Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration (FDA) has approved INGREZZA® (valbenazine) capsules for the treatment of adults with chorea associated with Huntington's disease (HD).1 INGREZZA is the only selective vesicular monoamine transporter 2 (VMAT2) inhibitor that offers an effective starting dosage that can be adjusted by a patient's healthcare provider based on response and tolerability, with no complex titration.1 Only INGREZZA offers simple dosing that is always one capsule, once daily.
Saturday, August 19, 2023
Third of Ukraine Crop Exports Wiped Out After Black Sea Block
The Kremlin’s efforts to paralyze Ukrainian food shipments are succeeding, with a third of the country’s crop exports wiped out since its Black Sea ports were effectively blocked last month.
The drop marks a significant setback for Ukraine’s economy and global food security, even with a €1-billion push by the European Union to build out alternative routes since the start of Russia’s invasion. The US this week said it’s working with European partners to keep grain exports flowing, relying on rivers like the Danube and other avenues after sea passage has become unsafe.
“The key question is the river ports,” said Evghenia Sleptsova, senior economist at Oxford Economics. But ramping up volumes through those could prove difficult “now Russia started bombing Izmail and Reni,” two ports along the Danube which were attacked earlier this week.
Ukraine was only able to export 3.2 million tons of grains, vegetable oils and meals in the four weeks through August 15, down from 4.4 and 4.8 million tons in May and June when the Black Sea deal was still in place, according to estimates from analyst UkrAgroConsult. Crop stockpiles are now expected to swell through next year as better-than-expected harvests face fewer routes to market.
Even in wartime, Ukraine is still an important grain exporter globally, and the Black Sea deal that Russia quit on July 17 helped calm global prices and maintain flows to consumers. Russia’s own grain trade is benefitting from Ukraine’s weakness. Its crop exports are booming, and are expected to make up nearly a quarter of global wheat trade in the 2023-24 season.
Ukrainian President Volodymyr Zelenskiy said that within a month after the grain deal broke down there have already been seven attacks on ports with drones and missiles, signaling how challenging it has been to find reliable workarounds.
Boeing Dreamliner Pilot Suffers "Fatal Cardiac Arrest" Shortly After Takeoff
In late January, US Sen. Ron Johnson (R-Wis.) sent a letter to Federal Aviation Administration (FAA) Acting Administrator Billy Nolen and Office of Aerospace Medicine Federal Air Surgeon Susan Northrup shedding light on a concerning trend of individuals in the aviation industry who experienced medical events after receiving a Covid-19 vaccine.
"What steps has FAA taken or will FAA take to investigate whether Cody Flint, Hayley Lopez, Greg Pierson, Bob Snow, Wil Wolfe, and other pilots experienced COVID-19 vaccine adverse events?" Johnson asked.
The senator wrote, "Based on data from the Defense Medical Epidemiology Database, the whistleblower reported that the total number of diseases and injuries in pilots across DoD was 265 in 2016; 252 in 2017; 164 in 2018; 223 in 2019; 2,194 in 2020; 2,861 in 2021; and 4,059 in 2022. These increases in disease and injuries in pilots across the DoD over the last three years, and particularly over the last year, raise questions as to whether FAA has seen similar increases in disease and injuries in individuals in the aviation industry."
This leaves us with the latest incident: a pilot in command of a Boeing 787-9 Dreamliner suffered a fatal cardiac arrest in the bathroom of a commercial flight from Miami to Chile on Monday.
"Flight LA505 (Miami - Santiago) diverted to Tocumen International Airport in Panama due to a medical emergency of one of the three members of the crew in command," according to CBS News, which obtained a statement from LATAM Airlines.
The airline continued, "Unfortunately, after landing and receiving further medical assistance, the pilot passed away."
... and remember this?
Here are the latest headlines of pilots suffering medical emergencies:
Two Indian Pilots Die In 2 Days, 1 At Airport, Another On Flight
Shocking Moment Pilot Suffers Cardiac Arrest In Virginia Airport
BA pilot dies shortly before he was due to captain Airbus flight to Heathrow
Southwest pilot suffers medical emergency on flight, off-duty pilot helps land plane
In Feb., Captain Robert Snow revealed he suffered a cardiac arrest on the final approach of an American Airlines flight. He said he was vaxxed in order to maintain his employment status with the airlines.
