 'I strongly recommend this to you,'" Weber said. "That's really important because many people mistrust the medical environment, but they love their own provider, so it's really important for that medical provider to make a strong recommendation to get the bivalent vaccine."

The vaccine will be all the more important due to the uncertainty around BQ.1 and BQ.1.1, said Peter Katona, MD, of the UCLA Fielding School of Public Health in Los Angeles.

"We know that they're taking over," he told MedPage Today. "It's a question of what direction they take us. Are they going to take us into a more benign situation, are there going to be things that we only have to be careful about -- because of long COVID and because of the people who get really sick."

Katona noted that the long-term outlook on these variants is unknown at this point, so the focus is on treating patients with the options that are currently available and effective. Since the outlook for this winter is not clear, he emphasized the need to keep track of the local developments with these variants.

"It's a complicated mess," Katona said. "You have to look at where you are locally to kind of give you some guide."

The bigger picture, according to Weber, is the ongoing rate of cases and deaths from COVID, irrespective of the variant. He pointed out that COVID-19 is still the third leading cause of death in the U.S., so until the rates of cases and deaths can be brought down, we should continue to expect new variants to develop.

"Everybody who gets COVID is a little incubator for developing a more efficient virus," Weber warned. "And because millions of people continue to get COVID worldwide, and we've already been through the Alpha, Beta, Delta, Omicron, BA.1 [and] 2, and then BA.4 waves -- so we've had five or six waves of this going over 3 years -- I don't think there's anything particularly surprising that we're continuing to see new variants."

https://www.medpagetoday.com/special-reports/exclusives/102042


Student Loan Relief: Biden Asks Supreme Court To Intervene In Second Lawsuit

 The Biden Administration asked the Supreme Court Friday to take up a second case challenging the White House’s student loan forgiveness policy—a move that won’t result in student debt relief being immediately reinstated, but makes it possible the program could take effect sooner.

KEY FACTS

The Biden Administration asked the court to consider U.S. Department of Education v. Brown, which blocked the student loan forgiveness program from being implemented after a decision from a federal judge.

The lawsuit was brought by individual borrowers who argue the White House improperly implemented the program because it did not allow for a public comment period before it went into effect.

U.S District Judge Mark Pittman, a Trump appointee, overturned the policy as a result, ruling the Biden Administration exceeded its authority in implementing the program—which the Biden Administration argued he “profoundly erred” by doing, as the judge made his decision based on legal arguments that were never brought up in the initial lawsuit.


The 5th Circuit of Appeals then ruled to keep the loan forgiveness program blocked until it issues a final ruling in the case, prompting the Biden Administration’s Supreme Court appeal.

The Biden Administration is asking the Supreme Court to immediately pause Pittman’s ruling, which means student loan relief could go into effect while the case is being appealed, or else take up the case for oral arguments alongside Biden v. Nebraska, a second lawsuit against the student loan forgiveness brought by GOP-led states that the court will hear in February.

If the Supreme Court pauses Pittman’s ruling while the case is appealed, it won’t put debt relief back into effect immediately, as the White House would need favorable rulings in both this case and the Nebraska case for loan forgiveness to be reinstated.

Debt relief could be reinstated as soon as the Nebraska case is resolved—which will be by June at the latest—rather than after the full appeals process plays out, which could stretch on for even longer.

CRUCIAL QUOTE

The rulings against student loan forgiveness “leave vulnerable borrowers in untenable limbo,” the Biden Administration argued to the Supreme Court. “Eligible borrowers have been told that they will be able to obtain meaningful debt relief … Yet because of the [rulings], the borrowers most likely to default if payment obligations resume without some relief face prolonged uncertainty about the scope of their payment obligations and when those obligations will resume.”

WHAT TO WATCH FOR

It’s unclear when the court could rule on whether or not they’ll take up the case, though its ruling in the other student loan forgiveness policy came relatively quickly. If the Supreme Court decides to hear the Brown and Nebraska cases together, it means a final ruling on student loan forgiveness—which would result in the program either being blocked forever, or being allowed to permanently take effect—will come by the time the Supreme Court’s term wraps up in June. That’s likely to be in time for when the moratorium on student loan repayments is scheduled to end on June 30, after the Biden Administration extended the pause on payments in response to loan forgiveness being blocked.

