target raised from USD 86 to USD 104.
Thursday, January 16, 2025
'US CDC recommends faster testing for bird flu in hospitalized patients'
People hospitalized for flu should be tested for bird flu within 24 hours, the U.S. Centers for Disease Control and Prevention said on Thursday, in an expansion of the agency's efforts to tackle ongoing infections in humans.
The advisory is intended to prevent delays in identifying human infections with avian influenza A (H5N1) viruses amid high levels of seasonal influenza.
The risk to the general public from bird flu is low, and there has been no further evidence of person to person spread, the agency said.
Influenza A-positive patients, particularly those in an intensive care unit, should be tested ideally within 24 hours of hospitalization to identify the viral subtype, the agency said.
Prior to Thursday's guidance, hospitals generally sent batches of samples to labs for subtyping every few days.
Faster testing also aims to help doctors identify how people became infected and provide their close contacts with testing and medicine more quickly, if needed, said Nirav Shah, the agency's principal deputy director, on a call with reporters.
The CDC does not believe it has been missing bird flu infections in people, Shah said.
"The system is working as it should," said Shah, adding that health officials want results sooner in case any public health action is needed. "What we need is to shift to a system that tells us what's happening in the moment."
Nearly 70 people in the U.S., most of them farmworkers, have contracted bird flu since April, as the virus has circulated among poultry flocks and dairy herds.
Most infections in humans have been mild, but one fatality was reported in Louisiana last week.
The U.S. Department of Agriculture has more than 300 personnel working on its bird flu response and has spent $1.5 billion on its efforts to curb the spread among poultry and dairy cattle, said Eric Deeble, a deputy undersecretary at the agency.
The CDC last week said it would rebuild a bird flu vaccine stockpile for poultry.
Officials at the Department of Health and Human Services, which encompasses CDC, have repeatedly met with the transition team of the incoming Donald Trump administration on Zoom calls and have shared their bird flu playbook, officials said on the press call.
Officials at the USDA have also met several times with the transition team to try to ensure a smooth handoff on agency actions to curb the spread of the virus, including a tabletop exercise at the White House on Wednesday, Deeble said.
Sling shoots at thyroid eye disease with its oral therapy
Thyroid eye disease (TED) therapy Tepezza – the top asset in Amgen's $26 billion takeover of Horizon in 2023 – could be facing competition from an easier-to-dose alternative from Sling Therapeutics.
The Michigan, US, biotech has announced topline data from a phase 2b/3 trial of linsitinib – claimed to be the first oral therapy to pass that milestone – and is planning to start a confirmatory phase 3 trial in the coming months that could support regulatory filings.
TED is a rare autoimmune disorder in which the muscles and fatty tissues behind the eye become inflamed, causing the eyes to be pushed forward and bulge outwards in a condition known as proptosis that, if severe, can become disfiguring and disabling.
Linsitinib is a small-molecule inhibitor of IGF-1R, taken twice daily. In the phase 2b/3 LIDS trial, more patients treated with a 150mg dose of the drug achieved a 2mm or better reduction in proptosis after 24 weeks compared to placebo, which was a statistically significant difference.
A lower, 75mg twice-daily dose did not outperform placebo, according to the company, but with both doses there was a "favourable safety profile", including for adverse events that are associated with IGF-1R-acting drugs, including hearing impairment, high blood sugar levels, and menstrual cycle changes.
Tepezza (teprotumumab) became the first FDA-approved treatment for TED in 2020 and is still the only drug for the disorder, which otherwise needs to be treated with surgery. It is already a blockbuster, with sales reaching more than $1.3 billion in the first nine months of 2024.
The drug is currently given once every three weeks for a total of eight infusions, so an oral alternative could be an attractive proposition for patients and healthcare systems if it reaches the market.
Amgen isn't resting on its laurels, though, particularly with other potential rivals circling, such as Viridian Therapeutics and its anti-IGF-1R antibody veligrotug that needs five infusions and has cleared a phase 3 trial.
It is developing a new formulation of Tepezza that could be dosed subcutaneously every two weeks, doing away with the need for visits to an infusion clinic, although, Viridian is also working on an injectable antibody that it believes could be given every four to eight weeks.
