Business
New Study of Ketamine for Depression Disorders Gets FDA Approval, But Not Medical Marijuana
Can Ketamine help fight depressive disorders?
The need for intense clinical research on the medical potentials of ketamine has always existed, however getting approval for such research has always been a problem. This is why the recent approval given by the FDA for a study on the use of ketamine infusion for depressive disorder has caught the eyes of many. It comes after a series of advocates have reportedly called for an increase in the available clinical data on the efficacy of ketamine for such conditions. Read on as we take a look into the nitty-gritty of this new test and what its results could mean for patients dealing with depressive disorder.
The new study in focus
The FDA recently finalized its review of the EHVVF IND application of Ehave Inc. for assessing the use of ketamine in patients dealing with Major Depressive Disorder (MDD). The company received full approval for the study where it will be assessing the clinical efficacy of low-dose, weekly intravenous (IV) ketamine infusion for MDD. This comes after the FDA has also approved a study for the use of ketamine in the prevention of injury during organ transplant. This shows that the FDA is more particular about ketamine in terms of approving clinical studies for a wider knowledge base.
The approved study is an open-label trial which will require 35 specific participants. The selected participants will have shown insufficient response to two FDA-approved therapies for MDD. This will also include the current first line of antidepressant therapy used in a sufficient dose and appropriate duration. According to the CEO of Ehave Ben Kaplan, this clinical trial will signify a key milestone in the history of the company’s clinical programs. It is also expected to be a breakthrough for patients dealing with MDD.
The importance of EEG to the study
Kaplan recently reinforced the justification of this new study and why it is said to possess much potential. He states that though ketamine has not been approved yet by the FDA for the remission of symptoms in patients living with MDD, it has significant potential. This is why the study will be making use of an electroencephalography machine to determine the activity of the brain during the administration of the infusion. The machine will also detect the concurrent responses of the brain to the infusion of ketamine being administered. The addition of the EEG machine further increases the complexity of the study and shows why there is much attention to it across borders.
The usefulness of the EEG machine in this study was also echoed by Dr Ali who is a board member at Ehave. He states that the use of the machine to observe brain changes is pivotal to identifying potential biomarkers that are yet untapped in times past. These biomarkers can then be used later to identify patients with MDD that can respond to the treatment with ketamine infusion upfront. This will encourage quicker recommendations to be made to patients. It is also expected to reduce the degree of trial-and-error use in the course of treatment of patients.
Benefits of ketamine therapy over conventional treatments
The current FDA-approved depression treatments involve the use of selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), and tricyclic antidepressants (TCA). Psychotherapy has also been actively used as an approved mode of treatment for depression yet all have proven ineffective for severe cases. The ineffectiveness of these common classes of pharmaceuticals led to the search for new drugs that can prove effective as an antidepressant. This led to the repurposing of anaesthetic ketamine as an antidepressant and off-label analgesic and is the basis for the current inquiry into the potential of ketamine with MDD.
The discovery of ketamine as a potential antidepressant has been a breakthrough, particularly for patients with MDD. This has spurned the demand for research on its effectiveness and degree of activity. The clinical research conducted on ketamine showed the disadvantages of the intravenous administration of ketamine. These symptoms include patient discomfort, serious adverse reactions, and increased risk of diversion to the grey market. Racemic ketamine has always been used traditionally intravenously as an anaesthetic at high doses however its use as an antidepressant is effective at lower doses.
The benefit of IV administration of ketamine at low doses for MDD has been actively spelt out by Ehave. The commencement of the therapy at low doses creates room for greater dose control and will allow for appropriate modulation of the dose with respect to the patient. The use of IV ketamine also offers the advantage of reduced cost of drug acquisition. This is bound to be good news for patients dealing with MDD as it reduces the economical demand for managing the condition.
What to expect after the results of the study
Some outpatient clinics in the U.S. are already offering IV ketamine therapy for patients dealing with MDD. These clinics have provided results that show the efficacy of the ketamine treatment for patients with MDD. We can therefore expect the number of such clinics to increase after the completion of this study and the delivery of results. If the efficacy of ketamine at low doses is sufficiently established, it will spark a new life in the quest for appropriate therapies used for depressive disorders.
This is just one in the line of new therapies that companies such as Ehave are beckoning on the FDA to give approval on to facilitate research. Once approval is given, there is room for exploration into the potential of these drugs and their efficacy in different conditions. In the case of ketamine, the conditions and intravenous administration and low dose usage. This can also be applied or modified to see its efficacy on other conditions related to depressive disorders. One thing that remains sure for now is that an increase in research is beneficial to both patients and health professionals and that is what we need at the moment.