BIG NUMBER

26 million. That’s the number of federal loan borrowers who applied for loan forgiveness before applications for the program were suspended on November 11—more than half of the 43 million total borrowers eligible for relief.

KEY BACKGROUND

The Biden Administration announced in August that it would forgive $10,000 in federal student debt for borrowers earning less than $125,000, or $20,000 in forgiveness for Pell Grant recipients—a move that’s attracted widespread criticism and a slew of litigation from Republicans even as many borrowers have cheered it. The Brown lawsuit was brought by the conservative Job Creators Network on behalf of two borrowers, one of whom has commercially held loans and thus isn’t eligible for forgiveness, while the other was not a Pell Grant recipient and thus is only eligible for $10,000 in relief. The plaintiffs alleged the policy is “irrational, arbitrary, and unfair” in how it excluded them from at least some loan forgiveness, and argued the policy should have been subject to a public comment period. Pittman responded to the lawsuit by striking the policy down entirely, ruling it should have been left up to Congress and the Biden Administration was not justified to forgive debt under the federal law it cited. In its filing to the Supreme Court, the Biden Administration noted that Pittman’s ruling did not actually grant the plaintiffs any relief, because they still can’t comment on the program now that it’s blocked. The ruling actually leaves the plaintiff eligible for $10,000 in relief “worse off than before,” the Biden Administration argued, as “he would receive neither the $10,000 the plan provides nor the $20,000 he seeks, but instead nothing at all.”

https://www.forbes.com/sites/alisondurkee/2022/12/02/student-loan-relief-biden-asks-supreme-court-to-intervene-in-second-lawsuit---heres-when-a-decision-could-come/

Beijing, Shenzhen loosen more COVID curbs as China fine-tunes policy

 Beijing residents on Saturday cheered the removal of COVID-19 testing booths while Shenzhen said it would no longer require commuters to present test results to travel, as an easing of China's virus curbs gathered pace.

Although daily cases are near all-time highs, some cities are taking steps to loosen COVID testing requirements and quarantine rules as China looks to make its zero-COVID policy more targeted amid a sharp economic slowdown and public frustration that has boiled over into unrest.

The southern city of Shenzhen announced it would no longer require people to show a negative COVID test result to use public transport or enter parks, following similar moves by Chengdu and Tianjin.

Many testing booths in Beijing have been shut, as the capital stops demanding negative test results as a condition to enter places such as supermarkets and prepares to do so for subways from Monday. Many other venues, including offices, still require testing.

A video showing workers in Beijing removing a testing booth by crane onto a truck went viral on Chinese social media on Friday.

"This should have been taken away earlier!," said one commentator. "Banished to history," said another.

Reuters could not immediately verify the authenticity of the footage. At some of the remaining booths, however, residents grumbled about hour-long queues for the tests due to the closures.

CHINA OUTLIER

Three years after COVID emerged in central China, the nation has been a global outlier with a zero-tolerance approach of lockdowns and frequent testing. The authorities say the measures are needed to save lives and avoid overwhelming China's healthcare system.

China began tweaking its approach last month, urging localities to become more targeted. Initial reactions, however, were marked with confusion and even tighter lockdowns as cities scrambled to keep a lid on rising cases.

Then a deadly apartment fire last month in the far western city of Urumqi sparked dozens of protests against COVID curbs in over 20 cities in a wave unprecedented in mainland China since President Xi Jinping took power in 2012.


Crypto Stocks Teeter Near Abyss as Fink’s Warning Adds to Angst

 Analysts and investors are struggling to call a bottom in crypto stocks in the wake of a brutal month that ended with the head of BlackRock Inc. saying most digital-asset firms won’t survive. 

Cryptocurrency firms including Coinbase Global Inc., Galaxy Digital Holdings Ltd. and MicroStrategy Inc. all plunged more than 25% last month. The declines added to the pain of a dismal year amid a deep and extended plunge in Bitcoin and other digital tokens. While that trio of firms rallied this week, they’ve still wiped out roughly $52 billion of shareholder value in 2022.

