OmniAb New Data on OmnidAb™ Platform

 OmniAb, Inc. (Nasdaq: OABI) announces the presentation of new scientific data on its OmnidAb™ platform, the industry’s first and only transgenic chicken host system producing single domain antibodies (sdAbs), at the 2023 Antibody Engineering & Therapeutics Conference underway in San Diego and hosted by The Antibody Society. The Company presented an overview of OmnidAb and its functionality to industry leaders and prospective customers today in a presentation by Christine Vuong, Ph.D., Senior Scientist, titled “Heavy Chain-Only Transgenic Chickens Produce Human Antibodies with Robust Immune Repertoires and High-Affinity Binding.”

https://www.businesswire.com/news/home/20231214937823/en/(Photo:

FDA Approves Merck’s WELIREG® (belzutifan) for Advanced Renal Cell Carcinoma

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).

https://www.marketscreener.com/quote/stock/MERCK-CO-INC-13611/news/FDA-Approves-Merck-s-WELIREG-belzutifan-for-the-Treatment-of-Patients-With-Advanced-Renal-Cell-45574413/

Pfizer Buy at Jefferies

 Jefferies is positive on the stock with a Buy rating. The target price is decreased from USD 37 to USD 32.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/PFIZER-INC-Jefferies-gives-a-Buy-rating-45567227/

Reports Of White Lung Syndrome Emerge In The US

  by George Citroner via The Epoch Times (emphasis ours),

Reports of a mysterious respiratory illness in China are sparking fears of a potential new pandemic.

Cases of what some are dubbing “white lung syndrome” have already been reported in several U.S. states, evoking chilling memories of the early days of COVID-19.

Health officials are racing to determine if this is simply the expected winter uptick of seasonal illnesses or if it could be a dangerous new pathogen. If the latter, the implications could be profound. Is history repeating itself? How quickly could this spread? How can you protect yourself?

Spike in Pediatric Pneumonia in China Hints at Possible New Contagion

Chinese media described overwhelmed children’s hospitals in Beijing and Liaoning Province (Northern China) in late November, according to a recent post on the International Society for Infectious Diseases’ online reporting system, ProMed.

Reported symptoms are high fever without cough, with some children developing lung nodules that can indicate bacterial infections like pneumonia.

Per the post, the Beijing Children’s Hospital lobby remained crowded with parents seeking treatment for their children’s pneumonia.

According to the post, the situation in Liaoning Province is “serious,” with the lobby of Dalian Children’s Hospital filled with sick children receiving intravenous drips. A Dalian Central Hospital staff member reportedly said that patients were waiting in line for two hours, and “we are all in the emergency department, and there are no general outpatient clinics.”

While only recently known, infectious disease website FluTrackers has logged reports of overwhelmed pediatric hospitals and cases of Mycoplasma pneumonia, caused by bacteria that often causes upper respiratory tract infections and pneumonia, in China since August.

China could be seeing a surge in respiratory infections as other countries did their first winter after COVID-19 lockdowns were lifted, Dr. Krutika Kuppalli, an infectious disease physician with the World Health Organization’s (WHO) Health Emergencies Program, said on X. “They have already reported surge of #Mycoplasma pneumonia but this could be anything - let’s gather data,” she wrote.

Outbreak in Ohio Started in August

Ohio’s Warren County Health District (WCHD) reported an “extremely high number” of pediatric pneumonia cases this fall. The roughly 145 cases reported since August alone exceed average numbers and meet the state outbreak definition.

“We do not think this is a novel/new respiratory disease but rather a large uptick in the number of pneumonia cases normally seen at one time,” the WCHD said.

A parent questionnaire identified the most common symptoms as cough, fever, and fatigue. Detected pathogens include Mycoplasma pneumoniae, Streptococcus pneumoniae (strep), and adenovirus. Some media refer to the condition as “white lung syndrome” due to how infected lungs can appear under X-rays.

Evidence suggests a mix of the same pathogens causing illness in China, Dr. Christopher Calandrella, chair of emergency medicine at Northwell Long Island Jewish Forest Hills in New York, told The Epoch Times.

