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Saturday, January 11, 2025

Pacira Prelims, 5-Year Objectives to Accelerate Transition to Innovative Biopharma

 Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced its five-year growth-oriented plan to accelerate its ongoing transition into an innovative biopharmaceutical organization and become a therapeutic area leader in musculoskeletal pain and adjacencies. In addition, the company reported preliminary unaudited total revenue of $701.0 million for the year ended December 31, 2024, compared with $675.0 million for the year ended December 31, 2023.

5x30 Path to growth and value creation

The company intends to achieve the following five objectives by 2030 (“5x30”):

  • Patients: More than three million patients treated per year
  • Product revenue: Double-digit compounded annual growth rate
  • Profitability: Five percentage point gross margin improvement over 2024
  • Pipeline: Clinical pipeline expansion with five novel programs in development
  • Partnerships: Establishing five partnerships including pipeline and commercial agreements

“We enter 2025 with a sharp focus on growth, operational excellence and a clear mission to deliver innovative, non-opioid pain therapies to transform the lives of patients,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Looking ahead, I am energized to lead Pacira during this exciting new chapter as we advance our 5x30 plan to address unmet patient needs in musculoskeletal pain and adjacencies. With a best-in-class commercial portfolio that is producing significant cash flow, we believe we are well equipped to extend our leadership in non-opioid pain management and transform Pacira into an innovative biopharmaceutical organization with a robust pipeline to support sustainable growth and enhanced value creation.”

Preliminary Unaudited Fourth Quarter Revenue Highlights

  • Fourth quarter EXPAREL net product sales of $147.7 million in 2024, compared with $143.9 million in 2023. Volume growth and a price increase in 2024 were partially offset by a shift in vial mix and discounting associated with the company’s new group purchasing organization, or GPO, partnerships.
  • Fourth quarter ZILRETTA net product sales of $33.1 million in 2024, compared with $28.7 million in 2023.
  • Fourth quarter iovera° net product sales of $6.5 million in 2024, compared with $6.0 million in 2023.
  • Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was zero in the fourth quarter of 2024, compared with $2.6 million in the fourth quarter of 2023.

Preliminary Unaudited Full-year Revenue Highlights

  • Full-year EXPAREL net product sales of $549.0 million in 2024, compared with $538.1 million in 2023. Full-year net product sales were comprised of average daily volume growth of 4 percent. There were 249 selling days in 2024 and 250 selling days in 2023.
  • Full-year ZILRETTA net product sales of $118.1 million in 2024, compared with $111.1 million in 2023.
  • Full-year iovera° net product sales of $22.8 million in 2024, compared with $19.7 million in 2023.
  • Other revenue, including sales of bupivacaine liposome injectable suspension and royalties, was $11.1 million in 2024, compared with $6.1 million in 2023.

Pentagon sending assets to California to battle wildfires

 The Defense Department is sending additional assets to California to assist with the massive wildfire spreading across Los Angeles and the southern part of the state.

Pentagon deputy press secretary Sabrina Singh told reporters Wednesday the U.S. was sending 10 Navy helicopters with water buckets.

Singh said the Pentagon is working closely with the California National Guard, which is adding two Modular Airborne FireFighting Systems.

The Nevada National Guard is also readying two more of those systems, which quickly discharge a retardant to battle fires.

“The president has directed this department to bolster whatever California needs,” Singh said, but added that they are constrained in how much they can contribute at the moment. “We have to work with California, and right now we can’t even get assets up in the air because the fires are so bad and because the winds are so bad.”

Wildfires — the Eaton Fire, Palisades Fire, Hurst Fire, Tyler Fire and Woodley Fire — have burned thousands of acres in southern California.

Two people have been killed and several injured from the Eaton Fire spreading in Los Angeles County.

President Biden on Wednesday visited California and has met with state firefighters.

https://thehill.com/policy/defense/5074825-defense-department-california-wildfires/

Hunter Biden investigation will proceed after father leaves White House, Jordan says

The House Judiciary Committee Chair Rep. Jim Jordan (R-Ohio) said the panel will continue its investigation into Hunter Biden’s criminal activity in a Thursday interview with Politico.