Already reeling from the so-called crypto winter, investors were dealt a major blow with the high-profile collapse of Sam Bankman-Fried’s FTX exchange in early November, which sent Bitcoin tumbling. To top it off, BlackRock Chief Executive Larry Fink said this week that he expects most crypto companies will fold after FTX’s demise. A Schwab index tracking crypto-linked stocks is coming off its worst month since June, and is down 63% this year.

“Questions about whether crypto has a future have become prevalent after a year during which many tokens lost more than 70% of their value and the collapse of FTX has exacerbated a crisis of confidence that had started in the spring,” said Mark Palmer, an analyst at BTIG LLC.

Few, if any, companies connected to the sector have been spared during the selloff, with even banks like Silvergate Capital Corp. and Signature Bank taking hits. Mining stocks have been among the worst performers, with Marathon Digital Holdings Inc. and Hut 8 Mining Corp. both seeing their share prices cut roughly in half in November. 

FTX’s sudden downfall sparked fears of contagion across the industry, which ultimately became a reality this week when crypto lender BlockFi Inc. also filed for bankruptcy.

“We expect the crypto space to continue to be toxic for investors in the near-term and expect overall chain activity to be relatively quiet among users as we continue to wait out potential contagion effects as a result of the bankruptcy of FTX,” Chase White, an analyst at Compass Point, wrote in a note to clients.

Silvergate now finds itself playing damage control. The company, whose shares tumbled by a record 52% in November, said several weeks ago that its exposure to FTX represented less than 10% of its digital-asset deposits. This week, it said exposure to BlockFi was less than $20 million.

It’s been a similar situation for Coinbase. Chief Executive Officer Brian Armstrong took to Twitter multiple times in recent weeks in an attempt to reassure investors that the cryptocurrency exchange remains on solid footing. So far, it seems to have done little to sway traders and analysts.

Coinbase closed at a record low on Nov. 21 and has been downgraded by analysts at firms including Bank of America Corp. and Daiwa Securities, leaving it with its lowest number of buy ratings since August 2021, data compiled by Bloomberg show. Coinbase shares just snapped a four-week slide, but they’re still down about 80% this year, erasing about $44 billion in value.

Cryptocurrency mining stocks have fared even worse as soaring energy costs add to the challenge of sinking cryptocurrency values. Core Scientific Inc. has seen its share price crumble nearly 99% this year. In its third-quarter earnings release, the company said losses for the nine months through September had reached $1.7 billion and it’s also said it might have to file for bankruptcy if it can’t find additional funding.

The slump in crypto-mining stocks is problematic for a group that was already struggling to pay back $4 billion in loans tied to mining-equipment.

Read more: Fink Says Most Crypto Firms Will Die Off Following FTX Implosion

To be sure, Fink, whose firm had invested roughly $24 million in FTX, said he still sees potential in the technology underlying crypto, including instant settlement of securities.

And some money managers see an opportunity in the beaten-down stocks. Cathie Wood’s Ark Investment Management added crypto investments in the weeks following FTX’s bankruptcy, including in Coinbase, Silvergate and the Grayscale Bitcoin Trust. Wood also told Bloomberg TV that she stands by her forecast that Bitcoin -- which traded at roughly $17,000 on Friday afternoon in New York -- will hit $1 million by 2030.

https://www.bnnbloomberg.ca/crypto-stocks-teeter-near-abyss-as-fink-s-warning-adds-to-angst-1.1854434

Why China Sucks: It's A Beta-Test For The New World Order

 by Brandon Smith via Alt-Market.us,

For over a decade there has been an open globalist obsession with the Chinese governmental model – A love affair, if you will. Many top proponents of global centralization including Henry Kissinger and George Soros have praised China in the past and hinted that the communist country is burgeoning into a major player within the New World Order. Soros expressed this exact sentiment way back in 2009, around the time that China began courting the IMF and issuing trillions in Yuan based treasury debt in order to join their global currency initiative.

Christine Gauthier rips Canadian government for offering to euthanize her

 She wanted a little help — not death.

