US Drug Regulator Approves Valneva's Single-Shot Chikungunya Vaccine Published 32 minutes ago

Posted By: Vishal Maurya Posted On: Nov 10, 2023

The US Food and Drug Administration (FDA) has approved Valneva's single-shot vaccine for individuals 18 years of age and older who are at increased risk of exposure to the chikungunya virus. Valneva's vaccine, with the brand name Ixchiq, is the first preventive shot to be approved in the country for the mosquito-borne disease.

“Today, the U.S. Food and Drug Administration approved Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus,” the FDA said in a statement on Thursday.

Chikungunya virus spreads to people through the bite of an infected mosquito. The virus is primarily transmitted to people through the bite of an infected mosquito. The most common symptoms of infection are fever and joint pain. Other symptoms may include headache, muscle pain, joint swelling or a rash. According to FDA, Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years.

The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.

This US approval for the vaccine is based on late-stage trials, which showed the vaccine was able to induce antibody levels that could neutralize the chikungunya virus in 98.9 percent of participants for 28 days post-vaccination. The US health regulator, however, asked the company to conduct a post-marketing study to assess the risk of severe chikungunya-like adverse reactions following administration of Ixchiq.

(With agency inputs)

Source: News18
Related Posts: CHIKUNGUNYA,FDA

Comment on Post

Leave a comment

If you have a News HTS user account, your address will be used to display your profile picture.



Lupin's Mandideep facility receives EIR from USFDA

Posted By: Ramesh Sharma Posted On: Oct 31, 2023
Lupin gets Establishment Inspection Report from the US health regulator for its Mandideep plant

Drug maker, Lupin, received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Mandideep Unit-2 facility in Madhya Pradesh.

The US drug regulator issues an EIR to a company when an inspection is satisfactorily closed. Lupin received EIR after the last inspection of its Mandideep-based facility was conducted from August 7 to August 11, 2023. Shares of the drug firm ended 1.04 percent down at ₹1,128.40 apiece on the BSE.

Also Read: Lupin Q2 Results: Board to meet on November 8 to discuss unaudited results

This month, the pharma major received approval from the US FDA to market its generic Fluconazole tablets and another generic medicine used to treat daytime sleeplessness. Fluconazole tablets are used in the treatment of fungal infections. The approval was granted by the USFDA for the abbreviated new drug application of Fluconazole tablets in strengths of 50 mg, 100 mg, 150 mg and 200 mg, Lupin said in a regulatory filing.

Also Read: Lupin mulls internal restructuring options, looks to separate its API business: Report

These medicines are a generic equivalents of Diflucan tablets, 50 mg, 100 mg, 150 mg, and 200 mg, of Pfizer Inc, it added. The mentioned generic medicine will be produced by Lupin at its Pithampur facility in India, the company said. The Fluconazole Tablets had an estimated annual sales of $43 million in the US, Lupin said citing IQVIA MAT July 2023 data.

Also Read: Q2 result preview: Strong US performance to lift the show for pharma companies

In the beginning of the month, the company received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution (0.5 g/mL), the Mumbai-based drug maker said in a statement. The product is equivalent to the generic equivalent of Jazz Pharmaceuticals' Xywav Oral Solution, said Lupin in its stock exchange filing. The medication will be produced at Lupin's Somerset facility in the US.

As per the estimates, the net product sales for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution stood at $ 958.4 million 2022 and $ 604.3 million in the first half of 2023.

"Exciting news! Mint is now on WhatsApp Channels 🚀 Subscribe today by clicking the link and stay updated with the latest financial insights!" Click here!

Source: Live Mint
Related Posts: LUPIN,USFDA,MANDIDEEP,ESTABLISHMENT INSPECTION REPORT

Comment on Post

Leave a comment

If you have a News HTS user account, your address will be used to display your profile picture.