“We think we need to look at David Weiss, the special counsel,” Jordan told the outlet. 

“There will be some additional work we need to do, I think, there because when we deposed him, he wasn’t willing to — he didn’t answer any questions, really, because it was [an] ongoing investigation,” he added.

He criticized President Biden for pardoning his son ahead of his exit from the White House on all crimes committed in a 10-year period.

“I didn’t agree with it. I think a lot of Americans didn’t,” Jordan said.

But he added that “the president can pardon anyone he wants to pardon.”

Jordan’s committee launched a broad probe into Hunter Biden and his uncle James Biden for alleged unethical business dealings which prompted their testimony before members of Congress last year.\

House Republicans have since claimed the two lied on the stand and recommended they be charged for perjury.

However, a false testimony from former FBI informant Alexander Smirnov on the Biden family’s dealings has cast doubt on claims of the family’s collective wrongdoing which some say was sparked by political opponents. 

Jordan’s statements about a deeper investigation of Hunter Biden will actualize under President-elect Trump, who has long critiqued Democrats for allegedly spurring baseless legal battles.

https://thehill.com/homenews/house/5079577-hunter-biden-investigation-will-proceed-after-father-leaves-white-house-jordan-says/

Friday, January 10, 2025

‘Worst in Show’ CES products put your data at risk and cause waste, privacy advocates say

So much of the technology showcased at CES includes gadgets made to improve consumers’ lives — whether by leveraging AI to make devices that help people become more efficient, by creating companions to cure loneliness or by providing tools that help people with mental and physical health.

But not all innovation is good, according to a panel of self-described dystopia experts that has judged some products as “Worst in Show.” The award that no company wants to win calls out the “least repairable, least private, and least sustainable products on display.”

“We’re seeing more and more of these things that have basically surveillance technology built into them, and it enables some cool things,” Liz Chamberlain, director of sustainability at the e-commerce site iFixit told The Associated Press. “But it also means that now we’ve got microphones and cameras in our washing machines, refrigerators and that really is an industry-wide problem.”

The fourth annual contest announced its decisions Thursday.

A new smart ring every few years?

Kyle Wiens, CEO of iFixit, awarded the Ultrahuman Rare Luxury Smart Ring the title of “least repairable.”

The rings, which come in colors like dune and desert sand, cost $2,200. Wiens said the jewelry “looks sleek but hides a major flaw: its battery only lasts 500 charges.” Worse, he said, is the fact that replacing the battery is impossible without destroying the device entirely.

“Luxury items may be fleeting, but two years of use for $2,200 is a new low,” he said.

Ultrahuman did not immediately respond to a request for comment.

An AI-powered smart crib?

Bosch’s “Revol” crib uses sensors, cameras and AI that the company says can help monitor vital signs like how an infant is sleeping, their heart and respiratory rates and more. The crib can also rock gently if the baby needs help falling asleep and signal to parents if a blanket or other object is interfering with breathing.

EFF Executive Director Cindy Cohn said the crib preys on parents’ fears and “collects excessive data about babies via a camera, microphone, and even a radar sensor.”

“Parents expect safety and comfort — not surveillance and privacy risks — in their children’s cribs,” she said in the report.

A spokesperson for Bosch told The Associated Press that all data is encrypted end-to-end and stored on Bosch-administered servers, “while all data at rest is secured locally with individual data encryption keys.”

“Caregivers have the final say on whether data is transmitted at all. The Revol has an offline mode, which keeps data local if preferred,” the spokesperson said, adding that the smart crib helps keep children safe.

Too much waste?

Although AI is everywhere at CES, Stacey Higginbotham, a policy Fellow at Consumer Reports, felt that SoundHound AI’s In-Car Commerce Ecosystem, powered by its Automotive AI, pushes it to unnecessary extremes.

