Category: 3. Business

By Charles Passy

America’s retirement system desperately needs reform

President Trump suggested the U.S. should consider the Australian retirement-savings model.

Could America’s signature retirement-savings program look a lot like Australia’s one day?

That’s the idea President Trump hinted at earlier this week, saying the Australian model is a “good plan” that has “worked out very well.”

“We’re looking at it very seriously,” Trump said.

In a nutshell, the Australian plan takes some of what’s already baked into the American 401(k) retirement-savings model, but expands upon it in significant ways that assure more people have more savings by the time they reach retirement age. Called the “superannuation” (or “super”) model, the program requires employers to make a 12% contribution to a retirement fund on behalf of the employee. The employee can also contribute an amount beyond that.

‘We’re looking at it very seriously.’President Donald Trump, on the U.S. possibly adopting the Australian retirement-savings model

In the U.S., the 401(k) model works by giving employees the chance to participate in a retirement-savings program through their employer, with tax benefits to employees for doing so. But the employer is not obligated to offer a 401(k) plan – and even if they do, there’s no requirement they make any kind of contribution to it.

Indeed, research has shown that 56 million private-sector workers in the U.S. lack access to a retirement-savings plan. And even among employees who have a 401(k), the employer contribution is typically in the form of a match, which often equates to 4% to 6% of an employee’s salary – far below that 12% Australian figure.

Australia’s program, with the mandatory employer-contribution aspect, has been in place since 1992, but it didn’t start at 12%. In fact, it began with just 3%, but over time the figure grew incrementally to the current 12%. Still, it has resulted in Australian workers, on average, accumulating the equivalent of around $115,000 (that’s roughly $173,000 in Australian currency (AUDUSD)).

Those enrolled in U.S. 401(k) plans actually have a bit more than that; the average 401(k) balance is $148,153, though it should be noted that wages and the cost of living are lower in Australia.

Perhaps the more relevant data point, however, is the fact that 78% of Australians participate in the “super” program. By contrast, just 59% of Americans have a retirement-savings plan, be it a 401(k), 403(b) or an individual retirement account (IRA), according to a Gallup survey.

But some financial experts say it might be politically tough to push through an Australian-style program in the U.S., especially given the financial burden it places on companies – and small ones in particular.

A plan that mandates that businesses contribute to employee retirement plans at such a high level “will never happen,” said Teresa Ghilarducci, a noted retirement authority who’s an economics professor at the New School in New York City.

Plus, even those who give the Australian system high marks point to issues within it. A key one: Even though the system helps ensure that workers save a significant sum for retirement, it doesn’t necessarily guide them on how to tap that money once they retire – by turning it into, say, a monthly income stream they can parse out carefully over time as they deal with any number of medical or other issues they may face as they age.

“The system still struggles to help retirees navigate longevity risk, inflation and cognitive decline,” said Tomas A. Geoghegan, founder of Beacon Hill Private Wealth in New Jersey.

That said, the American 401(k) model doesn’t offer any systemized way of parsing out, or annuitizing, one’s retirement savings, either.

In any case, there’s little question that the current retirement-savings system in the U.S. needs to be revamped. Without an improved safety net, Americans will be relying more heavily on Social Security than ever, experts note. And as Americans are constantly reminded, Social Security is under threat as it is.

“We absolutely have to do something,” said Holly Verdeyen, a partner at Mercer, a consulting firm that focuses heavily on retirement planning.

Mercer rates retirement systems throughout the world, and gives the Australian model a solid B+. By contrast, the U.S. gets a C+.

The U.S. has already been looking at ways to revamp its retirement-savings model, regardless of whether or not it considers the Australian one.

For starters, under what’s commonly referred to as the Secure 2.0 Act, Congress authorized such changes as letting employers automatically enroll employees into 401(k) plans and allowing employees between the ages of 60 and 63 to increase their maximum retirement contributions.

On top of that, a number of states are looking at ways for employees to access retirement-savings programs.

But more sweeping national reform is still needed, many argue. And some say it could come in the form of the Retirement Savings for Americans Act (RSAA), which is currently making its way through Congress. It calls for a program that would broaden accessibility to tax-advantaged retirement-savings accounts and would have the federal government match contributions for workers below certain income levels.

In the meantime, the Australian model is still out there.

White House spokesman Kush Desai wouldn’t get into specifics about how the model could work in the U.S., but told MarketWatch: “The administration is closely examining all options to help Americans build wealth and achieve prosperity.”

-Charles Passy

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

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Good afternoon and thank you for the flexibility in allowing me to deliver my remarks towards the end of the day due to scheduling issues. Earlier, the Committee engaged in discussions on corporate governance and tokenization and will later discuss artificial intelligence disclosures.

