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Thursday, June 6, 2024

'WHO confirms first death from bird flu strain not seen before in humans'

 The World Health Organization (WHO) said on Wednesday a man in Mexico died from a strain of bird flu, H5N2, that had not previously been reported in humans.

The strain is different from the H5N1 strain of the bird flu virus, which has caused an outbreak among livestock in the U.S. and has infected three dairy farm workers.

The WHO said the current risk of the virus to the general population is “low.”

A 59-year-old man from the State of Mexico died on April 24, the same day he was hospitalized in Mexico City. A week earlier, on April 17, he had developed symptoms including fever, shortness of breath, diarrhea, nausea and general malaise, the WHO said.

The man previously had “multiple underlying medical conditions,” his relatives told the WHO, and he had been bedridden for three weeks before the onset of acute symptoms. He died from “complications of his condition.”

The WHO said he had no prior exposure to poultry or other animals, and the source of exposure to the virus was still unknown.

Mexico has seen other cases of H5N2 among its poultry, but the WHO said it has not been able to establish a connection to the human case.

https://thehill.com/policy/international/4706631-who-first-death-bird-flu-strain-not-seen-before-in-humans/

'NAACP urges Biden to halt weapons to Israel to build Black voter support'

 The NAACP is calling on President Biden to halt the sale of weapons to Israel, arguing it will build support for him with Black voters ahead of the election.

The push comes amid polls showing that Biden may lose the support of Black voters over his support for Israel amid the violence in Gaza.

A March poll by In Our Own Voice: National Black Women’s Reproductive Justice Agenda with PerryUndem, found that 24 percent of Black voters identified the Israel-Hamas war as “extremely important” ahead of the election.

“The NAACP calls on President Biden to draw the red line and indefinitely end the shipment of all weapons and artillery to the state of Israel and other states that supply weapons to Hamas and other terrorist organizations,” the civil rights organization said in a statement, first reported by Reuters.

“It is imperative that the violence that has claimed so many civilian lives, immediately stop.”

Though the NAACP said Israel had a right to defend itself after Hamas’s Oct. 7 that Israel says killed around 1,200 people and took more than 250 hostages, it is also urging Israel to “commit to an offensive strategy that is aligned with international and humanitarian laws.” 

According to the Palestinian Health Authority, more than 36,000 Palestinians have been killed in Israeli military offenses, and Palestinians are facing widespread hunger and displacement. The International Court of Justice has accused Israel of violating the genocide convention. Israel denies these allegations.

The NAACP is also calling for Hamas to return the hostages and “stop all terrorist activity.” 

The 115-year-old civil rights organization has been hesitant to speak openly on the conflict, though it did express some support for college students’ right to protest last month. 

Now, the organization is warning Biden that if he does not use his influence with Israel to help orchestrate a permanent ceasefire to Gaza, he will risk Black voters’ frustration at the ballot box.

A majority of Black voters want to see the U.S. call for an immediate ceasefire, according to a survey by the Carnegie Endowment for International Peace, and believe that U.S. military aid to Israel should be conditional. 

Advocates have been warning Biden that Black voters feel a sense of connection with Palestinians for the oppression they have faced, a warning Johnson reiterated in an interview with Reuters.

The growing civilian deaths, NAACP President and CEO Derrick Johnson told Reuters, is “horrifying’ Black Americans, particularly young Black Americans.  

“It’s raising a lot of questions around why our tax dollars are being used to harm civilians,” said Johnson.

https://thehill.com/homenews/race-politics/4707546-naacp-urges-biden-to-halt-weapons-to-israel-to-build-black-voter-support/

NanoViricides Profile of NV-387 Enables Infrequent Dosing for Strong Antiviral Effect

 NanoViricides, Inc. (NYSE Amer.:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, reports on the highly desirable blood concentration profile of its lead clinical stage broad-spectrum antiviral agent NV-387 upon intravenous (I.V.) administration in a non-human primate (NHP) animal model.

The Company has found that its lead nanoviricide broad-spectrum antiviral drug candidate NV-387, when given as a slow bolus intravenous infusion, resulted in a relatively flat plateau of blood concentration of the drug with very slow decline over a 24 hour period in a cynomolgus monkey model.

The maximum concentration as well as the plateau concentration increased in a dose-dependent manner, as expected.

This sustained drug level in the blood stream for a relatively long period of time enables infrequent dosing. It is the result of the unique polymeric design of NV-387. NV-387 is a "chemical nanomachine". It is made up of polymer with its size chosen to minimize loss by renal filtration.

The observed pharmacokinetic profile of NV-387 supports a once-daily or less frequent dosing regimen.