Will the FAA or the Biden administration even be willing to investigate the surge in disease and injuries in pilots after the Covid shot?
https://www.zerohedge.com/medical/airline-pilot-dies-flight-miami-chile
Friday, August 18, 2023
Largest US study of e-cigarettes shows their value as smoking cessation aid
E-cigarettes do have value as a smoking cessation aid, according to a new study just released by a team of MUSC Hollings Cancer Center researchers.Whether e-cigarettes should be considered for smoking cessation is a hotly debated topic, and different countries have taken different approaches. E-cigarettes contain harm
ful chemicals, which has led many public health advocates to shun them. But they are less harmful than traditional cigarettes, which can cause a dozen types of cancer as well as heart disease, stroke, diabetes and chronic obstructive pulmonary disease. That's prompted others to say that e-cigarettes should be considered as a step-down method for adults who smoke and haven't been able to quit using FDA-approved aids, like nicotine replacement gum, lozenges or patches.
This new study, the largest trial of e-cigarettes in the U.S., showed that e-cigarette usage nudged people toward quitting smoking—even people who had entered the trial saying they had no intention of quitting. The results were published in eClinicalMedicine this month.
"This is not a panacea for smoking cessation," cautioned Matthew Carpenter, Ph.D., first author on the paper and co-leader of the Cancer Control Research Program at Hollings.
Nonetheless, he was surprised to find that all of the hypotheses tested in the study were confirmed.
"It's rarely the case that you're proven correct for almost everything that you predicted," he said. "Here, it was one effect after another: No matter how we looked at it, those who got the e-cigarette product demonstrated greater abstinence and reduced harm as compared to those who didn't get it."
Carpenter and his colleagues, including Hollings members Tracy Smith, Ph.D., Jennifer Dahne, Ph.D., Michael Cummings, Ph.D., and Graham Warren, M.D., Ph.D., designed the study in a naturalistic way to mimic real-world conditions as much as possible—also a first for e-cigarette studies.
Previous studies that have shown a smoking cessation benefit of e-cigarettes have been very structured, Carpenter said, in that they recruited people who wanted to stop smoking and gave them very detailed instructions about how to use the e-cigarettes.
"Some people have said, "That's fine, but the results of those studies don't apply to the real world because the real world isn't as structured,'" he explained. "So what we did was take a hands-off approach—we called it a naturalistic approach."
"First off, we took smokers who did and did not want to quit. So right off the bat, not everybody wanted to quit. Secondly, we gave them very little instruction on how to use it," he continued.
Instead, people were given e-cigarettes and told they could use them or not, as much or as little as they wanted. A control group didn't receive anything.
The study showed that people in the e-cigarette group were more likely to report complete abstinence from combustible cigarettes. They were also more likely to report that they'd reduced the number of cigarettes per day that they smoked and their number of "quit attempts." Quit attempts are an important metric because people usually need multiple tries before they can successfully stop smoking.
The study included people from 11 cities across the U.S. and spanned four years. At the beginning, Carpenter intended to collect biochemical samples from participants in the Charleston area to verify their self-reports of smoking behavior. However, COVID interrupted that plan and made in-person sample collection impossible.
Although that was a disappointing aspect of the study, replying on participants' self-reports of their smoking behavior is still considered highly reliable, he said.
The study will be another data point for the public health community and policymakers in deciding how to handle e-cigarettes. "No one wants e-cigarettes in the hands of kids, and we should do all we can to stop that. But we shouldn't do so by denying this option for adult smokers who can't otherwise quit," Carpenter said. He noted that other countries have taken a much more liberal approach to e-cigarette use than the U.S.
For example, in April the U.K. announced a "Swap to Stop" program that will distribute vaping starter kits to 1 million people who smoke.
In the U.S., e-cigarettes are not approved as smoking cessation aids. But Carpenter and Smith plan to conduct a study that will test e-cigarettes as a smoking cessation aid for adult smokers who've already tried two different FDA-approved methods.