A paraplegic former Canadian military member is ripping her government, which offered to euthanize her after she complained about delays having a wheelchair lift installed in her home.

Retired Army Corporal Christine Gauthier, who competed for Canada at the 2016 Rio de Janeiro Paralympics, testified in Parliament Thursday that a Veterans Affairs Canada caseworker offered the opportunity for a medically assisted death – and even to provide the equipment, according to the CBC.

“I have a letter saying that if you’re so desperate, madam, we can offer you MAID, medical assistance in dying,” said Gauthier who injured her back during a 1989 a training accident.

Testifying in French before the House of Commons veterans committee, she also said she’s been fighting for a home wheelchair ramp for five years and expressed her concerns about the assisted dying offer in a recent letter to Prime Minister Justin Trudeau.

Gauthier recently testified in French about her harrowing experience of being offered assisted suicide.
Gauthier recently testified in French about her harrowing experience of being offered assisted suicide.
CBC/Youtube

“I sent a letter to Prime Minister Trudeau and that they [Veterans Affairs] offered me MAID and would supply equipment,” said Gauthier.

Gauthier’s ordeal is “absolutely unacceptable,” Trudeau said Friday.

“We are following up with investigations, and we are changing protocols to ensure what should seem obvious to all of us: that it is not the place of Veterans Affairs Canada, who are supposed to be there to support those people who stepped up to serve their country, to offer them medical assistance in dying,” added the prime minister.

Prime Minister Justin Trudeau said Gauthier's ordeal was "unacceptable."
Prime Minister Justin Trudeau said Gauthier’s ordeal was “unacceptable.”
AFP via Getty Images

In testimony before the same committee last week, Veterans Minister Lawrence MacAulay revealed at least four other Canadian military veterans were offered the MAID option by a now-suspended veterans service agent. The cases have been referred to the Royal Canadian Mounted Police.

https://nypost.com/2022/12/03/canada-offered-to-help-euthanize-christine-gauthier/

Friday, December 2, 2022

Burned by Palfozia, Nestlé retreats from its pharma experiment

 Biopharma deal bankers can strike NestlĂ© off their lists of potential buyers. The group, better known for chocolate and vitamins, had made a handful of forays into the drug development world in recent years, but thanks to the commercial flop of the peanut allergy treatment Palforzia – an event that might not have taken everyone by surprise – this incursion is over.

Palforzia came with 2020's $2.6bn acquisition of Aimmune, a biotech that NestlĂ©, through its Health Sciences division, had handsomely supported for years before the takeout. NestlĂ©’s relationship with Seres has taken a similar path since 2015, minus the buyout, while only this summer Enterome received a $40m handshake. Might the Swiss firm also get cold feet on these deals?

The decision to sell or partner Palforzia was announced earlier this week as part of a day-long investor event. Greg Behar, chief executive of the Health Sciences unit and Aimmune board member from 2016, said the company had concluded that Palforzia was destined to become a “niche” allergy product.

“It is not delivering on our business case, which was for it to become a blockbuster,” he said. Feedback from doctors and parents was that Palforzia was performing better than the clinical data suggested, but not enough people could be persuaded to try it in the first place.

The group discovered that most parents were happy with the standard of care – peanut avoidance – while physicians were put off by the “heavy handholding” that Palforzia administration requires. Perhaps doctors were not making enough money to use the product, though NestlĂ© is not the first major company beaten by the US allergy market, a fragmented sector dominated by allergen extracts.

Palforzia is approaching reimbursement decisions in Europe and it is too soon to tell whether the same issues will arise, Mr Behar said. Nestlé presumably expects this to be the case.

After investing almost $3bn in Aimmune across various financings, a big impairment charge is on the way. The Health Sciences division will now focus on consumer care – vitamins, minerals and supplements – and medical nutrition, with no additional pharma M&A planned.

Others on the block?

So what does that pharma portfolio look like? Seres is the biggest bet NestlĂ© has placed after Aimmune, the microbiome player having received almost $300m in license fees to date. A further $125m is due should the lead project, SER-109 for recurrent C difficile infections, win FDA approval; a decision is due in April next year. Mr Behar is also on the Seres board.

