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Tuesday, April 16, 2024

Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025

 Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.

Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.

https://www.statnews.com/2024/04/11/medicare-will-spend-billions-on-alzheimers-drug-leqembi-eisai-biogen/

Pac Bio lower prelim revenue

 Announces Plan to Reduce Annualized Operating Expense Run Rate by $50 - $75 Million

Q1 2024 Earnings Conference Call Scheduled for May 9, 2024

Revenue in the first quarter was significantly lower than expected, and as a result, PacBio now expects 2024 revenue to be in the range of $170 million to $200 million.  The company believes that second quarter revenue will improve over the first quarter and that the second half of the year will improve sequentially as consumables return to sequential growth and the company closes some of the deals that were delayed in the first quarter.  At the midpoint of $185 million, the company believes that total Revio shipments for 2024 will be around 120 systems.  At the midpoint of the revised guidance, the company expects that consumable revenue will be around $80 million and consumable pull-through on the Revio system will be around $290,000 per system. 

Given the company's lowered outlook for 2024, PacBio believes it is unlikely to achieve its long-term revenue guidance of at least $500 million in 2026 and is reevaluating the timing of achieving it. The company expects to provide more details on its financial performance and outlook on its earnings call scheduled on May 9, 2024.

With the reduced revenue forecast and the planned cost reduction initiatives, PacBio currently expects to end 2024 with cash, cash equivalents, and investments balance in the range of $435 million to $450 million.

https://www.prnewswire.com/news-releases/pacbio-announces-preliminary-first-quarter-2024-revenue-and-updates-2024-revenue-guidance-302117738.html

Intra-Cellular builds case for depression drug with late-stage trial win

 An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.

The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.

More specifically, patients in the drug arm showed an average reduction of 14.7 points on a well-known, 60-point scale that clinicians use to gauge the severity of depressive symptoms. The control arm, meanwhile, had a reduction of 9.8 points. At the beginning of the study, both groups scored at or just above 30 points.

According to Intra-Cellular, researchers observed the drug — which is known scientifically as lumateperone and commercially as Caplyta — having a significant effect both in the first week of testing and throughout the main study period.

It was also generally safe and well-tolerated, with the most common adverse events being dry mouth, fatigue and tremors. Intra-Cellular said these events were mostly mild to moderate, resolved within a short period of time, and were similar to those seen in earlier studies testing the drug in people with schizophrenia or bipolar depression. The Food and Drug Administration approved Caplyta as a treatment for those conditions in 2019 and 2021, respectively.

The results were well-received on Wall Street. In notes to clients, Jefferies analyst Andrew Tsai wrote that “Caplyta is becoming a pipeline-in-a-pill,” while Mizuho Securities analyst Graig Suvannavejh noted how his team is “very pleased with the data.”

To Brian Abrahams of RBC Capital Markets, the findings are a “clear win” and “surpass even optimistic expectations.” Investors appear to agree, as shares of Intra-Cellular were up about 25% Tuesday morning, to trade at $81 apiece.

Target with class action lawsuit for collecting biometric data without consent

 An Illinois woman filed a class action lawsuit against Target, accusing the retail giant of collecting and storing her biometric data, including face and fingerprint scans, without her consent in violation of state law.

Arnetta Dean, who filed the lawsuit with the intention of preventing Target from further violating the privacy rights of state residents, is also pursuing statutory damages for the company's alleged collection, storage and use of customers' biometric data, according to the lawsuit obtained by FOX 32 Chicago.

The lawsuit, filed last month in Cook County, claims Target's surveillance systems, including cameras with facial recognition technology installed in Illinois stores, "surreptitiously" collect biometric data on customers without their knowledge or consent.

"Target does not notify customers of this fact prior to store entry, nor does it obtain consent prior to collecting its customers’ Biometric Data," the lawsuit said.

target

The lawsuit claims Target's surveillance systems "surreptitiously" collect biometric data on customers without their knowledge or consent. (iStock / iStock)

According to the lawsuit, Target violated the state's Biometric Information Privacy Act (BIPA) by collecting, storing and using biometric information without obtaining written consent from customers or providing them with adequate information about data retention and destruction policies.

BIPA, which passed in 2008, states that companies in Illinois are prohibited from collecting, storing or giving out biometric data without providing notice and obtaining personal consent. Companies are also required to inform individuals of the specific purpose and duration of data collection, and they must disclose how the information will be retained and when the information will be destroyed.

The lawsuit says Target failed to comply with the aforementioned requirements.

Biometric data is unlike other identifiers used to access sensitive information because it is biologically unique and cannot be easily changed if compromised, putting individuals at increased risk for identity theft, the lawsuit said.

"For example, social security numbers, when compromised, can be changed," according to the lawsuit. "Biometrics, however, are biologically unique to the individual; therefore, once compromised, the individual has no recourse, is at heightened risk for identity theft, and is likely to withdraw from biometric-facilitated transactions."

Target store in New Mexico

Target is accused of violating Illinois' Biometric Information Privacy Act. (iStock / iStock)

Target's "advanced system of electronic surveillance" includes operating 14 investigation centers and two forensic labs to "enhance video footage and analyze finger prints(sic)," according to the lawsuit, which noted that the system was created to detect shoplifters, but also captures customers' faces every time they enter or leave the store.

