Hersh: CIA Knows Zelensky & Top Generals Are Skimming Hundreds Of Millions In US Aid

 by Dave DeCamp via AntiWar.com,

On Wednesday, Investigative journalist Seymour Hersh published a report on Substack that alleged the CIA was aware of widespread corruption in Ukraine and the embezzlement of US aid.

The report said the Ukrainian government has been using US taxpayer money to purchase diesel from Russia to fuel its military. Hersh said Zelensky "has been buying the fuel from Russia, the country with which it, and Washington, are at war, and the Ukrainian president and many in his entourage have been skimming untold millions from the American dollars earmarked for diesel fuel payments."

Hersh said according to one estimate by CIA analysts, at least $400 million in funds were embezzled last year. Sources told Hersh that Ukrainian officials are also "competing" to set up front companies for export contracts to private arms dealers around the world.

The issue of corruption was raised during a meeting between CIA Director William Burns and Zelensky in January. An intelligence official with direct knowledge of the meeting told Hersh that Burns delivered a stunning message to Zelensky.

Hersh wrote: "The senior generals and government officials in Kiev were angry at what they saw as Zelensky’s greed, so Burns told the Ukrainian president, because 'he was taking a larger share of the skim money than was going to the generals.'"

During the meeting, Burns presented Zelensky with a list of 35 generals and senior government officials whose corruption was known to the CIA. Zelensky responded by dismissing 10 officials who were engaged in flagrant corruption.

"The ten he got rid of were brazenly bragging about the money they had—driving around Kiev in their new Mercedes," the intelligence official said.

Hersh said Zelensky’s "half-hearted response" and the "lack of concern" in the White House angered some US intelligence officials. The intelligence official speaking to Hersh criticized President Biden’s two main foreign policy advisors, Secretary of State Antony Blinken and National Security Advisor Jake Sullivan.

"They have no experience, judgment, and moral integrity. They just tell lies, make up stories. Diplomatic deniability is something else," the official said. The official said there was a "total breakdown between the White House leadership and the intelligence community."

The report said the rift started in the fall when the Nord Stream natural gas pipelines were blown up. According to Hersh’s earlier reporting, President Biden ordered the operation that took out the pipelines. "Destroying the Nord Stream pipelines was never discussed, or even known in advance, by the community," the official said.

The official said there is "no strategy for ending the war" within the Biden administration and offered more scathing criticism of Blinken and Sullivan.

"Burns is not the problem," the official said. "The problem is Biden and his principal lieutenants—Blinken and Sullivan and their court of worshippers—who see those who criticize Zelensky as being pro-Putin. 'We are against evil. Ukraine will fight ’til the last military shell is gone, and still fight.' And here’s Biden who is telling America that we’re going to fight as long as it takes."

Hersh’s story comes after a series of leaked top-secret documents from the Pentagon and other government agencies surfaced online. Some of the documents show US war planning for Ukraine and reveal the US doubts Kyiv’s ability to launch a successful counter-offensive, offering a starkly different view of Ukraine’s abilities than what Biden officials have been saying publicly.

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Meanwhile, for a deeper look at just who is propping up Ukraine's budget to the tune of hundreds of billions, see more below...

https://www.zerohedge.com/geopolitical/hersh-cia-knows-zelensky-top-generals-are-skimming-us-aid

FDA mandates new safety warnings for opioid pain medicines

 The U.S. Food and Drug Administration said on Thursday it will require new safety warnings to be added in the prescribing information on labels for opioid pain relievers, including a warning about increased sensitivity to pain.

FDA said data suggests patients who use opioids for pain relief after surgery often have leftover tablets, which puts them at risk for addiction and overdose.

The updated safety warnings for these drugs will provide clarity about which patients opioid pain drugs should be prescribed to and the appropriate dosage and administration, the health regulator said.

Among other changes, the new labeling would also have to carry a warning that risk of overdose increases with higher dosage and that immediate-release opioids should not be used for an extended period unless a patient's pain remains severe.

Privately held Alora Pharmaceuticals' Dsuvia and Collegium Pharmaceuticals' Nucynta are among opioid pain relievers currently sold in the United States.

https://news.yahoo.com/fda-mandates-safety-warnings-opioid-184344045.html

Lilly gets CRL for ulcerative colitis med

 Eli Lilly and Company (NYSE: LLY) announced the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the mirikizumab biologic license application (BLA) for the treatment of ulcerative colitis (UC). In the letter, the FDA cited issues related to the proposed manufacturing of mirikizumab, with no concerns about the clinical data package, safety, or label for the medicine.

