DCGI approves Themis Medicare's VIRALEX for Covid-19 treatment - Business Guardian
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DCGI approves Themis Medicare’s VIRALEX for Covid-19 treatment

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In a landmark development for the treatment of COVID-19, Themis Medicare Ltd. (Themis), a Pharmaceutical company headquartered in Mumbai with a legacy of over 50 years of making new treatment options available, announced the approval of its antiviral drug VIRALEX® by the Drug Controller General of India (DCGI). As per the results of a double-blind randomized controlled trials (RCT), the drug helps in early relief of the clinical symptoms in mild to moderate COVID-19 patients.

Viralex® has been found to be effective and well tolerated in mild to moderate COVID-19, in two Randomized Controlled Clinical Trials conducted on 499 Indian patients. In line with the DCGI’s current approach for approval of medicines for the management of the ongoing pandemic, approval for VIRALEX® (Generic name: Inosine pranobex) is based on the results of the robust phase 2 and phase 3 RCTs conducted in India, and the well-established safety profile of the drug.

As per the results of the Phase 3 Randomized, Double-blind, Placebo-controlled Trial, 80.17 per cent of patients treated with VIRALEX® showed clinical improvement on day 6, which is significantly higher (p<0.001) from that in the controlled group
(52.38 per cent) among the mild to moderate non-hospitalized COVID-19 patients. Clinical Cure was also significantly higher in the VIRALEX® group as compared to that in the placebo group on day 6 of treatment. There was early improvement and cure from symptoms in patients who received VIRALEX®. This drug was well tolerated by the patients without any serious side effects. The study was conducted during the Delta wave of the pandemic.

Randomized, Double-Blind, Placebo-controlled, Multicentre Trial is considered as the clinical research methodology of the highest global standard for evaluating drugs against diseases. Themis is one of the few companies to submit data from a higher number of patients from RCTs for approval in management of COVID- 19.
After detailed deliberation, the drug regulatory authority granted permission to manufacture and market this new drug for restricted emergency use of the drug as an add on therapy for treatment of mild and moderate COVID-19.

VIRALEX® would be available on the prescription.
Based on the promising study results, the drug appears to offer immense clinical benefit to the patients in the early stages of COVID-19, thus reducing the load on the health care system.
VIRALEX® is an immunomodulatory agent with broad-spectrum antiviral properties. It enhances both innate & adaptive immunity and strengthens the body’s defence response to viral infections. In an in vitro study initiated by Themis, it showed dose-dependent inhibition of viral replication against SARS- CoV-2 (COVID-19).

According to Themis, VIRALEX® will be manufactured at an EU-GMP-certified facility with the highest safety standards and stringent manufacturing protocols in place, and the medication will be available in the form of a 500 mg tablet at a much affordable price.
Speaking at the release, Dr Sachin Patel, Managing Director & CEO of Themis Medicare Ltd. said, “Our endeavor has always been to develop medicines that benefit patients and make healthcare far, far more effective. Given the current scenario of grave health concerns and economic challenges surrounding COVID- 19 in India, this is our effort to contribute to the wellbeing of people of India”.
“Due to the frequently mutating trend of the virus, the uncertainties of the pandemic continue. We hope access to effective treatment such as VIRALEX® will offer a much-needed therapeutic solution, and if initiated early in the disease, it would reduce the load on the health care system”,
Commenting on the significance of this development, Dr Ashok Swain, Head Clinical Development, congratulated the entire Themis Medicare Ltd. team for achieving an important milestone of adding this effective medicine with an established safety profile to address the unmet need in the management of the pandemic.

“VIRALEX® is a new ray of hope in these challenging times,” he said.
Dr Raja Dhar, eminent pulmonologist and Director and Head of Department of Pulmonology, C K Birla Hospitals, said “Inosine Pranobex is a drug which enhances host immunity (immunomodulatory effect) and can affect viral RNA and hence inhibits growth of several viruses. Phase 3 Double blind RCTs are rare in COVID 19. I am heartened to hear that Themis Medicare has come up with such a trial, which shows early clinical response and shortened period of recovery when used in mild to moderate COVID 19 cases. This drug, if successfully used in clinical practice would considerably reduce the burden on health care system.
Dr Dhar is also the current Chair of Training and Education Initiatives, Indian Chest Society, and Director of Research and Training, National Allergy Asthma Bronchitis Institute.