“Additionally, China recently lifted its pandemic restrictions, and as the population begins socializing more, it may contribute to an increase in cases, similar to what was experienced here in the United States last fall,” he said.

CDC Highlights New Vaccine Options

The U.S. Centers for Disease Control and Prevention (CDC) recently stated on its website that it is “monitoring reports of increased respiratory illness around the world,” including in China and Europe. However, the agency emphasized that pediatric pneumonia and other respiratory diseases typically rise each fall and winter.

The CDC also pointed out that, for the first time, there are now available “safe and effective immunizations” for three major viral respiratory illnesses: flu, COVID-19, and respiratory syncytial virus (RSV), an infectious virus that affects the lungs and airways and that can cause pneumonia.

China approved five new COVID-19 vaccines for emergency use amidst its current respiratory disease outbreak.

Currently, no data suggest these infections have different virulence or infectivity than U.S. pathogens, according to Dr. Calandrella, so there is no reason for alarm, he emphasized.

COVID-19 provided many critical lessons, including the vital role of hand hygiene, vaccines, and masks, “which can significantly reduce the risk of infections in general,” Dr. Calandrella added.

COVID-19 Shots Linked to Pneumonia

A little-discussed factor is whether these respiratory outbreaks may in some way be associated with COVID-19 vaccination.

A list of adverse events associated with Pfizer’s mRNA shot was released due to a Freedom of Information Act (FOIA) request, and according to the document, “atypical pneumonia” is one among hundreds of potential adverse reactions to receiving the gene-therapy-based drug, along with Mycoplasmal bronchitis, cardio-respiratory arrest, cardio-respiratory distress, and cough.

A 2022 Respirology Case Reports study presented the first organizing pneumonia case, a rare lung condition affecting the airways and air sacs, related to COVID-19 vaccination. A 78-year-old woman developed cough and breathing difficulty 10 days after her Pfizer shot.

Other research has found that vaccinated individuals’ immune function eight months post-second dose is lower than that of unvaccinated individuals. “As a safety measure, further booster vaccinations should be discontinued,” the study authors wrote.

https://www.zerohedge.com/medical/reports-white-lung-syndrome-emerge-us

Wash. Lawmaker Wants To Jail People Using Gas-Powered Leaf Blowers: They "Contribute To Climate Change"

 Democrat lawmakers in Washington State want to jail residents for using gas-powered landscaping tools such as leaf blowers and edgers.

State Rep. Amy Walen (D-Kirkland) has pre-filed legislation which would radically alter the state's Clean Air Act, according to Jason Rantz of MyNorthwest, who reports that HB 1868 would ban "gasoline-powered and diesel-powered landscaping and other outdoor power equipment" for "contributing to climate change."

As Rantz further explains, the bill contains a laundry list of unintended health consequences tied to the tools as well, including a claim that they cause asthma.

The bill gets to the ban by empowering the Department of Ecology to “adopt rules to prohibit engine exhaust and evaporative emissions from new outdoor power equipment” by either January 1, 2026 or sooner, if the state determines it’s feasible to do so earlier. Washingtonians are expected to upgrade their equipment to zero-emission alternatives. Government work, however, is partly exempt.

To make the transition more palatable, the zero-emission alternatives would not be subject to a sales tax. But it would still be prohibitively expensive for many small businesses. -MyNorthwest

If a resident violates the law, they could face up to a year in jail and/or a hefty fine.

Of course, as Rantz further notes, the new law wouldn't apply to government agencies or contractors working for the government under emergency circumstances.

We'll give the last word to Rantz, who suggests that the legislation will harm minorities the most;

What happened to equity?

Though Democrats argue their legislation should be viewed through an equity lens, this ban has a disproportionate impact on Latino and black business owners. Nationwide data stated 22.8% of landscaping companies are owned by Hispanics and 14.7% are owned by blacks.

The cost to transition to zero-emission alternatives is burdensome, too, even with financial assistance provided in the bill. For some businesses, it could still be prohibitively expensive. This financial burden could disproportionately affect minority-owned businesses, potentially leading to a reduction in diversity within the industry, if Democrat talking points are to be believed.

