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Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment
Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment

Business Standard

time7 days ago

  • Health
  • Business Standard

Zydus Lifesciences' Usnoflast receives USFDA fast track designation for ALS Treatment

Zydus Lifesciences announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track Designation to Usnoflast (ZYIL1), a novel oral NLRP3 inhibitor, for the treatment of Amyotrophic Lateral Sclerosis (ALS). The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Drugs granted this designation are eligible for benefits such as accelerated approval, priority review, and more frequent interactions with the USFDA during the drug development process. The company stated that people living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to the formation of neurofilaments, which first accumulate in the cerebrospinal fluid (CSF) of ALS patients and then slowly enter the bloodstream. Due to rapid neurodegeneration, steady loss of the ability to move, speak, eat, and eventually breathe, paralysis and death are common outcomes in ALS patients. ALS affects approximately 32,000 people in the U.S., with an average of 5,000 new patients diagnosed every year, according to statistics from the Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS. Usnoflast, a novel chemical entity (NCE), had earlier received Orphan Drug Designation (ODD) from the USFDA, which offers development incentives including tax credits for clinical testing, waiver of certain FDA fees, and a potential seven-year marketing exclusivity upon USFDA approval. Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor studied in preclinical models of neuroinflammation, Parkinsons disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS). Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial in 24 ALS patients across seven sites in India and recently received USFDA approval to initiate a Phase 2(b) randomized, double-blind, placebo-controlled trial in ALS patients. Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, This Fast Track Designation in addition to the previous Orphan Drug Designation granted by the USFDA, underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter. The counter shed 0.30% to Rs 915.22 on the BSE.

Nile Deploys the World's Largest Campus Network-as-a-Service Implementation at LEAP 2025
Nile Deploys the World's Largest Campus Network-as-a-Service Implementation at LEAP 2025

Yahoo

time03-03-2025

  • Business
  • Yahoo

Nile Deploys the World's Largest Campus Network-as-a-Service Implementation at LEAP 2025

Networking pioneer deploys campus NaaS in just three days to support over 200,000 attendees at this Tier-1 global technology conference SAN JOSE, Calif. & BARCELONA, Spain, March 03, 2025--(BUSINESS WIRE)--Today from Mobile World Congress in Barcelona, Nile, the pioneer of a new breed of enterprise network solutions that secure organizations from cyberattacks and automate network operations, announced that it deployed the world's largest Campus Network-as-a-Service (NaaS) at this year's LEAP 2025 conference. LEAP 2025, Saudi Arabia's award-winning global technology event, welcomed more than 200,000 visitors from February 9-12 at the Riyadh Exhibition and Convention Center in Malham. "Once again, it's Nile pushing the envelope of what's possible in enterprise networking," said Pankaj Patel, CEO and co-founder, Nile. "At an event where AI and digital transformation were the primary themes, it's fitting that Nile was chosen to deliver the connectivity that showcased these innovations. The unique architecture of the Nile Access Service, which combines AI-powered automation and built-in zero trust security in an 'as-a-service' framework, is the only solution in the market that could have possibly met LEAP 2025's rapid deployment requirements. We built a secure, world-class network serving over two hundred thousand of the world's most sophisticated users in a matter of days." Nile's autonomous network architecture enabled its team and its partners, solutions by stc and TAWAL, to deploy the network rapidly while also fulfilling numerous last-minute requirements that traditional systems could not accommodate, given the time frame and very limited resources available.​ For this project, Nile was tasked with building a campus network that covered almost 2M square feet (more than 185K square meters), including seven different conference halls. Based on data from Nile's extensive sensor infrastructure, the network consistently served around 55,000 concurrent visitors without a single network issue or security incident. "At solutions by stc, we are proud to collaborate with Nile in delivering groundbreaking innovations, such as the world's largest Campus Network-as-a-Service implementation at LEAP 2025," said Omer Alnomany, CEO of solutions by stc. "This partnership exemplifies the strength of our strategic alliances in enabling secure, scalable connectivity for transformative events like LEAP. Together, we are shaping the future of enterprise networking in the MEA region, driving digital transformation, and setting new benchmarks for customer success." Once installed, Nile's AI Automation Center worked continuously to ensure that availability, coverage, and capacity remained at optimal levels. Now in place, the Nile network infrastructure remains to serve the next event at the Riyadh International Exhibition and Convention Center in Malham. "Nile's architecture gave us the ability to augment our own service capabilities to quickly meet the urgent needs of an important customer," said Mohammed Al-Haqbani, CEO of TAWAL. "Its unique approach to Network-as-a-Service enabled us to build a very complex deployment in record time. We're looking forward to our next project together." "We had a very limited window to build a secure, high-performance network that had to meet the needs of a very large group of attendees along with a diverse mix of more than 1,800 global technology leaders and advanced startups, many of which were running demonstrations of their cutting-edge solutions in their booths," said Abdulrahman Almoaiqel, CCO of TAWAL, one of Saudi Arabia's leading network infrastructure organizations. "Only Nile's AI-powered innovations could provide the combination of performance, security, ease-of-deployment, and operational simplicity that enabled us to pull off an impressive deployment with only four installers on site." About Nile Nile is leading a fundamental shift in the networking industry, challenging decades-old conventions to deliver a radically new approach. By eliminating complexity and rethinking how networks are built, consumed, and operated, Nile is pioneering a new category designed for a modern, service-driven era. With a relentless focus on simplicity, security, reliability, and performance, Nile empowers organizations to move beyond the limitations of legacy infrastructure and embrace a future where networking is effortless, predictable, and fully aligned with their digital ambitions. For more information, visit About solutions by stc: solutions by stc is the #1 IT services provider in the Kingdom of Saudi Arabia and a leading enabler in digitally transforming businesses with a 25-year track record of anticipating and capitalizing on industry trends and dynamics, opportunities, elevating digital infrastructure, and improving customer's businesses across a variety of sectors including energy, telecoms, healthcare, and more. solutions is headquartered in Riyadh with operations across the Kingdom and beyond. About TAWAL TAWAL owns a portfolio of more than 21,000 telecom towers across Saudi Arabia, Bulgaria, Croatia, Slovenia and Pakistan. The company actively supports digital transformation plans in those markets. It is expanding its reach across new cities and rural areas and is actively rolling out smart-city-ready technologies such as camouflage telecom towers, smart poles capable of supporting 5G and IoT devices, in-building solutions (IBS), beside other tailored ICT infrastructure. View source version on Contacts Media Contacts: Haley Cudworthpress@ +1 (805) 540 1960 Sign in to access your portfolio

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