The feature “increases energy consumption, encourages wasteful takeout consumption and distracts drivers—all while adding little value,” Higginbotham said. That landed the in-car system as “least sustainable” on the list.

Soundhound AI’s platform allows drivers and passengers to order takeout for pick-up directly from the car’s infotainment system. The company did not respond to a request for comment. In a statement Tuesday, Keyvan Mohajer, CEO of SoundHound AI, said the product’s launch marks an moment “decades in the making.”

“What begins here with food and restaurants will ultimately open up a whole new commercial ecosystem for vehicle and device manufacturers everywhere,” he said.

Vulnerable to hacking

TP-Link’s Archer BE900 router won for “least secure” of CES. The company is a top-selling router brand in the U.S. But its products are vulnerable to hacking, said Paul Roberts, founder of The Security Ledger.

“By Chinese law, TP-Link must report security flaws to the government before alerting the public, creating a significant national security risk,” he said.

In an email response, TP-Link Systems contested the report.

“TP-Link Systems Inc. is a U.S.-headquartered company and does not provide any such security reporting to China as referenced by iFixit,” the company said. “TP-Link Systems has a secure, vertically-integrated, and U.S.-owned international supply chain. Nearly all products sold in the United States are manufactured in Vietnam.”

TP-Link said it controls its own supply chains, and “is constantly assessing potential risks to its U.S. operations, customers, and supply chain,” adding that it acknowledges that vulnerabilities exist across the industry.

“However, contrary to claims of widespread vulnerabilities, comparative data places TP-Link on par with, or in some cases ahead of, other major industry players in terms of security outcomes,” the company said.

Who asked for this?

The awards also feature a category called “who asked for this?” Top of that list was Samsung’s Bespoke AI Washing Machine, which Nathan Proctor, senior director of U.S. PIRG, a consumer advocacy group, said is filled “with features no one needs,” including the ability to make phone calls.

“These add-ons only make the appliance more expensive, fragile, and harder to repair,” he said.

Samsung did not respond to a request for comment.

At a press conference at CES Tuesday, Jong-Hee Han, vice chairman of Samsung’s device experience division, said that he was “proud of how we have introduced new technologies and intelligence to the home, connected key devices and set the standard for the home of the future.”

“We are reinforcing our commitment to delivering personalized experiences through our widespread implementation of AI and we will continue this journey of AI leadership in the home and beyond, not just for the next decade, but for the next century,” he said.

The worst overall

Gay Gordon-Byrne, executive director of The Repair Association called the LG “AI Home Inside 2.0 Refrigerator with ThinkQ” the worst product overall. The fridge adds “flashy features,” Gordon-Byrne said, including a screen and internet connection.

“But these come at a cost,” Gordon-Byrne said. “Shorter software support, higher energy consumption, and expensive repairs reduce the fridge’s practical lifespan, leaving consumers with an expensive, wasteful gadget.”

Christopher De Maria, director of public relations at LG Electronics, disagreed with Gordan-Byrne’s assessment of their new product.

“Of course, like any new innovation, there will be naysayers, but we believe that when we launch this product, consumers who are looking to elevate their kitchen experience will appreciate its innovative features, convenience and performance. We have not announced pricing or availability or shared any information regarding energy consumption, so these comments are respectfully without factual merit.”

https://thehill.com/homenews/ap/ap-business/ap-the-worst-in-show-ces-products-put-your-data-at-risk-and-cause-waste-privacy-advocates-say-2/

Erectile dysfunction drug formulation maker Aspargo Labs files for direct listing on NYSE

 Aspargo Labs, which makes an oral liquid suspension formulation of a drug for erectile dysfunction, filed on Friday to register its shares with the SEC and complete a direct listing on the NYSE. The shares of common stock listed will be sold by existing shareholders; Aspargo Labs will not raise new capital in its listing. The company did not disclose a reference price or anticipated timing of its listing.


The Registered Stockholders plan to sell up to 177 million shares. In the third quarter of 2024, Aspargo Labs sold 20.9 million shares at $0.87 per share.

