Zealand Pharma announces positive results from Part 1 of multiple ascending dose trial with amylin analog ZP8396
Doses of 0.6 and 1.2 mg ZP8396 administered once-weekly for six weeks led to 5.3% and 5.1% mean weight loss as compared to 2.6%, 3.6% and 4.2% weight loss following single doses of 0.7, 1.4 and 2.4 mg ZP8396, already reported
Part 2 investigates once-weekly dosing for 16 weeks and has been initiated, exploring significantly higher doses of ZP8396 based on the mild adverse event profile observed in Part 1 of the trial
Results support continued development of ZP8396 as an alternative to GLP-1-based therapies for the management of overweight and obesity
First phase 3 results for Daiichi Sankyo and AstraZeneca’s TROP2 directed ADC demonstrated statistically significant improvement in progression-free survival versus standard chemotherapy in previously treated locally advanced or metastatic disease
Trial will continue to assess the dual primary endpoint of overall survival
Topline results from the TROPION-Lung01 phase 3 trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care chemotherapy, in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at least one prior therapy.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
For the dual primary endpoint of overall survival (OS), the data were not mature and an early trend was observed in favor of datopotamab deruxtecan versus docetaxel that did not meet the pre-specified threshold for statistical significance at this interim analysis. The trial will continue as planned to assess OS with greater maturity. The investigators and participants will remain blinded to the results.
The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified. All grade interstitial lung disease (ILD) was generally consistent with prior clinical trials, with the majority being low grade. Some grade 5 events were observed.
Celltrion USAtoday announced the launch of Yuflyma® (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of Humira®(adalimumab) biosimilar, providing an alternative option for patients.
Yuflyma is indicated for the treatment of eight conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.1
First approved by the Food and Drug Administration on May 23, 2023, Yuflyma became commercially available among key distributors across the U.S. on July 2nd. Yuflyma is listed at $6,576.50 per month. Yuflyma is available in two device types — auto-injector and pre-filled syringe options.
More than 80% of patients treated with Humira in the U.S. rely on a high-concentration and citrate-free formulation.2 Yuflyma is a citrate-free formulation that is highly concentrated at 100mg/mL. It also maintains stability at 25℃ (77°F) for 30 days to provide longer shelf life than Humira and is administered via a latex-free device.1
Drug Enforcement Administration (DEA) Administrator Anne Milgram said Sunday that various social media companies are not complying with them to help address the ongoing fentanyl crisis.
During an appearance on NBC’s “Meet The Press,” Milgram told moderator Chuck Todd that social media has played a vital part in the sale of fentanyl. Milgram noted how drug cartels use the various platforms to market their material to people.
“Social media is also a vital part of the conversation. It is what I call the last mile. Because what the cartels need — they’re selling the deadliest poison we’ve ever seen — they need that to get —,” Milgram told Todd.
“They need a platform to advertise?” Todd asked.
“Exactly,” Milgram replied. “To be able to expand and sell more, they need to be able to reach people at massive rates. And that’s what social media’s doing.”
Milgram also said that her agency has had conservations with social media companies on these issues, saying that those platforms will have to buckle down and enforce their rules if they see illegal activity on their sites.
“We’ve been in conversations with the social media companies. The Deputy Attorney General convened all of us in April of this year and made it very clear, number one, that the companies have to comply with their own terms of service, which say, ‘This is illegal. You cannot be selling fake pills. You cannot be selling drugs on social media websites,’” Milgram told Todd.
“Number two, law enforcement needs to get information from the social media companies. We have not, until recently, gotten nearly as much cooperation as we need,” she added. “And finally, this is an outright emergency. So they need to be doing absolutely everything they can to get the deadly drugs off their platform.”
Milgram’s remarks come months after she testified before the Senate Foreign Relations Committee about how multiple cartels use social media sites like Snapchat to sell their drugs to young users on the platform.
“The cartels understand that if someone dies from taking their deadly fentanyl, that there are 100 million other users on Snapchat that they can sell their drugs to,” Milgram said at the hearing. She also named the Sinaloa and Jalisco cartels as the perpetrators of the fentanyl crisis in the country.