More information: Matthew J. Carpenter et al, Effect of unguided e-cigarette provision on uptake, use, and smoking cessation among adults who smoke in the USA: a naturalistic, randomised, controlled clinical trial, eClinicalMedicine (2023). DOI: 10.1016/j.eclinm.2023.102142
https://medicalxpress.com/news/2023-08-largest-e-cigarettes-cessation-aid.html
Repairing cornea damage with patient's own stem cells gets positive phase I trial results
A team led by researchers from Mass Eye and Ear, a member of Mass General Brigham, reports the results of a phase I trial of a revolutionary stem cell treatment called cultivated autologous limbal epithelial cell transplantation (CALEC), which was found to be safe and well-tolerated over the short term in four patients with significant chemical burns in one eye.
According to a study published August 18 in Science Advances, the patients who were followed for 12 months experienced restored cornea surfaces—two were able to undergo a corneal transplant and two reported significant improvements in vision without additional treatment.
While the phase I study was designed to determine preliminary safety and feasibility before advancing to a second phase of the trial, the researchers consider the early findings promising.
"Our early results suggest that CALEC might offer hope to patients who had been left with untreatable vision loss and pain associated with major cornea injuries," said principal investigator and lead study author Ula Jurkunas, MD, associate director of the Cornea Service at Mass Eye and Ear and an associate professor of ophthalmology at Harvard Medical School.
"Cornea specialists have been hindered by a lack of treatment options with a high safety profile to help our patients with chemical burns and injuries that render them unable to get an artificial cornea transplant. We are hopeful with further study, CALEC can one day fill this crucially needed treatment gap."
In CALEC, stem cells from a patient's healthy eye are removed via a small biopsy and then expanded and grown on a graft via an innovative manufacturing process at the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber Cancer Institute. After two to three weeks, the CALEC graft is sent back to Mass Eye and Ear and transplanted into the eye with corneal damage.
The CALEC project is a collaboration between Jurkunas and colleagues in the Cornea Service at Mass Eye and Ear, researchers at Dana-Farber Cancer Institute, led by Jerome Ritz, MD, Boston Children's Hospital, led by Myriam Armant, Ph.D., and the JAEB Center for Health Research.
People who experience chemical burns and other eye injuries may develop limbal stem cell deficiency, an irreversible loss of cells on the tissue surrounding the cornea. These patients experience permanent vision loss, pain and discomfort in the affected eye. Without limbal cells and a healthy eye surface, patients are unable to undergo artificial cornea transplants, the current standard of vision rehabilitation.
Existing treatment strategies have limitations and associated risks the CALEC procedure aims to address through its unique approach of using a small amount of a patient's own stem cells that can then be grown and expanded to create a sheet of cells that serves as a surface for normal tissue to grow back.
According to the authors, despite landmark studies describing an autologous stem cell approach over the past 25 years and similar methods being utilized in Europe, no U.S. research team had successfully developed a manufacturing process and quality control tests that met U.S. Food and Drug Administration (FDA) requirements or showed any clinical benefit.
"It was challenging to develop a process for creating limbal stem cell grafts that would meet the FDA's strict regulatory requirements for tissue engineering," said Ritz, executive director of the Connell and O'Reilly Families Cell Manipulation Core Facility at Dana-Farber and professor of medicine at Harvard Medical School. "Having developed and implemented this process, it was very gratifying to see encouraging clinical outcomes in the first cohort of patients enrolled on this clinical trial."
Studies like this show the promise of cell therapy for treating incurable conditions. Mass General Brigham's Gene and Cell Therapy Institute is helping to translate scientific discoveries made by researchers into first-in-human clinical trials and, ultimately, life-changing treatments for patients. The Institute's multidisciplinary approach sets it apart from others in the space, helping researchers to rapidly advance new therapies and pushing the technological and clinical boundaries of this new frontier.
In the phase I study, five patients with chemical burns to one eye were enrolled and biopsied. Four received CALEC; a series of quality control tests determined the cells in the fifth patient were unable to adequately expand. The CALEC patients were tracked for 12 months.
The first patient treated, a 46-year-old male, experienced a resolution of his eye surface defect, which primed him to undergo an artificial cornea transplant for vision rehabilitation. The second, a 31-year-old male, experienced a complete resolution of symptoms with vision improving from 20/40 to 20/30.
The third, a 36-year-old male, had his corneal defect resolved and his vision improved from hand motion—only being able to see broad movements like waving—to 20/30 vision.
The fourth, a 52-year-old male, initially did not have a successful biopsy that resulted in a viable stem cell graft. After re-attempting CALEC three years later, he underwent a successful transplant and his vision improved from hand motion to being able to count fingers. He then received an artificial cornea.