Today, also, is the final Committee Meeting for our Investor Advocate. I want to extend my appreciation to Cristina [Martin Firvida] for her dedication and professionalism. Cristina is the second Investor Advocate in the Commission’s history. When she was selected, I was not quite sure what to expect from her. However, Cristina won me over by finding areas of mutual agreement and then executing upon them. One of Cristina’s important contributions is reforming the selection process for Committee members. As an SEC staff member, I was here at the very beginning of the Committee. It became clear that the departure of a significant majority of the Committee members every four years was not conducive to longer-term thinking. Through Cristina’s efforts, we now have a plan where approximately a quarter of the Committee will be replaced annually, thereby obtaining a smoother transition of new members into the Committee. Thank you, Cristina, for your outstanding service and I wish you the best in your future endeavors!

Corporate governance plays a role in investor confidence and market integrity. It encompasses the systems, principles, and processes by which companies are directed and controlled. At its core, effective governance ensures that companies are accountable to shareholders and resilient in the face of evolving risks.

Over time, the role of governance has expanded beyond traditional oversight. Companies are increasingly expected to navigate complex issues such as cybersecurity and emerging technologies. A well-functioning board must not only monitor management but also anticipate and adapt to systemic shifts that could affect long-term value creation.

However, Congress specifically left the states in charge of governance under state corporate law. The federal securities laws and regulations play an important complimentary role in providing disclosure, describing the governance structure, the rights of shareholders, and potential risks associated with a company’s particular structure as well as for providing a regulatory framework for proxy solicitation.

Yet, as we consider reforms, we must be mindful of the temptation to use the Commission’s disclosure authority for registration statements and proxy materials, as well as oversight of exchange listing requirements, to impose prescriptive governance mandates. It is inappropriate to mistake the “investor protection” and “public interest” standards contained in the federal securities laws as Congressional authority to set national corporate governance standards. Congress does not “hide elephants in mouse holes.”

Corporate governance is best left to the market to decide. If a potential shareholder does not like a particular governance framework — such as whether it is board composition, independence, expertise, then there is a simple solution: do not invest. Companies with corporate governance structures that are not well received by investors will have a higher cost of capital and a depressed stock price.

Similarly, another area of recent discussion is the Commission’s clarification regarding mandatory arbitration provisions in registration statements and how the presence of such provisions will not be an impediment to acceleration of effectiveness. Some panelists might have argued earlier today that this represents a reversal of prior Commission policy or weakening of investor protections. In fact, the Commission has never had a policy prohibiting such provisions. Our recent Policy Statement simply articulates that, absent a clear congressional directive, the applicability of the Federal Arbitration Act was not overruled by the federal securities laws, and the existence of an arbitration provision is not grounds for denying effectiveness under Section 8(a) of the Securities Act.

This approach is consistent with judicial precedent and ensures that our rulebook is clear, transparent, objective, and predictable. To suggest otherwise is to mischaracterize both the law and the absence of any prior Commission’s policy.

During consideration of this Policy Statement at the open meeting, I specifically asked whether the Commission could adopt the opposite position. In other words, assume that the parade of horrible described by critics of mandatory arbitration provisions were to occur. Would the Commission have the legal authority to issue a policy statement specifically denying the acceleration of effectiveness of any registration statement if it disclosed the preference of a mandatory arbitration provision? The answer was essentially no — if the disclosure was adequate, then that would be essentially merit regulation, which was not authorized by the federal securities laws.

Finally, let me express my appreciation for the Committee’s recent work on artificial intelligence disclosures. This is a rapidly evolving area of corporate activity. As AI becomes more deeply integrated into business operations, the need for material information by investors may grow. The Committee has proposed that issuers:

1. Define what they mean by “artificial intelligence” in their disclosures;
2. Disclose board oversight mechanisms, if any, for AI deployment; and
3. Report separately on the material effects of AI on internal operations and consumer-facing matters.

I recognize that these recommendations are grounded in a materiality-based approach and are designed to fit within the existing disclosure framework under Regulation S-K. Furthermore, the Committee’s decision to build on existing disclosure items—rather than propose a standalone AI regime—is a pragmatic one that avoids unnecessary structural complexity.

That said, it is important to approach this area with caution. There are practical and conceptual challenges that merit further consideration. For example, the lack of a universally accepted definition of “artificial intelligence” could create interpretative and disclosure issues. Boards, management, and their outside counsel may struggle to determine what qualifies as AI, particularly when distinguishing between traditional automation and more advanced machine learning systems.

Similarly, while board oversight is a critical governance function, mandating disclosures in this area may not always yield meaningful insight for investors—especially if oversight responsibilities are diffuse or still evolving. And while reporting on the material effects of AI is a reasonable goal, it may be difficult in practice to isolate those effects separately from regular business operations.

