Serhiy Kolyada on the Maniacal Anger of Herod-Putin That a New Ukraine is Born.
Day: January 7, 2023
Michael Novakhov retweeted:
“GIULIANI would begin drinking shortly after awakening and would continue consuming alcohol persistently and in excess, affecting his behavior as her boss and lawyer.”
Stunning details in this new sexual harassment complaint against “America’s Mayor.”
RALEIGH, N.C. (AP) — The U.S. Securities and Exchange Commission has concluded its investigation of former North Carolina Sen. Richard Burr related to investment sales early in the coronavirus pandemic without taking any action, Burr said on Friday.
Burr, a Republican who didn’t seek reelection in November after three Senate terms, and Gerald Fauth, the brother of Burr’s wife, had been scrutinized for potential insider trading by the SEC. Fauth’s attorney said separately Friday that the SEC probe of his client is also over with no such trading found.
Burr and other members of Congress had been the focus of public criticism for aggressive trading in early 2020, before the economic threat from the virus was widely known.
Burr had already been cleared of wrongdoing by the Justice Department of President Donald Trump’s administration for offloading $1.6 million from his portfolio in January and February 2020. But the SEC continued to investigate, according to federal court filings made public in fall 2021.
“This week, the SEC informed me that they have concluded their investigation with no action,” Burr said Friday in a written statement released by his lawyer. Burr, who formally left the Senate on Tuesday as GOP Ted Budd was sworn in to succeed him, said he was “glad to have this matter in the rearview mirror as I begin my retirement from the Senate following nearly three decades of public service.”
Fauth attorney Joseph Warin said separately: “The SEC has closed its investigation into our client. We are thrilled that the SEC and the DOJ appropriately closed their investigations without any findings of insider trading.”
An SEC spokesperson said later Friday that the agency doesn’t comment on the opening or closing of a possible investigation.
A letter dated Wednesday from an SEC regional official to Warin said that “based on the information we have as of this date, we do not intend to recommend an enforcement action … against Mr. Fauth.”
Both Burr and Fauth were being investigated under the STOCK Act, which makes it illegal for members of Congress to act on inside information gained through their official duties to benefit financially.
Burr drew significant attention because he was captured in a recording privately warning a group of influential constituents in early 2020 to prepare for economic devastation. Burr denied trading on private information, but he stepped aside from his position as chairman of the Senate Intelligence Committee after the FBI obtained a search warrant to seize a cellphone.
Additional court filings stemmed from the case that had been brought by the SEC to force Fauth, who is a member of the National Mediation Board, to comply with a subpoena. The agency argued that his close relationship with Burr and a phone call between the two, followed by calls to Fauth’s brokers, made Fauth’s testimony critical. Fauth had repeatedly cited his health as a reason for not complying with the SEC’s request for him to testify.
Burr, from Winston-Salem, was elected to the U.S. House in 1994, where he served for 10 years until he defeated Democrat Erskine Bowles in the 2004 Senate race to succeed then-Sen. John Edwards. The mediation board upon which Fauth serves helps resolve disputed labor-management conflicts within the railroad and airline industries.
The Russian-installed governor of the Crimean city of Sevastopol said on Saturday that air defences had shot down a drone in what he suggested was the latest attempted Ukrainian attack on a port where Russia’s Black Sea Fleet is based.
Mikhail Razvozhaev, the Russian-backed governor of the city, made the accusation on the Telegram messaging service, alleging that the incident had occurred in the early hours of Jan. 7, which is Orthodox Christmas.
“Even the sacred holiday of Christmas was not a reason for these inhuman people to halt their attempts to attack our Hero City,” Razvozhaev wrote.
There was no immediate comment on the allegation from Ukraine, which has not in the past confirmed similar alleged incidents but has made clear it reserves the right to do what is necessary to return its own territory.
Russia annexed Crimea from Ukraine in 2014 and Kyiv says it is determined to return the Black Sea peninsula along with a swath of eastern Ukraine and other territory that Russian forces have seized since they invaded on Feb. 24 last year.
Crimea, which Russia says is now its sovereign territory, was one of the launchpads for what Moscow called its “special military operation” and has come under attack several times – most spectacularly in August, when a series of explosions destroyed a group of warplanes at a Russian naval base.
Russian President Vladimir Putin had proposed a truce to coincide with Orthodox Christmas. Kyiv rejected his offer as a cynical ruse to buy time for Russia’s forces to rest and bring in new equipment.
2023-01-07T08:50:42Z
The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease.
Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full FDA approval of the drug.
The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aim to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.
Nearly all previous experimental drugs using the same approach had failed.
“Today’s news is incredibly important,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable.”
Eisai said the drug would launch at an annual price of $26,500. Biogen shares, which had been halted, were up 3% at $279.40.
The Japanese company said it also planned to apply for marketing authorization for Leqembi in Japan and the European Union by the end of its business year on March 31, with hope of winning an approval from the Japanese authority by the end of this year.
Eisai estimated the number of U.S. patients eligible for the drug would reach around 100,000 within three years, increasing gradually from there over the medium to long term.
“Our assumption is that the number of global patients eligible for the drug will grow to around 2.5 million by around 2030,” Eisai CEO Haruo Naito told reporters and analysts on Saturday in Tokyo.
“The new drug may not generate a significant profit immediately after the launch, but it will start contributing to our profit in the latter half of the second year or the third year,” he said without giving any concrete figure.
Dr. Erik Musiek, A Washington University neurologist at Barnes-Jewish Hospital, said he was “pleasantly surprised” by the drug’s price.
“Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it’s in the ballpark of what I would expect,” he said.
Initial patient access will be limited by a number of factors including reimbursement restrictions by Medicare, the U.S. government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi.
“Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage … access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket,” the Alzheimer’s Association said in a statement.
Leqembi was approved under the FDA’s accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.
“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease,” FDA neuroscience official Billy Dunn said in a statement.
CMS said on Friday that current coverage restrictions for drugs approved under the accelerated pathway could be reconsidered based on its ongoing review of available information.
If the drug receives traditional FDA approval, CMS said it would provide broader coverage. Eisai officials have said the company plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.
The CMS decision was largely in response to a previous Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021 with little evidence that the drug slowed cognitive decline and despite objections by the FDA’s outside experts.
Biogen initially priced Aduhelm at $56,000 per year before cutting the price in half. With limited acceptance and insurance coverage, sales were only $4.5 million in the first nine months of 2022.
Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer’s dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing illness.
To receive the treatment, patients will need to undergo testing to show they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They will also need to undergo periodic MRI scans to monitor for brain swelling, a potentially serious side effect associated with this type of drug.
The medicine’s label says doctors should exercise caution if lecanemab patients are given blood clot preventers. This could be a safety risk, according to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died.
In the large trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s by 27% compared to a placebo. Nearly 13% of patients treated with Leqembi in the trial had brain swelling.
Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, said the approval will make a “big difference” in the field because it is based on biomarkers rather than just symptoms.
“It’s going to change how we make a diagnosis for Alzheimer’s disease, with more accuracy,” he said.
Tousi acknowledged that the benefit of the drug will likely be modest. “Still, it is a benefit that we were not able to achieve” before this approval.
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The logo of Eisai Co Ltd is displayed at the company headquarters in Tokyo, Japan, March 8, 2018. REUTERS/Issei Kato
A sign marks a Biogen facility in Cambridge, Massachusetts, U.S., March 9, 2020. REUTERS/Brian Snyder
