'Novavax Adapts to Continued Regulatory Uncertainty'

 

After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.

Novavax has been a symbol of biopharma’s struggle to adjust to the onslaught of regulatory changes that have hit the vaccine space over the past four months.

Company executives said they are unsure whether their newly approved next-generation COVID-19 shot Nuvaxovid will be on the agenda when the CDC’s recently revamped Advisory Committee on Immunization Practices (ACIP) meets next week. However, “ACIP is so important in vaccines . . . so we’re watching that space,” Silvia Taylor, chief corporate affairs and advocacy officer, told BioSpace on the sidelines of BIO2025 in Boston.

According to a federal notice released June 12, recommendation votes are scheduled for COVID-19, human papillomavirus (HPV), influenza, meningococcal and respiratory syncytial virus (RSV) vaccines. On June 18, however, CDC published a draft agenda that does not list a vote on COVID-19 vaccines, for which Health Secretary Robert F. Kennedy Jr. himself already announced changes to the CDC’s recommendations.

As for the eight new ACIP members appointed by Kennedy to replace the 17 he summarily turfed on June 9, Taylor said “some of them are maybe questionable choices to us,” while others might have a “mixed history of being supportive of vaccines.”

Novavax won FDA approval on May 16 for an updated version of Nuvaxovid—for seniors aged 65 years and older and those 64 years and under with an underlying condition that puts them at greater risk of severe outcomes from the disease. These restrictions—in line with new risk-based guidance issued days later by the agency—separate Novavax from the original mRNA-based vaccines from larger peers Pfizer/BioNTech and Moderna that are not encumbered by these limitations. The May 31 approval of Moderna’s next-gen COVID vaccine mNEXSPIKE, however, did come with the same set of restrictions.

When asked for their reaction to the approval, Taylor and Novavax colleague Ruxandra Draghia-Akli, head of R&D, said it is in line with vaccine uptake across age groups. As of Nov. 4, 2023, only 14% of people 18 to 50 years of age received a COVID-19 vaccine, according to CDC data. “So probably those individuals that are getting vaccinated are exactly the population that has a risk factor,” Draghia-Akli said.

Taylor agreed, saying that the population was “already behaving even more restrictive, when you think about it, than some of the references.”

The executives again expressed optimism about Nuvaxovid’s chances for growth in the COVID market, particularly as commercialization efforts switch hands to Big Pharma partner Sanofi this year. “They’re a huge player in vaccines. They can do a better job, not only in the U.S., but around the world,” Taylor said.

This strategy is representative of the agility that is enabling Novavax to weather the rapidly changing regulations in the vaccines space. In May 2024, Novavax and Sanofi inked a co-exclusive licensing agreement to co-commercialize Nuvaxovid and develop novel COVID-19–influenza combination vaccines based on Novavax’s Matrix-M adjuvant. “We give them our technology, they take the lead,” Taylor said. This enables the company to branch out into other areas—both through licensing and alone—including in RSV, shingles and avian influenza (bird flu).

Moderna recently took a hit in the latter space when HHS on May 29 terminated a contract previously awarded for the development of an mRNA-based bird flu vaccine. Despite this, Novavax is hoping for support from the Biomedical Advanced Research and Development Authority (BARDA) for an experimental bird flu vaccine, which is ready to enter the clinic. “We know that BARDA is still committed to funding something for pandemic influenza,” which could include bird flu, Taylor said.

She pointed to the fact that Moderna’s vaccine is based on mRNA technology, which the current administration appears to be targeting. While Taylor wouldn’t conjecture as to this being a factor in HHS’ decision regarding Moderna, National Institutes of Health officials have reportedly advised scientists to remove mentions of mRNA vaccine technology from grant applications. “Given that we’re protein-based, our conversations with them continue,” Taylor said.

She and Draghia-Akli also offered their thoughts on an ambitious goal floated by FDA Commissioner Marty Makary at the Drug Information Association’s annual meeting in Washington this week: that a universal flu vaccine could be available in the next five years.