Moreover, we must be mindful of the potential for regulatory overreach. Prematurely codifying rigid disclosure mandates could stifle innovation, particularly for smaller issuers that may lack the resources to implement complex compliance systems. A one-size-fits-all approach may not be appropriate in a space where use cases, risks, and maturity levels vary widely across industries.

As we consider the Committee’s recommendation, our goal should not be to use the federal securities laws as a backdoor attempt to regulate AI. Rather, we must ensure that investors are not left in the dark about material risks and opportunities that may arise from the use of AI in business operations and strategy and to do so in a manner without being encumbered by prescriptive or duplicative requirements.

The Committee provides a forum for this ongoing dialogue, and I look forward to continued engagement on this issue.

Total spending, updated annually as part of Volkswagen’s rolling five-year investment plan, compares with 165 billion euros for the 2025-2029 period and 180 billion for 2024-2028, with 2024 marking a peak.

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Blume told the weekly Frankfurter Allgemeine Sonntagszeitung that the focus in the latest spending plan was “on Germany and Europe,” including in products, technology and infrastructure. He said talks about an extended savings programme at Porsche would run into 2026.

PORSCHE NOT EXPECTED TO GROW IN CHINA, BLUME SAYS

“But it is true, of course, that shareholders have suffered losses since Porsche went public three years ago. I, too, must face up to this criticism.”

($1 = 0.8590 euros)

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– Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients –

– Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older –

– Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 –

BOSTON–(BUSINESS WIRE)–Dec. 6, 2025–
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY^® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and TDT ages 12 years and older, will be presented at the American Society of Hematology (ASH) Annual Meeting. CASGEVY is currently approved for eligible people ages 12 years and older with SCD or TDT in the United States, Great Britain, the European Union, the Kingdom of Saudi Arabia, the Kingdom of Bahrain, Kuwait, Qatar, Canada, Switzerland and the United Arab Emirates.

“These results — the first clinical data ever presented on any genetic therapy for children ages 5-11 years with SCD — again demonstrate the transformative potential of CASGEVY,” said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. “With dosing completed in the 5-11 age group and the Commissioner’s National Priority Voucher for CASGEVY in this population in hand, we are excited to begin global regulatory filings in the first half of next year and bring this potentially transformative therapy to eligible children as soon as possible.”

“As an investigator in the clinical program for patients 12 years and older and after having real-world experience with CASGEVY as an early commercial treatment center, I have seen firsthand the transformative impact this therapy has had on older patients with SCD or TDT. I am excited to hopefully be able to offer this option to my younger patients soon, early in life, before some of the most devastating impacts of these diseases begin,” said Haydar Frangoul, M.D., M.S., Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute and HCA Healthcare’s TriStar Centennial Children’s Hospital, Member of Vertex’s SCD Program Steering Committee, and presenting author of the 5-11 years old CASGEVY data at ASH.

First presentation of data in children ages 5-11 years treated with CASGEVY

• In children with SCD, 11 patients have been dosed with CASGEVY in the Phase 3 CLIMB-151 clinical study, and all (4/4) patients with sufficient follow-up achieved the primary endpoint of being free from vaso-occlusive crises (VOCs) for at least 12 consecutive months (VF12).
  • No patient experienced a VOC following infusion with CASGEVY, with the longest duration of VOC-free of approximately two years (range 3.2–24.1 months).
• In children with TDT, 13 patients have been dosed with CASGEVY in the Phase 3 CLIMB-141 clinical study, and all (6/6) patients with sufficient follow-up achieved the primary endpoint of transfusion independence for at least 12 consecutive months while maintaining a weighted average hemoglobin (Hb) of at least 9 g/dL (TI12).
  • Following CASGEVY infusion, 12/13 are transfusion free, with the longest duration of transfusion free just under two years (range 2.3–22.5 months).
  • One patient died from pneumonia in the setting of multi-organ failure due to severe veno-occlusive disease related to the busulfan conditioning.
• The safety profile of CASGEVY in younger patients is consistent with myeloablative conditioning and autologous transplant in both SCD and TDT, as established in clinical studies in older patients.
• Consistent with studies in older patients, children treated with CASGEVY have durable increases in fetal hemoglobin (HbF) and stable allelic editing.