Washington, D.C. authorities said that three local businesses on Sunday were hit with explosive devices and a Molotov cocktail.
In a news release, the Metropolitan Police Department (MPD) said that the suspected attacks happened within a fifteen-minute span.
At approximately 4:30 a.m., the suspect detonated an explosive device on the sidewalk outside the ATM of a Truist Bank located in the Northeast section of the city, adding that the explosive device caused damage at the location.
Six minutes later, authorities said the suspect detonated an explosive device on the sidewalk in front of the doors at the Nike Store located in the Northeast section of the city, also causing damage to the location.
Approximately nine minutes later, the suspect threw a Molotov cocktail-style object at the Safeway store located in the Northeast section of the city, which caused damage to the location.
In all three of the attacks, the suspect fled the scenes in a vehicle. The vehicle was described as an Acura TL gold/champagne color model with a Maryland plate tag.
“In each of these offenses, it appears the suspect targeted commercial establishments and it does not appear the suspect was targeting any members of the public. The establishments were closed at the time of the offenses,” MPD said in its news release, adding that no injuries were reported in those incidents.
This comes as the MPD and the Bureau of Alcohol, Tobacco, Firearms and Explosives Washington Field Division are offering up to $20,000 for anyone who provides information that leads to the arrest and conviction of the perpetrators of the incidents.
The new legislation will require businesses in lower Manhattan and northern Brooklyn during Sept. 11, 2001, terror attacks to contact workers employed during that time who may have been exposedto life-threatening toxins.
The 9/11 Notice Act was unanimously passed by both the state Assembly and Senate.
Governor Kathy Hochul is reviewing the bill and will likely approve it before the 9/11 anniversary. It hasn’t yet been sent to her desk.
Assemblyman Nader Sayegh (D-Yonkers) said he drafted the legislation following the 20th anniversary of the 9/11 terrorist attacks.
Sayegh said he was spurred into action after learning that of the 400,000 civilians exposed to 9/11 toxins, only a small percentage with qualifying medical conditions had registered for the 9/11 Victim Compensation Fund and the World Trade Center Health Program.
Both provide free monitoring and treatment for eligible individuals with WTC-related illnesses.
Assemblyman Nader Sayegh (D-Yonkers) said he drafted the new legislation following the 20th anniversary of the 9/11 terrorist attacks.Nader SayeghThe new legislation will require businesses in lower Manhattan and northern Brooklyn during Sept. 11, 2001, to contact workers employed during that time who may have been exposed to life-threatening toxins.Getty Images
By comparison, more than 80% of first responders have registered with the federal health and compensation programs.
Under the measure, employees who worked near Ground Zero between September 2001 and the end of May 2002 need to be contacted by their employers and former employers and made aware of their right to seek medical compensation.
“It is nearly 22 years after the terrorist attacks and an utter lack of awareness about the benefits and eligibility for the federal World Trade Center Health Program and 9/11 Victim Compensation Fund means we needed to act,” Sayegh said.
The World Trade Center was hit by two planes on September 11, 2001, in New York City.Getty ImagesPedestrians were pictured running away as the Twin Towers were collapsing in NYC.AFP via Getty Images
“The 9/11 Notice Act means that forgotten victims, including downtown office workers, doormen, construction workers, students, teachers, retail workers, and delivery people, must be notified of their eligibility status by their ex-employer. No one should be left to suffer from 9/11-related illness and be burdened with overwhelming medical bills when the federal resources are FREE and available to help them.”
Sen. Brian Kavanagh (D-Manhattan), who shepherded the bill through the upper house and whose district includes the World Trade Center site and is home to many 9/11 survivors, said many people “may be experiencing WTC-related illnesses and may be eligible for financial and healthcare benefits, but may not realize that they are.”
The Post has reported numerous cases of people — students as well as workers and first responders– stricken with cancers and other illnesses after being exposed to toxins following the collapse of the World Trade Center towers.
The 9/11 Notice Act was unanimously passed by both the state Assembly and Senate.Getty ImagesSayegh said he learned 400,000 civilians were exposed to 9/11 toxins, but only a small percentage with qualifying medical conditions had registered for the 9/11 Victim Compensation Fund.Getty Images
Of the 400,000 people exposed to Ground Zero toxins on 9/11 and afterward, 57,000 were residents south of Canal Street, as well as 15,000 students and staffers at downtown Manhattan schools, like Stuyvesant High School.