"We remain confident in mirikizumab's pivotal Phase 3 clinical data and its potential to help people with ulcerative colitis," said Patrik Jonsson, Lilly executive vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. "We are working diligently with the FDA and hope to launch mirikizumab in the U.S. as soon as possible."

Lilly recently received approval for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC in Japan. In addition, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment. Regulatory decisions are anticipated in additional markets around the world in 2023.

https://finance.yahoo.com/news/u-food-drug-administration-issues-203000748.html

atai Starts Phase 1 IV-to-Subcutaneous Bridging Study of R-Ketamine in Depression

 atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, announced that the first subject has been dosed in Perception Neuroscience’s Phase 1 intravenous-to-subcutaneous bridging study of PCN-101 (R-ketamine).

This Phase 1 open-label study is designed to assess the safety, tolerability, and pharmacokinetic profile of 60mg, 90mg and 120mg of PCN-101 delivered subcutaneously as compared to 60mg of PCN-101 delivered intravenously (IV). The trial will enroll approximately 16 healthy volunteers across the four cohorts and is expected to be completed in the middle of 2023.

In January 2023, atai announced results from the Phase 2a proof-of-concept study evaluating a single IV administration of PCN-101 in patients with treatment-resistant depression across three arms – 30mg, 60mg and placebo. While the results did not reach statistical significance on the primary endpoint, PCN-101 demonstrated an encouraging safety profile and signals of efficacy across all timepoints out to two weeks, potentially indicating a sustained duration of effect.

This IV-to-subcutaneous bridging study will potentially inform dosing regimens of the new subcutaneous formulation that may optimize the therapeutic index—the balance of safety, tolerability and efficacy—of PCN-101 in future studies, thereby supporting further exploration of the potential of R-ketamine as a rapid acting anti-depressant for at-home use.

atai continues to work with Perception Neuroscience to explore strategic partnership options.

https://finance.yahoo.com/news/atai-life-sciences-announces-first-105900051.html

Why Are Gene-Editing Stocks CRSP, EDIT, NTLA Stock Up

 Against the backdrop of a solid day on Wall Street, CRISPR Therapeutics (NASDAQ:CRSP) distinguished itself, popping up nearly 16%. The catalyst appears to center on CRISPR’s single-dose therapy for sickle cell disease (SCD), which it’s developing with Vertex Pharmaceuticals (NASDAQ:VRTX). Per a drug-pricing group, the drug may prove lucrative. Because of the potential for underlying advanced biotechnologies to usher in a paradigm shift in medicine, gene-editing stocks responded positively.

According to The Motley Fool, CRSP stock bounced after the Institute for Clinical and Economic Review stated that the SCD drug the two biotechnology firms are developing — called exa-cel — may be cost effective if priced below $1.9 million. Presently, the partners await word from the Food and Drug Administration (FDA) for exa-cel’s approval to treat SCD. As well, they seek approval for exa-cel’s other indication for transfusion-dependent beta thalassemia (TDT), another rare genetic blood disorder.

According to the Institute for Clinical and Economic Review’s Chief Medical Officer David Rind, “[s]ickle cell disease can affect nearly every organ system in the body, and severe sickle cell disease affects nearly every aspect of a person’s life.”

Further, Dr. Rind added, “From the earliest days of gene therapy, patients, families, and clinicians have imagined that someday it might be possible to address the underlying genetics of sickle cell to achieve a cure. These first two genetic therapies, using different technologies and altering different genetic targets may mean that day has nearly arrived.”

Because of Dr. Rind’s support of exa-cel and its broader implications, gene-editing stocks like Editas Medicine (NASDAQ:EDIT) and Intellia Therapeutics (NASDAQ:NTLA) jumped in sympathy.

While CRSP managed to steal the show on the Street today, the SCD therapeutic announcement presents tailwinds for other gene-editing stocks. Notably, NTLA jumped nearly 13% while EDIT found itself inching toward 19% up.

Fundamentally, the innovations undergirding gene-editing stocks may forever change medicine. According to government resource MedlinePlus, “[g]enome editing (also called gene editing) is a group of technologies that give scientists the ability to change an organism’s DNA. These technologies allow genetic material to be added, removed, or altered at particular locations in the genome.”