“There have been a lot of failures in this field,” Draghia-Akli said. “Maybe now, with all the AI, with machine learning, with the numerous platforms that have been tried and tested, can we get to something better? I think that five years is very optimistic, but who knows?”

https://www.biospace.com/drug-development/quick-on-its-feet-novavax-adapts-to-continued-regulatory-uncertainty

SoftBank's Son pitches $1 trillion Arizona AI hub, Bloomberg News reports

 SoftBank Group founder Masayoshi Son is envisaging setting up a $1 trillion industrial complex in Arizona that will build robots and artificial intelligence, Bloomberg News reported on Friday, citing people familiar with the matter.

Son is seeking to team up with Taiwan Semiconductor Manufacturing Co for the project, which is aimed at bringing back high-end tech manufacturing to the U.S. and to create a version of China's vast manufacturing hub of Shenzhen, the report said.

SoftBank officials have spoken with U.S. federal and state government officials to discuss possible tax breaks for companies building factories or otherwise investing in the industrial park, including talks with U.S. Secretary of Commerce Howard Lutnick, the report said.

SoftBank is keen to have TSMC involved in the project, codenamed Project Crystal Land, but it is not clear in what capacity, the report said. It is also not clear the Taiwanese company would be interested, it said.

TSMC is already building chipmaking factories in the U.S. with a planned investment of $165 billion.

Son is also sounding out interest among tech companies including Samsung Electronics, the report said.

The plans are preliminary and feasibility depends on support from the Trump administration and state officials, it said.

A commitment of $1 trillion would be double that of the $500 billion "Stargate" project which seeks to build out data centre capacity across the U.S., with funding from SoftBank, OpenAI and Oracle.

SoftBank and TSMC declined to comment. The White House and U.S. Department of Commerce did not immediately respond to requests for comment.

The proposed scheme follows a series of big investment announcements SoftBank has made this year.

In March it announced it would acquire U.S. semiconductor design company Ampere for $6.5 billion and in April said it would underwrite up to $40 billion of new investment in OpenAI, of which up to $10 billion would be syndicated to other investors.

This week SoftBank raised $4.8 billion from a sale of shares in T-Mobile.

https://finance.yahoo.com/news/softbanks-son-pitches-1-trillion-053605238.html

Canada Moves to Protect Steel and Aluminum Firms, Considers Higher Tariffs

 

Canada has opened the door to increasing its tariffs on US steel and aluminum next month if trade talks with the Trump administration stall.

The government “will adjust its existing counter-tariffs on steel and aluminum products on July 21, to levels consistent with progress that has been made in the broader trading arrangement with the United States,” according to a statement Thursday.

https://www.bloomberg.com/news/articles/2025-06-19/carney-to-roll-out-plan-to-help-canada-s-tariff-hit-steel-sector

Tesla signs deal for first China grid-scale battery station - report

 Tesla (NASDAQ:TSLA) has signed a deal to build its first grid-scale battery storage station in China, which will be located in Shanghai, according to local media Yicai.

The agreement was signed Friday between the U.S. automaker, China Kangfu International Leasing Co, and the Shanghai local government.

The project involves an investment of 4 billion yuan ($556.8 million), the Yicai report stated.

The Shanghai facility will utilize Tesla’s megapack batteries for the grid-scale energy storage system, marking the company’s entry into large-scale battery storage infrastructure in the Chinese market.

https://www.investing.com/news/stock-market-news/tesla-signs-deal-for-first-china-gridscale-battery-station--report-93CH-4103355

US Attorney Announces Largest-Ever, $225 Million Cryptocurrency Seizure

 by Tom Ozimek via The Epoch Times,

Interim U.S. Attorney for the District of Columbia Jeanine Pirro said her office has seized more than $225.3 million in cryptocurrency linked to a sprawling international fraud and money laundering network responsible for defrauding hundreds of victims through online investment scams.

Pirro announced at a June 18 news conference in Washington that the U.S. Attorney’s Office for the District of Columbia has filed a civil forfeiture complaint in federal court.

The action targets the proceeds of a vast international fraud operation with ties to organized crime syndicates and human trafficking networks operating out of scam compounds in Southeast Asia.

The $225.3 million seizure, now in the custody of the U.S. Marshals Service, is “the largest cryptocurrency seizure in U.S. Secret Service history,” according to Special Agent in Charge Shawn Bradstreet of the Secret Service’s San Francisco Field Office.

