ANI gets anxiety med OK

 ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that the Company received U.S. Food and Drug Administration (FDA) approval for the Abbreviated New Drug Application (ANDA) for Clorazepate Dipotassium Tablets.

ANI’s Clorazepate Dipotassium Tablets are the generic version of the Reference Listed Drug (RLD) Tranxene®. The current annual U.S. market for Clorazepate Dipotassium Tablets is approximately $25.8 million, according to IQVIA/IMS Health, a leading healthcare data and analytics provider.

https://finance.yahoo.com/news/ani-pharmaceuticals-announces-fda-approval-105000265.html

Fed to Lift Rates by 75 Basis Points in July, 50 Bps in September - Reuters Poll

 The Federal Reserve will deliver another 75-basis-point interest rate hike in July, followed by a half-percentage-point rise in September, and won't scale back to quarter-percentage-point moves until November at the earliest, according to economists polled by Reuters.

Last week the Fed hiked the federal funds rate by three-quarters of a percentage point, its largest rate increase since 1994, after official data just a few days earlier showed inflation unexpectedly rose despite expectations it had peaked.

The latest poll results, released on Wednesday before Fed Chair Jerome Powell was due to appear before the Senate Banking Committee as part of his twice-yearly monetary policy testimony to Congress, show momentum is still behind the U.S. central bank doing more, not less, despite rising recession concerns and a steep sell-off in financial markets. Bond yields are up sharply and major Wall Street equity indexes are already trading in a bear market, defined as 20% down from their peak.

In the June 17-21 Reuters poll, nearly three-quarters of economists, 67 of 91, expected another 75-basis-point U.S. rate hike in July. That would take the fed funds rate to a range of 2.25%-2.50%, roughly the neutral level where the Fed estimates the economy is neither stimulated nor restricted.

A strong majority expect the central bank to hike its policy rate by another 50 basis points in September, with opinion more split on whether it will hike by 25 or 50 basis points in November. A majority expect the Fed to raise rates by 25 basis points at its December meeting.

That would take the fed funds rate to a range of 3.25%-3.50% by the end of this year, 75 basis points higher than thought in a poll published just two weeks ago.

Powell last week signaled that a pause in the current tightening cycle would only be possible after a meaningful decline in inflation, which currently looks to be a more distant prospect than thought just a few weeks ago.

"Since the Fed is still underestimating the inflation problem ... not recognizing that a wage-price spiral has already started, we expect they will have to raise rates faster than they now expect," Philip Marey, senior U.S. strategist at Rabobank, wrote in a note.

"Unfortunately, the hiking path is also likely to be followed by a recession."

Graphic: Reuters Poll - US economy and Federal fund rate outlook - https://fingfx.thomsonreuters.com/gfx/polling/egvbkgazjpq/Reuters%20Poll-%20US%20economy%20and%20Fed%20rate%20outlook.PNG

Inflation will remain above the Fed's 2% target until at least 2025, according to its own projections and a separate Reuters poll. [ECILT/US]

Although the Fed was expected to shift down to 25-basis-point rate hikes in November, a significant minority, around 40%, expected a 50-basis-point hike at that month's meeting. Only a handful said the Fed would pause its rate hikes at some point this year.

Around three-quarters of respondents, 68 of 91, saw the end-year rate at 3.25%-3.50% or higher, in line with the Fed's own "dot plot" showing policymakers' projections.

Aggressive rate hikes come with their own risks, as reflected in the Fed's economic projections where forecasts for the U.S. unemployment rate were raised significantly and economic growth was predicted to average below trend.

The poll predicted only one 25-basis-point hike in the first quarter of next year, pushing the federal funds rate to 3.50%-3.75%, the possible terminal rate.

The Fed was expected to pause in the second and third quarters of 2023 and cut rates by 25 basis points in the final quarter of next year, according to the median forecast from a smaller sample. But forecasts for where the fed funds rate will be by the end of 2023 ranged between 2.50%-2.75% and 4.25%-4.50%, underscoring high uncertainty.

Despite Powell saying the Fed was not trying to induce a recession, a few primary dealers have either started predicting one as early as this year or have brought forward their recession calls.

https://money.usnews.com/investing/news/articles/2022-06-21/fed-to-lift-rates-by-75-basis-points-in-july-50-bps-in-september-reuters-poll

Fentanyl Entering US Through Southern Border at 'Unprecedented Levels': Rep. Higgins

 By J.M Phelps of The Epoch Times

Implementing a new law to punish traffickers of fentanyl and declaring deaths from the drug as a health crisis could curb the damage it is doing to the country.