With a strong R&D backup, skilled domestic & export teams, and 4 state-of-the- art manufacturing sites, the endeavour at Themis. has always been to support the medical fraternity with solutions for major unmet medical needs like VIRALEX® for COVID-19… and still counting!
Themis Medicare was incorporated in 1969 as a joint venture partnership at Vapi. Today, it is one of the fastest growing pharma Company specializing in the development of complex molecules. With strong research focus on injectables, complex generic products and drug-delivery systems, the Company has evolved into being a formidable player in the complex generics space.

It has a diversified business model with presence across the B2B model and strong presence in domestic B2C market. The Company also has a significant export presence in the RoW geographies. The qualified and experienced Management team is complemented by highly skilled R&D workforce. The Company has three vertically integrated manufacturing facilities, of which two are focused on developing APIs – 1 each involved in manufacturing Synthetic API and Fermentation based API, and 1 is involved in manufacturing of Finished Dosage Formulations. Themis offers products in various dosage forms in multiple therapeutics areas with leadership in Pain Management and Critical Care. The Company has a strategy to focus and grow its injectables portfolio and develop its NDDS presence.
For more details, please visit: www.themismedicare.com

Caution Concerning Forward-Looking Statements:
This document includes certain forward-looking statements. These statements are based on Management’s current expectations or beliefs and are subject to uncertainty and changes in circumstances. Actual results may vary materially from those expressed or implied by the statements herein due to changes in economic, business, competitive, technological and/or regulatory factors. The Company is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events, or otherwise.
This story is provided by Target Media. ANI will not be responsible in any way for the content of this article. (ANI/Target Media)

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BSF seizes gold biscuits at Indo-Bangladesh border, arrests Indian national

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Border Security Force (BSF) personnel apprehended an Indian national with gold biscuits in the Indo-Bangladesh border area following a tip-off. Acting on the intelligence received, troops from the Border Outpost (BOP) Hili-II of the 61 Battalion BSF under the Raiganj Sector of the North Bengal Frontier conducted an operation in the Dakshin Dinajpur district of West Bengal, resulting in the arrest of one Indian national identified as Jinnat Ali Mondal.

According to officials, Mondal was clandestinely carrying gold biscuits and was apprehended at the temporary fencing gate while attempting to cross from the village of Haripokhar, located ahead of the fence. During a thorough search conducted by the BSF, nine gold biscuits weighing a total of 1039.440 grams were recovered from Mondal’s possession. Subsequently, Mondal, along with the seized gold biscuits, was handed over to the Preventive Unit of Customs at Hili for further legal proceedings.

This incident is not the first of its kind in the region, as BSF troops had previously recovered four gold biscuits weighing 466.020 grams from the same area of BOP Hili on September 7, 2023, indicating the persistent nature of attempts to smuggle contraband across the border.

Meanwhile, in a separate operation conducted by the BSF’s Punjab frontier force on May 15, vigilant troops intercepted the movement of a drone ahead of the border fence in the Tarn Taran district. Following protocol, BSF personnel tracked the drone’s movement and sought to neutralize it. The suspected dropping zone was cordoned off, and an extensive search operation was launched. Subsequently, BSF troops successfully recovered a small drone with one packet of suspected heroin attached to it. The recovered packet, weighing approximately 550 grams, was wrapped in transparent adhesive tape, containing two smaller packets wrapped in yellow adhesive tape. Additionally, a ring made of nylon rope was found attached to the main packet. The recovered drone, identified as a DJI Mavic 3 Classic model manufactured in China, was found in a partially broken condition.

In a statement, the BSF commended the keen observation and timely reaction of its diligent troops on duty, which once again demonstrated their commitment to preventing the entry of narcotics through drones from across the border. These incidents highlight the multifaceted challenges faced by security forces in safeguarding India’s borders against illegal activities, including the smuggling of contraband such as gold and narcotics. Despite the vigilance and proactive measures adopted by security personnel, perpetrators continue to devise new methods to evade detection and circumvent border security measures.