Assemblyman Gary Pretlow (D Mount Vernon) said more people have died from 9/11 health-related illnesses — nearly 6,000 — than the 2,977 victims killed that day.
“I will never forget the smell of burning metal and the sight of the chalky dust cloud that engulfed Lower Manhattan after the terrorist attack on 9/11,” he recounted. “More than two decades later, the potent smell and powdery dust are gone; however, the effects of the toxins still linger, causing more than 5,891 deaths since 9/11—more than the death toll on that terrible day.”
The Post has reported numerous cases of people, including students, workers, and first responders, stricken with cancers and other illnesses after being exposed to toxins following the collapse.AFP via Getty Images
Tommy Steed, Chairman of the Association of BellTel Retirees, representing 134,000 retirees from Verizon, AT&T, and Empire City Subway, noted many who toiled in Ground Zero to repair communication lines after the terrorists attacked.
“Land lines were dead, cell phones had no signals, high-speed data could not transmit and federal, state, and regional first responders lacked a reliable means to connect,” he said.
“It was our members who were called in on Day 1, to restore service in Lower Manhattan and for the reopening of the financial markets. What we didn’t plan for was being exposed to the world’s largest and most toxic burn pit.”
The issue, as Wikipedia details is whether the 16th Amendment authorizes Congress to tax unrealized gains as income.
Background
Charles and Kathleen Moore invested $40,000 in an Indian business named KisanKraft in 2005, in exchange for 11% of the company’s equity. KisanKraft is a controlled foreign corporation. The company has made a profit every year of its existence, and rather than distributing its earnings to shareholders, it has reinvested profits in the business. Prior to the passage of the Tax Cuts and Jobs Act in 2017, income tax on such earnings generally did not have to be paid until they were distributed to shareholders. The 2017 law changed the corporate and Subpart F tax regime to focus on domestic profits, and imposed a one-time mandatory repatriation tax on profits held overseas. The Moores paid the $14,729 in tax owed and challenged the law in the United States District Court for the Western District of Washington as violating the Sixteenth Amendment’s requirement that income be realized before it can be taxed, as set forth in Eisner v. Macomber (1920). The district court ruled for the government, and the United States Court of Appeals for the Ninth Circuit affirmed. joined by three other judges, dissented.
The Moores filed a petition for a writ of certiorari on February 21, 2023. The Supreme Court granted certiorari on June 26, 2023, meaning that it would head the case.
The Moores sued for a refund, but a three-judge panel of the Ninth Circuit ruled that “realization of income is not a constitutional requirement.” This defies the traditional understanding in U.S. tax law, and in Supreme Court doctrine, that income must be realized before it can be taxed. That is, the income must be real income, not merely an increase in the value of an asset in market value or on some company’s books.
A 1920 case, Eisner v. Macomber, held that a gain in asset value qualifies as income only if it is “received or drawn by the recipient (the taxpayer) for his separate use, benefit and disposal.” The fight will be whether that precedent still holds under the Constitution’s Sixteenth Amendment that allowed the income tax.
Bernie Sanders, Elizabeth Warren, and Senate Finance Chairman Ron Wyden are all on board for a wealth tax.
State Exit Taxes
California, New York, Massachusetts, Hawaii, and Washington have all proposed exits taxes on unrealized gains when someone moves out of state.
A proper Supreme Court ruling would kill these ideas before they take hold.
Slam Dunk
This case is a slam dunk for the Supreme Court. In short, the constitution authorizes a tax on “income.” Fluctuations in value of an asset have been ruled not to be income and for good reason, given the meaning of the word income.
People with illiquid assets would be punished. Family farms would be crushed when the principle owner moved.
The case is simple. Expect a huge majority decision. Then expect Elizabeth Warren, President Biden, and Bernie Sanders to piss and moan when their Marxist wealth grab ideas bites the dust.
The Supreme Court is on a roll this year, all of it good.
Supreme Court Strikes Down Student Debt Cancellation, Cites Nancy Pelosi