Longer-term data for people with SCD and TDT ages 12 years and older treated with CASGEVY

New longer-term data from the pivotal clinical studies of CASGEVY in people 12 years and older will also be presented at ASH. These data, as of April 2025, continue to demonstrate the transformative, durable clinical benefits that CASGEVY provides to people living with SCD or TDT. In SCD, 100% of patients (45/45) achieved VF12 in either CLIMB-121 or the long-term follow-up study CLIMB-131, with a mean duration of VOC-free for 35.3 months (range 12.9–67.7 months). In TDT, 98.2% (55/56) achieved TI12 in either CLIMB-111 or CLIMB-131 with a mean duration of transfusion independence of 41.4 months (range 13–72.3 months). The safety profile remained consistent with myeloablative conditioning and autologous transplant in both SCD and TDT.

About Sickle Cell Disease (SCD)

SCD is a debilitating, progressive and life-shortening disease. It is an inherited blood disorder that affects the red blood cells, which are essential for carrying oxygen to all organs and tissues of the body. SCD causes severe pain, organ damage and shortened life span due to misshapen or “sickled” red blood cells. The clinical hallmark of SCD is vaso-occlusive crises (VOCs), which are caused by blockages of blood vessels by sickled red blood cells and result in severe and debilitating pain that can happen anywhere in the body at any time. SCD requires a lifetime of treatment and results in a reduced life expectancy. In the U.S., the median age of death for patients living with SCD is approximately 45 years. SCD patients report health-related quality of life scores well below the general population, and the lifetime health care costs in the U.S. of managing SCD for patients with recurrent VOCs is estimated between $4 and $6 million.

About Transfusion-Dependent Beta Thalassemia (TDT)

TDT is a serious, life-threatening genetic disease. It requires frequent blood transfusions and iron chelation therapy throughout a person’s life. Due to anemia, patients living with TDT may experience fatigue and shortness of breath, and infants may develop failure to thrive, jaundice and feeding problems. Complications of TDT can also include an enlarged spleen, liver and/or heart, misshapen bones and delayed puberty. TDT requires lifelong treatment and significant use of health care resources, and ultimately results in reduced life expectancy, decreased quality of life and reduced lifetime earnings and productivity. In the U.S., the median age of death for patients living with TDT is 37 years. TDT patients report health-related quality of life scores below the general population and the lifetime health care costs in the U.S. of managing TDT are estimated between $5 and $5.7 million.

About CASGEVY^® (exagamglogene autotemcel)

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene through a precise double-strand break. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT.

The use of CASGEVY in children ages 5-11 years is investigational.

About the CLIMB Studies

The Phase 1/2/3 open-label studies, CLIMB-111 and CLIMB-121, are designed to assess the safety and efficacy of a single dose of CASGEVY in patients ages 12-35 years with TDT or with SCD and recurrent VOCs. Patients will be followed for approximately two years after CASGEVY infusion in these studies. CLIMB-141 and CLIMB-151 are ongoing Phase 3 open-label studies, designed to assess the safety and efficacy of a single dose of exagamglogene autotemcel in patients ages 2-11 years with TDT or with SCD and recurrent VOCs. Enrollment and dosing are complete for the 5-11-years-old cohort in both studies with the plan to extend to ages 2-4 years.

Each patient will be asked to participate in the ongoing long-term, open-label study, CLIMB-131. CLIMB-131 is designed to evaluate the long-term safety and efficacy of CASGEVY in patients with up to 15 years of follow up after CASGEVY infusion.

Next steps for CASGEVY in children ages 5-11 years

Enrollment and dosing are complete for the 5-11 years cohort in both studies. Vertex expects to initiate global regulatory filings for this age group, including a supplemental Biologics License Application (sBLA) in the U.S., in the first half of next year. Vertex recently received a Commissioner’s National Priority Voucher for CASGEVY in the 5-11 years age group from the U.S. Food and Drug Administration to accelerate the review of the sBLA once submitted. Products under the program will be subject to a 1–2-month review clock from the start of FDA’s review and will also benefit from enhanced communication opportunities with the agency.

U.S. INDICATIONS AND IMPORTANT SAFETY INFORMATION FOR CASGEVY

WHAT IS CASGEVY?

CASGEVY is a one-time therapy used to treat people ages 12 years and older with:

• sickle cell disease (SCD) who have frequent vaso-occlusive crises or VOCs
• beta thalassemia (β-thalassemia) who need regular blood transfusions

CASGEVY is made specifically for each patient, using the patient’s own edited blood stem cells, and increases the production of a special type of hemoglobin called hemoglobin F (fetal hemoglobin or HbF). Having more HbF increases overall hemoglobin levels and has been shown to improve the production and function of red blood cells. This can eliminate VOCs in people with sickle cell disease and eliminate the need for regular blood transfusions in people with beta thalassemia.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about CASGEVY?

After treatment with CASGEVY, you will have fewer blood cells for a while until CASGEVY takes hold (engrafts) into your bone marrow. This includes low levels of platelets (cells that usually help the blood to clot) and white blood cells (cells that usually fight infections). Your doctor will monitor this and give you treatment as required. The doctor will tell you when blood cell levels return to safe levels.

• Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of platelet cells:
  • severe headache
  • abnormal bruising
  • prolonged bleeding
  • bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood

• Tell your healthcare provider right away if you experience any of the following, which could be signs of low levels of white blood cells:

You may experience side effects associated with other medicines administered as part of the treatment regimen for CASGEVY. Talk to your physician regarding those possible side effects. Your healthcare provider may give you other medicines to treat your side effects.

How will I receive CASGEVY?

Your healthcare provider will give you other medicines, including a conditioning medicine, as part of your treatment with CASGEVY. It’s important to talk to your healthcare provider about the risks and benefits of all medicines involved in your treatment.

After receiving the conditioning medicine, it may not be possible for you to become pregnant or father a child. You should discuss options for fertility preservation with your healthcare provider before treatment.

STEP 1: Before CASGEVY treatment, a doctor will give you mobilization medicine(s). This medicine moves blood stem cells from your bone marrow into the blood stream. The blood stem cells are then collected in a machine that separates the different blood cells (this is called apheresis). This entire process may happen more than once. Each time, it can take up to one week.

During this step rescue cells are also collected and stored at the hospital. These are your existing blood stem cells and are kept untreated just in case there is a problem in the treatment process. If CASGEVY cannot be given after the conditioning medicine, or if the modified blood stem cells do not take hold (engraft) in the body, these rescue cells will be given back to you. If you are given rescue cells, you will not have any treatment benefit from CASGEVY.

STEP 2: After they are collected, your blood stem cells will be sent to the manufacturing site where they are used to make CASGEVY. It may take up to 6 months from the time your cells are collected to manufacture and test CASGEVY before it is sent back to your healthcare provider.

STEP 3: Shortly before your stem cell transplant, your healthcare provider will give you a conditioning medicine for a few days in hospital. This will prepare you for treatment by clearing cells from the bone marrow, so they can be replaced with the modified cells in CASGEVY. After you are given this medicine, your blood cell levels will fall to very low levels. You will stay in the hospital for this step and remain in the hospital until after the infusion with CASGEVY.

STEP 4: One or more vials of CASGEVY will be given into a vein (intravenous infusion) over a short period of time.

After the CASGEVY infusion, you will stay in hospital so that your healthcare provider can closely monitor your recovery. This can take 4-6 weeks, but times can vary. Your healthcare provider will decide when you can go home.

What should I avoid after receiving CASGEVY?

• Do not donate blood, organs, tissues, or cells at any time in the future

What are the possible or reasonably likely side effects of CASGEVY?

The most common side effects of CASGEVY include:

• Low levels of platelet cells, which may reduce the ability of blood to clot and may cause bleeding
• Low levels of white blood cells, which may make you more susceptible to infection

Your healthcare provider will test your blood to check for low levels of blood cells (including platelets and white blood cells). Tell your healthcare provider right away if you get any of the following symptoms:

• fever
• chills
• infections
• severe headache
• abnormal bruising
• prolonged bleeding
• bleeding without injury such as nosebleeds; bleeding from gums; blood in your urine, stool, or vomit; or coughing up blood

These are not all the possible side effects of CASGEVY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of CASGEVY

Talk to your healthcare provider about any health concerns.

Please see full Prescribing Information including Patient Information for CASGEVY.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East. Vertex is consistently recognized as one of the industry’s top places to work, including 16 consecutive years on Science magazine’s Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex’s history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube and X.

Vertex Special Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, statements made by Carmen Bozic, M.D., and Haydar Frangoul, M.D., M.S., and statements regarding expectations for the clinical benefits of CASGEVY, plans to initiate global regulatory submissions for children 5-11, including in the U.S., in the first half of 2026, expectations that the use of a Priority Voucher will accelerate the review of the sBLA, expectations for the design of the CLIMB studies, including plans to follow patients after infusion, expectations that each patient will be asked to participate in the CLIMB-131 study and expectations that the studies will be extended to children 2-4 years of age. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company’s beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company’s research and development programs may not support registration or further development of its potential medicines in a timely manner, or at all, due to safety, efficacy or other reasons, that the company may be unable to make the anticipated regulatory submissions on the expected timeline, or at all, and other risks listed under the heading “Risk Factors” in Vertex‘s most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission at www.sec.gov and available through the company’s website at www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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Source: Vertex Pharmaceuticals Incorporated

For the first time since 2018, the sale of cannabis seeds in the US will be restricted due to a last-minute provision in the spending bill that ended the government shutdown last month – a move that experts say will kill the market in this country.