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Legally Speaking

Supreme Court holds off on decision in Baba Ramdev contempt case

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The Supreme Court has deferred its decision on a contempt notice issued against yoga guru Ramdev, his associate Balkrishna, and their company Patanjali Ayurved in connection with a case involving misleading advertisements. The bench, comprising Justices Hima Kohli and Ahsanuddin Amanullah, stated, “Orders on the contempt notice issued to respondents 5 to 7 (Patanjali Ayurved Ltd, Balkrishna, and Ramdev) are reserved.” The Uttarakhand State Licensing Authority (SLA) informed the court that manufacturing licenses for 14 products of Patanjali Ayurved Ltd and Divya Pharmacy have been suspended immediately. The Supreme Court noted that the counsel representing the firm had requested time to submit an affidavit detailing the actions taken to retract the advertisements of Patanjali products and to recall the medicines.

Highlighting the importance of public awareness and responsible influence, the court emphasized that Baba Ramdev wields significant influence and should employ it responsibly. It awaits an affidavit from Patanjali outlining the measures implemented to withdraw the existing misleading advertisements of the company’s products, with instructions for submission within three weeks.

During the proceedings, Indian Medical Association (IMA) President R V Asokan extended an unconditional apology to the bench for remarks made against the top court in a recent interview with news agency PTI. Justice Kohli conveyed to Asokan that public figures cannot criticize the court in media interviews. However, the court indicated its disinclination to accept the apology affidavit submitted by the IMA president at present. In an earlier hearing on May 7, the apex court had denounced Asokan’s statements as “very, very unacceptable.” The court reiterated its stance that celebrities and social media influencers are equally liable for the products they endorse, warning that if such products are found to be misleading, they could face repercussions.

The case stems from a plea filed in 2022 by the IMA alleging a smear campaign by Patanjali against the Covid-19 vaccination drive and modern medical systems. As the legal proceedings unfold, the Supreme Court continues to emphasize the importance of accountability and responsible conduct in advertising and public discourse. The case underscores the need for stringent regulations to curb misleading advertisements and ensure consumer protection. With the demand for transparency and ethical practices on the rise, the judiciary plays a pivotal role in upholding standards of integrity in commercial communications.

As the court awaits the submission of the affidavit from Patanjali, stakeholders across industries are keenly observing the developments, anticipating their implications on advertising practices and regulatory enforcement in the country.

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Vantage Markets & Cristina Gutierrez Honor Moms

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Gutierrez’s exceptional success in motorsport is rooted in her deep connection to her mother’s guidance, which she gratefully acknowledges as the foundation of her journey.

Vantage Markets, a prominent multi-asset broker, is joining in the celebration of Mother’s Day alongside NEOM McLaren Extreme E Driver, Cristina Gutierrez, emphasizing the significance of family support and values in her successful career. In an exclusive interview with Vantage, Gutierrez attributes her championship journey to the values instilled by her mother, highlighting perseverance, loyalty, and the importance of family as guiding principles. She reminisces about her first Dakar Rally experience in 2017, where her mother’s presence made the achievement particularly memorable for the entire family. Despite her remarkable achievements in motorsport, Gutierrez remains deeply connected to her mother’s guidance and wisdom, acknowledging her roots and expressing gratitude for the experiences life has offered her.

Vantage extends warm wishes to all mothers and their families on Mother’s Day, with Marc Despallieres, Chief Strategy and Trading Officer, emphasizing Gutierrez’s journey as a testament to maternal support and guidance. Vantage’s celebration follows their recent International Women’s Day campaign with Gutierrez, amplifying messages of empowerment and inclusion.

Vantage Markets, also known as Vantage, offers clients access to a diverse range of trading products, including Forex, Commodities, Indices, Shares, ETFs, and Bonds. With over 13 years of market experience, Vantage provides a trusted trading ecosystem and user-friendly platforms, empowering clients to seize trading opportunities.

As Vantage continues to champion diversity and inclusion, they proudly support Gutierrez and mothers worldwide, recognizing the invaluable role of family support in personal and professional success. This heartfelt celebration underscores the enduring bond between mothers and their children, highlighting the influence of family values in shaping individuals’ lives and careers.