Business
EU Pressure Builds on Google as Regulators Face Calls for Massive Fine Over Search Practices
A growing coalition of European industry groups is intensifying pressure on regulators to take decisive action against Google over allegations of unfair search practices that could reshape competition rules across the region’s digital economy.
Investigation Under Digital Markets Act Gains Momentum
The case is being examined by the European Commission under the European Union’s landmark Digital Markets Act (DMA), introduced to curb the dominance of major technology platforms and ensure fair competition.
Launched in March 2024, the investigation focuses on whether Google has been prioritising its own services in search results, potentially disadvantaging rival businesses that rely on online visibility to reach customers.
Industry Groups Demand Swift Action
Several prominent European organizations have jointly urged regulators to conclude the probe without further delay. They argue that prolonged investigations allow alleged anti-competitive practices to continue, putting European companies—especially startups—at a disadvantage.
Signatories include the European Publishers Council, the European Magazine Media Association, the European Tech Alliance, and EU Travel Tech.
In a joint statement, these groups warned that delays in enforcement are affecting innovation, profitability, and growth prospects for regional businesses competing in digital markets.
Google Denies Allegations
Google has rejected claims of bias, stating that its search algorithms are designed to deliver the most relevant and useful results to users. The company has also proposed adjustments to address regulatory concerns.
However, critics argue that these changes are insufficient and fail to address the core issue of market dominance.
Potential Billion-Euro Penalties
If found in violation of the DMA, Google could face significant financial penalties. Under EU rules, fines can reach a substantial percentage of a company’s global turnover, potentially amounting to billions of euros.
Regulators may also impose corrective measures requiring changes to business practices, which could have long-term implications for how digital platforms operate in Europe.
Wider Implications for Big Tech
The case highlights ongoing tensions between European regulators and major U.S. technology firms. In recent years, the EU has taken a more aggressive stance in enforcing competition laws, aiming to create a level playing field for local businesses.
A final ruling against Google could set a major precedent, influencing future enforcement actions and shaping the regulatory landscape for global tech companies operating within Europe.
As scrutiny intensifies, the outcome of the investigation is expected to play a critical role in defining the future of digital competition across the European Union.
AI & Technology
Amazon Faces Potential Criminal Trial in Italy Over €1.2 Billion Tax Evasion Allegations
Milan: U.S. tech giant Amazon is facing the prospect of a major legal showdown in Italy, after prosecutors in Milan formally requested a court to move forward with criminal proceedings over alleged tax evasion totaling approximately ₹12,500 crore (€1.2 billion).
The case targets Amazon’s European division along with four senior executives, marking one of the most significant tax-related investigations involving a global e-commerce platform in Europe.
Trial Push Despite Multi-Million Euro Settlement
The move comes even after Amazon reached a financial settlement with Italian tax authorities in December, agreeing to pay around ₹5,500 crore (€527 million), including interest, to resolve part of the dispute.
Typically, such settlements lead to the closure of criminal investigations. However, Milan prosecutors have opted to proceed, signaling a tougher stance on alleged corporate tax violations.
A preliminary hearing is expected in the coming months, where a judge will decide whether to formally indict the company and its executives or dismiss the case.
Allegations of VAT Evasion Through Marketplace Sellers
At the center of the investigation are claims that Amazon’s platform enabled non-European Union sellers to avoid paying value-added tax (VAT) on goods sold to Italian consumers between 2019 and 2021.
Prosecutors allege that the company’s marketplace structure allowed thousands of foreign vendors—many reportedly based in China—to operate without fully disclosing their identities or tax obligations. This, authorities argue, led to substantial VAT losses for the Italian government.
Under Italian law, online platforms facilitating sales can be held partially liable if third-party sellers fail to comply with tax requirements, a key point in the prosecution’s case.
Italian Government Named as Affected Party
In their filing, prosecutors identified Italy’s Economy Ministry as the injured party, citing significant financial damage resulting from the alleged tax evasion.
Legal experts say the outcome of the case could have wide-ranging implications across the European Union, where VAT systems are harmonized and similar compliance rules apply to digital marketplaces.
Multiple Investigations Add to Pressure
The VAT probe is just one of several legal challenges facing Amazon in Italy. The European Public Prosecutor’s Office is reportedly examining additional tax-related issues covering more recent years.
Meanwhile, Milan authorities are pursuing separate investigations into alleged customs fraud linked to imports from China and whether Amazon maintained an undeclared “permanent establishment” in Italy—potentially exposing it to higher tax liabilities.
In a separate regulatory action, Italy’s data protection authority recently ordered an Amazon unit to stop using personal data from over 1,800 employees at a warehouse near Rome.