The U.S. Secret Service and FBI used blockchain analysis to trace a complex laundering network involving more than 144 cryptoexchange accounts, 263,000 transactions, and more than $3 billion in digital currency, according to the complaint.

Funds were routed through layers of intermediary “pass-through” accounts to obscure their origin, with evidence pointing to scam centers operated with trafficked labor.

The schemes—also known as “pig butchering” scams—typically involve criminals luring victims into sending funds for purported investments, often in the form of cryptocurrency, which turn out to be fraudulent.

One notable case cited in the complaint involved a Kansas bank CEO who was persuaded by scammers running a cryptocurrency confidence scheme to embezzle $47 million from the bank to invest in a fake crypto platform—through which the criminals then defrauded him of the embezzled funds.

In another case, a Texas victim lost $7 million after being persuaded to invest in a platform that he realized was fraudulent when he tried to withdraw his funds.

More than 430 individuals fell victim to the scams detailed in the complaint.

“This is about quick money,“ Pirro said. ”It’s about old crimes being committed in new ways. Every fast and loose criminal for centuries knows how it’s done, and they’ve done it over and over again, and they continue to do it today.”

Criminals begin by identifying targets—often on social media, through deceptive job postings or fraudulent investment pitches. They work to earn the victim’s trust, then exploit that trust to siphon funds under the guise of legitimate investment opportunities.

The perpetrators behind the scams often use techniques such as “peel chains”—in which crypto is broken into smaller amounts and passed through hundreds of wallets—and “chain hopping” to move assets across blockchains and currencies to mask their movement and origin, according to the complaint.

What sets today’s schemes apart, Pirro said, is the unprecedented speed and scale made possible by digital platforms and emerging technologies.

“So the hopeful investor now enters the Wild West on an international scale, where the crime is global, where there are no borders, and where the crypto criminals avoid the rules because this is an unregulated Wild West,” Pirro said.

Bradstreet said in a statement: “These scams prey on trust, often resulting in extreme financial hardship for the victims.

“The U.S. Secret Service, FBI, and our private partners worked diligently to trace these illicit transactions, identify victims, and seize these funds so that they can eventually be returned to their rightful owners.”

https://www.zerohedge.com/crypto/us-attorney-announces-largest-ever-225-million-cryptocurrency-seizure

The Cost Of Restoring Order In Los Angeles

 Via Open The Books,

Following a week of protests that have given way to rioting in Los Angeles, Open the Books is taking a look at the cost of restoring and maintaining order.

Already ravaged by wildfires earlier this year, the city is now dealing with violence toward law enforcement, incendiary devices, arson and more. And all of that is on the heels of years of seemingly endless, rolling Covid lockdowns under Governor Gavin Newsom and Mayor Karen Bass. The latter had the effect of shrinking revenues and thus staffing levels across the city, putting Los Angeles – America’s second-most populous city – in a unique financial and logistical position as it faces a summer of more disorder.

A record-breaking era of overtime pay is likely to keep costs high as police, fire and other first responders carry out their duties.

The cost to taxpayers isn’t limited to California or Los Angeles, though. City officials have alternately declared the protests peaceful and claimed they had them well in hand, and then also admitted they were “out of control” and that the LAPD was “overwhelmed.” Regardless of the varying protestations and the outright legal and political battle being waged by Newsom, President Trump has taken control of the state’s National Guard to defend federal property and officers. Secretary of Defense Pete Hegseth has allowed that it’s likely a 60-day investment with an accompanying $134 million price tag for federal taxpayers.

That’s all before we factor in the cost of duking it out in federal court as Newsom seeks to stop the President from utilizing the Guard.

The Overtime Epidemic

The City of Los Angeles is no stranger to excessive overtime pay. Open the Books reported last year that 20 city employees earned at least $300,000 in overtime pay in 2023. That’s before even factoring in their base salaries.

But overtime costs reached new heights in 2024, with the city spending a record $1.1 billion on extra hours. That’s enough money to pay off the city’s entire budget deficit. In overtime alone, five people earned more than the $400,000 salary we pay the President of the United States.

A revenue pinch amid Covid lockdowns led to a spate of early retirements that have exacerbated the need for extra-hours pay. And as the Los Angeles Police Department faces rioting, the force’s ranks are at their smallest in two decades—but the payroll is still growing.