On this special occasion of Mother’s Day, Vantage Markets, in collaboration with NEOM McLaren Extreme E Driver Cristina Gutierrez, takes a moment to honor the profound impact of maternal support and guidance. Gutierrez’s journey to championship glory serves as a poignant reminder of the role mothers play in shaping their children’s destinies. As Gutierrez reflects on her achievements, she attributes much of her success to the core values instilled by her mother: perseverance, loyalty, and the importance of family. These principles have not only propelled her forward on the racetrack but have also guided her through life’s challenges.

One particularly memorable moment Gutierrez shares is her first Dakar Rally experience in 2017, where her mother’s presence made the triumph all the more meaningful. The shared joy of accomplishment underscored the tight-knit bond that exists within their family, leaving an indelible mark on Gutierrez’s heart. Despite her ascent to motorsport stardom, Gutierrez remains grounded in her roots, cherishing the wisdom and guidance passed down by her mother. She expresses gratitude for the lessons learned and the unwavering support that continues to fuel her journey.

Vantage Markets extends heartfelt wishes to all mothers and their families, recognizing the immeasurable contributions they make every day. Chief Strategy and Trading Officer Marc Despallieres emphasizes Gutierrez’s story as a testament to maternal love and encouragement, echoing sentiments of empowerment and inclusion.

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International Affairs

Japan’s Teleworking shrinks, Hybrid work surges: Govt. survey

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With the gradual decline of the COVID-19 pandemic, Japan is observing a significant change in work dynamics, as more people adopt a “hybrid work” approach, blending remote and in-office work. Insights from the fiscal 2023 government survey, administered by the transport ministry in October and November, illuminate the shifting teleworking landscape in the nation.

According to the survey results, the proportion of teleworkers in Japan has declined, with 16.1 percent of the 36,228 respondents reporting working from home or elsewhere outside the office in the last year. This represents a decrease of 2.7 percentage points from the previous survey. The decline marks a departure from the peak teleworking period during the height of the pandemic, reflecting a gradual return to pre-pandemic work arrangements.

Teleworking emerged as a prominent strategy during the pandemic, as the government sought to reduce the flow of people and curb the spread of infections. However, the survey highlights a discernible shift in this trend as the pandemic situation evolves. The ratio of teleworkers stood at 21.4 percent in the fiscal 2021 survey, declining to 18.8 percent the following year, and further dropping to 16.1 percent in fiscal 2023.

Despite the decrease in teleworking overall, the survey indicates that the average frequency of teleworking remains relatively stable, with individuals teleworking an average of 2.3 days per week, unchanged from the previous year. However, there has been a noticeable change in the distribution of teleworking frequency. Following the government’s decision to downgrade the legal status of COVID-19 in May last year, aligning it more closely with seasonal influenza, there has been a notable increase in the number of individuals working remotely for one or two days a week. Conversely, the proportion of those working remotely for five to seven days a week has decreased.

A ministry official attributed this shift to a growing trend of combining office-based work with telework, reflecting a broader adaptation to changing work dynamics in the post-pandemic era. This hybrid work model allows individuals to enjoy the benefits of both remote work, such as flexibility and reduced commuting time, and in-office collaboration and social interaction.

The survey also highlights regional variations in teleworking rates, with bigger cities exhibiting higher rates of remote work. For instance, the greater Tokyo area, including Tokyo and its surrounding prefectures, recorded a teleworking rate of 28 percent, indicating a strong prevalence of remote work practices in Japan’s bustling capital. In comparison, regions such as the Kinki region (covering Osaka and Kyoto) and the Chukyo region (centered on Nagoya) reported lower teleworking rates.

Overall, the findings of the fiscal 2023 government survey underscore the evolving nature of work arrangements in Japan, characterized by a shift towards hybrid work models that blend remote work with traditional office-based work. As organizations and individuals continue to adapt to the post-pandemic reality, flexible work arrangements are likely to remain a key feature of Japan’s work culture, promoting efficiency, resilience, and work-life balance in the years to come.