The Epoch Times spoke to Rep. Clay Higgins (R-La.) about the growing fentanyl crisis in the United States. The Republican lawmaker represents Louisiana’s 3rd congressional district, which includes Lafayette Parish. According to the local coroner, there were 32 drug-related deaths in 2015, and fentanyl was not associated with any of them. However, by 2021, the number of deaths rose to 136 and fentanyl was responsible for 101.

According to the Drug Enforcement Agency (DEA), fentanyl is the driving force of a deadly nationwide epidemic. Preliminary data from Centers for Disease Control and Prevention (CDC) indicates that fentanyl was involved in 77 percent of overdose deaths in the United States in 2021, accounting for about 71,000 deaths.

“The fentanyl crisis the country is facing right now must be confronted at the local, state, and federal level,” Higgins said.

The country has to start working together, he said, adding that the nation needs to confront the border crisis and influx of fentanyl “without abusing law enforcement jurisdictional authority, without abusing sovereignty, [and] without abusing rights.”

“It all has to be done while operating within the parameters of the law and the Constitution,” said Higgins. Fentanyl trafficking, in particular, must be “attacked passionately and aggressively,” he added.

Title 42 Reinterpreted

The Biden administration had hoped to end Title 42 by the end of May. Title 42 was the Trump-era initiative put in place in March 2020 to slow the spread of COVID-19, allowing illegal immigrants to be quickly turned away at the southern U.S. border rather than processed at immigration detention facilities under Title 8 immigration law.

However, a Texas judge recently blocked the cancellation of the public health order that has been used to expel illegal migrants.

While Higgins is pleased with the extension, he said it is time for a “reinterpretation of Title 42 within the parameters of the Constitution.” According to the lawmaker, “the fentanyl crisis can now be more effectively defined as a health crisis than the COVID pandemic.”

“With regard to Title 42 enforcement,” Higgins said, “the definition of health crisis needs to be expanded to include the fentanyl crisis, [because] overdoes are certainly a threat to the health of tens of thousands of people.”

Stop the Flood

Higgins said, “Something has to be done to fight against the fentanyl entering [the United States] through the southern border.”

“We have lost operational control of the southern border months ago, and fentanyl is entering the country at unprecedented levels—and there’s no end in sight,” he added.

Continue reading at Epoch Times

https://www.zerohedge.com/political/fentanyl-entering-us-through-southern-border-unprecedented-levels-rep-higgins

CMS Decision on Alzheimer's Drug Harbinger of Things to Come

 Alzheimer's patients and their loved ones cheered last year when the Food and Drug Administration approved Aduhelm, the first new treatment for the debilitating disease in 20 years.

The celebration, however, was premature. The approval set off a melee in Washington over whether Medicare would cover Aduhelm. Answer: for most patients, it won't.

This is the first of the epic battles to come over coverage of breakthrough new medications. From now on, political meddling in Americans' medicine cabinets will be intense as Medicare seeks ever-greater authority to set prices for drugs.

The Aduhelm decision was fraught for many reasons. First was that Medicare authorities deviated from all routine by restricting access to an FDA-approved use of a drug. Never before has CMS used this power.

Second, Medicare restricted access to an entire class of drugs based solely on Aduhelm’s clinical trial results. So much for following the science.

Third, in order to have a chance to get Aduhelm at all, patients must participate in a clinical trial. That means some will receive a placebo -- an ethically dubious proposition for a drug the FDA has approved. Making matters worse, those receiving the placebo will pay coinsurance costs out-of-pocket despite having no potential for clinical benefit.

Fourth, CMS applied the clinical trial restriction to drugs using FDA’s “accelerated approval” process designed to speed treatments to patients. New treatments may forgo this process to reduce the risk of Medicare bureaucrats limiting access to their products. New treatments will therefore take longer to reach patients.

Finally, while Medicare officials couched their objections in terms of the need for more clinical study, their real concern was transparently the cost the government would incur paying for the treatment -- notwithstanding the potential health benefits for millions of people.

Once the Centers for Medicare & Medicaid Service (CMS) said no to Aduhelm, the nation's private insurers, as expected, followed suit. The drug has all but disappeared from the market.