Cannabis seed companies have enjoyed comparatively relaxed regulatory standards for the past several years because seeds themselves contain a negligible amount of THC, the compound that makes cannabis federally illegal.

Sergio Martínez, chief executive officer and founder of Spain-based Blimburn Seeds, said that the 2018 farm bill eased restrictions on seeds by defining hemp as any product containing less than 0.3% delta 9 THC.

“This definition was reinforced in 2022 when the DEA formally clarified that cannabis seeds meeting this threshold are legally considered hemp and therefore are not controlled substances under the Controlled Substances Act, even if the plants grown from them may exceed the THC limit,” Martínez said.

Since then, most states have allowed seeds to be purchased and shipped without triggering any drug laws, and companies can sell and import seeds without special permits.

But the provision in the spending bill that will ban most hemp products includes explicit language to ban seeds as well. The ban will restrict “any viable seeds from a Cannabis sativa L. plant that exceeds a total tetrahydrocannabinol concentration (including THCA) of 0.3% in the plant on a dry weight basis”, essentially restricting seeds based on the plants they might produce.

Experts in the industry say this way of regulating seeds will destroy the market and doesn’t make logical sense.

“All [seeds] look the same until you wait a minimum of three months to see what they really are. There is a misunderstanding about strains, even hemp plants registered in Europe as less than 0.3% THC if you are a good grower, you could get these numbers up,” Martínez said. “So how are you able to know what kind of seed is legal and what is not?”

In the current legal landscape, seeds “can even be shipped internationally”, Martínez noted. While the US now has the world’s most robust cannabis seed market, Martínez expects that if the ban goes through, “other countries will take the lead”.

The ban will be especially impactful for individual consumers who grow their own cannabis. In some states, growing cannabis is illegal even if seeds are not. In others, individuals can legally grow a limited amount – sometimes only with a medical cannabis card.

Jamie Pearson, president and founder of the New Holland Group, an international cannabis consultancy, is especially concerned for consumers who grow their own plants for medical reasons. The legal seed market has allowed some companies to cultivate strains.

“That work for epilepsy or that work for pain or that work for chemotherapy nausea. What these consumers are relying on is going to be gone,” Pearson said.

Growing at home can be especially important for medical consumers and anyone concerned about their health.

“To grow any kind of plant always makes you feel better, the act of growing is medicine for yourself already,” says Martínez, who also pointed out that homegrown cannabis can help the health of the planet as it eliminates many of the environmental costs of transporting and packaging products.

Pearson agrees that homegrown cannabis allows consumers to avoid contaminants like pesticides, mold and heavy metals.

“You’re in control of what you’re putting into the plant,” she said.

It’s unclear how seed companies will be expected to prove that their products can only grow plants with low levels of THC in order to comply with the hemp ban, but Pearson thinks whatever these restrictions are, only a handful of the most well-resourced companies will be able to do it. She compares the variety of cannabis seeds available now to the varieties of wine available in stores.

“These genetics are really the heart and soul of the cannabis industry. It’s sort of like when you talk about the difference between a pinot noir grape and a chardonnay grape,” Pearson said, adding that these grapes can make many subtly different varieties of wine, and that cannabis can have even more variety.

But if the ban goes through, she noted, “it’s going to be a handful of the really large companies that have those right licenses. All those genetics, the good wine will go underground, and you’re just going to get Ernest and Julio Gallo, rather than all the varietals that we can get at our local wine store. And so it’s going to really impact the consumer experience.”

ROME, Dec 6 (Reuters) – Italy’s market regulator has found no evidence of a secret agreement involving Monte dei Paschi di Siena and some of its shareholders to gain control of Mediobanca and insurer Generali, Il Sole-24 Ore reported on Saturday.

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The Italian financial daily cited a document dated September 15 from Consob’s issuer supervision division and said it had found “no secret pact exists”.

The regulator had addressed allegations of a “concerted effort” involving MPS’s CEO Luigi Lovaglio, Delfin’s chairman Francesco Milleri, and construction tycoon Francesco Gaetano Caltagirone, to gain control of Mediobanca and insurer Generali, while avoiding a mandatory takeover bid.

A Consob spokesperson declined to comment.

Lovaglio, Milleri, and Caltagirone have denied any wrongdoing.

Il Sole-24 Ore said the Consob document, which “completely diverges from the investigators’ hypotheses,” has been sent to the Milan prosecutor’s office.

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If you are a millennial, part of gen X or a boomer, you probably do not give a second thought to picking up the phone to talk to someone or chit-chatting beside the office water cooler. But for gen Z, those common workplace moments are a huge source of anxiety.

According to a study released this week, early mornings, working with older colleagues and making small talk are just some of the things employees born between 1997 and 2012 dread.

