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Saturday, April 20, 2024

'CENTCOM denies US behind Iraq air strike'

 US Central Command (CENTCOM) is refuting reports claiming the U.S. conducted airstrikes in Iraq following a blast at a military base in the country that killed a member of an Iraqi security force. 

“We are aware of reports claiming that the United States conducted airstrikes in Iraq today,” CENCTOM said in a Friday night post on the social media platform X. “Those reports are not true. The United States has not conducted air strikes in Iraq today.” 

A blast at Kalso military base, around 30 miles south of Iraq’s capital city Baghdad, in early hours on Saturday local time, killed one member of Iraq’s Popular Mobilization Forces (PMF) and left eight wounded, according to Reuters

A technical committee of the Iraqi military said it was investigating the cause of the explosion, with the force commander referring to it as an attack, according to Reuters. The army said it is doing a probe into the incident. 

“The air defence command report confirmed, through technical efforts and radar detection, that there was no drone or fighter jet in the air space of Babil before and during the explosion,” the Iraqi military said in a statement, according to Reuters. 

Two security sources said prior that an airstrike caused the explosion at the base, per Reuters. 

The military base housed pro-Iranian militia. The PMF contains Iran-backed groups that have advanced Iran’s interest in the Middle East. 

The blast comes just days following Israel’s early Friday strike on Iran, which followed Tehran’s missile and drone assault on the country on April 13, which Iran said was in retaliation for Israel’s airstrike in early April on the Iranian Consulate in Syria, which left several IRGC officers dead.

The Hill has reached out to CENCTOM for further comment.

https://thehill.com/policy/international/4608649-centcom-denies-us-behind-iraq-air-strike/

Calif. Dems Tout Ties To Criminal Leniency Group

 by Susan Crabtree via RealClearPolitics,

The mayors of California's three biggest cities have rankled some progressive activists in recent months by joining a wave of fellow Democrats renouncing once popular initiatives to defund the police, reduce sentencing, and undertake other criminal justice reforms amid deep concerns over public safety. 

Facing a public backlash over rampant thefts and an epidemic of fentanyl deaths related to drug trafficking, San Francisco Mayor London Breed and San Diego Mayor Todd Gloria in recent months have joined the GOP fight to dismantle Proposition 47. That law, approved by voters in 2014, recategorized thefts below $950 from felonies to misdemeanors, and many critics blame it for the spate of smash-and-grab robberies at department and convenience stores across California. 

We should be locking up criminals, not laundry detergent,” Gloria, who refers to himself as a progressive Democrat, declared in his state-of-the-city address in January. 

Meanwhile, Los Angeles Mayor Karen Bass has called for adding hundreds of police officers to the city’s rolls and boosting their pay. 

But Democratic incumbents and candidates in several of the most competitive U.S. House of Representatives races across California – the outcome of which will play a critical role in determining control of the chamber in the next Congress – are either swimming against the tough-on-crime tide or trying to avoid alienating a key ally. 

These Democrats have been touting their close ties to a progressive lobbying powerhouse that helped usher in some of the most controversial changes to criminal justice laws across the state in recent years. 

Equality California began as a Sacramento-based LGBTQ+ advocacy group 20 years ago but has since become a major player on several issues, including its self-proclaimed priority of transforming the Golden State’s criminal justice system. The influential organization, which rakes in millions from Hollywood celebrities and business interests and received a state grant windfall last year, has been instrumental in promoting a reform agenda that many prominent California Democrats are now trying to reverse. 

The group campaigned aggressively to eliminate cash bail for many types of crimes, legalize prostitution, shorten probation periods for misdemeanors and some felonies, and end qualified immunity for police, making it easier for victims of alleged excessive force and other police misconduct to sue officers. The push to lift legal protections for police failed on the federal level but largely succeeded in California when Gov. Gavin Newsom signed a Senate bill into law in the fall of 2021. 

In 2022, the group’s PAC also contributed $5,000 to embattled Los Angeles District Attorney George Gascon, the original author of Proposition 47. Gascon survived a close recall effort in 2022, just two months after San Francisco voters ousted District Attorney Chesa Boudin in a blow to the national movement toward more lenient prosecution given the city’s status as one of the nation’s most liberal enclaves. 