Therefore, rather than relying on harsh attacks on disease that may harm patients as well, gene-editing offers targeted therapeutics. Theoretically, the innovation should alter society and the economy for the positive.

However, investors also need to apply a cautious approach with gene-editing stocks. While the science compels, it’s still largely unchartered territory.

Interestingly, investor and entrepreneur Cathie Wood’s ARK Innovation ETF (NASDAQ:ARKK) acquired more shares of CRSP stock. In addition, Cantor Fitzgerald analyst Olivia Brayer recently initiated coverage of CRISPR with a “buy” rating. The expert’s price target stands at $72, which implies over 44% upside potential.

https://investorplace.com/2023/04/why-are-gene-editing-stocks-crsp-edit-ntla-stock-up-today/

Cutera, Inc. to Hold Special Meeting of Stockholders

 CUTERA, INC. (the "Company") (Nasdaq: CUTR), a leading provider of aesthetic and dermatology solutions, today announced it will hold a Special Meeting of Stockholders ("Special Meeting") on June 9, 2023, at 9:00 am PT in or near Brisbane, California for the purpose of considering proposals offered by J. Daniel Plants and David Mowry to remove, without cause, five of the six directors who were independent at the time of receiving the notices (the "Targeted Directors").

As previously announced, the Board has empaneled a Special Committee of the Board of Directors (the "Special Committee") to consider the Special Meeting notices provided by Mr. Plants and Mr. Mowry and to provide stockholders with a recommendation on how to vote on the proposals at any such Special Meeting.

Chair of the Special Committee Juliane T. Park commented, "The Special Committee welcomes the input of Cutera stockholders and is confident that, once fully informed, they will strongly support the Targeted Directors who have been diligently serving the interests of all Cutera stockholders."

The Special Committee will provide its recommendation in respect of the Special Meeting to stockholders in due course. Additional details will be made available in the Company’s definitive proxy statement to be filed with the SEC in connection with the Special Meeting. Stockholders are not required to take any action at this time.

https://finance.yahoo.com/news/cutera-inc-hold-special-meeting-200100484.html

QuidelOrtho prelims; sees revenue above views

 QuidelOrtho Corporation (Nasdaq: QDEL) (the “Company” or “QuidelOrtho”), a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, today announced preliminary revenue results for the first quarter ended April 2, 2023.

The Company expects total revenues in the first quarter of 2023 to be in the range of $840 million to $850 million. Respiratory product revenue is expected to be in the range of $262 million to $267 million, including COVID-19 product revenue of $212 million to $217 million. Non-respiratory product revenue is expected to be in the range of $578 million to $583 million, representing 5% growth on a supplemental combined basis and 7% growth on a constant currency basis at the midpoint. The increase in first quarter revenue results was driven by our Labs business unit, including an approximate $21 million settlement related to one of our collaboration agreements.

The preliminary revenue results described herein are based on management’s initial analysis for the first quarter ended April 2, 2023 and are subject to adjustments based on the Company’s completion of its quarter-end financial close process.

“After an exceptional fourth quarter of 2022, I am very pleased with our sustained momentum in the first quarter of 2023, which was ahead of expectations. This strong start to the year was supported by delivering more instruments driving strong results in our Labs business as well as better-than-expected results in the Point of Care business,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho. “Our team delivered solid non-respiratory revenue growth across all major geographic regions, with notable strength in China, demonstrating the power of our newly created scale and breadth of offerings across the diagnostics continuum, as well as the durability of our business model. As we look ahead, our supply chain is improving, we are focused on our key growth drivers and we are confident in our ability to deliver sustainable high-single-digit growth over the coming years.”

Quarterly Conference Call Information

QuidelOrtho will report financial results for its first quarter 2023 after the market close on Wednesday, May 3, 2023. Following the release of the financial results, QuidelOrtho will hold a conference call beginning at 2:00 p.m. PDT/5:00 p.m. EDT to discuss the financial results. Interested parties can access the conference call on the “Events & Presentations” section of the “Investor Relations” page of QuidelOrtho’s website at https://ir.quidelortho.com/. Those unable to access the webcast may join the call via phone by dialing 833-470-1428 (domestic) or 404-975-4839 (international) and entering Conference ID number 036290.

A replay of the conference call will be available shortly after the event on the “Investor Relations” page of QuidelOrtho’s website, under the “Events & Presentations” section.

https://www.businesswire.com/news/home/20230413005803/en/QuidelOrtho-Reports-Preliminary-Revenue-Results-for-the-First-Quarter-2023