RFK Jr Calls For "Mature Conversation" On Ukraine As Admin Is "Lying To Us"

 2024 presidential candidate Robert F. Kennedy Jr. has once again blasted the United States government for lying to the public and to the world about Ukraine, while calling out the Military Industrial Complex in particular.

It's not the first time. Earlier this month an avalanche of mainstream media headlines condemned his take when he told UnHerd the following: "We should have listened to Putin over many years. We made a commitment to Russia, to Gorbachev, that we would not move NATO one inch to the east. Then we went in, and we lied."

More recent speaking engagements wherein he utters unpopular truths on Ukraine have gone viral this week. In one of them, he tells an audience at a campaign event, "Our government is lying to us about it. The media is going on with the lie…It’s a laundering operation for the Military Industrial Complex."

Among Kennedy's chief talking points is that the country needs a "mature conversation" on the conflict, but that the American public is not getting that.

Interestingly, he said that while many Americans are moved by compassion for the Ukrainian people, including his son who actually early on went to fight within Ukraine's foreign legion, Washington has been deceptive in selling Americans on the billions in defense aid poured into the conflict.

"We were told that the reason we were going over there is because it was a humanitarian mission," RFK Jr said. "But then every choice that we made along the way, that's been about prolonging the war and increasing the bloodshed, and refusing to negotiate. If it was a humanitarian mission we would won't to terminate the war, to shorten it, and to reduce the amount of bloodshed," he continued.

He then talked about the "real reason" for escalation of the conflict seen in the rhetoric of Biden and some of his top officials as including regime change against Vladimir Putin, as well as weakening and exhausting Russia's military in order to prevent its effectiveness in future conflicts elsewhere in the world. Defense Secretary Lloyd Austin has long been on record as saying this is about 'weakening' Russia.

Below is an April speech that included similar statements by Robert F. Kennedy Jr...

"Well as it turns out, opposing Vladmir Putin has been for 20 years the principle focal aspiration of the neocons who were thrown out after the debacle in Iraq. And we thought they were all gone for good, but now they've all reemerged in the Biden White House... it's the opposite of a humanitarian mission."

He further described Ukraine as a small country which is now tragically being "ground into dust by the geopolitical ambitions of the neocons in the White House." Ultimately the Ukrainians find themselves stuck in the middle of a proxy war between two rival superpowers, he explained.

Among the more interesting of RFK Jr.'s remarks on the issue...

"If Mexico did that and then started killing – they killed 14,000 Russians in Donbass, the Ukrainian government – if Mexico did that to expatriate Americans, we would invade in a second," Kennedy said, adding that Putin "repeatedly told us: these are the red lines, you are crossing."

As expected, mainstream media sources have dismissed him as a "crackpot" for this analysis, including recently in The Daily Beast. At the same time, many such MSM publications are currently dying and struggling for readership when compared to a number of prominent and rising independent outlets.

https://www.zerohedge.com/geopolitical/rfk-jr-calls-mature-conversation-ukraine-us-lying-us

Cronos Group to Exit U.S. CBD Market

 Cronos Group Inc. (NASDAQ: CRON) (TSX: CRON) (“Cronos” or the “Company”), an innovative global cannabinoid company, today announced its decision to streamline its operating structure by winding down and exiting its existing U.S. hemp-derived CBD-focused operations by the end of the second quarter of 2023. Cronos has made this decision to improve its cash flow in the near term and position itself to directly enter the U.S. THC market when the necessary changes in U.S. regulatory conditions occur.

Consequently, beginning with the second quarter of 2023, the Company intends to report its financial results under one consolidated segment and will no longer report the U.S. and Rest of World as separate segments. Cronos is also increasing its previously announced 2023 operating expense savings target from a range of $10 to $20 million to a new range of $20 to $25 million, partially due to its decision to wind down and exit its existing U.S. operations.

In connection with the exit of its existing U.S. operations, Cronos expects to incur expenses in the second quarter of 2023, of up to $1.8 million comprised of inventory write-offs, severance and other employee costs, and asset impairment charges.

The Company is committed to maximizing the value of its global branded product portfolio. It anticipates bringing the Lord Jones® brand back to its adult-use roots by launching it in the Canadian market in the fourth quarter of 2023. Cronos will continue to invest in R&D and product development in Canada to keep building our portfolio of borderless products across categories to equip us for when the U.S. THC market opens.  

Cronos’ adult-use brand, Spinach®, is currently the number-3 ranked cannabis brand in Canada and is currently the only cannabis brand in Canada that is top-10 in all categories it participates in, which includes the number-1 ranking in the gummies category, during the first quarter of 2023 according to HiFyre data. Cronos looks forward to utilizing its brand-building strength across both the Spinach® and Lord Jones® brands in Canada.

https://www.morningstar.com/news/globe-newswire/8850016/cronos-group-announces-streamlined-operating-structure-to-improve-cash-flow

FDA approves Pfizer’s RSV vaccine for older adults

 The US Food and Drug Administration on Wednesday approved Pfizer’s RSV vaccine for older adults, the second such shot approved for the common virus.