In context, the government’s move on Aduhelm is the latest in a multi-dimensional chess game designed to transfer control of healthcare decisions to Washington by giving government officials the authority to control prices.

Under current law, federal officials are explicitly prohibited from negotiating with drugmakers over the price of Medicare medications. That task falls to health insurers contracted by Medicare. This aggressive negotiation has been effective, resulting in discounts averaging 25 to 35 percent -- in some cases, discounts reach 90 percent. The Congressional Budget Office found that negotiations have been so effective that the average net price of prescriptions in Medicare's drug benefit fell from $57 in 2009 to $50 in 2018.

Progressive lawmakers would love to take this negotiating authority away from health plans and empower political appointees and bureaucrats to set prices. Despite the evidence, they don't trust the market and believe they can cut costs without risk by eliminating the profit motive throughout the system. But lawmakers have been unable to pass legislation to end the prohibition on government negotiating. The most recent attempt came in President Biden's "Build Back Better" legislation, which floundered in December.

The Medicare determination for Aduhelm was an indirect step to the same end. Saying "no" to coverage was a way to test how to drive price negotiations. If Aduhelm's developer came back with a price of pennies on the dollar, Medicare's restrictions on coverage would likely have vanished overnight. The government would have made its point and pocketed its victory, confident that other drug developers got the message.

So they would, but the message would be to quit investing in potential blockbuster treatments that mainly benefit older Americans. Medicare officials know perfectly well that price controls, whether direct or indirect, will slow or cut off the flow of expensive new medications in the drug pipeline. That's not an unintended consequence of gaining the control they want and have seized in the Aduhelm case. It's the purpose. The question is whether seniors and lawmakers who want to preserve our world-class system of medical innovation will let them get away with it.

There are plenty of smart ways to reduce the cost of prescription drugs. Turning every new drug approval into a vitriolic public policy battle devoid of scientific reason and indifferent to patient welfare isn't one of them.

Joel White is the president of the Council for Affordable Health Coverage, a nonprofit advocacy organization that seeks to lower the cost of healthcare for all Americans.

https://www.realclearhealth.com/articles/2022/06/21/cms_decision_on_alzheimers_drug_is_a_harbinger_of_things_to_come_111353.html

‘Jane’s Revenge’ group appears to threaten violence if Supreme Court overturns Roe

 The militant abortion rights organisation Jane’s Revenge appears to be calling for an “night of rage” in the nation’s capital should the Supreme Court, as is expected, overturn Roe v. Wade later this month.

A flyer signed with the group’s name circulating in Washington, DC reads, “THE NIGHT SCOTUS OVERTURNS ROE V. WADE HIT THE STREETS YOU SAID YOU’D RIOT.”

It continues, “TO OUR OPPRESSORS: IF ABORTIONS AREN’T SAFE, YOU’RE NOT EITHER.’ JANE’S REVENGE.”

Those threats may not be idle. Jane’s Revenge has taken responsibility for the firebombing of multiple anti-abortion crisis pregnancy centers since a draft of the high court’s looming Roe v Wade opinion was leaked to Politico in May, claiming attacks in Madison, Wisconsin, Des Moines, Iowa, and other locations.

Very little is concretely known about the group, which operates a website and has spread its messages with graffiti and flyers, but has said that it is comprised of multiple other unidentified groups and does not have any known core members. Some have expressed skepticism that the group is in fact a left-wing militant organisation and postulated that it may instead be a right-wing organisation maneuvering to turn people against the group’s goal of abortion rights for all.

“This is not a declaration of war,” their statement read, in part. “War has been upon us for decades. A war which we did not want, and did not provoke. Too long we have been attacked for asking for basic medical care. Too long have we been shot, bombed, and forced into childbirth without consent.”

Now, facing the imminent demise of Roe v Wade and the functional erasure of abortion access for millions of Americans, Jane’s Revenge is calling for action in Washington DC and cities across the country.

“This is an event that should inspire rage in millions of people who can get pregnant…and yet, the response thusfar has been tepid,” their website home page reads. “We have agonized over this apparent absence of indignation. Why is it that we are so afraid to unleash hell upon those who are destroying us?”

The organisation’s tactics have divided abortion rights advocates, many of whom have both moral and strategic objections to the use of violence in the battle for rights. Planned Parenthood of Wisconsin, for instance, strongly condemned the attack in Madison.

“Our work to protect continued access to reproductive care is rooted in love,” group president Tanya Atkinson said. “We condemn all forms of violence and hatred within our communities.”