"Patients must currently choose between an invasive orbital surgery or eight infusions over 24 weeks, which can be inconvenient and time-consuming and pose serious potential risks," said Raymond Douglas, a professor at Cedars-Sinai Medical Center, who also serves as Sling's chief scientific officer.
"As a practising physician, it makes sense to start a new patient's treatment journey with an oral therapy that shows an early response that increases over time," he added.
https://pharmaphorum.com/news/sling-shoots-thyroid-eye-disease-its-oral-therapy
Santhera preps UK Duchenne drug launch after NICE says yes
Santhera Pharmaceuticals will launch its new drug for Duchenne muscular dystrophy in the UK within the next few weeks, after getting confirmation it will be covered by the NHS in all four nations.
The announcement follows finalised recommendations this week that backed Agamree (vamorolone) as a treatment for patients aged four and over with DMD from the National Institute for Health and Care Excellence (NICE), covering England, Wales, and Northern Ireland, as well as the Scottish Medicines Consortium (SMC).
The Swiss pharma company said that it expects to make its first sales of Agamree in the UK later this quarter, after launching the drug in its first market, Germany, almost exactly a year ago. It is also available in Austria and in the US through licensee Catalyst Pharma. It has also been approved in the EU, China, and Hong Kong.
The pending launch continues a turnaround in fortunes for Santhera, which was forced to slash staff and restructure its operations after its first DMD candidate, idebenone, failed a phase 3 trial in 2020.
The company licensed in a three-way deal with fellow Swiss firm Idorsia (formerly Actelion) and US biotech ReveraGen BioPharma shortly afterwards, saying at the time that it expected vamorolone to have peak sales potential of around $500 million a year.
Catalyst, meanwhile, licensed US, Canadian, and Mexican rights to the drug last year in a deal worth up to $231 million, including $90 million upfront, whilst also taking an option on some European markets and Japan.
In Europe, Santhera intends to focus its efforts on six key markets – Germany, France, Italy, Spain, the Benelux countries, and the UK – and seek commercial partners elsewhere. Earlier this month, Santhera signed an exclusive agreement with Clinigen to manage supply and distribution in countries where the product is not otherwise commercially available.
Vamorolone is a novel and fully synthetic glucocorticoid that has been shown in trials to slow down muscle degeneration and prolong the ability of DMD patients to walk without causing the weight gain, bone weakness, and mood changes associated with the use of regular corticosteroids like prednisone – a standard therapy for DMD. It binds to the same receptor as steroids, but avoids a downstream pathway associated with toxicity.
In its final guidance, NICE said that Agamree improves muscle function compared with placebo, but it is uncertain whether the drug is similar at improving muscle function outcomes, and how well it works in the long term, compared with currently available corticosteroids.
"Compared with prednisone, the evidence suggests that vamorolone is likely to have fewer side effects, although to what extent is uncertain," continued NICE, noting that the discount on Agamree's list price of £4,585.87 per 100ml of a 40mg/ml oral suspension means that likely cost-effectiveness estimates "are within the range that NICE considers an acceptable use of NHS resources."
NICE has estimated that there are around 1,700 patients in England alone who could be eligible for treatment with the drug.
https://pharmaphorum.com/news/santhera-preps-uk-duchenne-drug-launch-after-nice-says-yes
'FDA OKs sales of Zyn nicotine pouches, citing health benefits for adult smokers'
Federal health officials on Thursday backed the public health benefits of nicotine pouches, authorizing Philip Morris International’s Zyn to help adult smokers cut back or quit cigarettes.
The Food and Drug Administration OK’d 10 Zyn flavors, including coffee, mint and menthol. It’s the first time regulators have authorized sales of nicotine pouches, which are the fastest-growing segment of the U.S. tobacco market.
The pouches have been available for more than a decade as FDA reviewed company data intended to show the products can serve as an alternative to cigarettes and other traditional tobacco products. The decision doesn’t mean that Zyn is safe, just less harmful than older alternatives.
To remain on the market, companies generally must show that their products will reduce disease among adult tobacco users without attracting teens and adolescents.
FDA officials said Thursday that Zyn contains fewer harmful ingredients than cigarettes and various types of chewing tobacco, including snuff, which are linked to cancer and other life-threatening diseases. Company data also showed “a substantial portion of adults” who previously smoked switched completely to Zyn, regulators said. The pouches are sold in two different strengths.