Earlier in May, the agency approved the world’s first RSV vaccine for older adults, made by GSK. The vaccines could be available for seniors by fall, pending recommendations from the US Centers for Disease Control and Prevention and its vaccine advisers, who are scheduled to meet in June.

Respiratory syncytial virus, known as RSV, is a highly contagious virus that causes flu-like illness in people of all ages. Although RSV is often associated with babies and young children, it can also be dangerous for seniors. In the US, an estimated 159,000 adults 65 and older are hospitalized each year with RSV, and an estimated 10,000 to 13,000 die as a result of their infection.

In a clinical trial, the Pfizer vaccine – which will be marketed under the brand name Abrysvo – was 66.7% effective at preventing moderated lower respiratory tract illness with two or more symptoms and 85.7% effective at preventing illness with three or more symptoms in people 60 and older, according to Pfizer.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted 7-4 with one abstention in February that there was adequate data to support the vaccine’s safety and effectiveness.

The FDA is also reviewing Pfizer’s maternal vaccine to protect infants and is expected to make a decision by the end of August.

More RSV vaccines may be on the way, too. Moderna is finishing its Phase 3 trial for an mRNA vaccine for RSV in older adults and expects to submit results to the FDA within the next few months. Bavarian Nordic also said it will report results from a Phase 3 trial of its RSV vaccine for older adults this year.

https://www.cnn.com/2023/05/31/health/fda-pfizer-rsv-vaccine/index.html

Veeva stock rallies after cloud company’s quarterly profit, revenue surpass forecasts

 Shares of Veeva Systems Inc. (VEEV) rallied more than 7% in the extended session Wednesday after the cloud-software company focused on life sciences reported fiscal first-quarter earnings and revenue above Wall Street forecasts. Veeva earned $131.5 million, or 81 cents a share, compared with $100.1 million, or 62 cents a share, in the year-ago quarter. Adjusted for one-time items, Veeva earned 91 cents a share. Revenue rose 4% to $526.3 million, the company said. Analysts polled by FactSet expected the company to report adjusted earnings of 79 cents a share on sales of $516 million. Veeva guided for fiscal 2024 revenue between $2.36 billion and $2.37 billion, and adjusted EPS of about $4.59, also topping FactSet consensus. "It was a strong start to the year for Veeva and we are executing well on our goal to power the most critical functions for the life sciences industry," Chief Executive Peter Gassner said in a statement.

https://www.morningstar.com/news/marketwatch/20230531937/veeva-stock-rallies-after-cloud-companys-quarterly-profit-revenue-surpass-forecasts

AstraZeneca/Merck: FDA OK for Lynparza With Abiraterone for Prostate Cancer

 The Food and Drug Administration (FDA) approved Lynparza (olaparib) for use with abiraterone and prednisone to treat adults with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, the FDA announced on Wednesday.

This approval was based on findings from the PROpel trial, which demonstrated that Lynparza plus abiraterone significantly improved radiological progression-free survival (the time during and after treatment when a patient with cancer lives without disease worsening) compared with placebo with abiraterone, according to a press release from the FDA. In particular, progression-free survival was not reached in patients with metastatic castration-resistant prostate cancer assigned Lynparza plus abiraterone — meaning that more than half of patients in the trial did not meet this outcome — compared with eight months in patients assigned placebo with abiraterone.

Findings from the PROpel trial also showed that the improvement in radiological progression-free survival was primarily a result of patients with metastatic BRCA-mutated metastatic castration-resistant prostate cancer, according to the release.

The most common side effects in the trial, which occurred in at least 10% of patients treated with Lynparza plus abiraterone, included fatigue (38%), anemia (48%), diarrhea (19%), nausea (30%), lymphopenia (14%), decreased appetite (16%), abdominal pain (13%) and dizziness (14%). In addition, 72 patients from the trial —18% of the population — needed at least one blood transfusion, and 46 patients (12%) required several transfusions, according to the release.

In the PROpel trial, researchers analyzed data from 796 patients with metastatic castration-resistant prostate cancer, according to the listing on ClinicalTrials.gov.

https://www.curetoday.com/view/lynparza-receives-fda-approval-with-abiraterone-for-treatment-of-specific-patients-with-prostate-cancer

iRhythm gets FDA warning letter on alleged regulatory 'nonconformities' in heart monitor patch

 A recent warning letter from the FDA may have iRhythm Technologies changing its tune.

The remote monitoring tech maker disclosed its receipt of the letter in a filing (PDF) with the U.S. Securities and Exchange Commission on Tuesday. The May 25 letter sums up the FDA’s findings from an inspection of iRhythm’s facility in Cypress, California, that concluded last August.

