What is the Higher Education Act?

 After the Supreme Court struck down President Joe Biden’s student loan forgiveness program Friday, he later announced a “new path” to provide debt relief grounded in the Higher Education Act.

“Just moments ago, (Education Secretary) Miguel Cardona took the first official step to initiate this new approach,” Biden said on Twitter Friday afternoon.

Activists and politicians had been calling for the Biden Administration to use provisions in the Higher Education Act to cancel student debt, even before the Supreme Court decision came down.

New York Democrat Rep. Alexandria Ocasio-Cortez wrote on Twitter that the Biden Administration should use the act to continue loan forgiveness “ASAP“, and other lawmakers such as Rep. Ilhan Omar, D-Minn, and Missouri Sen. Cori Bush, also a Democrat, took to social media as well.

The Higher Education Act, which was signed in 1965 by former President Lyndon B. Johnson, establishes federal aid programs such as grants and loans to help students pay for college and university. A provision in the act allows the Secretary of Education to compromise, waive or release federal student loans.

What is the Higher Education Act?

According to NerdWallet, the HEA allows the Education Secretary to waive the loans without specific requirements, such as a national emergency.

NerdWallet wrote the act has been used to cancel student debt before, such in the case Public Service Loan Forgiveness and income-driven repayment programs, where eligible borrowers’ debt is erased after they make payments for a certain number of years. Public Service Loan Forgiveness is for full-time employees of federal, state, local and tribal governments or not-for-profit organizations.

Biden’s current student loan forgiveness program invoked different legislation, the Higher Education Relief Opportunities for Students Act, to cancel up to $10,000 for those who earn less than $125,000 a year. Those who received Pell grants are eligible for $20,000 of relief.

The HEROES Act lets the Education Secretary “waive or modify” statutory or regulatory provisions when it comes to federal student financial assistance programs to make sure “borrowers are not placed in a worse position financially” regarding loans as a result of war or other national emergencies.

The COVID-19 pandemic was declared a national emergency by both Presidents Donald Trump and Biden, which allowed Cardona to use the HEROES act to enact a pause on federal student loan repayment, interest accrual and involuntary collections during the entirety of the pandemic.

However, the Congressional Research Service points out the HEROES Act has not been used to cancel existing student loan balances before.

Could Higher Education Act end student debt?

Advocates, such as the Debt Collective, have said it is possible for the Biden administration to use the Higher Education Act to cancel student debt.

“When the Higher Education Act of 1965 made student loan authorities permanent, it solidified their power to compromise,” the Debt Collective wrote in a 2019 memo. “Just as the Securities and Exchange Commission can cut low-dollar deals with banks that break the law, for example, the secretary can settle with debtors for a fraction of what they owe or suspend the collection of student debt altogether.”

Insider reported a number of Democratic lawmakers, including Massachusetts Sen. Elizabeth Warren, introduced a resolution in 2021 urging Biden to use the authority given in the Higher Education Act to put broad debt relief into place. Sen. Richard Blumenthal, a Connecticut Democrat and progressive Vermont independent Rep. Bernie Sanders have also given their support for using the act, Bloomberg said.

The Legal Services Center of Harvard Law School wrote a memo for Warren that said “broad or categorical debt cancellation would be a lawful and permissible exercise of the (Education) Secretary’s authority under existing law.”

Friday on Twitter, Warren said Biden has more tools he can use to cancel student debt — “and he must use them.”

“More than 40 million hard-working Americans are waiting for the help that President Biden promised them, and they expect this administration to throw everything they’ve got into the fight until they make good on this commitment,” the senator said.

But Bloomberg writes the actual process of using the Higher Education Act could be time-consuming, with one expert saying any relief could be delayed until after the 2024 election. Jed Shugerman, a law professor at Fordham University, told the publication the Higher Education Act requires a lengthy rule-making process and comment period that could take about a year. Litigation by opponents could drag things out even longer, Shugerman said to Bloomberg.

Luke Herrine, an assistant law professor at the University of Alabama and former legal director of The Debt Collective, said in NerdWallet that Congress could also step in and block this action via the Congressional Review Act.

Another option would be for the Department of Education to issue an order, which Herrine called a “quasi-judicial act.” An order would potentially be subject to judicial challenge, but not the Congressional Review Act, Herrine said, and it would also not require a year or rulemaking.

https://www.newsnationnow.com/us-news/education/higher-education-act-student-debt-forgiveness/

US Regulator Considers Limiting Big Banks’ Borrowing From Backstop Lender

 

• FHFA considering recommending curbs on advances to big banks
• Review has gotten more attention since March bank crisis

US officials are considering limits on the ability of large lenders to use Federal Home Loan Banks as a financial backstop, part of a broader proposal to overhaul the system.