California Abandons Regulations Phasing Out Diesel Trucks
by Travis Gillmore via The Epoch Times,
California’s Air Resources Board sent a letter on Jan. 14 to the U.S. Environmental Protection Agency, withdrawing its prior waiver request that would have forced a transition from diesel to zero-emission trucks in the state.
The federal environmental agency responded to the board’s withdrawal request on Jan. 14 with notice that no further action will be taken, and the matter is considered closed.
Regulators had previously requested in November 2023 that the agency approve a waiver to allow the state to enforce stricter rules for automobiles and diesel trucks.
Federal authorities agreed to some of the requests, but such related to the diesel truck rules were not yet decided.
“California has withdrawn its pending waiver and authorization requests that U.S. EPA has not yet acted on,” Liane Randolph, chair of the air resources board, said in a statement emailed to The Epoch Times.
“While we are disappointed that U.S. EPA was unable to act on all the requests in time, the withdrawal is an important step given the uncertainty presented by the incoming administration that previously attacked California’s programs to protect public health and the climate and has said will continue to oppose those programs.”
She suggested that President-elect Donald Trump’s incoming administration could challenge the clean air regulations implemented by President Joe Biden.
With federal government approval of more stringent regulations uncertain, the board could pursue other methods of achieving clean air goals by partnering with private industry, as was done in the first Trump administration.
“The California Air Resources Board is assessing its option to continue its progress as part of its commitment to move forward the important work of improving the state’s air quality and reducing harmful pollutants that contribute to poor health outcomes and worsen climate change,” Randolph said.
“The waivers and authorizations recently approved, along with other existing programs, will advance essential emissions reductions in key sectors as we assess next steps.”
Some industry representatives applauded the decision and said the regulations were practically impossible and too costly to comply with.
“The California Trucking Association has consistently stated the Advanced Clean Fleets Rule was unachievable,” Eric Sauer, CEO of the California Trucking Association, told The Epoch Times by email.
“We look forward to engaging all stakeholders, including CARB and EPA, to continue the trucking industry’s efforts to further reduce emissions in a technologically feasible and cost-effective manner that preserves our state and the nation’s critical supply chain.”
One state lawmaker said the decision to rescind the waiver request would benefit the state’s economy and noted the decision could be one of the other policy shifts seen soon as state agencies respond to a change of power at the federal level.
“I think it’s great news. This is good for everyone,” Republican Leader Assemblyman James Gallagher told The Epoch Times on Jan. 15.
“They’re waving the white flag because they couldn’t get the waiver approved before the Trump administration came in.”
Highlighting the integral role trucks play in delivering many of the goods Californians rely on, he expressed concern that if only electric vehicles were allowed, costs would inevitably increase.
The assemblyman suggested the new decision would help mitigate concerns trucking companies had about navigating mandates that some said were “literally impossible” to comply with.
“From the very beginning, I’ve denounced this policy,” Gallagher said.
“It makes no sense to force everybody to go electric when we don’t have the infrastructure to support it.”
The existing charging network statewide is inadequate for current demand levels if fleets were switched to electric, according to industry experts.
Acquiring heavy-duty electric trucks for sale presents its own challenges, as the prices are much higher, and maintenance and operational costs are yet to be well understood.
“Nobody has real numbers when we ask for details about maintenance and replacement costs,” Nelson Sibrian, owner of Sibrian Trucking based in Wilmington, California, told The Epoch Times.
“With diesel, we know our cost per day to maintain the vehicle.”
Maintenance costs make up most of a trucking company’s operating expenses, he said, and uncertainty about expenditures is problematic.
How far electric semi-trucks can travel before they need another charge is another area of concern. Traditional diesel 18-wheelers can drive more than 1,000 miles before they need to refuel, while industry estimates show similar-sized electric vehicles topping out at about 300 miles before they need charging.
“We need to know all of these things in order to plan,” Sibrian said. “If we don’t know the actual range, it makes it impossible to schedule, and they can’t give me a straight answer on how long [the trucks] will take to charge.”