In the middle of the riots after the police-custody death of George Floyd in Minneapolis, Equality California was one of several organizations that called for donations to groups on the “frontlines” of the protests, including the Minnesota Freedom Fund. That fund eventually received $35 million in donations during the tumultuous summer of 2020 and used the money to bail out dozens of defendants, including those accused of murder, violent felonies, and sex crimes. 

Like Equality California, the Minnesota Freedom Fund aggressively pushed for defunding the police and ending cash bail for all individuals accused of crimes. 

Under the “issues” section on its website, Equality California lists “criminal justice reform” first among all the issues it works on, including education, faith and religion, gun safety, hate crimes and safety, health care and HIV issues. 

“LGBTQ+ people face disproportionate rates of arrest, conviction, incarceration, and recidivism compared to their non-LGBTQ+ peers,” the website asserts in explaining why the group prioritizes reducing criminal penalties and is pushing for more leniency in other aspects of criminal justice law. 

Seven Democrats in the most competitive House races have touted their Equality California endorsements on social media. They include Adam Gray, Josh Harder, Joe Kerr, David Min, Will Rollins, Rudy Salas, and George Whitesides.

Whitesides (pictured at top), a former aerospace executive challenging GOP Rep. Mike Garcia in a key House battleground north of Los Angeles, has the closest ties to Equality California. He and his wife donated an undisclosed amount to the group in both 2020 and 2021. 

Those donations qualified the Whitesides as Equality California’s “regional influencers” for 2020 and 2021. It’s a title the couple shared with the hedge-fund billionaire Tom Steyer, record executive David Geffen’s foundation, California Lt. Gov. Eleni Kounalakis and her husband, as well as Rep. Sara Jacobs (the granddaughter of Qualcomm founder Irwin Jacobs), and Tom Sandoval, a cast member of the TV reality series “Vanderpump Rules.” (The 2020 and 2021 annual reports do not list an amount associated with the “regional influencers” tier, but the group’s 2019 annual reports notes that a such a designation is earned for contributions of $10,000 to $19,999.)

Whitesides’ campaign did not respond to a request for comment about whether he backs Equality California’s criminal justice priorities. 

In February, Will Rollins, a former federal prosecutor challenging veteran GOP Rep. Ken Calvert in a district stretching from Riverside to Palm Springs, touted his Equality California endorsement on X.com, along with a photo of himself dining with the group’s board of directors. 

“It was great joining @eqca board members of their board of directors lunch,” Rollins tweeted. “I am proud to be endorsed by Equality California in my race for Congress. When I get to D.C., I am going to fight to advance LGBTQ+ rights for all Americans. Together, we will win.” 

The Calvert-Rollins race is a closely fought rematch, with crime taking center stage. Rollins has touted his role as a prosecutor and has criticized Calvert for voting in favor of the First Step Act, President Trump’s signature justice reform package, which released more than 2,200 federal inmates in 2019. The bill was passed with broad bipartisan support in Congress before the pandemic-era crime spikes while the criminal justice reform agenda was gaining Republican and Democratic support. Media outlets have since reported that it released more than 100 violent criminals and sex offenders. 

In a local newspaper op-ed, Calvert tried to lump Rollins into the same camp as Gascon and Boudin, calling him “the worst kind of liberal prosecutor” who “routinely cuts soft plea deals with perps and wants to reduce sentences for criminals wreaking havoc on our streets.” Last month, Calvert’s campaign also cut a television ad calling Rollins “extreme” and noting that he “even supports reducing sentences for violent criminals including drug traffickers while California fentanyl deaths skyrocket.” 

Rollins has denied the accusations about supporting cash bail and lighter sentences for violent criminals and drug traffickers, asserting that he had a 99% conviction rate and helped put “murders, terrorists, MS-13 and Sinaloa cartel members in prison.” He was less forthright about cash bail, noting that defendants that pose a danger to society or are a flight risk should be detained before trial, but Rollins didn’t indicate whether he supports ending cash bail in other circumstances. 