According to the company, the letter lays out alleged “nonconformities to regulations for medical devices,” focusing specifically on issues with the reporting practices and quality system standards related to its Zio AT system, an adhesive patch that can be worn for up to 14 days and offers near-real-time heart monitoring to spot arrhythmia events as they occur.

“The company takes these matters very seriously,” iRhythm said in the SEC filing, adding that it “intends to respond within the specified time period and work diligently to address the FDA’s concerns.”

iRhythm didn’t provide specifics about the issues highlighted by the FDA in the letter but noted that it has already begun making adjustments in line with those regulatory concerns, after the FDA detailed its initial observations from the inspection in a Form 483 sent to iRhythm on Aug. 12, 2022. 

The devicemaker said it will not only continue working to address the issues highlighted in the original Form 483 but will also start correcting the additional concerns listed in this month’s warning letter—all while staying in contact with the FDA throughout the process.

Even so, iRhythm included a disclaimer that its corrections may not be up to the regulator’s standards. If that’s the case, “additional legal or regulatory action may be taken with or without further notice,” potentially including a mandate to pull the Zio AT system from the market that could take a hit to iRhythm’s bottom line.

Until then, however, because the current warning letter didn’t include any restrictions on the manufacturing, production or shipment of any of iRhythm’s technologies, the company said in the filing that it believes “that its receipt of this warning letter, without further adverse action initiated by the FDA, will not have a material impact to the company’s financial results.”

Currently, according to a recent first-quarter earnings report, iRhythm is hoping to see its revenues grow between 17% and 19% compared to 2022’s haul, for a total that could reach as high as $490 million.

Those predictions represent a slight uptick from the forecast iRhythm issued at the start of the year, which capped the company’s year-over-year growth at 18%.

iRhythm doubled down on that initial forecast as recently as March, as it embarked upon a “business transformation” that included the resignation of Douglas Devine, its chief operating officer, and is estimated to cost the company between $23 million and $30 million throughout 2023. The restructuring plan will “result in the transition or augmentation of staff of certain operations to the Philippines,” and may also include a reworking of iRhythm’s revenue cycle management operations.

https://www.fiercebiotech.com/medtech/irhythm-hit-fda-warning-letter-over-alleged-regulatory-nonconformities-heart-monitor-patch

Alzheimer's pipeline, strong as ever, now needs patients

 Calling all Alzheimer’s disease patients and caregivers: There’s a study out there waiting for you.

There are, at this moment, 187 clinical trials for the neurodegenerative disease underway, the highest ever on record, according to a new report from the Alzheimer’s Association (AA). The research was published in the association’s journal, Alzheimer’s & Dementia: Translational Research and Clinical Interventions, last week, featuring data scraped from the ClinicalTrials.gov database. Last year, the report found 172 clinical trials in progress and 143 unique drugs. This year there are two fewer drugs on the list.

The boost in clinical development is thanks to a rise in interest among Big Pharmas, which have jumped back into the space after key successes from Biogen and Eisai with Leqembi and Eli Lilly’s donanemab. Industry-sponsored trials rose 8% over the past year to 108, accounting for 58% of all trials conducted, compared to 9% that were conducted through public-private partnerships and 32% by academic medical centers.

“The recently approved therapies provide treatment for a relatively limited segment (e.g., early AD) of the large and growing AD population,” the authors wrote. “They represent initial steps in the march toward more comprehensive treatments with multiple therapeutic options for those with or at risk for AD.”

Biologics, mainly monoclonal antibodies like Leqembi, are the therapeutic of choice, rising 10% over the past year in terms of trial uptake for disease-modifying therapies.

All this renewed interest is great for research. But AA found that recruitment has been a major challenge—especially for phase 2 and 3 studies. Recruitment can take as long as 100 weeks and, for some studies, up to 200 or more. This significantly slows down progress. Phase 1 trials are slightly faster, but not by much.

To fill all of the available clinical trials, 57,465 patients are needed, according to the report. That would mean 41,864 for phase 3 trials; 13,829 for phase 2 trials; and 1,772 for phase 1. For phase 4, which are studies that are conducted after approval—like for Leqembi and its predecessor Aduhelm, for example—4,632 patients are needed.

Biogen and Eisai have a requirement to conduct a post-approval study for Leqembi after receiving an accelerated nod for the therapy. The same caveat was added to Aduhelm's approval in 2021; however, the companies have mostly backed off that drug after its controversial launch. 

It’s not just the sheer numbers, either. A lack of diversity in trial recruitment has contributed to the delays and stalled desperately needed treatments from advancing in the clinic.

The approval of Leqembi, and phase 3 clinical success for donanemab, are great for patients. However, AA notes that the availability of treatments may further hamper clinical trial enrollment as patients opt for those instead of participating in research.

https://www.fiercebiotech.com/biotech/calling-all-alzheimers-patients-theres-study-out-there-you