Biden’s Bizarro World of Foreign Policy “Achievements”
by Victor Davis Hanson
Departing President Joe Biden offered a farewell brag this week to his State Department about how his tenure had improved America’s stature abroad. In his now accustomed weird mix of whispering and fiery shouting, Biden apparently felt he had to lie or mislead about almost every one of his “achievements.”
Yet to the extent that anything improved abroad on his watch—the weakening of Iran or the near destruction of Hamas and Hezbollah—it was due despite, not because of, Biden.
Biden, bowing to election year political pressure, did all he could to restrain and block Israeli retaliations to the October 7 massacres. Only after he was repeatedly proven wrong does he now shamelessly take credit for what Israel ironically achieved by ignoring his own threats directed at Israel.
Biden is correct only that Iran is “weaker than it’s been in decades.” But Tehran was aided, not hurt, by Biden’s nonstop efforts to lift sanctions, to allow Iran to make billions in oil revenues, to pay the theocracy billions of dollars in hostage ransom, and to beg the mullahs to reenter the ill-starred Iran deal. Everything Biden did makes it much harder for Israel to survive.
So, Iran is now weakened only because Israel ignored Biden’s nonstop ankle-biting and finger-shaking not to retaliate to Iranian aggression. Instead, the Netanyahu government systematically destroyed Iranian air defenses after killing most of Iran’s foreign terrorist operatives.
Biden referenced the end of the Assad regime in Syria, but it imploded not due to any effort by Biden. It was overwhelmed instead only after the Israeli decimation of Hezbollah and humiliation of Iran—coupled with the election victory of Donald Trump—that encouraged Assad’s enemies to attack a now isolated and weakened regime.
Biden is also taking credit for rumors that Hamas might release its hostages, who have been held in a subterranean labyrinth since October 7.
But why, with less than a week left in his tenure, did Biden believe Hamas might begin releasing the hostages when even his own Secretary of State, Antony Blinken, has criticized the administration for spending 16 months pressuring Israel, which only emboldened Hamas’s stonewalling?
Much more likely, the election of Donald Trump and his threat to unleash terrible retribution on Hamas (and implicitly on Iran) had prompted the terrorists’ tardy willingness to negotiate a release.
Of the horrific scramble from Afghanistan—the greatest humiliation of the US military in a half-century that cost the lives of 13 Marines—Biden boasted: “[I am] the first president in decades who’s not leaving a war in Afghanistan to his successor.”
Think of his warped logic: Biden does not leave a war to his successor only because he fled in humiliation and lost it.
Biden also took credit for saving Ukraine from Russia. But he conveniently omitted why Russia invaded in the first place.
Had Biden not destroyed American deterrence by fleeing Kabul and leaving behind billions of dollars in abandoned U.S. military equipment, had he not claimed, prior to the Russian invasion, that his reaction to Putin’s likely aggression would hinge on whether it was “a minor incursion,” then the Russians might never have invaded at all.
Vladimir Putin grabbed Crimea and the Donbass in 2014 during the Obama-Biden administration. He later sought to swallow the entire country with an attack on Kyiv in 2022 on Biden’s watch.
However, Putin stayed within his borders only during one of the last four administrations—Donald Trump’s.
Biden crowed that he accomplished all these misadventures without the use of force—“We have not gone to war to make these things happen.”
But Biden did more than any other recent president to weaken the U.S. military. Under his tenure, the Pentagon suffered a real reduction in its budget. And it never quite recovered from the Afghanistan debacle.
Annually, the military now comes up 40,000 recruits short due to Biden’s draconian vaccination requirements, its new woke mandates, and its constant false accusations of “white rage” and “white privilege” in the ranks—libels that prompted a Pentagon internal investigation that found no such racism.
China was never more bellicose than during Biden’s presidency. It serially threatened Taiwan, used cyber warfare to bully the U.S., brazenly expropriated U.S. military technology, and without worry sent a spy balloon to traverse the U.S. with impunity.
Biden’s open border saw more than 10 million illegal entries, among them thousands of Chinese nationals. Meanwhile, Chinese investors were freed to systematically buy up thousands of acres of America’s farmland adjacent to sensitive US military bases and installations.
Add it all up, and Biden would have done better to have just kept quiet and departed his failed presidency in shame.
https://amgreatness.com/2025/01/16/joe-bidens-bizarro-world-of-foreign-policy-achievements/
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