Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer’s Disease Under the Accelerated Approval Pathway
TOKYO and CAMBRIDGE, Mass., May 10, 2022 - (JCN Newswire via SEAPRWire.com) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401) for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. As part of the completed rolling submission, Eisai has requested Priority Review. If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. While Eisai is currently submitting lecanemab under the accelerated approval pathway, the lecanemab Phase 3 confirmatory Clarity AD clinical trial conducted with 1,795 patients will report out in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Dependent upon the results of the C...
A new age of 2.5D materials
TSUKUBA, Japan, May 6, 2022 - (ACN Newswire via SEAPRWire.com) - Scientists are exploring new ways to artificially stack two-dimensional (2D) materials, introducing so-called 2.5D materials with unique physical properties. Researchers in Japan reviewed the latest advances and applications of 2.5D materials in the journal Science and Technology of Advanced Materials.By stacking layers of different 2D materials, it is now possible to create 2.5D materials with unique physical properties that can be used in solar cells, quantum devices and devices with very low energy consumption. (Credit: STAM)"The 0.5D concept symbolizes freedom from the composition, materials, angles and space typically used in 2D materials research," explains nanomaterials scientist and lead author Hiroki Ago of Kyushu University in Japan.2D materials, like graphene, consist of a single layer of atoms and are used in applications like flexible touch panels, integrated circuits and sensors.Recently, new methods have been introduced to make it possible to artificially stack 2D materials vertically, in-plane or at twisted angles regardless of their compositions and structures. This is thanks to the ability to control...
G3 Global Awarded RM118 Million Contract to Drive Digital Transformation of KLIA and klia2
KUALA LUMPUR, May 5, 2022 - (ACN Newswire via SEAPRWire.com) - Artificial Intelligence (AI) specialist G3 Global Berhad has secured the Group's largest contract since restructuring the business with an RM118.38 million agreement to design and develop the Airport Integrated Security and Safety System (AIS3) for Malaysia's two busiest airports - Kuala Lumpur International Airport (KLIA) and klia2 - in collaboration with SenseTime, a leading AI software company listed on the Main Board of the Stock Exchange of Hong Kong Limited (HKEX).Mr. Dirk Quinten, Managing Director of G3 Global BerhadMr. Martin Huang, Managing Director of SenseTime InternationalThe contract, which was awarded by Malaysia Airports (Sepang) Sdn Bhd (MA Sepang) on 15 April 2022, is the first master system architect project among the world's Top 10 airports. MA Sepang is a wholly-owned subsidiary of Malaysia Airports Holdings Berhad and provides maintenance and airport facilities administration services.G3 Global will leverage its AI capabilities and the deep industry knowledge of SenseTime to develop a state-of-the-art integrated platform that includes enhancing existing systems to improve the overall safety and sec...
CleverTap Appoints Honey Bajaj as SVP & Global Chief of Consumer Experience
MOUNTAIN VIEW, Calif. and MUMBAI, India, May 5, 2022 - (ACN Newswire via SEAPRWire.com) - CleverTap, the world's leading retention cloud, today added to its core leadership team with the appointment of Honey Bajaj as SVP & Global Chief of Consumer Experience. In this position, Bajaj will pioneer CleverTap's extensive program to help companies reimagine customer experience and realize the "Art of Possible".CleverTap Appoints Honey Bajaj as SVP & Global Chief of Consumer ExperienceBajaj is a design strategist, an innovation leader and a social entrepreneur with extensive work in India and the U.S. Her ability to problem solve and identify patterns in human behavior has earned her multiple prestigious awards and recognition as an Innovation Global Shaper and Inventor of the Year (2016). She is also a dual degree holder with a Master's Degree in Engineering and Management and a Master's in Sustainability Studies from the Massachusetts Institute of Technology. She is currently pursuing her Ph.D. in Design and Innovation Methodologies in the Digital World.Before joining the CleverTap Leadership Team, Honey built an innovation pipeline for several Fortune 500 companies, including ...
Novotech Acquires US CRO NCGS, Expands Global Expertise
Singapore & Charlotte, NC, May 5, 2022 - (ACN Newswire via SEAPRWire.com) - Novotech, the leading Asia-Pacific biotech specialist CRO, has acquired US CRO NCGS as part of its expansion program, and can now offer its biotech clients clinical services in the US to support later phase global studies. NCGS, established in 1984 in South Carolina, is a privately held CRO with a biopharma client base and a workforce of about 300 professionals across the US.Novotech CEO Dr. John Moller said "We are very pleased to acquire such an impressive company with a strong history of quality and delivery in the United States. The company's growth is a real credit to the knowledge and expertise of founder Nancy Snowden and the exceptional team she has formed."This is a strategic move to provide US-based expertise and infrastructure for our US clients wanting trials in APAC and the US, and for our APAC clients wanting US clinical programs. Clients will receive seamless service, with a unified approach to systems and SOPs well developed," Moller said.Nancy C.G. Snowden, founder and CEO of NCGS, said the company was excited about becoming part of Novotech operations globally and supporting Novotech's...