The results of the Calvert-Rollins face-off in 2022 were so close that the Democratic hopeful was attending a new member orientation in Washington when new alerts came across his phone that he had lost to Calvert, the dean of the California delegation. 

David Min, a Democratic state senator running against GOP attorney and former state legislator Scott Baugh in a tight race for the Orange County seat vacated by Rep. Katie Porter, was the only Democrat to respond to RCP’s inquiry about the Equality California’s endorsement, and whether he backs the group’s criminal justice agenda.  

Concerns about public safety have been making headlines in the country in recent weeks as the traditionally more conservative area strives to discourage criminal elements from nearby Los Angeles from becoming active there. Last month, the Orange County District Attorney’s Office announced a novel public safety campaign aimed at deterring thieves with a message plastered on billboards and bus ads: “Crime doesn’t pay in Orange County.” 

“If you steal, we prosecute,” the signs sternly warn. 

Min, who was arrested last year for drunk driving in a taxpayer-funded car, still managed to outmaneuver fellow Democrat Joanna Weiss in the primary and secure the endorsement of Porter and the California Democratic Party. 

Min campaign spokesman Orrin Evans forwarded the lawmaker’s endorsements from the state’s largest police union, the Peace Officers Research Association of California, or PORAC, and the California Fraternal Order of Police. Evans also touted Min’s record of supporting police budget priorities, including successful requests he made for $2 million for a “real-time crime center” to help police track crime quickly and $1 million for new electric police cruisers. 

Sen. Min has always ensured that law enforcement and first responders have the tools they need to keep Southern California’s families safe and secure,” Roger Hilton, president of the state Fraternal Order of Police, said in a statement along with the endorsement. 

In contrast, Baugh has the backing of Orange County Sheriff Don Barnes and several House Republican leaders. In an interview with RCP, the former GOP leader of the state assembly cited a strong tough-on-crime record dating back to the 1990s. Barnes and local District Attorney Todd Spitzer also voted for Baugh to become the chairman of a local gang reduction and intervention program. 

Baugh, who previously served as county GOP chairman, countered that Min has supported some of the same sweeping criminal justice reforms as Equality California during his time in Sacramento. Min voted in favor of a 2021 bill eliminating cash bail and another measure in 2022 to automatically seal many felons’ criminal records, including domestic violence convictions. 

“Min’s hiding behind the PORAC labor endorsement to run from his progressive policies, including support for no-cash bail,” Baugh said in the interview. “This is the type of cowardly behavior we don’t need in Congress.” 

Equality California also keeps track of state and federal lawmakers’ legislative records on key priorities and issues an annual scorecard. In 2022, the score included votes on several bills, including the George Floyd Justice in Policing Act, which, if passed, would have eliminated qualified immunity for police. According to the Congressional Budget Office, it also would have cost local departments hundreds of millions of dollars in training and equipment just when several major cities across the country had slashed funding for police. 

While Congress was considering the measure, the Fraternal Order of Police argued that ending qualified immunity was “anti-police” and would drastically reduce the number of candidates choosing to become police officers. 

Over the past several years, police departments across the country, including in San Francisco and Los Angeles, have faced severe staffing shortages as they struggle to recruit and retain officers. At the height of the defund the police movement, California lost 2,100 police officers (with full arrest powers) and roughly 1,100 civilian staff, diminishing the number of patrol officers to 1991 levels. 

In 2021 Equality California scored votes on a handful of bills, including the George Floyd Justice in Policing Act and a measure that would have allowed adults who entered the U.S. as undocumented children to become lawful permanent residents and citizens. That year (and in 2022), Reps. Mike Levin, who is facing a rematch from GOP challenger Matt Gunderson, and Harder, who is in a tight contest against Stockton Mayor Kevin Lincoln, earned 100% ratings from Equality California. 

As state legislators, Gray, Min, and Salas received a 100% rating on the group’s 2022 scorecard, with Min maintaining his perfect rating from 2021. 

With so many leading California Democrats backtracking on criminal justice reforms, Republicans plan to hammer their opponents who remain undecided about repealing Proposition 47 and other more lenient laws as soft on crime and weak on the border. Despite polls showing voters deeply concerned about illegal immigration and President Biden’s open border policies, California Democrats have continued to support broad amnesty for illegal immigrants and the state’s controversial sanctuary state law, both of which Equality California strongly backs. 