POPULAR News

icon
Bussiness She moved to the US from India at a tender age of 11. She was just 15 when she launched her technology startup. She now employs 10 people in her firm, valued at a whopping ₹100 crore. This is the life story of Pranjali Awasthi, the 16-year-old Indian protégé who has proved age is merely a number when it comes to entrepreneurship.
icon
Bussiness The Goods and Services Tax (GST) Council has chosen to delegate the taxation of Extra Neutral Alcohol (ENA), which is used for the manufacture of portable alcohol, to the states. Furthermore, it has reduced the levy rates on millet flour and molasses.
icon
Bussiness Bengaluru: As part of its pre-Series B funding round, elder care platform Age Care Labs has raised $11 million in fresh capital from fintech unicorn Zerodha's investment arm Rainmatter Capital and proptech investment firm Gruhas. Bengaluru: As part of its pre-Series B funding round, elder care platform Age Care Labs has raised $11 million in fresh capital from fintech unicorn Zerodha's investment arm Rainmatter Capital and proptech investment firm Gruhas.
icon
Latest News Ed Sheeran noted that he's hosted friends' weddings in the area. Ed Sheeran noted that he's hosted friends' weddings in the area. Ed Sheeran noted that he's hosted friends' weddings in the area. Ed Sheeran noted that he's hosted friends' weddings in the area.
icon
World The United States warned against any "escalation" in the Middle East in the wake of Israel's war with Hamas, Defense Secretary Lloyd Austin said Sunday, hours after the Pentagon moved to step up military readiness in the region. The United States warned against any "escalation" in the Middle East in the wake of Israel's war with Hamas, Defense Secretary Lloyd Austin said Sunday, hours after the Pentagon moved to step up military readiness in the region.
icon
Sports Asian Games, Javelin Throw Highlights: Neeraj Chopra Claims Gold With 88.88m Throw, Kishore Jena Bags Silver
icon
Technology Instagram is not working on a dedicated app for iPad users and they shouldn't expect one anytime soon. That's the message directly from Adam Mosseri, who claims the company has other priorities before launching the app for iPad. Instagram is not working on a dedicated app for iPad users and they shouldn't expect one anytime soon. That's the message directly from Adam Mosseri, who claims the company has other priorities before launching the app for iPad.
icon
Technology YouTube on Monday said it did not detect materials related to child sexual abuse on its platform despite multiple probes and also has not received evidence of such content on the video streaming platform from regulators. YouTube on Monday said it did not detect materials related to child sexual abuse on its platform despite multiple probes and also has not received evidence of such content on the video streaming platform from regulators.
icon
Latest News As excitement brews for Amazon's highly anticipated Prime Big Deal Days, this piece of advice by the company's founder and executive chairman, Jeff Bezos, is something every consumer should keep in mind amid economic uncertainties. In an interview with CNN, Bezos expressed concerns about the current economic landscape, stating, "Things are slowing down. You're seeing layoffs in many sectors of the economy."
icon
Technology Google Pixel Launch Event 2023 Live Updates: Can Google Pixel 8 Take On iPhone 15? Updated 9 minutes ago
icon
Latest News Vijay Dashmi is a major cultural festival in India. Vijay Dashmi is a major cultural festival in India. Vijay Dashmi is a major cultural festival in India. Vijay Dashmi is a major cultural festival in India. Vijay Dashmi is a major cultural festival in India.
icon
Latest News
icon
Technology Grand Theft Auto fans are mercilessly mocking a GTA VI (GTA 6) leaker for their inaccurate predictions of the announcement date. Grand Theft Auto fans are mercilessly mocking a GTA VI (GTA 6) leaker for their inaccurate predictions of the announcement date.
icon
Latest News A video capturing impatient passengers rushing to enter a train through a narrow opening of the door, each vying for a coveted spot inside, was shared online. The video was posted on Reddit with a caption that reads, “Automatic door in Mumbai trains.” The clip shows how the passengers hurled themselves through the half-open doors.
icon
Technology Alphabet Inc.'s Google will begin to make its Chromebook laptops in India through a partnership forged with HP Inc. Alphabet Inc.'s Google will begin to make its Chromebook laptops in India through a partnership forged with HP Inc. Alphabet Inc.'s Google will begin to make its Chromebook laptops in India through a partnership forged with HP Inc.
icon
Latest News Delhi High Court directed both platforms to refrain from using each other's copyrighted material Delhi High Court directed both platforms to refrain from using each other's copyrighted material Delhi High Court directed both platforms to refrain from using each other's copyrighted material
icon
Horoscope National Boyfriend's Day is a special occasion celebrated annually on October 3rd. It's a day dedicated to appreciating and honouring boyfriends around the world. On this day, people take the opportunity to express their love, gratitude, and affection for their significant others, acknowledging the love and support they provide in their lives. Whether through thoughtful gestures, kind words, or memorable gifts, National Boyfriend's Day is a chance to celebrate the important men in our lives and the meaningful connections we share with them. It's a day to show just how much they mean to us.
icon
Life Style Discover an array of captivating restaurants and exciting events that beckon you to indulge in unforgettable experiences. From culinary gems offering delectable dishes to cultural exhibitions celebrating artistry and heritage, these venues promise to satisfy your senses. Whether you're a food enthusiast seeking gourmet delights or an art aficionado craving inspiration, there's something for everyone to savor. Embark on a journey of taste, culture, and entertainment at these must-visit destinations.
icon
Horoscope A post shared by Mariana Louis (@persephonessister) A post shared by Mariana Louis (@persephonessister) A post shared by Mariana Louis (@persephonessister) A post shared by Mariana Louis (@persephonessister) A post shared by Mariana Louis (@persephonessister)
icon
World Prime Minister Benjamin Netanyahu on Thursday alleged babies were murdered and burned by Hamas terrorists during their onslaught against Israel. Prime Minister Benjamin Netanyahu on Thursday alleged babies were murdered and burned by Hamas terrorists during their onslaught against Israel.
icon
Technology Google is said to be in the works to introduce emojis as a means to reply to emails instead of composing a complete response for Gmail users. According to reports, the tech giant is currently in the process of integrating the feature to express reactions to emails through emojis directly within the Gmail platform.
icon
Life Style In a world where traditional work norms and relentless work hours have been the norm, a new trend is emerging that challenges these conventions and is poised to reshape India's workforce. Dubbed the “lazy girl job,” this trend champions work-life balance, defying the old paradigm of relentless work hours and potential burnouts. It has the potential to not only change the way we work but also transform gender inclusion and the gig economy.
icon
Latest News The luxurious home has also been featured as the location for other TV projects. The luxurious home has also been featured as the location for other TV projects. The luxurious home has also been featured as the location for other TV projects. The luxurious home has also been featured as the location for other TV projects.
icon
Latest News Pietro, a German Shepherd in the Carmel Police Department, is receiving tons of love on social media. The dog lent a paw to his human partner for a very important mission. He helped round up 30 goats running loose in a street in New York. A video of the dog on duty was also captured and later shared online.
icon
Latest News Humans of Bombay (HOB) recently filed a case in Delhi High Court against People of India (POI) over protecting their intellectual property. The platform's founder Karishma Mehta has now taken to Instagram to address the controversy around the case and also inform that the court has ‘upheld their contentions'.