Seres’s name featured in the NestlĂ© Health Sciences slide deck in a section titled “disrupting with partnerships”, and the biotech’s microbiome specialism fits with the Swiss group’s functional food businesses. And there is certainly unmet need for treatments for resistant C diff, although it is notable that SER-109 was to be sold through the Aimmune business. 

Follow-on Seres projects for ulcerative colitis feel more vulnerable, though after the failure of the lead candidate in phase 2 earlier this year there is little perceived value left in these anyway. Microbiome approaches have promised much but delivered little clinical evidence in inflammatory bowel conditions – Takeda walked away from a similar project from Finch earlier this year.

NestlĂ©'s deal this year with Enterome suggests that the Swiss group still sees a future in the microbiome, and this French group’s name was also included under partnerships. But the terms extracted by Enterome and Seres point to products destined for the prescription drug market, not over-the-counter food supplements and probably not medical nutrition either.

“We will take our learnings [from Palforzia] very seriously,” Mr Behar said. The message to investors is clear: having gained first-hand experience of a drug launch, NestlĂ© will not stumble into making the same mistakes again. 

NestlĂ© Health Sciences: playing on the fringes of prescription drug development 
Date CompanyScope of dealDeal terms 
Jul 2022EnteromeEB1010 (inducer of IL-10) for food allergies and IBD and access to microbiome drug discovery platform$40m in cash and equity plus milestones
Jul 2021SeresSER-109 for recurrent CDI (microbiome-based therapeutic)$175m up front and $350m in milestones for joint US & Canada rights
Jan 2021Senda Research collaboration around three undisclosed preclinical "nutritional therapies" for metabolic conditionsTerms undisclosed 
Oct 2020AimmunePalforzia for peanut allergy and desensitisation immunotherapy platformCompany acquired for $2.6bn 
Aug 2020Epitomee MedicalPolymer-based ingestible product aimed at promoting weight lossDevelopment and commercialisation deal, terms undisclosed 
Feb 2020ValbiotisTotum-63 for reducing the risk of type 2 diabetes (combination of five plant extracts)$5m up front plus $66m milestones
Dec 2019G3 Pharmaceuticals Galectin-3 inhibitors for nutritional use in conditions such as heart failure and chronic kidney diseaseOption development deal, terms undisclosed
Apr 2019AmazentisUrolithin A technology for dietary supplements, and research programme to extend useEquity stake and global rights, terms undisclosed 
Oct 2017CodexisOption for global rights to CDX-6114, an enzyme for management of phenylketonuria, and access to protein engineering platform $14m up front plus undisclosed milestones
Nov 2016AimmuneStrategic development collaboration around food allergy therapies $145m equity investment (followed by equity investments of $30m in Feb 2018 and $98m in Nov 2018)
Feb 2016Pronutria (now Axcella Health)Projects for serious conditions linked to amino acid imbalances $42.5m equity investment, terms of collaboration undisclosed
Jan 2016SeresSER-109, SER-262 for recurrent CDI, SER-287 and SER-301 for IBD (microbiome therapeutics)$120m up front and $1.8bn milestones for ex US and Canada rights
Sep 2015Lipid TherapeuticsLT-02, a barrier function therapy for ulcerative colitisWW rights ex-Europe and Australia, terms undisclosed 
Jan 2015SeresEquity investment$65m series D 
May 2015Flagship VenturesInvestment in venture fund with an interest in nutritional therapy Total investment undisclosed 
Mar 2013PamlabMaker of medical foods for patients with cognitive impairment and neuropathiesCompany acquisition, terms undisclosed
Jul 2012AcceraAxona, a prescription medical food for Alzheimer's Equity stake, terms of collaboration undisclosed
Note: Deals variously target prescription and OTC markets.  CDI=C difficile infection. Companies in bold named in NestlĂ© presentation. Source: Evaluate Pharma & company communications. 

https://www.evaluate.com/vantage/articles/news/corporate-strategy/burned-palfozia-nestle-retreats-its-pharma-experiment