The changes, which are being discussed as part of a sweeping review by an American regulator, would amount to the most dramatic reshaping of the $1.6 trillion system in decades. The Federal Housing Finance Agency may still adjust its plans before announcing the recommendations in the coming months, according to people familiar with the matter. Reining in big lenders’ ability to borrow could also require congressional action.

https://www.bloomberg.com/news/articles/2023-06-30/us-regulator-weighs-limiting-big-banks-borrowing-from-fhlbs

LumiraDx Submits 510k Application for Revolutionary 5Minute COVID Ultra Test

 On June 30, 2023, LumiraDx Limited made a groundbreaking move by submitting its first 510(k) application to the U.S. Food and Drug Administration (FDA). This application sought clearance for the revolutionary LumiraDx 5-minute COVID Ultra Test.

The comprehensive submission included the LumiraDx Platform, the LumiraDx Instrument, the LumiraDx SARS-CoV-2 Antigen (Ag) Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab Kit. These components work together seamlessly to deliver accurate and reliable results in a matter of minutes.

The LumiraDx SARS-CoV-2 Ag Ultra Test has already made its mark in Europe and various international markets. Its exceptional accuracy and reliability have instilled confidence in healthcare professionals and patients alike. Throughout the pandemic, LumiraDx had received Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests, solidifying its reputation as a trusted provider of diagnostic solutions.

This 510(k) submission marks a significant milestone for LumiraDx as it is the first time the LumiraDx Instrument has undergone such a review. It demonstrates LumiraDx’s unwavering commitment to delivering a complete solution that meets the highest standards of performance and safety. Once this submission is reviewed, it will pave the way for future submissions to the FDA, with a focus on the assay components.

The LumiraDx SARS-CoV-2 Ag Test is a cutting-edge microfluidic immunofluorescence assay designed to detect the presence of the nucleocapsid protein antigen in nasal and nasopharyngeal swabs. Leveraging LumiraDx’s advanced technology, the SARS-CoV-2 Ag Ultra Test sets a new standard for diagnostic accuracy and reliability. In just five minutes, it enables healthcare professionals to conduct accurate and confident testing on a larger scale.

https://beststocks.com/lumiradx-submits-510k-application-for-revolut/

Scholar Rock: New Data from Phase 2 Spinal Muscular Atrophy Trial

 Scholar Rock announced new data from the Phase 2 TOPAZ trial extension period evaluating patient outcomes at 36 months of treatment with apitegromab. These data showed that continued treatment with apitegromab over the extended treatment period was associated with substantial and sustained improvement in motor function, as well as improvements in patient-reported outcome measures in patients with nonambulatory Types 2 and 3 spinal muscular atrophy (SMA) receiving survival motor neuron (SMN)-targeted therapy. For the 36-month data, an observed case analysis was conducted, which pooled data for all nonambulatory patients (including those patients on 20 mg/kg of apitegromab for the full duration of the trial, and those who switched from 2 mg/kg to 20 mg/kg at various time intervals in year 2) and was based upon the available data.

These analyses exclude data for patients post scoliosis surgery. Improvement in Patient-Reported Outcomes Consistent with Improvements in Motor Function: Nonambulatory patients (ages 2-21) had improvements in PEDI-CAT (measure of activities of daily living) and PROMIS-Fatigue (a patient-reported outcome tool measuring fatigue) that were consistent and sustained at 36 months. The mean change in PEDI-CAT daily activity domain from baseline at 36 months was 2.2 (95% CI: –0.1, 4.5; N=17), indicating an improvement in the ability to perform daily activities.

The mean change in PROMIS-Fatigue from baseline at 36 months was –4.6 (95% CI: –8.7, –0.5; N=14), indicating a decline in fatigue. These improvements in PEDI-CAT and PROMIS-Fatigue were generally consistent with improvements in motor function across the 36 months of the study period. Consistent Safety Data: Treatment-emergent adverse events (TEAEs) at 36 months were consistent with previous reports at 12 and 24 months, with no new findings after an aggregate of 198 patient-years of exposure.

