Search This Blog

Wednesday, May 22, 2024

Amneal Begins Supplying OTC Naloxone Spray to U.S. Retail Pharmacies, Cal. State

 

Significantly expanding access to affordable, life-saving opioid overdose rescue medicine

Entered distribution agreement with California; actively engaging with other states and municipalities to expand access

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has begun supplying its over-the-counter (OTC) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg to U.S. retail pharmacies and the State of California. The product is now available for direct distribution to states and municipalities across the U.S.

The U.S. Food and Drug Administration approved Amneal’s Naloxone HCI Nasal Spray in April 2024. Amneal’s Naloxone HCI Nasal Spray is a generic equivalent to OTC NARCAN® HCI Nasal Spray, a medication widely used to help treat opioid drug overdoses. The Company also entered into a distribution agreement with California to provide Naloxone HCI Nasal Spray through the CalRx® Naloxone Access Initiative. Amneal expects to have capacity to produce approximately ten million two-packs annually at its New Jersey manufacturing facility, starting in 2025.

https://www.businesswire.com/news/home/20240522229390/en/

Biden Cancels Another $7.7 Billion In Student Debt For 160,000 Borrowers

 by Naveen Athrappully via The Epoch Times,

President Joe Biden announced his latest student loan forgiveness plan by canceling $7.7 billion in debts, taking the total amount of such loans canceled under his administration to $167 billion.

“Today, my Administration is canceling student debt for 160,000 more people, bringing the total number of Americans who have benefitted from our debt relief actions to 4.75 million,” President Biden said in a May 22 statement.

Each of those borrowers has received an average of over $35,000 in debt cancellation. These 160,000 additional borrowers are people enrolled in my Administration’s SAVE Plan; are public service workers like teachers, nurses, or law enforcement officials; or are borrowers who were approved for relief because of fixes we made to Income-Driven Repayment (IDR).”

Out of $7.7 billion, $5.2 billion is relief granted to 66,900 borrowers under Public Service Loan Forgiveness (PSLF), a program for government and NGO employees. Once a borrower has made 120 qualifying monthly payments on their debt, PSLF can forgive the remaining portion of the dues. In total, the Biden administration has approved $68 billion in forgiveness for over 942,000 borrowers under PSLF.

$1.9 billion will go to provide relief to 39,200 borrowers through administrative adjustments made to individuals with IDR plans. The administration has so far approved $51 billion in IDR relief for over one million borrowers.

The remaining $613 million in relief will be granted to 54,300 borrowers enrolled in the SAVE plan. Enrolled individuals can get relief if they’ve made payments for at least 10 years, provided they borrowed $12,000 or less. Around $5.5 billion in loan forgiveness has been granted to 414,000 borrowers under the SAVE plan by the Biden administration.

With the latest announcement, the Biden–Harris administration has approved $167 billion in loan forgiveness to 4.75 million Americans.

President Biden’s latest loan forgiveness comes less than six months before the presidential election. The issue of student loans remains high on the agenda of younger voters, many of whom have concerns about Biden’s foreign policy on the war in Gaza and fault him for not achieving greater debt forgiveness.

The campaign of former President Donald Trump, Biden’s Republican challenger in the White House race, in March criticized the student loan cancellation as a bailout that was done “without a single act of Congress.”

poll published by the Institute of Politics (IOP) at Harvard Kennedy School last month showed that younger voters were not particularly impressed with President Biden’s student debt relief plans—only 39 percent of poll participants approved of the president on the issue.

U.S. Secretary of Education Miguel Cardona said the Biden administration “remains persistent about our efforts to bring student debt relief to millions more across the country, and this announcement proves it.”

More than 1 out of every 10 federal student loan borrowers have been approved for some debt relief under the Biden administration, which means that “one out of every 10 borrowers now has financial breathing room and a burden lifted,” he said.

US Student Debt Burden

In June of last year, the Supreme Court voted to strike down the Biden administration’s massive student loan forgiveness program, which would have resulted in a government burden of about $800 billion or even over $1 trillion, according to some estimates.

President Biden criticized the SCOTUS decision.

“They said no, no, literally snatching from the hands of millions of Americans thousands of dollars in student debt relief that was about to change their lives,” he said while promising to find a “new way” to circumvent the Supreme Court ruling.

In an interview with The Epoch Times, Caleb Kruckenberg, an attorney at Pacific Legal Foundation, warned that student debt forgiveness measures are a bad idea.

“We have a student loan system that assumes that people are going to pay their debt back, and instead, it’s just this massive government spending policy that has negative effects for everybody,” he said.

