Merck Keytruda misses endpoints in prostate, lung cancer trials

 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided updates on two Phase 3 trials, KEYNOTE-641 and KEYNOTE-789. Merck is discontinuing the Phase 3 KEYNOTE-641 trial evaluating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with enzalutamide and androgen deprivation therapy (ADT) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) based on the recommendation of an independent Data Monitoring Committee. At an interim analysis, KEYTRUDA in combination with enzalutamide and ADT did not demonstrate an improvement in radiographic progression-free survival (rPFS) or overall survival (OS), the trial’s dual primary endpoints, compared to placebo plus enzalutamide and ADT, and crossed a pre-specified futility boundary for OS. Merck is informing study investigators of the decision and advises patients in the study to speak to their physician regarding treatment.

Merck also announced that the Phase 3 KEYNOTE-789 trial evaluating KEYTRUDA in combination with pemetrexed plus platinum-based chemotherapy did not meet its dual primary endpoint of OS for the treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with epidermal growth factor receptor (EGFR)-genomic tumor mutations, who have previously progressed on a tyrosine kinase inhibitor (TKI), including osimertinib. At the final analysis of the study, there was an improvement in OS for patients who received KEYTRUDA plus pemetrexed with platinum-based chemotherapy compared to pemetrexed with platinum-based chemotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. At an earlier interim analysis, the trial’s other dual primary endpoint, progression-free survival (PFS) was tested and showed an improvement in the KEYTRUDA arm compared to chemotherapy alone, but these results did not reach statistical significance.

https://finance.yahoo.com/news/merck-provides-phase-3-trials-114500104.html

Bristol Opdivo for skin cancer to get US, EU review

 The applications are based on results from the Phase 3 CheckMate -76K trial, in which Opdivo demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival

The U.S. Food and Drug Administration has assigned a target action date of October 13, 2023

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application and European Medicines Agency Validates Application for Opdivo (nivolumab) as an Adjuvant Treatment for Patients with Completely Resected Stage IIB or IIC Melanoma

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900042.html

Vanguard CEO Abandons ESG Investing Alliance: "Not In The Game Of Politics"

 Environmental, social, and governance (ESG) has been a hotly debated topic over the last few years.

The seemingly unquestioned march towards corporate utopia has met with resistance among those who oppose the idea that government oligarchs should dictate the affairs of private business firms. The long-term effects of the ESG movement are largely ignored by the mainstream.

As Tom Czitron previously commented, ESG is largely justified on the basis that corporations and financial institutions should be socially responsible. They should work obsessively to address the perceived menaces of climate change, racism, sexism, and a host of subjects. Our benevolent political and economic elite define what is virtuous and what is not for a grateful public.

But, as of late, there are some naysayers that dare to stand up to the socialism-by-stealth promoters with Tim Buckley, chief executive at Vanguard, perhaps the biggest name yet to buck the ESG orthodoxy.

“Our research indicates that ESG investing does not have any advantage over broad-based investing,” Mr. Buckley said in a recent interview with the Financial Times.

Matching word to deed, his comments came after he had withdrawn his firm from the $59 trillion Net Zero Asset Managers initiative, an organization that is part of the $150 trillion United Nations-affiliated Glasgow Financial Alliance for Net Zero.

“We don’t believe that we should dictate company strategy,” he said, in his first public comments about the decision.

“It would be hubris to presume that we know the right strategy for the thousands of companies that Vanguard invests with. We just want to make sure that risks are being appropriately disclosed and that every company is playing by the rules.”

As The Wall Street Journal reports, Mr. Buckley effectively claims that ESG managers are playing the fool and taking their clients’ money with them.

Fewer than 1 in 7 active equity managers outperform the broad market in any five-year period. Over the past five years, not one relied exclusively on a net-zero investment methodology. 

Betting his clients’ money on politicians and regulators consistently doing the “right” thing would be irresponsible.

There is a receding chance the globe will be at net zero by 2050. No one should promise to base his entire investment strategy on such odds.

The Vanguard boss also warned investors not to expect superior returns from ploughing money into ESG funds and alternative assets - two of the fastest growing parts of the asset management industry - rather than the index-trackers championed by his firm.

“We cannot state that [environmental, social and governance] investing is better performance wise than broad index-based investing,” said Buckley.

“Our research indicates that ESG investing does not have any advantage over broad-based investing.”