TEAEs were mostly mild-to-moderate in severity, and generally consistent with the underlying patient population and background therapy. The five most common TEAEs were headache, pyrexia, COVID-19, nasopharyngitis, and upper respiratory tract infection. No deaths or suspected unexpected serious adverse reactions or hypersensitivity reactions were observed with apitegromab at 36 months.

https://www.marketscreener.com/quote/stock/SCHOLAR-ROCK-HOLDING-CORP-43499888/news/Scholar-Rock-Announces-New-Data-from-the-Phase-2-TOPAZ-Trial-Extension-Period-Evaluating-Patient-Out-44244069/

VBI Vaccines Secures Lucrative Contract and Makes Noteworthy Developments

 As of June 30, 2023, VBI Vaccines has secured a lucrative contract worth $25.35 million from the Department of Health and Human Services for the production of “2023 Adult Vaccines.”

In addition to this significant achievement, VBI Vaccines has been involved in various other noteworthy developments:

1. A groundbreaking license and collaboration agreement has been established between VBI Vaccines and Brii Biosciences. This partnership entails an investment of up to $129 million, along with royalties, with the aim of developing a functional cure for Hepatitis B.

2. VBI Vaccines has joined forces with Resilience to facilitate the development and manufacturing services required for the production of its coronavirus vaccine candidates. This collaboration is crucial in ensuring the timely and efficient delivery of these potential vaccines.

3. Recognizing the importance of combating Hepatitis B, VBI Vaccines has announced an intensified focus on this disease. This strategic shift has prompted organizational changes and a reverse stock split, demonstrating their commitment to addressing this global health concern.

4. VBI Vaccines has recently signed a first amendment to their collaborative research agreement, specifically targeting the development of therapeutics, vaccines, and emerging infections that impact human health. This amendment signifies their dedication to advancing medical breakthroughs in these crucial areas.

5. To further enhance their commercial capabilities, VBI Vaccines has entered into a master commercial services agreement with inVentiv Commercial Services, LLC. This partnership will enable VBI Vaccines to leverage inVentiv’s expertise and resources for the successful commercialization of their products.

6. As part of their commitment to transparency and compliance, VBI Vaccines has filed a Form 10-K with the United States Securities and Exchange Commission. This filing ensures that stakeholders and regulatory bodies have access to accurate and up-to-date financial information.

These recent developments underscore VBI Vaccines’ dedication to advancing medical science and addressing pressing global health challenges. Through strategic partnerships, organizational changes, and ongoing research efforts, VBI Vaccines continues to make significant contributions to the field of immunization and infectious disease prevention.

https://beststocks.com/vbi-vaccines-secures-lucrative-contract-and-m/

Navidea Rejects Unsolicited Offer To Acquire Certain Assets

 Following the Company’s Fix, Fund, Propel approach, the proposal substantially undervalues Navidea and is not in the best interests of stockholders.

 

Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) (“Navidea” or the “Company”), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, today announced the Company’s Board of Directors, in consultation with G2G Ventures as Executive Consultants, has unanimously rejected an unsolicited, non-binding offer from ProPhase Labs, Inc. (Formerly Known as Quigley Corporation) to acquire certain assets from the Company on the terms disclosed in their press release on June 29, 2023.

“After careful review and consideration of ProPhase Labs’ unsolicited proposal, our Board determined that the proposal substantially undervalues Navidea’s assets, is opportunistic, and is not in the best interest of our stockholders,” said Josh Wilson, Navidea’s Director. “While we certainly understand and are appreciative of the interest in Navidea’s unique technologies, the Board is confident that the Company’s stated objectives and its Fix, Fund, Propel approach to advancing our innovations to market will generate far superior long-term value for stockholders.”

The Company, with G2G Ventures as Executive Consultants, recently announced the receipt of $7.5 million cash from Cardinal Health in lieu of a contingent milestone payment, and provided additional insight on its recent performance in line with its Fix, Fund, Propel approach.

https://www.biospace.com/article/releases/navidea-biopharmaceuticals-inc-rejects-unsolicited-offer-to-acquire-certain-assets/

FDA Decision Tracker 2023: BioMarin, CellTrans, Pfizer and OPKO Health

 The FDA has been on a roll in the first half of 2023, approving 28 novel treatments thus far. And if the first six months is any indication, the biopharma industry should expect several more novel therapies to be greenlit, including a few more first-in-class treatments. But it’s not always good news that companies have to deliver to their stakeholders; the year has already seen its fair share of Complete Response Letters.

BioSpace looks forward to keeping you up to date on all the FDA’s action as we launch our FDA Decision Tracker.  