Last month, President Biden detailed a new proposal that would cancel at least some debt for more than 30 million Americans. It’s been in the works for months after the Supreme Court rejected Biden’s first try at mass cancellation.

The latest proposal is more targeted than his original plan, focusing on those for whom student debt is a major obstacle. The new plan uses a different legal justification—the Higher Education Act, which allows the Secretary of Education to waive student loan debt in certain cases.

The Education Department has been going through a federal rulemaking process to clarify how the secretary can invoke that authority.

The new plan targets five categories of borrowers, focusing on those believed to be in the greatest need of help. It would provide relief to an estimated 30 million borrowers. The administration has not said how much the plan would cost.

The widest-reaching provision aims to reset student loan balances for borrowers who have seen their debt grow because of unpaid interest.

It would cancel up to $20,000 in interest for Americans who now owe more than they originally borrowed. That cap wouldn’t apply to individuals who make less than $120,000 a year or couples who earn less than $240,000 and also are enrolled in an income-driven repayment plan.

Republicans have called Biden’s student loan forgiveness approach an overreach of his authority and an unfair benefit to college-educated borrowers while other borrowers received no such relief.

As of the end of 2023, 43.2 million U.S. student loan recipients had over $1.6 trillion in outstanding loans, according to the website of the Federal Student Aid website, an office of the U.S. Department of Education. Higher education debt has tripled since the 2008 financial crisis.

https://www.zerohedge.com/political/biden-cancels-another-77-billion-student-debt-160000-borrowers

Royalty Pharma, Cytokinetics Expand Funding Up to $575 M for Commercial Launch, R&D

 

  • Deal provides Cytokinetics with diversified access to capital as company advances its specialty cardiology franchise

 Royalty Pharma plc (Nasdaq: RPRX) and Cytokinetics, Incorporated (Nasdaq: CYTK) today announced they have entered into a strategic funding collaboration providing capital to support the commercialization of aficamten and advance the company’s expanding cardiovascular pipeline while diversifying access to capital as the company advances its muscle biology-directed specialty cardiology business.

https://www.globenewswire.com/news-release/2024/05/22/2886859/0/en/Royalty-Pharma-and-Cytokinetics-Announce-Expanded-Strategic-Funding-Collaboration-Totaling-Up-to-575-Million-to-Support-Commercial-Launch-of-Aficamten-and-to-Advance-R-D-Pipeline.html

Congress Calls Out the FDA's Regulatory Failures and the Surge of Illicit Chinese Vapes

 As Food and Drug Administration (FDA) Commissioner Califf faced bipartisan scrutiny from members of both the House Oversight and Appropriations Committee, the agency's failed enforcement issues and glaring inadequacies in tackling the spread of illicit Chinese vapes flooding the American market became crystal clear. These hearings served as a stark reminder of the FDA's failures to properly regulate the rapidly evolving vaping landscape.

During his opening statement, House Oversight Committee Chairman James Comer's (R-KY) scathing critique of the FDA's sluggish authorization process encapsulated the frustration felt by lawmakers, responsible manufacturers, and concerned citizens. Since 2020, thousands of illicit vapor brands have flooded the market, with foreign manufacturers blatantly disregarding FDA all regulation. Since then, the FDA has been slow to respond and their inaction has allowed these brands to now make up more than half the market. With only 23 e-cigarette products authorized out of 26 million applications over 15 years, the FDA's regulatory framework appears more like an insurmountable obstacle course rather than a streamlined pathway for compliance and approval of products that are scientifically proven to be less harmful for adult smokers. 

These hearings laid bare the agency's neglect of its duty to protect America's youth from the lure of illicit vapes. According to the most recent National Youth Tobacco Survey, three of the top five most popular vape brands middle and high school students reported using are illicit. The FDA has issued minor warning letters and fines to vape these manufacturers but these efforts have been unsuccessful and useless given there has been no real change. The FDA also failed to go after major manufacturers, leaving the most influential players in the market held to little to no accountability. What makes it even more clear these efforts have been ineffective is that over 50% of the products named in these warning letters are still on the market, highlighting a clear lack of follow-through and enforcement capability on the part of the FDA.

Meanwhile, American shelves are overwhelmed with unscrupulously manufactured illegal Chinese products, casting doubt on the FDA's commitment to enforcing the very rules the agency established. In the Appropriations Committee hearing focused on the FDA's fiscal year 2025 budget request, Subcommittee Chairman Rep. Andy Harris (R-MD) emphasized that addressing the illicit vapor market should be the agency’s top priority, not coming up with new rules that further exacerbate the illicit market.