This ban is also anti-business, of course. Not only will it take landscapers significantly more time to do the same amount of work, thanks to inefficient battery-powered tools, it can be very expensive. Writing in the Orange County Register, Brooke Staggs notes the strain this can put on small businesses: “Commercial-grade electric-powered gear can cost anywhere from 15% to 300% more upfront, before factoring in the cost of batteries, chargers and potential electrical upgrades needed to keep them running all day.”

Larger companies can more easily absorb the cost of transitioning to electric equipment, but the smaller businesses, which represent the majority of the industry, will struggle. It’s also worth considering the current limitations of electric landscaping equipment, such as battery life and power, which can’t meet the demands of larger or more intensive landscaping projects. Even with tax credits, will they last long enough to cover the constant need to upgrade to better and more efficient technology?

https://www.zerohedge.com/energy/washington-state-democrat-wants-toss-people-jail-using-gas-powered-leaf-blowers-contribute

Apple Quietly Changes Policy, Search Warrant Required for Certain Customer Data To Law Enforcement

 by Stephen Katte via The Epoch Times,

Apple has quietly changed its legal guidelines to now require U.S. law enforcement agencies to obtain a court order if they want access to specific aspects of the tech giant's customer data.

In Apple's updated guidelines, the tech giant will now only share customer data about push notifications with law enforcement "in response to a search warrant issued upon a showing of probable cause, or customer consent." In the past, the company accepted a subpoena to hand over customer data.

The critical difference between the two is that a subpoena compels the company to act in response to a request for information. In contrast, a search warrant is far more aggressive and authorizes a legal authority to take action to retrieve the information.

Push notification data is considered especially sensitive because the alerts inform the smartphone user about breaking news, weather bulletins, and other everyday content. At the same time, the data can reveal a great deal about users' online activities.

For requests about other types of data, such as information related to device registration or customer service, Apple has kept its initial guidelines and will comply with law enforcement if presented with "a subpoena or greater legal process."

According to Apple's guidelines, the company can also decide to share customer data with law enforcement in cases of emergency, when there is no time to go through the proper legal channels if it is believed lives are in danger or national security is at immediate risk. However, Apple says not all requests are granted. Each one is considered by its team of legal experts and can still face rejection.

"A trained team in our legal department reviews and evaluates all requests received, and requests which Apple determines to have no valid legal basis or considers to be unclear, inappropriate, or over-broad are objected, challenged, or rejected," the guidelines state.

Cause of Policy Shift Unknown

The tech giant didn't formally announce the policy shift, and what sparked the change is unclear. Some competitors in the tech space, such as Google, already require a court order for law enforcement to get push notification-related data.

Last week, Sen. Ron Wyden (D-Ore.) wrote to the Department of Justice, warning he received a tip that foreign governments had requested Apple and Google to hand over records of smartphone notifications. He didn't provide any extra details about which governments had made the request.

"Apple and Google should be permitted to be transparent about the legal demands they receive, particularly from foreign governments, just as the companies regularly notify users about other types of government demands for data," Sen. Wyden said in his letter to Attorney General Merrick Garland.

"These companies should be permitted to generally reveal whether they have been compelled to facilitate this surveillance practice, to publish aggregate statistics about the number of demands they receive, and unless temporarily gagged by a court, to notify specific customers about demands for their data."

It's not publicly known if the scrutiny sparked by Sen. Wyden's letter had any bearing on Apple's policy change or if the shift was already planned and the timing was just a coincidence.

The Epoch Times has contacted Apple and Sen. Ron Wyden for further comment.

https://www.zerohedge.com/technology/apple-quietly-changes-policy-search-warrant-now-required-send-certain-customer-data-law

Steps to improve lung cancer screening

 Each year, we lose 127,000 Americans to lung cancer. That's nearly the equivalent of a commercial airliner packed with passengers falling out of the sky every other day, making lung cancer "by far the leading cause of cancer death in the U.S.

opens in a new tab or window," according to the American Cancer Society. For perspective, in people older than 50, we lose more friends, family members, and loved ones to lung cancer annually than we do to colon cancer, breast cancer, and prostate cancer combined.