In the state, border issues may divide some heavily Latino districts, but Republicans have a greater chance for traction when it comes to crime. Americans’ worries about what they describe as the nation’s crime problems are at a recent high, with 63% characterizing public safety concerns as either extremely or very serious in a November Gallup survey. That’s up from 54% when Gallup last polled voters on the issue and the highest level the polling company has recorded in recent years. The prior high of 60% was recorded in the initial 2000 polling, as well as in 2010 and 2016. 

It's hard to predict whether support for specific criminal justice reforms, such as eliminating cash bail, will hold sway with voters. But with Breed, who is in a tough reelection fight for mayor, and other Democrats pivoting away from the reform movement, it will be easier to focus voters on the issue. 

While there is little comprehensive research about the impact of eliminating cash bail on crime, a study by the Yolo County District Attorney’s Office in Northern California early last year found that individuals released on cash-free or low-cost bail were much more likely to re-offend than those who pasted bail. They were also far more likely to commit new violent offenses. 

The study used a random sample of 100 people arrested during the county’s zero-bail policy, which was in effect from April 2020 through May 2021. It compared those results to 100 people who were arrested and posted bail in 2018 and 2019. The study found that people released were arrested for new crimes at an average rate 70% higher than those who posted bail, committed felonies 90% more often, and committed misdemeanors 123% more often. 

Susan Crabtree is RealClearPolitics' national political correspondent.

https://www.zerohedge.com/political/calif-dems-tout-ties-criminal-leniency-group

New therapeutic target for traumatic brain injury

 For the roughly 1.5 million Americans per year who survive a traumatic brain injury, health outcomes vary widely. Not only can these injuries lead to a loss of coordination, depression, impulsivity, and difficulty concentrating, but they come with an amplified risk of developing dementia in the future.

The glaring absence of treatments for such a widespread condition drove a team of scientists at Gladstone Institutes to uncover, on a , how traumatic brain injuries trigger neurodegeneration—and, just as importantly, how to target that process to prevent long-term damage.

"We set out to address the fundamental question of exactly what happens in the brain after injury to ignite the damaging process that destroys neurons," says Jae Kyu Ryu, Ph.D., a scientific program leader in the lab of Katerina Akassoglou, Ph.D. at Gladstone Institutes.

Most traumatic brain injuries come as a result of falls, car crashes, or violent assaults, according to the Centers for Disease Control, but many also stem from sports accidents or certain military operations such as explosions. In each case, the external force is strong enough to move the brain within the skull, causing a significant breakdown in the blood-brain barrier and allowing blood to move in.

"We knew that a specific blood protein, fibrin, was present in the brain after , but we didn't know until now that it plays a causative role in  after injury," says Ryu, who led the study that appears in the Journal of Neuroinflammation.

Ryu and others in Akassoglou's lab have long investigated how blood that leaks into the brain triggers neurologic diseases, essentially by hijacking the brain's immune system and setting off a cascade of harmful, often irreversible effects. Fibrin, a protein that normally helps blood coagulate, is the culprit.

"Across many neurological diseases, toxic immune responses in the brain are triggered by blood leaks and drive neurodegeneration," says Akassoglou, a senior investigator at Gladstone and the director of the Center for Neurovascular Brain Immunology at Gladstone and UCSF. "Neutralizing the toxic immune responses in the brain paves the way to new therapies for ."

In diseases such as Alzheimer's and multiple sclerosis, abnormal leaks in the protective blood-brain barrier allow fibrin to seep into areas responsible for cognitive and motor functions, causing neurodegeneration. But in this case, the traumatic brain injury itself causes the blood to leak into the brain. The new study showed, for the first time, that fibrin is responsible for turning good immune cells bad, causing dangerous inflammation and unleashing toxins that kill neurons.

The Gladstone team used state-of-the-art imaging technology to study mouse brains, as well as brains from people who experienced a traumatic brain injury. They also produced three-dimensional imaging of a whole intact mouse brain, showing  leaks and abundant fibrin in traumatic brain injury. In both mouse and human brains, fibrin was present together with activated immune cells.