Los Angeles Police Department

The LAPD spent $265.5 million on overtime, another record, in 2024. Prior to that, no police officer had ever earned more than $235,000 in overtime. Last year? It happened seven times. The pay raises Mayor Karen Bass gave police in 2023 — 13% over four years — were likely a contributing factor as overtime is calculated from base pay.

Detective Nathan Kouri took home a $404,875 overtime check. He made $603,887 in total when combined with his base salary. Thirty-five other police officers also had cash compensation of at least $400,000.

Payments like Kouri’s don’t just affect the city’s budget; they have prevented the police from doing their jobs properly for at least 15 years. In 2010, the LAPD ordered Kouri and several others to stop working for six weeks because they had no money left to pay their overtime salary. The LA Times reported, “The drain on homicide squads has hampered investigations … Detectives said their investigations are frequently put on hold while they take days off, delaying witness interviews and other potentially important leads. And, in the crucial first hours after a killing, several supervisors said they now dispatch fewer detectives to the crime scene.”

Today, the LA Times says the problem is worse than ever. The LAPD’s budget request predicts it will lose 150 cops next year, leaving 8,620 police officers — the smallest force since 1995.

Although staffing levels have dropped, payroll expenses have not. The LAPD’s 2020 payroll lists 14,902 employees making a total of $1.71 billion. In 2024, there were 12,617 employees making $1.73 billion.

Overtime Beyond the Cops

None of that means the problem is limited to the LAPD. There were 2,092 city workers who earned at least $100,000 in overtime in 2024, with firefighters and Department of Water & Power (LADWP) employees topping the list.

SIDENOTE: LADWP came under fire in March when historic wildfires spread across the Palisades and Altadena, and firefighters were confronted with empty hydrants. Read our Substack on that here.

Fire Battalion Chief Nicholas Ferrari made $644,456 of overtime and $905,060 in total in 2024. From 2021 to 2024, Ferrari took home over $2.5 million from the city.

Ricardo Pacheco, an electric distribution mechanic with the Water & Power department, made $425,632 in overtime.

The staffing shortages have existed for years but reached new heights after the Covid-19 pandemic. The most recent data from the city controller shows a 17.5% job vacancy rate as of December 2023, meaning one in six city positions were unfilled. The vacancy rate was only 11% before the pandemic, but more than 2,000 workers retired early in 2020 under a program meant to reduce the city payroll after the pandemic harmed revenues.

Dana Brown, head of the city’s personnel department, blamed the staff shortages on “archaic” civil service rules that often force applicants to wait six months or more during the hiring process. Police data supports that claim. The LAPD received 53% more job applications in 2024 than in 2022, but delays meant 9% fewer candidates received a background check from the city.

Overtime Boosts Rank-and-File Employees to Leadership Pay

Although staffing shortages mean rank-and-file employees are the highest earners, top officials are still doing well for themselves. Police Chief Jim McDonnell makes $450,000, $100,000 more than his predecessor and almost double the police chiefs in New York and Chicago.

Mayor Karen Bass made $328,394 last year.

Overall, there were 4,114 Los Angeles employees who outearned Gov. Newsom’s salary of $242,295.

CONCLUSION

Between draconian lockdowns, inefficient onboarding processes, and sky-high union-negotiated deals, Los Angeles is set to take a financial beating as it deploys officers and personnel to respond to the chaos.

https://www.zerohedge.com/political/cost-restoring-order-los-angeles

'Safely Taper Benzodiazepines According to Patient Response: New Guideline'

Long-term, regular use of benzodiazepines is common and can lead to physical dependence and withdrawal when the dose is reduced or the medication is abruptly stopped. However, evidence has been lacking on the best tapering methods for the medications commonly prescribed for uses including sleep disorders and anxiety. Additionally, patients have different reactions to the withdrawal process.

In light of the clinical concerns, the American Society of Addiction Medicine has partnered with nine other medical societies and professional associations and on Tuesday published the Joint Clinical Practice Guideline on Benzodiazepine Tapering, in the Journal of General Internal Medicine.