Rep. Byron Donalds (R-FL) further addressed these concerns and highlighted that the unintended consequences of the FDA’s failures have created fertile ground for the illicit trade, posing additional risks to public health. He went on to push the commissioner to recognize that strict regulatory barriers and a slow-moving approval process for American manufacturers have benefited brands overseas who easily bypass any oversight or regulatory approval. One would hope that Chinese manufacturers capitalizing on the vaping craze in the United States would serve as a wake-up call to the FDA, but there has been little to no sense of urgency from any FDA leader or official.

At the House Oversight hearing, Rep. Raja Krishnamoorthi (D-IL) displayed one of these illicit products - a new Mike Tyson-branded flavored vape - and demanded answers on why the FDA has ignored Congressional inquiries on the issue. When questioning the commissioner, he highlighted that "on December 7th, 2023, a dozen of us wrote to you asking for a comprehensive approach to dealing with these illicit Chinese vapes [...]The reason why you didn't respond to us with your approach to clearing the shelves of these illicit vapes from China is perhaps because you don't have an answer" and warned that these products are "the next chapter in this youth vaping epidemic, and it is time we take this seriously."

Rep. Virginia Foxx (R-NC) rightly highlighted the paradox of an already bloated bureaucracy failing to meet its own deadlines, most notably the FDA has yet to complete its review of premarket tobacco product applications, which is over two years past the court-ordered deadline. Despite doubling in size and receiving substantial funding, the Center for Tobacco Product (CTP) remains mired in inefficiency, leaving manufacturers in limbo and consumers vulnerable to unvetted products. Given that the agency has adequate resources to address this crisis, it should be fully capable and prepared to step up enforcement efforts and approve well-regulated alternative products.

If the recent hearings are any indication, the FDA remains woefully unprepared to create a well-regulated vaping market in the U.S. The agency must heed the impassioned pleas of lawmakers and stakeholders, prioritize the swift approval of harm-reduction products, and intensify efforts to combat illicit imports. Failure to do so not only perpetuates the youth vaping problem, but also jeopardizes the promise of tobacco harm reduction for adult smokers. It's time for the FDA to step up, fulfill its mandate, and protect the public from the perils of unregulated vaping.

Susan B. Aiken, Anderson, S.C. is a retired mother, grandmother, elected as national delegate to republican national convention 5 times, including 2024, and former aide to U.S. Sen. Tim Scott, U.S. Sen. Jim Demint, U.S. Congressman Gresham Barrett

https://www.realclearhealth.com/blog/2024/05/22/congress_calls_out_the_fdas_regulatory_failures_and_the_surge_of_illicit_chinese_vapes_1033252.html

Time For Congress to Take a Good Look at UnitedHealth and the AARP

 Earlier this month, the CEO of UnitedHealth Group was called to testify before the U.S. House of Representatives and U.S. Senate regarding his company’s handling of a major cyberattack on its wholly owned health IT subsidiary company, Change Healthcare. Considering that the massive company interacts with nearly a third of all medical records and has just acknowledged that a “substantial proportion of people in America” could be impacted in some form or another due to the breach, Congressional hearings on the issue are likely justified.

The scope of the attack signals that a broader examination of UnitedHealth’s anti-competitive practices is in order, making an upcoming May 23 House Budget Committee hearing on healthcare monopolies even more timely. 

Despite it being the catalyst for the recent hearing, certain members of Congress were wise to expand beyond questions over the cyberattack to ask more fundamental questions about the company’s business model, its impact on our nation’s healthcare system, and recent allegations regarding its practices. In doing so, these lawmakers helped illuminate many of the critical risks and inflated costs resulting from the increasing stranglehold giant health services cartels like UnitedHealth have on patients, seniors, and families. The House Budget Committee hearing gives members of Congress the opportunity to expand this line of questioning to bring UnitedHealth’s monopolistic practices to light.

For example, earlier this month, Rep. Buddy Carter put the company on blast, asking the CEO directly how UnitedHealth can justify “clear conflicts of interest.” He went on to say, “This vertical integration that exists in health care in general has got to end.”

Carter’s assertion that companies like UnitedHealth are “vertically integrated” is completely accurate. Leveraging government entitlement programs like Medicare, Medicaid, and Obamacare to fund their acquisitions and fuel their growth, these are no longer just large health insurance and services companies. They are self-integrated networks of highly profitable enterprises that own, operate, and drive customers across their pharmacies and pharmacy benefit manager (PBM) subsidiaries, primary and urgent care practices, surgical centers, home health, and health IT companies (ex., Change Healthcare), and more. They’re even exempted from federal anti-kickback corruption laws to allow them to operate as they do. 