"It became clear that fibrin is activating these immune cells," Ryu says. "We realized that we could prevent the  if we could block fibrin, but we had to do it in a precise way."

The team leveraged genetic tools with a specific mutation in fibrin that can block it from activating immune cells without affecting the protein's beneficial blood-clotting abilities. This is especially critical for traumatic brain injuries, as excessive bleeding into the brain has been known to occur among patients who were taking anticoagulant medications before their injury.

Akassoglou's lab previously developed a drug, a therapeutic monoclonal antibody, that acts only on fibrin's inflammatory properties without adverse effects on blood coagulation. This fibrin-targeting immunotherapy protects from multiple sclerosis and Alzheimer's disease in mice. A humanized version of this first-in-class fibrin immunotherapy is already in Phase 1 safety clinical trials by Therini Bio.

"It's exciting to have a therapeutic option to neutralize blood toxicity in neurologic diseases," Ryu says. "Future studies are needed to test the effects of the fibrin immunotherapy in traumatic brain injury."

"This study identifies a potential new strategy to diminish the devastating impacts of brain injuries," says Lennart Mucke, MD, director of the Gladstone Institute of Neurological Disease.

"Brain injuries can have profound effects on a person's cognitive abilities, emotional health, and motor skills, touching every part of their life. It will be interesting to explore whether blocking the disease-promoting effects of  can improve the outcome of brain surgeries and reduce disability when implemented after traumatic brain injuries have occurred."

More information: Terry Dean et al, Fibrin promotes oxidative stress and neuronal loss in traumatic brain injury via innate immune activation, Journal of Neuroinflammation (2024). DOI: 10.1186/s12974-024-03092-w


https://medicalxpress.com/news/2024-04-therapeutic-traumatic-brain-injury.html

Community pharmacies can help people quit smoking

 A new study shows community pharmacies may play a key role in helping people quit smoking. The findings came out in the article "Closing the Tobacco Treatment Gap," published in the 10th anniversary special issue of Pharmacy. The results provide valuable insights into the implementation of tobacco cessation services within community pharmacies while identifying barriers to further improvements.

Tobacco use remains a leading preventable cause of death. Although two thirds of people who smoke would like to quit, many individuals trying to quit on their own are not successful. To address this gap, the study explored how pharmacists and pharmacy technicians could assist in providing tobacco cessation support.

Led by researchers at UC Davis Comprehensive Cancer Center and other  across the country, the study involved seven independent community pharmacies in California affiliated with the Community Pharmacy Enhanced Services Network. A total of 22 California pharmacists and 26 pharmacy technicians who underwent tobacco cessation training participated.

"Community pharmacies are important partners to expand access to tobacco cessation services," said Elisa Tong, a UC Davis Health internist and director of the cancer center's Tobacco Cessation Policy Research Center. "By , pharmacists can furnish all forms of nicotine replacement therapy (NRT) without a provider prescription."

California's law allowing pharmacists to provide the cessation tool took effect in 2014. Eligible pharmacists must complete two hours of tobacco training and follow the state-approved protocol, which consists of reviewing patients' current  and prior quit attempts, screening for appropriateness of NRT, providing medication counseling, and addressing or referring patients for behavioral counseling. Tobacco cessation has been integrated into the curricula of California pharmacy schools since 2000, and many other  are available for pharmacies.

"After completing tobacco treatment training, our research showed that pharmacies successfully initiated cessation services," said the study's senior author Karen Hudmon from Purdue University College of Pharmacy. "Compatibility with existing workflows, staff buy-in and the crucial role of pharmacy technicians significantly helped."

Continued research efforts are underway to study policy implementation strategies, especially for  reimbursement. California's law authorizes Medi-Cal and  to pay pharmacies for enhanced services including education and medication management.

"Pharmacists and pharmacy technicians play a pivotal role in providing effective support for tobacco treatment and other related health issues," said Robin Corelli, a UC San Francisco pharmacy faculty member and study co-author. "Being part of the local community is important and we need sustainable models for providing these services."