Lung cancer screening can help detect cancers early. For patients at high risk of lung cancer, an annual low-dose chest CT can reduceopens in a new tab or window the risk of dying from lung cancer by 20%. Yet, even though we have an effective screening process to identify lung cancer in early stages, only 5.8%opens in a new tab or window of eligible people have undergone screening. Of those few patients who underwent screening, only 20%opens in a new tab or window came back for the necessary second round of screening.

Why are we under-utilizing such a valuable resource in lung cancer care? It's an urgent question, and the answer we give could save lives. Like all weighty questions, this one is complicated.

First and foremost, not enough people know about lung cancer screening. Though most people are aware of breast, colon, and prostate cancer screening, far feweropens in a new tab or window know about lung cancer screening and how to obtain it.

Next, available guidelines have conflicting recommendations that are difficult for patients and providers to follow. Several societies recommend lung cancer screening, but their recommendations may differ. Take for example the recently updatedopens in a new tab or window screening guidelines from the American Cancer Society. While expanding screening eligibility to an additional 5 million people, the updated guidelines are distinct from the U.S. Preventive Services Task Force (USPSTF) recommendations.

So, which recommendations are best practice? Perhaps both. It's clear we're not screening everyone who is high risk for lung cancer. Though the American Cancer Society and USPSTF recommendations advance our ability to find lung cancers early, some patients would benefit from screening but don't meet established criteria. For example, a younger patient with a family history of lung cancer, heavy smoking history, and prior work around asbestos may benefit from screening but may not meet age criteria for screening.

Insurance requirements and reimbursement (which are generally based on USPSTF guidelines) can also be barriers to lung cancer screening. Though most insurance policies cover baseline lung cancer screening, specific documentation is required for reimbursement, and follow-up testing is not always covered. The result: it is more difficult than it should be for patients to find, obtain, and pay for lung cancer screening.

Unfortunately, the challenges don't stop there. Another big hurdle is the way we talk about lung cancer. Many patients who smoke (or used to smoke) feel stigmatized and are reluctant to ask for help; they've been conditioned to being criticized or shamed about their history, leading to delayed or skipped screening. We can improve screening rates by recognizing the stigma and changing the way we talk about lung cancer.

Finally, we're not offering lung cancer screening equitably. Black Americans, for example, are less likelyopens in a new tab or window to (1) be eligible for lung cancer screening, (2) undergo lung cancer screening, and (3) have lung cancers diagnosed in early stages. As a result, lung cancer survival is shorteropens in a new tab or window in Black Americans compared with their white neighbors.

What can we do to improve lung cancer screening challenges?

• More federal and state resources are needed: awareness campaigns, consistent insurance coverage, and efforts to improve racial and ethnic disparities.
• Let's open the dialogue with increased awareness and better communication. Honest, open, and non-judgmental discussions with physicians, family, and friends would be a big step toward reducing stigma.
• More individualized care is essential. Our system should revisit the way we think about lung cancer screening. Determining an individual's risk gives more insight into the benefit from screening. This straightforward and personalized approach will pose some organizational challenges. But, if implemented, such a system would make for a much more strategic -- and accurate -- approach to detecting lung cancer early.

These recommendations don't require as much of an overhaul as it might seem. Our system is already changing for the better. The USPSTF first issued recommendations for lung cancer screening in 2013. In 2021, the guidelines were updated to include more patients and address the racial disparities mentioned above. We're moving in the right direction.

It's high time we took America's deadliest cancer for what it is -- not a stigmatized condition related to prior lifestyle choices, but rather a challenge for each one of us to grapple with personally. Our friends, family, and patients are depending on us. We have no time to lose.

Brett Bade, MD, is a pulmonologist with Northwell Health. Subroto Paul, MD, MPH, is the chief of thoracic surgery at Northwell Health's Lenox Hill Hospital.

https://www.medpagetoday.com/opinion/second-opinions/107768