But Jane’s Revenge, whose Night of Rage name is a callback to the Weathermen’s “Days of Rage” campaign during the trial of the Conspiracy Eight in Chicago in 1969, is arguing that mainstream organisations like Planned Parenthood have not been up to the challenge of defending abortions — and channeling the rage many feel at the state of the mainstream resistance or lack thereof to the impending Supreme Court decision.

“Several weeks ago, we watched and waited as self-proclaimed ‘feminist organizations’ and non-profits took the lead on arranging their demure little rallies for freedom,” Jane’s Revenge’s website reads. “We were told to let them handle it, and to defer to the political machinery that has thusfar failed to secure our liberation.”

In anticipation of the Roe decision, which could come as early as this week, President Joe Biden signed a bill extending security protection to the family members of Supreme Court justices. Barriers have already been erected around the Court itself.

https://money.yahoo.com/jane-revenge-group-appears-threaten-204241874.html

Biden administration plans to reduce nicotine levels in cigarettes

 The Food and Drug Administration (FDA) is set to propose limits on the levels of nicotine tobacco companies can place in traditional cigarettes in an attempt to make them less addictive, according to a notice published in the agency’s biannual regulatory agenda.

Proponents think the rule could save millions of lives from cancer and other smoking-related diseases if the White House can overcome the expected fierce opposition from the powerful tobacco industry.

Each year, 480,000 people die prematurely from a smoking-attributed disease, which makes tobacco use the leading cause of preventable disease and death in the United States. 

According to the notice, the FDA will propose by 2023 “a tobacco product standard that would establish a maximum nicotine level in cigarettes and certain finished tobacco products.”

“Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” the agency said.

The FDA said reducing nicotine levels would also help to prevent young people from becoming regular smokers. 

“The proposed product standard is anticipated to benefit the population as a whole while also advancing health equity by addressing disparities associated with cigarette smoking, dependence, and cessation,” the agency said in the notice.

No other details were released Tuesday, and it was not clear just how much nicotine would be permitted under the proposal.

The Biden administration will be facing pressure from anti-tobacco advocates to move quickly, as they argue such a measure is long overdue.

The FDA’s plan to set a nicotine threshold follows the agency’s proposed ban on menthol-flavored cigarettes, which was announced at the end of April.  

Congress gave the FDA the power to regulate tobacco products in 2009. Scott Gottlieb, who ran the agency under former President Trump, floated a plan in 2017 for reduced nicotine levels in combustible cigarettes, but it was never formalized. Gottlieb left the agency in 2019.

Nancy Brown, CEO of the American Heart Association, said if the move happens, it would be one of “the most consequential actions the FDA could take to change the deadly trajectory of tobacco use in this country.”

Matt Myers, president of the Campaign for Tobacco-Free Kids, called the proposal “game changing” but said the gains will be realized only if the administration and the FDA “demonstrate a full-throated commitment to finalizing and implementing this proposal.”

“There is no other single action our country can take that would prevent more young people from becoming addicted to tobacco or have a greater impact on reducing deaths from cancer, cardiovascular disease and respiratory disease,” Myers added.

But the regulatory process does not usually move quickly, especially if there are legal challenges. 

Critics argue people would wind up smoking more just to get the same level of nicotine they have grown accustomed to. They also argue a nicotine ban would lead to a black market of illegal activity and dangerous products. 

And if the regulation is not finished before the end of Biden’s term, a new president could stop the agency from implementing it.

https://thehill.com/policy/healthcare/3531899-biden-administration-plans-to-reduce-nicotine-levels-in-cigarettes/

Global AFib study finds simple ablation has best outcomes

 Results from one of the largest global studies of atrial fibrillation (AFib) procedures show that the simple approach is usually best when it comes to ablation, a procedure where physicians destroy or ablate cardiac tissue to correct irregular heart rhythms. The findings could change the way patients are treated for AFib.

Researchers from Tulane University and partner institutions found that using advanced image-guided technology to more aggressively target diseased areas of the heart that cause arrythmias didn't lead to better outcomes for patients -- and put some at higher risk of strokes, according to results of the DECAAF II trial published in JAMA.

"Simplicity is key. Don't ablate too much, especially at advanced stages," said lead study author Dr. Nassir Marrouche, director of the Tulane Heart and Vascular Institute and The Research Innovation for Arrhythmia Discoveries (TRIAD) at Tulane University School of Medicine. "Too much ablation is not helping our patients today. It is putting them at higher risk. This is a practice-changing finding from our study."