The study, commissioned by Trinity College London, surveyed more than 1,500 people aged between 16 and 29 across the UK. It found that 38% of young people dread having to make small talk in the workplace. Almost 60% said they would struggle to work with older colleagues while 30% feared picking up the phone.

Here, experts share their tips on how to overcome gen Z’s biggest anxieties.

Telephobia

“There’s a massive skill to learning to make calls,” says Liz Baxter, a careers adviser at Nottingham College who runs coaching sessions on phone confidence. She says demand for the college’s “telephobia” course is high.

While previous generations grew up having no option but to pick up the phone, Baxter says texting, online booking platforms and AI customer service have made making a phone call one of the biggest generational divides.

Baxter explains confidence comes with practice. She suggests calling friends and family first “to practise the ebb and flow of a two-way conversation in real time”.

Baxter stresses the importance of sitting up straight, speaking slowly and smiling as “the caller will hear it in your voice”.

Sophie Rains, a customer support and experience manager who manages a call centre, says that before dialling you should jot down “what the purpose of your call is and any relevant information. That way if you get nervous or confused you can refer back to your notes.”

If someone is rude or angry, Rains says: “I usually let them vent and eventually they run out of steam and are often a bit calmer.”

Rains says to remember not to take anything personally. “You don’t know what is going on in the caller’s life, or you might have caught them at a bad time.”

Colleagues and office chit-chat

Rather than fearing encounters with new people, Marie O’Riordan, an executive coach, suggests viewing it as an adventure, with many people making lifelong friends through work.

The former editor-in-chief of Marie Claire and Elle UK, who now specialises in helping women transition into leadership roles, says small talk can often lead to other opportunities.

She suggests starting with workplace topics such as how long someone has been with the company, rather than subjects such as someone’s home life, which could be considered too personal.

“Gen Z often underestimate how flattering it is to be asked questions,” O’Riordan says. “It shows a generosity and you can learn so much from other people.”

Early birds

If you need to set an early alarm, Dr Radha Modgil, the author of Know Your Own Power: Inspiration, Motivation and Practical Tools for Life, suggests treating yourself as if you were a child going back to school after the summer holidays. In the weeks leading up to a new job, start by bringing your bedtime and getting-up time forward.

For an efficient morning routine, take your start time and work backwards. “Look at travel timetables. Get your work clothes ready the night before. Lay out your breakfast,” Modgil says. “These are things that all sound very simple but they help prepare you and can reduce anxiety.”

According to the report, 28% of gen Z favoured flexible working hours and no emails after 6pm, while 32% wanted mental health days as standard. A desire to work from home was expressed by 68% of the respondents. Modgil says a lot of trepidation stems from gen Z feeling like the workplace will be detrimental to their wellbeing.

Modgil suggests treating each month like a marathon and coming up with a plan. “It helps to pace yourself so that you can be present and have the mental and emotional energy to work effectively.”

US natural gas prices are soaring as the country ships record amounts of the fuel overseas, contributing to an affordability crisis that is causing political problems for Donald Trump. 

Wholesale prices have jumped more than 70 per cent in the past 12 months, with the US benchmark Henry Hub price settling at $5.29 on Friday, its highest level since December 21 2022 during the energy crisis sparked by Russia’s full-scale invasion of Ukraine.

The price surge is contributing to a deepening sense of runaway costs in the US, and flies in the face of Trump’s claims to have driven down energy prices during his first year back in office.

It comes alongside frigid temperatures across the US, pushing up demand for power generation to heat homes and businesses.

Trump has prioritised boosting LNG exports overseas and gas production at home to fuel the AI boom, as part of a strategy to unleash “US energy dominance”.

But he faces growing pushback from consumers and industry concerned that rising power prices are worsening a “cost of living crisis” and denting competitiveness.

“As North America exports more natural gas, it imports higher and more volatile gas prices as a result,” said Clark Williams-Derry, analyst at the Institute for Energy Economics and Financial Analysis, a think-tank backed by environmental foundations.

“This is great news for the gas industry, which has seen a bump in revenues. But it’s not so great if you’re a US consumer who relies on gas for heating or power,” he said.

Analysts say it may also reflect a structural shift in gas pricing, as an increasing share of production is diverted to booming LNG exports and an anticipated rise in demand from energy-hungry artificial intelligence data centres.

“During the coldest days of winter, LNG exports and local consumers are competing for the same supply molecules. In extreme weather scenarios, there may not be enough gas supply to satisfy both,” said Eric McGuire, analyst at Wood Mackenzie, an energy consultancy.

Industrial Energy Consumers of America, a group representing large energy-consuming manufacturers, said US policymakers should prioritise domestic customers over LNG exports.