The guideline outlines evidence-informed and consensus-based strategies to help clinicians, particularly primary care physicians, and patients work together to safely taper the medications while minimizing withdrawal symptoms, which can be severe and potentially life-threatening. Primary care physicians prescribe most benzodiazepines. The guideline is not meant for palliative care and end-of-life physicians, the authors noted.

Tapering Can Take More Than a Year

The guideline, with lead author and Chair Emily Brunner, MD, with the Hazelden Betty Ford Foundation in Minneapolis recommends a slow tapering process, adjusted according to each patient’s response. For those who have been using the medication for years, tapering can take a year or more, the authors noted.

Among the key recommendations:

• Never abruptly stop benzodiazepines when patients are likely to be physically dependent on the medication and at risk for withdrawal.
• Consider tapering long-term use in older adults, unless there are compelling reasons for continuation.
• Regularly assess patients to weigh the risks and benefits of continuing benzodiazepine therapy compared with tapering. That calculation can change over time.
• Consider tapering when risks outweigh benefits of continued therapy.
• Begin tapering slowly and with small dose reductions (perhaps a 5%-10% reduction in total daily dose every 2-4 weeks).
• Routinely monitor patients and adjust the tapering as needed.

Patients List Their Hopes for Physicians

Aleksandra E. Zgierska, MD, PhD, with Penn State College of Medicine in Hershey, Pennsylvania, pointed out in an accompanying editorial that patients who experienced tapering helped develop the guideline at each step.

Patient-advisers said they hoped physicians would:

• Be aware of the broad range of potential withdrawal symptoms and the risk for symptoms lasting months and years after stoppage.
• Know how to support patients who need very slow tapers, for example, by using “micro tapering” strategies with liquid benzodiazepine formulations when needed.
• Understand, and help patients understand, the time needed for the brain’s gamma-aminobutyric acid receptors to return to homeostasis (eg, avoiding alcohol and sedatives, including other benzodiazepine-like z-drugs such as zolpidem, zopiclone, and zaleplon).

Prioritize Those at Highest Risk of Harm

Zgierska and colleagues offer help on thinking about which patients most need tapering.

“As we saw after the release of the CDC Guideline for Prescribing Opioids for Chronic Pain in 2016, guidelines can have unintended consequences,” they wrote. “There may be a large population of patients for whom benzodiazepine tapering is indicated. Clinicians should prioritize those who are at the highest risk of harm.”

In a related Viewpoint in JAMA, published simultaneously, the guideline’s lead author, Brunner, and co-editorialists, explained that after the CDC’s 2016 guideline on opioid use was published, misapplication “led some prescribers to abruptly discontinue pain medications without first developing a plan for safe tapering, putting patients at risk of withdrawal and transition to illegally obtained opioids while also failing to address pain symptoms.”

They explained that benzodiazepines are effective in managing conditions including anxiety, seizures, agitation, insomnia, and alcohol withdrawal. In 2023, they wrote, “9% of US adults received a benzodiazepine prescription.” Treatment guidelines have generally advised against use for more than 4 weeks because of the accompanying risk of falls, vehicle crashes, cognitive impairment, delirium, and overdose. Despite that, in an analysis of prescribing to US adults, “one quarter of those prescribed a benzodiazepine were prescribed a supply exceeding 120 days,” they wrote. “Many patients are currently prescribed long-term benzodiazepines for conditions that could be managed with lower-risk interventions.”

In some cases — such as those with treatment-resistant generalized anxiety disorder or sleep disorders with abnormal movements — long-term use of benzodiazepines may be warranted, they explained.

While clinicians may read the guideline and decide large numbers of their patients may need tapering, the authors of the Viewpoint wrote, “It is critical that the guideline not be used to justify abrupt discontinuation of benzodiazepines in patients who may have developed physical dependence.”

Resources for Implementation

A number of resources have been developed to help clinicians implement the recommendations in the guideline, including continuing medical education, pocket guides, and handouts, and downloadable tools such as benzodiazepine dose equivalents and decision flow charts.

Report authors and the Viewpoint authors declared no relevant financial relationships. Zgierska, lead author of the editorial, is a member of the board of directors for the American Society of Addiction Medicine.

https://www.medscape.com/viewarticle/how-safely-taper-benzodiazepines-according-patient-response-2025a1000gcs