The Company has already developed an injectable formulation of NV-387, namely NV-387 Solution for Injection, Infusion, and Inhalation.

An injection of NV-387 would be useful for moderate to severe illness, especially because of the sustained blood profile that requires infrequent dosing.

An infusion would be suitable for severely ill hospitalized patients.

Importantly, this NV-387 Solution can be readily delivered directly into the lungs of a patient using a simple handheld nebulizer over a period of a few minutes. Such delivery can enable direct attack on the virus where such attack is most needed in the cases of severe lung infection.

The utility of NV-387 is extremely broad, reminiscent of the utility of antibiotics.

https://www.accesswire.com/871242/the-sustained-slow-declining-blood-concentration-profile-of-nv-387-enables-infrequent-dosing-for-strong-antiviral-effect

Halozyme Raises Full Year Guidance and Updates 5-Year Financial Outlook

 Halozyme Therapeutics, Inc. (NASDAQ: HALO) ("Halozyme") today announced that the Company is raising its full year 2024 financial guidance and updating its 5-year financial outlook based on the grant of European Patent No. 4269578, covering the ENHANZE® rHuPH20 product obtained from Halozyme's ENHANZE® manufacturing methods that the Company provides to its current and future licensees. The new patent is licensed under all of Halozyme's ENHANZE® licenses. It will be validated in 37 European countries and expires on March 6, 2029.

"We are pleased to be able to raise our full year 2024 financial guidance and 5-year financial outlook, which now reflect the original royalty rate for DARZALEX SC in Europe from the granting of this new European patent, which is valid through March 6, 2029," said Dr. Helen Torley, president and chief executive officer of Halozyme.

Under the terms of Halozyme's ENHANZE® license with Janssen, the newly granted patent prevents the reduction in the royalty rate on sales of DARZALEX® SC in the European countries where it is validated until the patent expires. The new patent is not expected to have any impact to royalties under other ENHANZE® licenses with an issued or pending collaboration patent, as current royalty rates for these licenses already are expected to extend beyond expiration of the new patent. 

Based on the new European patent for ENHANZE®, the Company is raising its full year 2024 financial guidance and updating its 5-year financial outlook during its investor presentation.

https://www.prnewswire.com/news-releases/halozyme-raises-full-year-2024-financial-guidance-and-updates-5-year-financial-outlook-302165654.html

Vanda Gets Unsolicited, Non-Binding Indication of Interest from Cycle Group

 Vanda Pharmaceuticals Inc. ("Vanda" or the "Company") (Nasdaq: VNDA) today confirmed that it has received an unsolicited, non-binding indication of interest from Cycle Group Holdings Ltd. ("Cycle Group") to acquire the Company for $8.00 per share in cash.

Consistent with its fiduciary duties, and in consultation with its independent financial and legal advisors, the Vanda Board of Directors (the "Board") will carefully review and evaluate the indication of interest to determine the course of action that the Board believes is in the best interests of Vanda and its shareholders.

Vanda does not intend to comment further on the indication of interest before the Board has completed its review.

There is no action for shareholders to take at this time.

https://www.prnewswire.com/news-releases/vanda-pharmaceuticals-confirms-receipt-of-unsolicited-non-binding-indication-of-interest-from-cycle-group-holdings-ltd-302166196.html

ACLU To Sue Biden Administration Over New Border Rules

 by Eric Lundrum via American Greatness,

The far-left American Civil Liberties Union (ACLU) announced its intention to sue the White House after Joe Biden announced a new executive order that would ostensibly reduce access to the asylum system for illegal aliens.

According to Axios, the ACLU had made preparations for such a lawsuit even before Biden officially announced the executive order, which he signed on Tuesday. There had been leaks to the press in the days ahead of the order confirming many details of the plan.

“We intend to sue. A ban on asylum is illegal just as it was when Trump unsuccessfully tried it,” said Lee Gelernt, a civil rights lawyer at the ACLU, following the announcement of the executive order.

But the Biden White House, apparently having expected such challenges, has prepared to defend the executive order in court and with certain caveats in its implementation.

For example, the order’s parameters will only activate when there is a certain number of illegal border crossings; the order also includes “humanitarian exemptions.”

Biden’s order has also been criticized by conservatives, who say it does nothing to address the underlying problems that have led to a historic surge in illegals flooding across the border.

The order has also been accused of implementing a sort of soft amnesty on hundreds of thousands of illegals who had pending asylum cases, by simply dismissing the cases altogether without making a clear ruling one way or another, thus allowing the illegals to go free.

The border crisis and immigration as a whole has consistently remained the top concern for voters, according to exit polling throughout the presidential primaries this year.