“As export volumes grow, price and reliability risks increase for US consumers and directly impact manufacturing competitiveness,” said Paul Cicio, chief executive of the Industrial Energy Consumers of America. 

“We do not have an alternative. We are stuck at the end of a pipeline.”

A Yahoo/YouGov poll published last week found that by a two-to-one margin, respondents believed Trump had done more to raise prices (49 per cent) than lower them (24%). This week, the president described cost-of-living concerns as a “con job by the Democrats”.   

During last year’s election campaign Trump promised to cut energy prices in half during his first 12 months in office — a message that resonated with voters stung by high inflation and energy costs during the Biden administration.

But since his election the cost of electricity and gas piped into homes has continued to climb, with rates increasing by 5.1 per cent and 11.7 per cent respectively in September, compared to a year earlier, data published by the US Bureau of Labor Statistics shows.

The average price of natural gas paid by electric power plants this year will increase by 37 per cent and the price paid by industrial sector customers will rise by 21 per cent compared to the 2024 averages, according to the Energy Information Administration, the US government’s statistical arm.

Residential and commercial consumers are expected to pay 4 per cent more this year on average, compared to last year.

In September the US exported a record 9.41mn metric tonnes of LNG, up nearly 20 per cent in the same month a year earlier, according to the EIA.

US LNG helped supply Europe during the worst energy crisis in decades, as the continent tried to wean itself off Russian energy after Moscow ordered the full-scale invasion of Ukraine, with the primary destination for US cargoes including Spain, France, the UK and the Netherlands.

The LNG industry and gas producers argue surging LNG exports are not to blame for rising retail prices, as there is no shortage of gas to drill in the US. Instead, they blame a political failure to enable the construction of new pipelines and gas storage facilities, to supply key markets.

“It’s not AI, it’s not LNG exports. It’s very simple. It’s because political force has overwhelmed market forces and political force has shown up in the form of pipeline and energy infrastructure blockages,” said Toby Rice, chief executive of EQT, the largest gas producer in the US.

A lack of infrastructure is causing markets in the US to become disconnected, according to EQT, which expects to sell gas for approximately $4 per million British thermal units this winter in Appalachia while Boston and parts of New England will pay a much higher rate of close to $14 per mmbtu for natural gas, owing to very limited pipeline capacity to the city.

“This isn’t just the most expensive natural gas in the country, it’s the most expensive natural gas in the world,” said Rice.  

But analysts say booming LNG supply, growing demand from data centres and rising cost of extracting gas from some US basins, such as the Haynesville, would maintain pressure on natural gas prices.

“Between now and 2030, LNG export capacity in the US Gulf Coast will double what it is currently and that will definitely have an impact on price,” said Mathieu Utting, analyst at Rystad.

A recent investigation into Intellexa, the Israeli spyware firm behind Predator— a one-click spyware tool that covertly infects devices to harvest sensitive data, including messages, photos, location, and audio, while also enabling remote surveillance and control — has uncovered evidence of its ongoing operations despite international sanctions, with some leaks indicating the use of the spyware in Pakistan

Jointly published by Haaretz, Inside Story and WAV Research Collective, the leaks reveal that Intellexa continues to operate its spyware systems with minimal disruption. Despite being sanctioned by the U.S Treasury Department in 2024 for selling spyware to various governments, Intellexa’s tools remain active.

Leaked documents suggest Intellexa staff retained remote access to customers’ surveillance operations. This included viewing data from devices infected by Predator, which exceeds what the firm has publicly disclosed and raises questions about the company’s accountability.

In addition, Intellexa has reportedly developed a new infection vector called “Aladdin”, which uses malicious online advertisements to infect users’ devices. This zero-click exploit is more insidious than previous methods, as simply viewing an ad can result in an infection, making surveillance far more stealthy and difficult to detect.

Predator in Pakistan

Leaks suggest Predator spyware has been used in Pakistan. In 2025, a human-rights lawyer in Balochistan received a suspicious WhatsApp link later linked to Intellexa’s spyware. This is reported as the first confirmed case of Predator spyware use in the country.

A senior Pakistani intelligence officer has reportedly rejected the claims, calling them “baseless” and suggesting the report was intended to undermine the country. Evidence from Amnesty’s Security Lab, including forensic data and technical analysis, suggests the situation is more complex

According to the report, Intellexa’s founder, Tal Dilian, has denied any criminal activity.

Once activated via the one-click method, Predator blends into background processes and collects sensitive information. It establishes a communication channel between the infected device and the attacker’s command-and-control server, allowing attackers to issue commands remotely.

The spyware regularly sends the stolen data to a remote server, where it is stored for analysis or further use. This data transfer happens in the background, without triggering alerts on the device.