Aspargo is focused on developing proprietary oral liquid suspension formulations of leading oral solid dose prescription and over-the-counter (OTC) medications. Its first commercial product, Sildenafil Oral Suspension, indicated for the treatment of erectile dysfunction, is an oral liquid suspension formulation of sildenafil citrate, the active pharmaceutical ingredient contained in Viagra, administered through a metered dose container closure system consisting of a 30 ml bottle and mechanical pump. The company markets Sildenafil Oral Suspension in Spain under the brand name Bandol, and in Germany and the UK under the brand name Hezkue, though it has generated limited revenues to date. Sildenafil Oral Suspension is undergoing the approval process in the US.

The New York, NY-based company was founded in 2019 and plans to list on the NYSE under the symbol AAGO. Aspargo Labs filed confidentially on May 14, 2024. As a direct listing without a firm commitment offering, there are no underwriters on the deal; instead, Oppenheimer & Co. will serve as a financial advisor.

Antibody discovery may lead to a cure for age-related lung diseases

 Research led by Brock University has found a possible cure for lung diseases typically found in older adults, such as pulmonary fibrosis. The findings are published in the journal Aging Cell.

Professor of Health Sciences Newman Sze and his international team have identified a specific antibody that targets age-related damage to proteins, a type of biomolecule, in  and reduces inflammation in the lungs.

"Treatments for  are currently focused on symptom management," says Sze, who is the Canada Research Chair in Mechanisms of Health and Disease. "The antibody we identified is treating the root cause of the disease, so this would be a cure instead of just making the patient feel better."

As time passes, biomolecules damaged by lifestyle and  accumulate in body tissues, fueling the aging process and age-related chronic diseases.

Since this damage often occurs spontaneously, both the damage itself and subsequent age-related chronic diseases were thought to be incurable, says Sze. Typical therapeutic strategies targeting genes or enzymes were also ineffective.

In their study, "Immunotherapeutic Targeting of Aging-Associated isoDGR Motif in Chronic Lung Inflammation," Sze and his team examined isoDGR, a type of biomolecule called a peptide motif that contains three amino acids—molecules that combine to form proteins. The amino acids in isoDGR are damaged.

The researchers began their study by examining the presence of isoDGR in human lung tissues obtained from people having a variety of ages and backgrounds as well as from patients diagnosed with lung fibrosis.

The team found isoDGR concentrations increased with age, with levels being eight times as high in tissues from fibrosis patients.

Using animal models to better understand how and why isoDGR gathers in the lungs, the researchers created an antibody—a protein produced by the immune system to fight off harmful substances—that binds specifically with isoDGR.

"This antibody activated the immune system to remove isoDGR from the body," says Sze. "Because this damaged protein is the root cause of , when it was removed, the tissue actually became healthy again."

Pulmonary fibrosis is one of many diseases triggered by isoDGR. Other conditions include , cardiovascular disease, lung edema, hypoxemia and vascular congestion.

In fact, isoDGR is stored in areas throughout the body such as the blood vessels, says Sze.

"Since biomolecular damage is a main cause of many chronic age-related diseases, targeting and removing the damaged proteins with antibodies may offer therapeutic benefits beyond lung diseases," says Sze.

"This immunotherapeutic approach holds significant promise for reducing the burden of age-related diseases and supporting healthy aging in elderly populations."

Sze says the next steps in the research are working with companies to modify the antibody for compatibility with the human immune system for  and further developing it for patient use.

More information: Pazhanichamy Kalailingam et al, Immunotherapeutic targeting of aging‐associated isoDGR motif in chronic lung inflammation, Aging Cell (2025). DOI: 10.1111/acel.14425


https://medicalxpress.com/news/2025-01-antibody-discovery-age-lung-diseases.html

US Crippling Itself With Climate Change Regulations, China Is Not

 by Mike Fredenberg via The Epoch Times,

Maintaining a strong military requires a strong economy.