The decision to withdraw from the coalition has sparked fury among environmental activists, with Al Gore calling Mr. Buckley’s decision “irresponsible and shortsighted.”

Buckley, however, said, as The FT reports, that Vanguard was “not in the game of politics”.

“Politicians and regulators have a central role to play in setting the ground rules to achieve a just transition to a lower carbon economy,” he said, when asked about the increasing politicisation of ESG investing.

As Terrence Keeley writes in an op-ed via WSJ, freeing the asset-management industry from a prevailing orthodoxy that promises wealth and environmental sanctity while delivering neither requires monumental fortitude.

https://www.zerohedge.com/markets/vanguard-ceo-abandons-esg-investing-alliance-not-game-politics

Rein in dangerous chemical abortion drugs

Earlier this year, the Biden administration’s Food and Drug Administration (FDA) issued an alarming rule change to allow dangerous life-ending chemical abortion drugs to be ordered online or purchased in a retail pharmacy without ever seeing a doctor in person, turning brick-and-mortar pharmacies and post offices into abortion centers. This reckless policy is the latest in a long line of decisions by the FDA that have put the profits of abortion industry over both federal law and the health and safety of mothers and babies who are directly threatened by chemical abortion drugs.  For the first time in decades, however, accountability could be on the horizon for the FDA and the abortion industry. 

On Nov. 18, 2022, four national medical associations and four doctors, who care for pregnant and post-abortive women, sued the FDA for its decisions to approve and subsequently deregulate chemical abortion drugs.  We were proud to lead a delegation of 13 senators and 54 representatives in signing an amicus brief, with the help of Americans United for Life, in support of these pro-life medical associations and doctors. 

Alliance for Hippocratic Medicine v. FDA before the Northern District of Texas presents a long-overdue opportunity for the court to rein in the FDA for unlawfully exceeding its authority in putting the health and safety of women and girls in jeopardy, and for running afoul of longstanding federal laws that criminalize the mailing and shipping of abortion drugs (despite the administration’s efforts to reinterpret these laws out of existence). 

Since the FDA first approved mifepristone in 2000—the first of a two-drug regimen to cause chemical abortions, we now know even more about the harms these drugs cause to women and girls, and their unborn babies. Potential complications for the mother from abortion drugs can include severe bleeding, infection, potential surgical intervention, and even death. 

Despite weak reporting requirements, we know of at least 28 deaths of pregnant women and more than 500 life-threatening complications associated with mifepristone—on top of thousands of serious adverse events. Chemical abortions are four times more dangerous to the mother than surgical abortions and can cause serious complications. Compared to surgical abortions, women who use chemical abortion drugs are 50 percent more likely to require emergency care within 30 days of use. 

In approving abortion drugs, FDA grossly abused an expedited approval process by treating pregnancy as an “illness” and asserting that the drugs provide “meaningful therapeutic benefit” over existing treatments. The FDA also failed to comply with its obligations under federal law to study the impact of the drugs on adolescent girls and failed to prove their safety under the labeled conditions.  

The FDA’s most recent approval of do-it-yourself abortion drugs by mail and telemedicine, also unlawfully prioritized the interests of the abortion industry over the exacting safety protocols that the law demands, while also violating federal criminal laws. Under the FDA’s new teleabortion protocols, pregnant women are denied chance to be first clinically screened in-person by a doctor to rule out potentially life-threatening contraindications like an ectopic pregnancy or to accurately determine the age of the baby. Abortionists, instead, can offload care for their patients’ complications onto local emergency rooms.  

The American people deserve better from their government, especially when it comes to protecting innocent lives and prioritizing women’s health and safety. The FDA was created to protect the public from dangerous drugs, but the agency has violated its core purpose with its decision to approve and then deregulate abortion drugs, to the point of now allowing the drugs to be mailed to pregnant women who have not seen a doctor in person.  

Finally, the courts should not allow themselves to give in to the intimidation and scare tactics of pro-abortion forces. We are deeply concerned by the dangerous rhetoric from some elected Democrats calling for the FDA to resist any decision in this case if it is not in favor of the abortion industry. Respect for the rule of law necessarily entails respect for the authority of the judiciary to apply the law, and a duty to comply with any lawfully-issued injunction.  

We again call on the FDA to pull the deadly abortion drug mifepristone from the market, or at the very least, restore the health and safety requirements that have been callously and recklessly dismantled by the Biden administration. Since the FDA continues to fail in its duty and exceed the powers given to it by Congress, we will continue to support efforts through the courts to hold the FDA accountable. 