Solving barriers could help pharmacies reach more people

Given that 89% of Americans live within five miles of a community pharmacy, they can be convenient locations for receiving . Pharmacists have shown to be effective in helping patients quit. They can reach uninsured and under-resourced patients as well as patients living in  who might experience barriers to accessing primary care. However, the study showed certain barriers exist to making  cessation programs effective.

The research showed that billing complexities, software limitations and training gaps for handling complicated patient cases all pose challenges to successful implementation of tobacco  services at pharmacies.

However, the data collected implied a forward-thinking health care model where the pharmacists and their staff can play a fundamental and dynamic role in local health management, and ultimately, in cultivating a healthier population. The study serves as a valuable resource for policymakers, health care professionals and stakeholders in population health efforts to combat tobacco use.

More information: Katy Ellis Hilts et al, Closing the Tobacco Treatment Gap: A Qualitative Study of Tobacco Cessation Service Implementation in Community Pharmacies, Pharmacy (2024). DOI: 10.3390/pharmacy12020059


https://medicalxpress.com/news/2024-04-community-pharmacies-people.html

Dietary treatment found to be more effective than medicines in irritable bowel

 A study conducted at the University of Gothenburg found that with dietary adjustments, more than 7 out of 10 irritable bowel syndrome (IBS) patients had significantly reduced symptoms, compared with medications. The work is published in The Lancet Gastroenterology & Hepatology journal.

IBS is a common diagnosis that causes , gas and abdominal bloating, diarrhea, and constipation, in various combinations and with varying degrees of severity.

Treatment often consists of dietary advice such as eating small and frequent meals and avoiding excessive intake of food triggers such as coffee, alcohol and fizzy drinks. Patients may also be given medications to improve specific symptoms, such as gas or constipation, diarrhea, bloating or abdominal pain. Antidepressants are sometimes used to improve symptoms in IBS.

The study compared three treatments: two dietary and one based on use of medications. The participants were  with severe or moderate IBS symptoms at Sahlgrenska University Hospital in Gothenburg.

More symptom relief after dietary adjustment

The first group was given traditional IBS dietary advice, focusing on eating behavior combined with low intake of fermentable carbohydrates, known as FODMAPs. These include products with lactose, legumes, onions, and grains, which ferment in the colon and can cause pain in IBS.

The second group received a dietary treatment low in carbohydrates and proportionally high in protein and fat. In the third group, the best possible medication was given based on the patient's most troublesome IBS symptoms.

Each group included around 100 participants and the treatment periods lasted four weeks. When the researchers then examined how well the participants responded to the treatments, using an established IBS symptom scoring scale, the results were clear.

Of those who received traditional IBS dietary advice and low content of FODMAPs, 76% had significantly reduced symptoms. In the group receiving low carbohydrates and high protein and fat, the proportion was 71%, and in the medication group 58%.

All groups reported significantly better quality of life, fewer physical symptoms and fewer symptoms of anxiety and depression.

The importance of personalization

At a six-month follow-up, when participants in the dietary groups had partially returned to their previous eating habits, a large proportion still had clinically significant symptom relief; 68% in the traditional  and low FODMAP group, and 60% in the low-carbohydrate diet group.

The study was led by Sanna Nybacka, Researcher and Dietician, Stine Störsrud, Associate Professor, and Magnus Simrén, Professor and Senior Consultant, all at Sahlgrenska Academy, University of Gothenburg.

"With this study, we can show that diet plays a central role in the treatment of IBS, but that there are several  that are effective," says Sanna Nybacka.

"We need more knowledge about how to best personalize the treatment of IBS in the future and we will further investigate whether there are certain factors that can predict whether individuals will respond better to different treatment options," she concludes.

More information: Sanna Nybacka et al, A low FODMAP diet plus traditional dietary advice versus a low-carbohydrate diet versus pharmacological treatment in irritable bowel syndrome (CARBIS): a single-centre, single-blind, randomised controlled trial, The Lancet Gastroenterology & Hepatology (2024). DOI: 10.1016/S2468-1253(24)00045-1


https://medicalxpress.com/news/2024-04-dietary-treatment-effective-medicines-bowel.html

'USDA: Cow-to-cow transmission a factor in bird flu spread'

 The U.S. Department of Agriculture said this week that cow-to-cow transmission is a factor in the spread of bird flu in dairy herds, but it still does not know exactly how the virus is being moved around.