June

June 29:

Capping a busy week, the FDA approved BioMarin’s Roctavian (valoctocogene roxaparvovec-rvox) as the first gene therapy for adults with severe hemophilia A. Hemophilia is a rare genetic bleeding disorder caused by a mutation in the gene that encodes factor VIII (FVIII), which is necessary for blood to clot. A one-time gene therapy, Roctavian contains a healthy gene for factor VIII. Delivered through an adeno-associated virus (AAV) vector, the gene is expressed in the liver to increase blood levels of FVIII, thereby reducing the risk of uncontrolled bleeding. 

June 28:

The FDA notched another milestone with the approval of the first cellular therapy for type 1 diabetes. Lantidra (donislecel) developed by Chicago-based CellTrans, is a cell therapy made from the pancreatic islet cells of deceased donors. It is intended for adult patients whose repeated hypoglycemic episodes leave them unable to hit average blood glucose levels. In a clinical trial of 30 patients, 21 were insulin-free for at least a year; 11 didn’t require insulin for between one and five years and 10 were insulin-free for more than five years. Five patients failed to achieve any days of insulin independence.

June 28:

Pfizer’s bet on OPKO Health’s human growth hormone analog paid off as the FDA approved the treatment—which will be marketed as Ngenla—to treat children whose production of growth hormones is impaired. Pfizer purchased exclusive global commercialization rights for the then-experimental treatment in December 2014 for $295 million upfront and a promise of up to $275 million in milestones. This was the partners’ second try for FDA approval after the regulator rejected Ngenla’s first bid in January 2022. Pfizer and OPKO did not state the reasons for the initial denial.

June 28:

The FDA declined to approve Eton Pharmaceuticals’dehydrated alcohol injection for the treatment of methanol poisoning, citing concerns related “primarily to Chemistry Manufacturing and Controls.” This is the second Complete Response Letter issued to Eton for this proposed treatment. In the first, issued in March 2021, the FDA indicated that travel restrictions due to the COVID-19 pandemic prevented a timely inspection of the company’s European contract manufacturing site.

June 27:

The FDA approved UCB’s Rystiggo (rozanolixizumab), a subcutaneously administered humanized IgG4 monoclonal antibody, to treat generalized myasthenia gravis, a rare muscle-wasting autoimmune disease. Rystiggo is the only treatment approved to treat patients who are anti-acetylcholine receptor- or anti-muscle-specific tyrosine kinase antibody-positive. The regulatory green light was based on a Phase III trial that showed Rystiggo led to significant improvements in symptoms related to breathing, talking, swallowing and rising from a chair.

June 23:

The FDA greenlit Pfizer’s Litfulo (ritlecitinib) for the treatment of patients as young as 12 years with severe alopecia areata, an autoimmune disease characterized by patchy or complete hair loss on the scalp, face or body. Litfulo inhibits Janus kinase 3 and the tyrosine kinase and is believed to work by blocking the signaling of cytokines and cytolytic activity of T cells, which are implicated in alopecia areata.

June 22: 

In one of the year’s most-anticipated regulatory decisions, the FDA approved Sarepta’s Elevidys—formerly SRP-9001—for children 4 to 5 years with Duchenne muscular dystrophy. Elevidys is the first-ever gene therapy for DMD, a neuromuscular disease characterized by progressive muscle weakness and atrophy that strikes primarily young boys. The gene therapy was approved via the FDA’s accelerated approval pathway based on data that established it increased the expression of the Elevidys micro-dystrophin protein.

June 21:

Eli Lilly and Boehringer Ingleheim’s Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) picked up another indication, becoming the first and only SGLT2 inhibitors approved for children 10 years and older with type 2 diabetes. Previously, there had only been one oral drug for this indication: metformin, which was approved in 2000.

June 20:

Argenx will bring to market the first subcutaneous injectable for generalized myasthenia gravis (gMG), a rare muscle-wasting autoimmune disease. Vyvgart (efgartigimod) was first approved in 2021 as a one-hour intravenous infusion. Vyvgart is an antibody fragment that binds to the neonatal Fc receptor to prevent recycling of immunoglobulin G back into the blood. This includes a reduction in abnormal AChR antibodies, which are present in approximately 85% of gMG patients. AChR antibodies block the acetylcholine receptors from being able to receive signals from the nerve to stimulate a muscular response. Their normalization should ostensibly improve muscular function.

https://www.biospace.com/article/biospace-fda-decision-tracker-2023-biomarin-celltrans-pfizer-and-opko-health/