Women and their unborn children deserve nothing less. 

August Pfluger represents the 11th District of Texas and Cindy Hyde-Smith is the junior senator for Mississippi. 

https://thehill.com/opinion/congress-blog/3876301-its-time-to-rein-in-dangerous-chemical-abortion-drugs/

House Republicans launching probe into DOT response to Ohio train derailment

 House Republicans are launching an investigation into the Department of Transportation's response to the Norfolk Southern train derailment in East Palestine, Ohio, accusing Transportation Secretary Pete Buttigieg of being too slow to get involved.

Republicans have blasted Buttigieg, who took 10 days to publicly address the crisis, for not visiting the town sooner, among other things. Buttigieg told CBS News Tuesday that he should have publicly addressed the crisis sooner, and that it was a "lesson learned" for him, but said he was focused on making sure his Transportation Department employees had what they needed.

Republicans, led by House Oversight and Accountability Committee Chairman Rep. James Comer of Kentucky, are asking Buttigieg for all documents and communications about his public response to the derailment; all records showing when he learned about the derailment; any change to DOT train maintenance and procedures since January 2021; and all documents and communications regarding the National Transportation Safety Board's progress on the cause of the derailment.

"This incident is an environmental and public health emergency that now threatens Americans across state lines," the Republicans wrote to Buttigieg. "Despite the U.S. Department of Transportation's responsibility to ensure safe and reliable transport in the United States, you ignored the catastrophe for over a week. The American people deserve answers as to what caused the derailment, and DOT needs to provide an explanation for its leadership's apathy in the face of this emergency."

Buttigieg tweeted a response to news of Republicans' probe.

"I am alarmed to learn that the Chair of the House Oversight Committee thinks that the NTSB is part of our Department," he wrote. "NTSB is independent (and with good reason). Still, of course, we will fully review this and respond appropriately."

https://www.yahoo.com/news/house-republicans-launching-probe-dot-213151414.html

Mental health startup Cerebral to lay off

 Telehealth startup Cerebral said on Monday it is cutting its workforce by about 15% following a year of increased scrutiny and federal investigations into its prescribing practices.

The Business Insider reported earlier in the day that the company, which provides mental health services through its telehealth platform, would be laying off 285 people in its third round of job cuts in less than a year.

Last October, the company had cut its workforce by 20%.

"Affected employees will be fully supported with extended severance pay and benefits, as well as outplacement services," the company said on Monday, without providing details on its staff strength or the number of employees being laid off.

The announcement comes as Cerebral faces investigations from various authorities, including the U.S. Federal Trade Commission, into whether the company engaged in deceptive or unfair practices related to advertising or marketing of mental health services.

https://www.yahoo.com/now/mental-health-startup-cerebral-lay-000456616.html

U.S. Commerce to ask companies seeking chips funding to provide childcare for employees

 The U.S. Commerce Department said on Monday it plans to ask companies seeking at least $150 million in funding from a $52 billion semiconductor law to submit a plan for how they will provide affordable childcare for their workers.

The Biden administration unsuccessfully sought $200 billion in funding for universal pre-kindergarten and other childcare programs in a bid to boost economic growth by paying child and home healthcare workers better, and freeing up unpaid caregivers to go to paying jobs.

Commerce cited data that a lack of affordable and accessible childcare "is one of the largest constraints keeping Americans - and especially women" - out of the labor workforce in making the case that companies getting chips funding should show how they will provide affordable childcare.

The childcare component shows the Biden administration's willingness to direct federal funds - in this instance, earmarked under the CHIPS and Science Act - toward companies that agree to advance its policy objectives.

Nobel laureate Joseph Stiglitz said on Twitter lack of childcare is a significant barrier to labor force participation. "Worker scarcity is a significant challenge in our economy, especially in high-tech industries. The provision that companies receiving CHIPS money provide childcare for workers is an important component."

On Tuesday, the Commerce Department will release the first funding opportunity. Congress allocated $39 billion for manufacturing incentives to encourage companies to build and expand facilities and the law also creates a 25% investment tax credit for building chip plants estimated to be worth $24 billion.

The department on Tuesday will outline other factors it will consider in making awards. The law prohibits applicants from using government funds for dividends or stock buy backs.

The New York Times reported Monday companies will be required to share a portion of any "unanticipated profits" with the federal government.

https://www.yahoo.com/now/u-commerce-ask-companies-seeking-003115428.html