AstraZeneca's COVID-19 antibody cocktail Evusheld is not currently authorized for use in the United States until further notice, the U.S. Food and Drug Administration said on Thursday.
The therapy is unlikely to provide protection against currently dominant COVID-19 variants, the regulator added.
The FDA had limited Evusheld's use earlier this month, as it did not expect the therapy to provide protection against the Omicron subvariant XBB.1.5, which has been causing concern due to its rapid spread in the country in December.
Evusheld was first authorized in late 2021 by the FDA to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
AHunter Biden email about Ukrainefrom 2014 looks ‘suspiciously’ like it could have come from classified information, a leading GOP senator has claimed.
Ron Johnson (R-Wis.) said the April 12, 2014 message to one of the first son’s business partners resembles documents that the State Department gives members of the Senate when they travel overseas.
“It reads like one of those scene-setters — highly detailed information in terms of Ukraine,” Johnson told Fox News Tuesday.
The email from Hunter to Devon Archer includes a granular 22-point memo the Biden scion described as “thoughts after doing some research.”
Those “thoughts” include the prescient predictions that Petro Poroshenko would be elected Ukraine’s president the following month and that “some sort of decentralization will likely occur in the East.”
A Hunter Biden email about Ukraine from 2014 may have been derived from secret information that was improperly shared with him.FOX News/Tucker Carlson Tonight
“If it doesn’t the Russians will continue to escalate there [sic] destabilization campaign, which could lead to a full scale take over of the eastern region most critically Donetsk,” Hunter Biden wrote. “The strategic value is to create a land bridge for RU[ssia] to Crimea.”
The 1,300-word email — far more detailed and lengthy than anything else found on Hunter’s abandoned laptop — also referenced an upcoming trip to Ukraine by then-Vice President Joe Biden and appeared to acknowledge the older Biden’s penchant for gaffes.
“The announcement of my guys [sic] upcoming travels should be characterized as part of our advice and thinking — but what he will say and do is out of our hands,” Hunter Biden wrote. “In other words it could be a really good thing or it could end up creating too great an expectation. We need to temper expectations regarding that visit.”
The email from Hunter to Devon Archer includes a granular 22-point memo the Biden scion described as “thoughts after doing some research.”
Johnson noted that the email was written at the same time “when Devon Archer and Hunter Biden were trying to get on the board of [Ukrainian energy company] Burisma and get their $3, $4 million worth of payday trying to prove their worth.”
“Three days later, Vice President Biden meets with Devon Archer in the White House,” he said. “Then [Joe Biden] goes to Ukraine and is listed as the face of the Obama administration in Ukraine.”
“It’s obvious Hunter Biden is selling access to information,” Johnson added. “Does that have anything to do with some of the classified documents Vice President Biden was squirreling away in his residence? I don’t know, but it looks incredibly suspicious.”
However, an official with knowledge of Ukraine intelligence matters scoffed at the notion that the email may have been gleaned from classified information, telling The Post late Wednesday: “It sounds like something he got from Wikipedia or a YouTube interview — like a paraphrased version of open-source reporting.”
Hunter Biden and Devon Archer were both named to the Burisma board of directors, with the first son getting paid as much as $83,000 a month — equivalent to $1 million a year — despite having no experience in the energy industry, according to information stored on his infamous laptop.
Hunter Biden’s 1,300-word email also referenced an upcoming trip to Ukraine by then-Vice President Joe Biden.
But that salary was slashed after Joe Biden left office and Hunter Biden resigned from the board in April 2019, when his business dealings began complicating his dad’s White House bid.
An email also showed that Vadym Pozharskyi, who advised the company’s board, asked Hunter Biden for “advice on how you could use your influence” on Burisma’s behalf.
Global ratings agency Moody’s is working on a system to score up to 20 stablecoins based on the quality of their reserves attestations, according toa report from Bloomberg, citing a person familiar with the plans.
The project is in its infancy, however, and won’t be issuing official credit ratings, another person told Bloomberg.
The resiliency of stablecoins and whether they're backed by a reliable pile of money is a longstanding issue in the crypto industry. Stablecoins are meant to closely track the value of something else, often the U.S. dollar. So if investors have put, say, $10 billion into a stablecoin, there should, in theory, be $10 billion sitting somewhere to back it up.
The largest stablecoin, Tether's USDT, has been dogged for years by concern that it has not been fully backed. In 2021, Tether was forced to pay $18.5 million in penalties after New York State found that it had falsely claimed that its stablecoin was fully backed 1-to-1 by U.S. dollars.
One of the most notable aspects of the FDA's track record on complete response letters is that the agency seems to hand out a remarkably similar number each year. This much is true for the last five, with 2022 seeing 34 rebuffs, bang on the five-year average. There was a slight uptick in the peak pandemic year of 2020, when delays in manufacturing plant inspections presumably peaked, and this issue remained live last year. Those hit by the FDA's ongoing Covid travel restrictions included Alvotech and Teva with their Humira biosimilar, the China-based cancer players Junshi and Hutchmed, andUCB, whose US launch of an important new growth driver, the psoriasis drug bimekizumab, was painfully delayed. This factor should fade in 2023, and the numbers below do not point to any particular tightening up of reviews at the US regulator.The clampdown on accelerated approvalsis more likely to crimp the volume of novel agents hitting the market in the future. Still, it is always important to remember the big caveat of this analysis, which is that it relies on company disclosure. Private developers and some larger groups might not always feel obliged to announce a knockback.
Centessa Pharmaceuticals plc (Nasdaq: CNTA), a clinical-stage pharmaceutical company that aims to discover and develop medicines that are transformational for patients, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2a first-in-human, clinical trial of LB101 for the treatment of solid tumors. LB101, a conditionally tetravalent PD-L1xCD47 LockBody® bispecific monoclonal antibody targeting solid tumors, is the first product candidate developed using the Company’s proprietary LockBody technology which is designed to selectively drive potent effector function activity, such as CD47, in the tumor microenvironment (TME) while avoiding systemic toxicity.
Europe's drug regulator has decided not to label the ongoing shortage of antibiotics in the continent a "major event", according to a source familiar with the matter.
The declaration of a "major event", would allow the European Medicines Agency (EMA) to coordinate action at a pan-European level and increase the reporting obligations of manufacturers.
Certain widely-used antibiotics, including amoxicillin - used to treat bacterial infections and often prescribed for ear and chest infections in children - have been in short supply since October.
Nearly all the countries in Europe are reporting shortages, according to the EMA.
A meeting of the EMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) took place earlier on Thursday, where the issue was discussed.
The EMA did not immediately respond to Reuters' request for comment.
On Wednesday, a consortium of patient and consumer groups wrote to the EMA saying not enough was being done to address the ongoing shortages, and that the use of alternative antibiotics was squeezing supplies of these other medicines. The groups also recommended the EMA declare the situation a 'major event'.
