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New Study of Ketamine for Depression Disorders Gets FDA Approval, But Not Medical Marijuana

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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.

Source: https://cannabis.net/blog/medical/new-study-of-ketamine-for-depression-disorders-gets-fda-approval-but-not-medical-marijuana

Business

Alleged Crores Pharma Scam Mastermind Arrested from Surat

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After evading law enforcement for nearly 13 years, an accused linked to a large-scale pharmaceutical fraud case has been arrested by Delhi Police from Surat, Gujarat. The suspect is alleged to have orchestrated a series of financial scams involving fake identities, forged documents, and dishonoured cheques used to procure high-value pharmaceutical raw materials.

Authorities say the accused, identified as Himmat Singh Lodha, is believed to have defrauded multiple pharmaceutical companies in Delhi of goods worth approximately ₹98 lakh before disappearing and remaining underground for years.

Fake Business Deals and Dishonoured Cheques Used in Fraud

Investigators claim the accused posed as a legitimate pharmaceutical trader and placed bulk orders for expensive drug ingredients, offering post-dated cheques as payment security.

In one documented case from 2013, he allegedly obtained around 550 kilograms of Gliclazide, a diabetes-related pharmaceutical ingredient, valued at over ₹26 lakh. When suppliers attempted to encash the cheques, they were reportedly returned with the remark “account closed.”

Following the transaction, the accused allegedly vacated his office and rented residence and disappeared without settling payments. He was later declared a proclaimed offender in 2016 after repeatedly failing to appear before court proceedings. Authorities had also issued a reward for information leading to his arrest.

Multiple Identities and Repeated Fraud Pattern

Police investigations further link the accused to another cheating case dating back to 2012, where he allegedly used a fake identity, “Kailash Jain,” to obtain a large consignment of Ambroxol HCL, a pharmaceutical compound used in cough medications. The value of that consignment was estimated at around ₹72 lakh.

Officials believe the accused followed a consistent modus operandi—posing as a credible businessman, securing high-value goods on deferred payment terms, and then disappearing after delivery while shutting down business operations.

Investigators suspect that forged business records, fake company credentials, and fabricated financial histories were used to build trust with suppliers and gain access to expensive raw materials.

Multi-State Surveillance Leads to Arrest in Surat

A special Crime Branch team tracked the accused through coordinated surveillance efforts across multiple cities, including Mumbai, Ahmedabad, and Surat. After nearly a month of technical monitoring and intelligence gathering, officials located and arrested him from a residential area in Surat.

Authorities also revealed that the accused had been involved in property-related activities while staying under the radar to avoid detection.

Growing Threat of Corporate Identity Fraud

The case highlights a rising trend of organised financial fraud targeting industries that rely heavily on trust-based transactions and deferred payments. Experts note that criminals increasingly exploit gaps in corporate verification systems by using fake GST registrations, temporary offices, and forged documentation to appear legitimate.

Cybercrime and financial fraud specialists warn that such schemes are becoming more complex with the widespread availability of digital business tools, making it easier to create convincing but fraudulent corporate identities.

Experts Urge Stronger Due Diligence in High-Value Transactions

Experts, including former IPS officer and cybercrime specialist Prof. Triveni Singh, emphasize the need for stricter verification procedures in commercial dealings. He noted that relying solely on paperwork or digital business profiles can expose companies to significant financial risk.

Authorities and industry experts recommend physical verification of business operations, bank account validation, and detailed background checks before engaging in high-value or deferred-payment transactions—particularly in sectors like pharmaceuticals, where single consignments can involve transactions worth crores.

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EU Pressure Builds on Google as Regulators Face Calls for Massive Fine Over Search Practices

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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.

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Amazon Faces Potential Criminal Trial in Italy Over €1.2 Billion Tax Evasion Allegations

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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.

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