Former President Donald Trump has vowed to carry out a massive deportation operation and finish building the southern border wall if he is returned to the White House this November.

https://www.zerohedge.com/political/aclu-sue-biden-administration-over-new-border-rules

ECB Cuts Rates For The First Time Since 2019, Does Not "Pre-Commit To A Particular Rate Path"

 And so, the second G7 central bank to launch an easing cycle in the past 24 hours (the BOC was the first) is in the history books.

Moments ago the ECB confirmed that, as widely previewed and expected, it cut rates by 25bps as follows:

  • ECB Cuts Deposit Facility Rate by 25bps to 3.75%; Est. 3.75%
  • ECB Cuts Main Refinancing Rate by 25bps to 4.25%; Est. 4.25%
  • ECB Cuts Marginal Lending Facility Rate by 25bps to 4.50%; Est. 4.50%

Commenting in its statement on the first ECB rate cut since 2019, the central bank said that "based on an updated assessment of the inflation outlook, the dynamics of underlying inflation and the strength of monetary policy transmission, it is now appropriate to moderate the degree of monetary policy restriction after nine months of holding rates steady. Since the Governing Council meeting in September 2023, inflation has fallen by more than 2.5 percentage points and the inflation outlook has improved markedly. Underlying inflation has also eased, reinforcing the signs that price pressures have weakened, and inflation expectations have declined at all horizons. Monetary policy has kept financing conditions restrictive. By dampening demand and keeping inflation expectations well anchored, this has made a major contribution to bringing inflation back down."

At the same time, despite the progress over recent quarters, the ECB noted that "domestic price pressures remain strong as wage growth is elevated, and inflation is likely to stay above target well into next year. The latest Eurosystem staff projections for both headline and core inflation have been revised up for 2024 and 2025 compared with the March projections. Staff now see headline inflation averaging 2.5% in 2024, 2.2% in 2025 and 1.9% in 2026. For inflation excluding energy and food, staff project an average of 2.8% in 2024, 2.2% in 2025 and 2.0% in 2026. Economic growth is expected to pick up to 0.9% in 2024, 1.4% in 2025 and 1.6% in 2026."

Translation: goodbye 2% inflation target.

Finally, in conclusion for those expecting guidance about more rate cuts, this is how the ECB previewed its next actions:

The Governing Council is determined to ensure that inflation returns to its 2% medium-term target in a timely manner. It will keep policy rates sufficiently restrictive for as long as necessary to achieve this aim. The Governing Council will continue to follow a data-dependent and meeting-by-meeting approach to determining the appropriate level and duration of restriction. In particular, its interest rate decisions will be based on its assessment of the inflation outlook in light of the incoming economic and financial data, the dynamics of underlying inflation and the strength of monetary policy transmission. The Governing Council is not pre-committing to a particular rate path.

Also of note, here are the ECB’s new economic projections:

  • ECB Sees 2025 Inflation at 2.2%; Prior Forecast 2%
  • ECB Sees 2026 Inflation at 1.9%; Prior Forecast 1.9%

Yes, the ECB raised its 2025 inflation target as it cuts rates.

Bottom line: no surprises, with the ECB cutting rates as expected, and remaining murky on the future, but the take home message is clear: any 2% inflation target the central bank may have had is dead.

The market reaction was generally as expected, with the lack of dovish guidance lifting the EURUSD from 1.0863 to 1.09 over the course of 10-minutes.

At the same time, Bund Sep'24 fell from 131.14 to 130.93 before then extending to a trough of 130.82 around eight minutes later. BTP-Bund yield spread has widened modestly from around 129bp to just over 130bp.

Equities also came under pressure: the Dax Jun'24 fell from 18739 to 18711 and then slipping further to 18686 10-minutes later

Summarizing the decision, Newsquawk writes that overall, the decision was largely as expected with the ECB cutting by 25bp and not committing to any rate path with decision ahead to be data-dependent and meeting-by-meeting. The details from the statement (see below) err on the hawkish side and as such, thus far. the ECB can be described as a hawkish-cut with data-dependence taking centre stage.

Within the statement the ECB acknowledged that the outlook for inflation has improved markedly, however despite recent progress ‘ domestic price pressures remain strong as wage growth is elevated, and inflation is likely to stay above target well into next year.' Furthermore, the ECB continues to pledge to keep policy “sufficiently restrictive for as long as necessary to attain the 2% goal. On that. HICP forecasts were lifted for 2024 and 2025 on the headline and both by more than expected, with the core views also raised as well. Furthermore, the 2026 GDP view was maintained defying some calls for a moderation.

https://www.zerohedge.com/markets/ecb-cuts-rates-first-time-2019-does-not-pre-commit-particular-rate-path