AFib occurs when the upper and lower chambers of the heart are out of sync, causing the heart to beat irregularly. It affects more than 2.7 million Americans and is a leading risk factor for strokes. When AFib cannot be controlled by medication, doctors perform a procedure to ablate fibrotic or diseased areas of the heart with heat or cold to create a scar that disrupts the electrical signal that causes the arrhythmia.

For the study, researchers followed 843 AFib patients undergoing ablation treatment at 44 hospitals in 10 countries, including the United States, Germany, France and Australia. All the patients received magnetic resonance imaging (MRI) scans to quantify the amount of diseased tissue within their hearts. (Those with a higher percentage of diseased tissue are at higher risk for arrythmia relapse, according to findings from the original DECAAF trial.)

Half of the patients received standard care -- pulmonary vein isolation (PVI) treatment where doctors ablate areas in the left upper chamber of the heart where the four lung veins meet.

For the other group, doctors used the MRI scans to create a detailed 3D map of all diseased areas along the left atrium of the heart. They performed conventional PVI treatment and then used the digital map to ablate diseased tissue more aggressively and precisely outside of conventional treatment areas.

All of the study patients received smartphone EKG devices to monitor their heart rhythms daily after treatment, and researchers followed up with them at 3-, 6- and 12-month intervals.

Researchers found no significant difference in arrhythmia recurrence between the two groups. However, the group that received the more aggressive treatment experienced a higher rate of poor safety outcomes with six patients (1.5%) suffering a stroke.

Marrouche said that the study shows that AFib patients with extensive fibrosis have too much scarring for aggressive ablative therapy to be effective using conventional tools. Researchers also suspect that it is not only the extent of fibrosis that played a role in the study outcomes. In evaluating hundreds of procedures by the world's leading electrophysiologists, they discovered that there is little uniformity in how doctors perform ablation interventions, which may also contribute to disparate outcomes, Marrouche said.

"Atrial fibrillation procedures have become too complex over the years. We are ablating hundreds of thousands of people a year now, and we have been striving to do more and more ablation for the population with persistent or continuous AFib," Marrouche said. "But our study shows that isn't necessary, especially for those with more myopathy. Simple ablations can effectively treat these patients instead of going for extensive ablation to treat fibrotic areas that we struggle to control."

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Story Source:

Materials provided by Tulane University. Note: Content may be edited for style and length.

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Journal Reference:

1. Nassir F. Marrouche, Oussama Wazni, Christopher McGann, Tom Greene, J. Michael Dean, Lilas Dagher, Eugene Kholmovski, Moussa Mansour, Francis Marchlinski, David Wilber, Gerhard Hindricks, Christian Mahnkopf, Darryl Wells, Pierre Jais, Prashanthan Sanders, Johannes Brachmann, Jeroen J. Bax, Leonie Morrison-de Boer, Thomas Deneke, Hugh Calkins, Christian Sohns, Nazem Akoum, Ahmad Abdul Karim, Alexander Costea, Alexander Leber, Andrzej Lubinski, Arif Elvan, Bengt Herweg, Bruce Koplan, Chris Jones, Christian Mahnkopf, Christian Sohns, Darryl Wells, David Wilber, Doug Packer, Emile Daoud, Felipe Atienza, Felipe Bisbal, Francis Marchlinski, Gerhard Hindricks, Gianluca Pontone, Heidi Estner, Helmut Puererfellner, Hemanth Ramanna, Hugh Calkins, Johannes Brachmann, Jon Kalman, Juergen Siebels, Lucas Boersma, Marco Gotte, Margot Vloka, Mattias Duytschaever, Mont Lluís, Moussa Mansour, Nassir Marrouche, Nazem Akoum, Oussama Wazni, Peter Kistler, Pierre Jais, Prashantan Sanders, Reza Wakili, Rukshen Weerasooriya, Saman Nazarian, Sandep Gautam, Suneet Mittal, Thomas Deneke, Thomas Maurer, Thomas Neumann, Vivek Reddy, William Spear. Effect of MRI-Guided Fibrosis Ablation vs Conventional Catheter Ablation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation. JAMA, 2022; 327 (23): 2296 DOI: 10.1001/jama.2022.8831

https://www.sciencedaily.com/releases/2022/06/220621114703.htm