The more captive the patient or sponsor is to their network – and the more government directly or passively assists them in gaining greater control of our healthcare system – the more revenue they can generate. UnitedHealth is now the largest health insurance company in America. They’re the biggest issuer of Medicare Advantage policies for older Americans. They own one of the biggest PBMs and have made multi-billion acquisitions in the home health and care delivery sectors. And by way of a recent health IT shopping spree, they now obviously own Change Healthcare. All told, with revenues of $371 billion last year, UnitedHealth Group is one of the largest companies in the world. 

But what value are Americans getting in return for all the efficiencies large integrated companies like UnitedHealth supposedly provide? Well, not many seem to be raving about improved levels of quality of service and care. Instead, they see insurer-imposed costs for patients, seniors, families, taxpayers, employers, and government programs skyrocketing. Simultaneously, healthcare consumers are quite literally being trained, or worn down, by a form of customer service and billing torture that occurs if they attempt to go outside their “network.” Doing so can often lead to delays or denials or cost them even more money in unexpected fees.

This is not the free-market capitalism we support; it’s corporate rent-seeking behavior operating at the expense of consumers and patients. And despite all their talk of holding big corporations accountable, liberal leaders in Congress, who once wore their disdain for “Big Insurers” as badges of honor, are hypocritically and quietly helping, or turning a blind eye, to facilitate much of what is occurring. Even U.S. Senator Amy Klobuchar (D-Minn.), chair of the powerful Senate Judiciary Antitrust Subcommittee – one who rarely passes a microphone to rail against big companies – is AWOL on addressing these healthcare cartels’ massive accumulation of power.

As for the so-called advocate for older Americans, the AARP, they’ve now been paid roughly $8 billion dollars via UnitedHealth in recent years. And from absurd drug pricing rebates and patient cost-shifting abuses to billions in Medicare overcharges and AI-enabled patient care denials, has anyone seen any major AARP grassroots campaigns taking on big insurers or PBMs? Nope. Meanwhile, AARP’s executives in Washington spent over $60 million to help pass the insurer-friendly and subsidy-laden Inflation Reduction Act (IRA). 

To date, Democrat majorities and the insurer-funded AARP have offered little scrutiny of these massive company’s business practices unless forced to do so. That’s likely because, from Obamacare’s implementation through the passage of IRA, liberals, the health cartels, and AARP have had shared financial and political interests.

As an advocate of true free market capitalism, I’d say without hesitation that America’s healthcare system today is anything but a free market, pro-consumer, or healthy for America. Congress was right to get to the bottom of the cyberattack on Change Healthcare. Now, the House Budget Committee has another opportunity to dig into the broader impact of today’s giant health services cartels on American patients and families.

Andrew Langer is director of the CPAC Foundation’s Center for Regulatory Freedom and the Executive Director of the Coalition Against Socialized Medicine (CASM).

https://www.realclearhealth.com/blog/2024/05/22/time_for_congress_to_take_a_good_look_at_unitedhealth_and_the_aarp_1033240.html

NeuroBo DA-1241-Semaglutide Combo Improves Liver Fibrosis

 NeuroBo Pharmaceuticals, Inc. (Nasdaq: NRBO), a clinical-stage biotechnology company focused on the transformation of cardiometabolic diseases, today announced that pre-clinical data suggests that DA-1241, a novel G-Protein-Coupled Receptor 119 (GPR119) agonist, in combination with semaglutide (Wegovy®), improves liver fibrosis and demonstrates additive hepatoprotective effects in pre-clinical metabolic dysfunction-associated steatohepatitis (MASH) models compared to either treatment alone. Members of the Dong-A ST Research Center and Contract Research Organization, Gubra, will present the data in two poster presentations at the EASL Congress 2024, taking place June 5-8, in Milan, Italy, as well as virtually.

https://www.prnewswire.com/news-releases/neurobo-pharmaceuticals-da-1241-in-combination-with-semaglutide-improves-liver-fibrosis-and-demonstrates-additive-hepatoprotective-effects-in-pre-clinical-mash-models-compared-to-either-treatment-alone-302152170.html

Sanofi Drug Shows Promise in Asthma After Blood Disorder Success

 

Sanofi experimental drug showed promise in treating asthma, supporting the French drugmaker’s plan to begin more late-stage studies of a medicine that it sees as a potential blockbuster.

The therapy, called rilzabrutinib, helped adults better control their asthma and alleviated symptoms in a mid-stage study, Sanofi said in a statement Wednesday. The results were positive for groups that received both a high dose and a low dose of the oral treatment during a 12-week study, with improvements seen as soon as the second week, Sanofi said.

https://www.bloomberg.com/news/articles/2024-05-22/sanofi-drug-shows-promise-in-asthma-after-blood-disorder-success