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Global light show: Solar storm wows, no major issues reported

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A potent solar storm treated observers to a stunning celestial display worldwide overnight, resulting in seemingly minor disruptions to the electrical grid, communication networks, and satellite positioning systems. The US National Oceanic and Atmospheric Administration (NOAA) said extreme geomagnetic storm conditions continued Saturday, and there were preliminary reports of power grid irregularities, degradation of high-frequency communications and global positioning systems. But the Federal Emergency Management Agency said that, so far, no FEMA region had reported any significant impact from the storms.

The US Department of Energy said Saturday it is not aware of any impact from the storms on electric customers. NOAA predicted that strong flares will continue through at least Sunday, and a spokeswoman said via email that the agency’s Space Weather Prediction Center had prepared well for the storm. Brilliant purple, green, yellow and pink hues of the Northern Lights were reported worldwide, with sightings in Germany, Switzerland, China, England, Spain and elsewhere.

NOAA issued a rare severe geomagnetic storm warning when a solar outburst reached Earth on Friday afternoon, hours sooner than anticipated. The agency alerted operators of power plants and orbiting spacecraft, as well as FEMA, to take precautions. “For most people here on planet Earth, they won’t have to do anything,” said Rob Steenburgh, a scientist with NOAA’s Space Weather Prediction Center, as quoted by AP. “That’s really the gift from space weather: the aurora,” Steenburgh said.

He and his colleagues said the best views may come from phone cameras, which are better at capturing light than the naked eye. The most intense solar storm in recorded history, in 1859, prompted auroras in Central America and possibly even Hawaii. This storm poses a risk for high-voltage transmission lines for power grids, not the electrical lines ordinarily found in people’s homes, NOAA space weather forecaster Shawn Dahl told reporters. Satellites also could be affected, which in turn could disrupt navigation and communication services here on Earth.

An extreme geomanetic storm in 2003, for example, took out power in Sweden and damaged power transformers in South Africa. Following the storm’s passing, NOAA warns that signals between GPS satellites and ground receivers may experience interference or interruption. However, due to the abundance of navigation satellites, any disruptions are expected to be brief, as highlighted by Steenburgh.

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March records 449 Infra projects with Rs 5.01 trillion cost overrun: MoSPI

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An official report revealed that in March 2024, a total of 449 infrastructure projects, each requiring an investment of Rs 150 crore or more, experienced a cost overrun exceeding Rs 5.01 trillion. The Ministry of Statistics and Programme Implementation (MoSPI), responsible for monitoring infrastructure projects valued at Rs 150 crore and higher, indicated that out of 1,873 projects surveyed, 449 encountered cost overruns while 779 projects faced delays.

“The total original cost of implementation of the 1,873 projects was Rs 26,87,535.69 crore and their anticipated completion cost is likely to be Rs 31,88,859.02 crore, which reflects an overall cost overrun of Rs 5,01,323.33 crore (18.65 per cent of the original cost),” the ministry’s latest report for March 2024 said.

According to the report, the expenditure incurred on these projects till March 2024 is Rs 17,11,648.99 crore, which is 53.68 per cent of the anticipated cost of the projects. However, the number of delayed projects decreased to 567 if the delay is calculated based on the latest schedule of completion, it added.

Further, it said that for 393 projects, neither the year of commissioning nor the tentative gestation period has been reported. Out of the 779 delayed projects, 202 have overall delays in the range of 1-12 months, 181 have been delayed for 13-24 months, 277 projects for 25-60 months, and 119 projects have been delayed for more than 60 months. The average time overrun in these 779 delayed projects is 36.04 months.

Reasons for time overrun, as reported by various project implementing agencies, include delay in land acquisition, obtaining forest and environment clearances, and lack of infrastructure support and linkages. Delays in tie-up for project financing, finalization of detailed engineering, change in scope, tendering, ordering, and equipment supply, and law and order problems are among other reasons.

The report also cited state-wise lockdowns due to Covid-19 (imposed in 2020 and 2021) as a reason for the delay in the implementation of these projects. It has also been observed that project executing agencies are not reporting revised cost estimates and commissioning schedules for many projects, which suggests that time/cost overrun figures are under-reported, it added.

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