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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval. “The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen to NYSE. Adding that the company is in discussions with the FDA on the additional documents required to clear its application. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Shankar Musuniri, chief executive of Ocugen.

This development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.

The company has been betting on being able to launch its vaccine in regulated markets as it looks to gain validation at a time where authorization of a covid vaccine from WHO or a regulator such as USFDA or the European Union is needed to cross borders. At present, several countries do not recognize the Bharat Biotech vaccine, and those who have received two doses of the vaccine are considered “unvaccinated” in some countries.

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The Madras High Court has granted early screenings of Vijay’s Leo movie from 7 AM, requesting the TN government to resolve any issues.

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The Madras High Court has granted early screenings of Vijay’s Leo movie from 7 AM, requesting the TN government to resolve any issues.

Madras High Court Grants Early Screenings of Vijay’s “Leo” Movie at 7 AM, Urges TN Government to Address Concerns

The Madras High Court has made a landmark decision in favor of the much-anticipated Tamil film “Leo,” starring actor Vijay. In a significant move, the court has granted permission for early screenings of the movie from 7 AM, urging the Tamil Nadu government to swiftly address any issues and facilitate the smooth release of the film. This decision marks a pivotal moment in the realm of Tamil cinema and the entertainment industry at large.

Historical Context:

The Indian film industry, particularly the Tamil film industry, has seen its share of controversies and challenges related to film releases. Issues such as censorship, political disputes, and public sentiment have often played a significant role in shaping the release schedules and screening times for films. Vijay, one of Tamil cinema’s most prominent actors, has been at the center of such controversies in the past. This decision by the Madras High Court is, therefore, particularly noteworthy.

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The Ruling:

The Madras High Court’s decision to permit early screenings of “Leo” comes as a response to a plea filed by the film’s producers. The court, while considering the plea, took into account various factors, including the film’s anticipated popularity and the prevailing circumstances. The court emphasized the importance of accommodating the audience’s interests and allowing them to enjoy the film without disruptions.

A Step Towards Normalization:

The court’s decision signifies a positive shift in the film industry, where release dates and screening times are often mired in controversy. By allowing screenings to commence at 7 AM, the court aims to reduce the chances of public unrest and congestion near theaters, especially in the wake of high-profile film releases.

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The Role of the Tamil Nadu Government:

The Madras High Court, in its ruling, also called upon the Tamil Nadu government to cooperate in ensuring a seamless release for the film. This cooperation extends to providing necessary security measures to maintain law and order around theaters during the early screenings.

Implications for the Entertainment Industry:

The decision is expected to set a precedent for the release of other highly anticipated films, not just in Tamil cinema but also in the broader Indian film industry. The court’s emphasis on the importance of accommodating the audience’s interests could lead to more flexible screening times for movies in the future.

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The Audience’s Perspective:

For moviegoers and fans of Vijay, this decision comes as a welcome relief. They can now look forward to enjoying the film without any undue delays or disruptions, ensuring a memorable cinematic experience.

In conclusion, the Madras High Court’s ruling to allow early screenings of Vijay’s “Leo” at 7 AM while urging the Tamil Nadu government to resolve any issues paves the way for a more audience-centric approach in the film industry. It is a landmark decision that highlights the importance of balancing the interests of filmmakers and the movie-loving public. This judgment is poised to make a positive impact on the release of future films, ushering in a new era of flexibility and convenience for cinema enthusiasts.

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