And a strong economy requires reasonable regulations that make sense from both an economic and scientific viewpoint.

Unfortunately, many policy makers have bought into an extreme regulatory agenda driven by ideology that does not make sense scientifically or economically, that is harming both our economy and our military.

This agenda was on display at the 2024 United Nations Climate Change Conference, also known as COP29, held in Baku, Azerbaijan from November 11 to 22 of last year. The premise for the conference, and such agreements as the Paris Accord, is that man-made climate change poises an existential threat to human existence. Further it is claimed that even now climate change is wreaking havoc around the world and that regulations, mandates and new technology will slow down and even reverse it.

Those pushing these beliefs also claim that it is the duty of more developed countries to transfer 100’s of billions, even trillions of dollars to developing countries so that they can continue developing using so-called green technology vs. dirty old legacy technology.

Here in the United States, climate-change driven polities and mandates are being rolled out on the premise/claim that that climate change is even now disproportionately affecting the poor and disadvantaged. They also claim that man-caused climate change is negatively impacting GDP.

In other words, if you don’t support draconian climate-change driven policies and mandates you support a weaker economy and have a callous disregard for how climate change is hurting those occupying the lower socioeconomic strata.

These claims, believed by many in academia and the media establishment, have taken on religious overtones, and consequently there is little tolerance for opposing viewpoints in both academia and legacy media. Be that as it may, many scientists, engineers, and other knowledgeable, extremely bright people don’t believe the rhetoric and have provided convincing arguments debunking what they believe to be pseudoscience.

One such group of distinguished academicians is the Climate Intel group (Clintel). And one of the most distinguished members of this group is Nobel Prize winner Dr. John F. Clauser, who in August of 2023 signed the Clintel Climate Declaration which declares that there is no climate emergency. As of today, 1600 plus scientists and experts have signed the declaration, with Nobel Prize winner Dr. Ivar Giaever being the first signee.

The declaration states that climate science has become politized and is lacking scientifically. It notes that climate change models are fully dependent on what go into them including hypotheses, assumptions, relationships, parameterizations, stability constraints, etc. And that “to believe the outcome of a climate model is to believe [blind faith] what the model makers have put in. This is precisely the problem of today’s climate discussion to which climate models are central. Climate science has degenerated into a discussion based on beliefs, not on sound self-critical science.”

Suffice it to say, the repeated failures of these models leaves plenty of room for doubt in the popular narrative on climate change. And given that the regulations and mandates aren’t actually stopping or even slowing climate change, we must question the wisdom of implementing regulations and mandates that cripple our economy and our military, even as China’ economy and military continue to expand unhindered by such crippling mandates and regulations.

Still, for the last 15 years plus, the United States has led the world in reducing carbon emissions. The extent of this leadership can be found in the 2024 Statistical Review of World Energy, which shows that over the last 15 years, the U.S. has experienced the largest decline in carbon dioxide equivalent emissions from energy, process emissions, methane and flaring. Indeed, as compared to 2013, the U.S. has been able to reduce carbon dioxide equivalents by 8.5 percent even as it has massively grown it economy through aggressive drilling for and using cleaner burning natural gas, including natural gas from fracking instead of coal. During this same period, China’s CO2 equivalents went up by 20 percent to make China by far and away the biggest emitter of green-house gases (GHGs).

China also leads the world in plastics pollution, and only India beats China when it comes to the sulfur dioxide emissions (SO2) responsible for acid rain.

Of note, when it comes to SO2 emissions the United States produces about one-sixth that of China.

Hence, as of today if the climate change narrative is correct, it is China that by far and away that is doing the most damage and it the United States that has done the most to combat it.

Consequently, with the United States already leading the developed world in reducing GHGs and with huge chunks of the world producing GHGs and other pollutants largely unabated, it hardly makes sense for the United States to voluntarily cripple its economy and military even as China and other potential adversaries pay lip service to the climate change narrative.

*  *  *

https://www.zerohedge.com/geopolitical/united-states-crippling-itself-climate-change-regulations-china-not