Under BIPA, individuals have a private right of action to file a lawsuit for violations of the act, with damages ranging from $1,000 for negligent violations to $5,000 for intentional or reckless violations, as well as attorneys' fees and injunctive relief.

Dean's lawsuit is attempting to do just that, seeking $5,000 for "each and every intentional reckless violation" of the law, or statuary damages of $1,000 for any violation found to have been committed negligently, along with attorneys' fees and other litigation expenses.

https://www.foxbusiness.com/technology/illinois-woman-hits-target-class-action-lawsuit-collecting-biometric-data-without-consent

UNH Revenues of $99.8 Billion Grew Nearly $8 Billion

 

  • Earnings Reflect $0.74 per Share of Impacts from Change Healthcare Cyberattack; $0.49 to Support Direct Response Efforts and $0.25 in Business Disruption Impacts
  • Company has Provided Over $6 Billion in Advance Funding and Interest-Free Loans to Support Care Providers in Need
  • First Quarter Net Loss of $1.53 Per Share is Due Primarily to Currency Effects of Previously Reported Brazil Sale and the Cyberattack
  • Adjusted Earnings of $6.91 Per Share Include the $0.25 in Business Disruption Impacts but Exclude Brazil Sale and Direct Response Costs

argen X VYVGART and VYVGART Hytrulo Drive Transformative Outcomes in Debilitating Autoimmune Disease

 

  • ADHERE data show VYVGART®Hytrulo has potential to be first advancement for CIDP patients in 30 years
  • Real-world data demonstrate gMG patients able to significantly reduce steroid use over first six months of initiating VYVGART® treatment

Water In Texas: A Window Into Problems Across The US

 by Suzanne Gasparatto via The Epoch Times,

Humans cannot live without water, yet many of us take for granted that water is readily available. As more people move to cities, adding to already crowded populations, the availability of potable water isn’t a given any longer.

While this planet has plenty of water, its distribution does not always coincide with areas where lots of people choose to live.

For decades, Texans, like citizens of other states, have been struggling with regional water issues. Heavily populated but still growing Central Texas has long been known as an area of perpetual drought occasionally interrupted by flash floods. The booming metropolis of Austin, Texas, literally sits on top of water problems. Underneath Austin is the Edwards Aquifer, which experiences rapid changes in water levels due to high demand. Other Texas cities have similar problems.

Cities as small as San Angelo and as large as San Antonio have purchased water rights in rural areas, diverting the supply of water used by farmers and ranchers over long distances for urban use. Rural Texas, which already had serious water deficits, is in trouble. Farmers and ranchers must have reliable supplies of water to produce the food that we eat.

The Highland Lakes northwest of Austin were originally built to control downstream flooding and deliver water to farmers and ranchers. The population shift from rural to urban has placed huge demands on this water supply. Lack of rain plus additional urban population has caused water levels in lakes to be so low that boat docks are far from the shoreline.

The recent large influx of people to Texas has spurred groups of investors to buy rural land and develop it into subdivisions. These investors are often from other states and are unaware of our water woes. They don’t realize that most rural Texas properties, including my location north of fast-growing Austin, depend upon individual water wells drilled by each property owner. Municipal water systems are nonexistent. Drilling deeper wells is not an option. Good-quality water isn’t available below relatively shallow levels.

Existing wells are drying up as demand for more wells arises with the building of new subdivisions. Many people, including those in existing subdivisions, are having to purchase water in bulk and have it delivered to meet their basic needs.

County officials in Texas do not have sufficient authority to manage growth while protecting our water resources. This authority needs to come from the Texas Legislature soon. Requiring larger acreage to qualify to drill a well is critical. Today, permission to drill a well can be obtained if you own as little as two acres.

Adjacent to my ranch, developers are selling four-acre to six-acre tracts that will result in 205 additional water wells. Folks who spend $250,000 to $350,000 for these tracts will expect that there is plentiful water to fill their swimming pools and water their landscaped lawns. This isn’t accurate.

These new wells will decimate our agricultural wells that are already low from years of drought. My County Commissioners Court doesn’t have authority to control this growth in a reasonable and fair manner for all residents.

A short-term solution involves increasing the acreage required to drill a well from two acres to at least ten acres and requiring rainwater collection systems in conjunction with all new wells. When I bought this land, a professional engineer designed a rainwater collection system off the metal roof of my barns, from which I water all my livestock. That allowed me to reserve well water for personal use only, and I monitor usage daily.

Requiring new wells to have pumps that limit pumping gallonage is necessary.

The regional underground water conservation district recently added some new regulations, which, for new wells on small acreage, will limit pumping output.

This is only a start in trying to manage over-consumption of available groundwater.

A medium-term solution is to build desalination plants to clean up the brackish water that exists below current potable water well levels.

A longer-term solution is building desalination plants along the Gulf Coast and creating a network of water pipelines throughout Texas to transport desalinated water to areas needing it. Existing easements for oil and gas pipelines can be made accessible for these water pipelines.

U.S. taxpayers contributed vastly to the development of desalination plants around the world. It is time to take care of our own citizens’ water needs.

In many populated areas, we have a shortage of adequate distribution of water. Vast parts of the western United States, on the other hand, have little water at all, and what they have is often being bought by cities and piped away from the source. Solutions are available. We only have to have the will to implement them.

https://www.zerohedge.com/geopolitical/water-texas-window-problems-across-us