Amazon Denies Allegations
Amazon has consistently denied wrongdoing and indicated it will strongly contest the allegations in court if the case proceeds. The company has also warned that prolonged legal uncertainty could impact investor confidence and Italy’s appeal as a destination for international business.
Broader Impact on Europe’s Digital Economy
If the case moves to trial, it could become a landmark moment for the regulation of global e-commerce platforms in Europe. Governments across the region are increasingly scrutinizing how digital marketplaces handle tax compliance, especially in cross-border transactions.
With online retail continuing to expand, regulators are under mounting pressure to ensure that multinational platforms and third-party sellers adhere to the same tax rules as traditional businesses.
Aviation
IndiGo Crisis Exposes Risks of Monopoly: What If Telecom or E-commerce Collapses Next?
Airports across India witnessed scenes of distress and confusion as thousands of passengers were stranded due to IndiGo’s massive flight disruptions. Families with medical emergencies, funerals, and personal crises were left helpless as the airline cancelled hundreds of flights without adequate communication or support.
Passengers described desperate situations — a mother pleading for sanitary pads for her daughter, a woman unable to transport her husband’s coffin, and others stranded while trying to reach family funerals or hospitals. “It was like a lockdown at the airport,” one passenger said, describing the panic that unfolded as IndiGo’s mismanagement crippled operations nationwide.
Root Cause: IndiGo’s Market Monopoly
The turmoil, industry experts argue, stems from IndiGo’s monopolistic control over India’s domestic aviation market. The airline operates nearly 2,100 flights daily and holds around 60% market share — meaning every second plane flying within India belongs to IndiGo.
This dominance has given the company unparalleled influence. When IndiGo falters, the entire aviation system suffers. Passengers are left with few alternatives, as other airlines lack capacity to absorb stranded travellers. The result: skyrocketing ticket prices, chaos at terminals, and total dependence on a single private operator.
Aviation pioneer Captain G.R. Gopinath, founder of Air Deccan, criticised the government’s inaction, noting that on some routes, IndiGo’s economy fares surged to ₹1 lakh. He compared the situation to a hostage crisis, writing that the airline “held the system ransom” and forced regulators to defer new safety rules meant to protect pilots and passengers.
Government Intervention and Regulatory Weakness
The crisis erupted after IndiGo failed to comply with the Flight Duty Time Limitations (FDTL) — rules introduced by the DGCA in January 2024 requiring adequate rest for pilots. Despite having nearly two years to adapt, IndiGo blamed the rule for operational disruptions, citing a shortage of pilots.
Under mounting public pressure, the government stepped in, temporarily relaxing FDTL norms and capping airfare hikes. Officials claimed the move was to protect passengers, but analysts say it exposed the state’s vulnerability to corporate monopolies. “The government had no option but to yield,” said one aviation policy expert, pointing out that ignoring safety regulations for short-term relief could have long-term consequences.
The crisis also rekindled memories of the June 2025 Air India crash near London, which claimed over 240 lives. Experts warn that compromising pilot rest and safety standards to maintain flight schedules could risk another tragedy.
If Telecom Giants Fail: A National Paralysis
The article raises a troubling question — what if a similar crisis struck the telecom sector, where Jio and Airtel together control nearly 80% of subscribers and serve over 780 million users?
If both networks failed simultaneously, the repercussions would be catastrophic. Internet shutdowns would halt UPI transactions, online banking, OTP verifications, video calls, OTT streaming, and emergency communications. Critical services such as airports, hospitals, stock exchanges, and small businesses — many of which rely on WhatsApp and digital payments — would come to a standstill.
In essence, a telecom breakdown could paralyse India’s digital economy, exposing the nation’s dependence on a duopoly.
E-commerce Monopoly: Another Fragile Ecosystem
The same risk looms over the e-commerce sector, where Amazon and Flipkart dominate nearly 80% of the market. A disruption similar to IndiGo’s could cripple daily life — halting delivery of groceries, medicines, and essential goods, freezing refunds and customer support, and leaving small sellers without platforms to trade.
Local retailers, freed from competition, might exploit shortages by inflating prices. Such a scenario underscores the perils of market centralisation in sectors critical to everyday living.
A Wake-Up Call for Regulators
The IndiGo crisis, analysts say, is a warning shot for policymakers and regulators. A single company’s operational failure exposed systemic weaknesses in India’s infrastructure and consumer protection mechanisms.
As the aviation regulator DGCA investigates and IndiGo works to restore normalcy, the broader lesson remains clear: unchecked monopoly power in any essential service — whether air travel, telecom, or e-commerce — poses a direct threat to economic stability and citizen welfare.
Without stronger competition laws, redundancy frameworks, and regulatory oversight, India risks repeating this crisis across multiple sectors — each time with millions of citizens paying the price.
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