Farmers and veterinarians have been waiting for confirmation on how the virus is transmitted to better control its spread. Dairy herds in eight states tested positive over the past month, along with one dairy worker in Texas.

"Those of us that have worked with influenza for a long time were fairly quickly saying, 'Yep it moves cow to cow,'" Jim Lowe, an associate dean at the University of Illinois College of Veterinary Medicine, said on Friday. "You can't explain the epidemiology any other way."

Wild migratory birds are believed to be the original source of the virus. But the USDA said its investigation into cow infections "includes some cases where the virus spread was associated with cattle movements between herds." There is also evidence the virus spread from dairy cattle premises "back into nearby poultry premises through an unknown route," the department said.

The USDA said cows shed the virus in milk at high concentrations, so anything that comes in contact with unpasteurized milk may spread the disease. Respiratory transmission is not considered a primary way for the virus to spread in cattle, the department added.

Despite uncertainty over transmission, USDA has not imposed quarantines to restrict the movement of cattle around infected dairies, as it does with chickens and turkeys around infected poultry farms. Infected cattle appear to recover, while bird flu is usually lethal for poultry.

The USDA said it expects that minimizing cattle movement and testing those that must be shipped, along with safety and cleaning practices on farms, should avoid the need for regulatory restrictions.

Officials reported last month that bird flu primarily affected older cows, though additional data now indicates younger cattle have been affected, the USDA said.

https://www.yahoo.com/news/usda-confirms-cow-cow-transmission-183050781.html

FDA fast-tracks AskBio’s heart failure gene therapy

 A gene therapy for heart failure being developed by Bayer’s AskBio unit has been granted fast-track status by the FDA, shortly after it showed preliminary signs of efficacy in a phase 1 trial.

The designation is for AB-1002 (also known as NAN-101) as a one-shot therapy for adults with non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III heart failure symptoms, which is being put to the test in the phase 2 GenePHIT trial.

The adeno-associated virus (AAV) based therapy delivers a gene coding for a therapeutic protein, known as inhibitor-1 or I-1, which blocks the activity of protein phosphatase 1 (PP1), an enzyme thought to play a role in the development of heart failure.

PP1 levels are known to be increased in the failing heart and seem to be involved in depressed cardiac function and the development of cardiomyopathy.

Fast-track status is reserved for new drugs and vaccines that aim to treat or prevent serious conditions, for which there are few or no alternative therapies, and can speed up their development and review, getting them to patients more quickly.

AskBio’s chief medical officer, Canwen Jiang, said the designation is “an important accomplishment for the clinical development of this programme and highlights [its] goal of bringing potentially effective treatments to patients with advanced congestive heart failure.”

GenePHIT got underway earlier this year and is still at the stage of patient enrolment, with a target size of 90 to 150 male and female subjects, who will be randomised to one of two doses of the gene therapy or a placebo administered via intracoronary artery infusion.

The main outcome measures are cardiovascular death and the change from baseline in NYHA classification, left ventricular ejection fraction (LVEF), peak oxygen (VO2), and six-minute walk test scores, with heart-failure-related hospitalisations also being assessed as a secondary endpoint.

At last year’s AHA annual congress, AskBio reported data from the first 11 patients recruited in a phase 1 trial of AB-1002 who had completed 12 months of follow-up, saying there were “clinically meaningful” improvements in LVEF and other measures.

Bayer launched its cell and gene therapy business in 2020, shortly before it acquired AskBio for $4 billion, and AB-1002 is one of several clinical-stage gene therapy programmes at the unit.

This week, AskBio also reported new 18-month data from a phase 1b trial of Parkinson’s disease candidate AB-1005, showing it was well tolerated with no attributed serious adverse events and preliminary signs of efficacy with clinical motor improvements seen in some patients.

It now expects to start a phase 2 trial of AB-1005, called REGENERATE, in the US, EU, and UK later this year.

https://pharmaphorum.com/news/fda-fast-tracks-askbios-heart-failure-gene-therapy