The researchers are finalizing the next phase of the clinical trial in 15 CALEC patients they are tracking for 18 months to better determine the procedure's overall efficacy. Their hope is that CALEC can one day become a treatment option for patients who previously had to endure long-term deficits when existing treatment options were not an option given the severity of their injuries.
More information: Ula Jurkunas, Cultivated autologous limbal epithelial cell (CALEC) transplantation: development of manufacturing process and clinical evaluation of feasibility and safety, Science Advances (2023). DOI: 10.1126/sciadv.adg6470. www.science.org/doi/10.1126/sciadv.adg6470
https://medicalxpress.com/news/2023-08-cell-therapy-cornea-patient-stem.html
Gaetz introduces resolution to censure judge in Trump Jan. 6 case
Florida Rep. Matt Gaetz (R) is introducing a resolution Friday to censure the judge overseeing special counsel Jack Smith’s case against former President Trump related to efforts to overturn the 2020 election.
In a statement obtained by The Hill, Gaetz’s office said he is introducing the resolution against U.S. District Judge Tanya Chutkan “for showing open bias and partisanship in her official duties on the bench.” The statement also features a quote by Gaetz, a Republican known for his strong pro-Trump stances, in which he says he is concerned about Chutkan’s “blatant political bias from the bench.”
“Judge Tanya Chutkan’s extreme sentencing of January 6th defendants, while openly supporting the violent Black Lives Matter riots of 2020, showcases a complete disregard for her duty of impartiality and the rule of law,” Gaetz said in the quote. “Justice may be blind, but the American people are not – we see Judge Chutkan for her actions, and we rebuke them in the greatest possible sense,”
Chutkan has tried to emphasize the nonimportance of politics to her decisions in the case. At a hearing over a protective order last week, she said she will not consider how her decisions affect political campaigns “on either side.”
“The existence of a political campaign is not going to have any bearing on my decision. I intend to keep politics out of this,” Chutkan said at the hearing.
Jordan subpoenas Cititbank in investigation into bank info sharing with FBI
House Judiciary Committee Chairman Jim Jordan (R-Ohio) subpoenaed Citibank on Thursday for not cooperating in an investigation into whether financial institutions are sharing data with the FBI.
“On June 12, 2023, we requested your voluntary cooperation with our oversight to determine the extent to which financial institutions, such as Citibank, have worked with the FBI to collect Americans’ financial data,” the subpoena reads. “To date, Citibank has declined to comply with our request voluntarily, and counsel has represented that it will only comply pursuant to a subpoena.”
In June, the Judiciary Committee sent letters to multiple financial organizations “requesting voluntary cooperation to determine the extent to which banks illegally supplied the FBI with Americans’ financial data.” Overall, seven banks were asked for information: Bank of America, Citibank, J.P. Morgan, PNC, Truist, U.S. Bank and Wells Fargo.
In Thursday’s statement, Jordan’s office accused Bank of America of sharing “Americans’ private financial data,” to the bureau “without legal process.” They noted that the data allegedly shared was related to “transactions made in the Washington, D.C., area around Jan. 6, 2021.”
The Ohio Republican also alleged that individuals who purchased a firearm with a Bank of America product around the time of the Jan. 6 riot on the Capitol were elevated to the top of the list provided to the FBI.
The transaction data, according to CNN Business, could have been used to show the travel routes and location of suspected rioters — or used to detect the purchase of weapons.
Jordan said lawmakers obtained documents that show a Citibank representative on emails and Zoom discussions organized by the FBI and another agency that was focused on information sharing following the insurrection.
“Federal law enforcement’s use of back-channel discussions with financial institutions as a method to investigate and obtain private financial data of Americans is alarming,” he wrote in his letter.
Citibank, according to reports, was the only one that did not comply with the committee’s request.
That request came after the committee launched the investigation in May, following reports by an FBI whistleblower that Bank of America was “voluntarily” sharing the information.
“An FBI whistleblower has disclosed that shortly after the events at the Capitol on January 6, 2021, Bank of America (BoA) provided the FBI — voluntarily and without any legal process — with a list of individuals who had made transactions in the Washington, D.C., metropolitan area with a BoA credit or debit card between January 5 and January 7, 2021,” the May letter to Bank of America reads.
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