Biotechnology

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BiotechnologyFDA Grants Orphan Drug Designation to MicuRx’s MRX-5 for NTM Infections

Shanghai MicuRx Pharmaceutical Co., Ltd. (“MicuRx”，688373.SH) announced that MRX-5, its self-developed anti-infection drug, has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of non-tuberculous mycobacteria (NTM) infections. This designation marks a significant milestone for MicuRx in the field of NTM infection treatment. MRX-5 is a novel benzoxazole antibiotic developed for the treatment of mycobacteria infections, particularly infections caused by non-tuberculous Mycobacteria (NTM). In recent years, NTM diseases have...

by PRNewswire

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BiotechnologyWuXi Biologics Ranks Top in 2024 Dow Jones Sustainability Indices for Second Consecutive Year

WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced that it has been named to the 2024 Dow Jones Sustainability Indices (DJSI), and given among the top scores for its unremitting efforts and notable achievements in promoting sustainable development. The DJSI are a family of best-in-class benchmarks for investors who have recognized that sustainable business practices are critical to generating long-term shareholder value and wish to reflect...

by PRNewswire

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BiotechnologyVeeda Group Rebrands as ‘Veeda Lifesciences’

Veeda Group has unveiled a new logo and brand identity—Veeda Lifesciences—marking a key milestone in its journey. The new brand name reflects the evolution from a generics-focused Contract Research Organization (CRO) to a drug development services enterprise for different modalities of drugs including generics and novel chemical and biological entities. Veeda Lifesciences will operate through four Strategic Business Units: Clinical Trials, Healthy Volunteer Services, Biopharma Services, and Preclinical & Non-Clinical Testing Services, making Veeda an...

by PRNewswire

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BiotechnologyFapon Biopharma Introduces FP008 at Biotech Showcase: A Safer and More Effective Immunotherapy for Refractory Cancers

Fapon Biopharma, an innovator in developing therapeutic antibodies and fusion proteins, will present its latest breakthrough immunocytokine, FP008, on Jan 14, 2025, at the Biotech Showcase investor conference, following J.P. Morgan Healthcare Week. This bifunctional anti-PD-1/IL-10M fusion protein is designed to address populations refractory to anti-PD-1 therapies. The presentation will introduce Fapon Biopharma’s continued strength and innovation in the development of anticancer drugs. FP008 is a proprietary and patented drug candidate using Fapon Biopharma’s cutting-edge antibody technology....

by business wire

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BiotechnologyDatopotamab Deruxtecan Application in the EU for Patients with Advanced Nonsquamous Non-Small Cell Lung Cancer Voluntarily Withdrawn

Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have voluntarily withdrawn the marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase 3 trial. The decision to withdraw the MAA was informed by feedback from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA). Daiichi Sankyo and AstraZeneca will...

by business wire

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BiotechnologyAnaergia to Supply Organic Waste to Energy Solution to PepsiCo in Colombia

Anaergia Inc. (“Anaergia” or the “Company”) (TSX: ANRG) announced today that its Canadian subsidiary, Anaergia DB Inc., has entered into an integrated technology supply contract with PepsiCo Alimentos Z.F. LTDA (“PepsiCo”) to provide its high-efficiency digestion technology and integrated biogas conditioning and upgrading technology at PepsiCo’s food production facility in Funza, part of the Metropolitan Area of Bogotá, Colombia. “By providing our proven solutions to create renewable fuel and energy from organic waste, we are...

by PRNewswire

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BiotechnologyBybit Champions Web3 Innovation and Strengthens Ties with Asia’s Crypto Community at Taipei Blockchain Week

Bybit, the world’s second-largest cryptocurrency exchange, debuted at the Taipei Blockchain Week Dec. 12 to 14, 2024, spotlighting the vibrant Web3 innovations on its platform alongside a dynamic roster of its strategic Layer 1 ecosystem partners. BGA’s MK Chin at the Marketing Web3: Strategies to Engage and Onboard the Next Billion Users panel at Taipei Blockchain Week 2024. Bybit’s Angela Huang at the Networked Intelligence: The Rise of Decentralized AI panel at Taipei Blockchain Week 2024. Featuring side...

by PRNewswire

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BiotechnologyRactigen Therapeutics Announces First Patient Dosed in Phase I Clinical Trial for RAG-17 in SOD1-ALS

Ractigen Therapeutics, a clinical-stage pharmaceutical company dedicated to developing RNA-based innovative therapies, today announced the successful dosing of the first patient in the Phase I clinical trial of RAG-17, an innovative siRNA therapy targeting Amyotrophic Lateral Sclerosis (ALS) associated with superoxide dismutase 1 (SOD1) gene mutations at Second Affiliated Hospital of Zhejiang University School of Medicine. The Phase I clinical study is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety/tolerability, pharmacokinetics, pharmacodynamics, and preliminary...

by PRNewswire

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BiotechnologyAptamer developed by HKBU for treating rare bone disease ‘X-linked hypophosphatemia’ receives Orphan Drug Designation and Rare Pediatric Disease Designation by U.S. FDA

A research led by Hong Kong Baptist University (HKBU) and the Shanghai Sixth People’s Hospital Affiliated to School of Medicine at Shanghai Jiao Tong University (Shanghai Sixth People’s Hospital) has discovered that an aptamer developed by HKBU can be used to treat X-linked hypophosphatemia (XLH), a rare bone disease. The aptamer, originally developed to treat osteogenesis imperfecta, has been granted Orphan Drug Designation and Pediatric Rare Disease Designation by the U.S. Food and Drug Administration (FDA). Professor Zhang Ge, Associate...

by business wire

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BiotechnologyEllipses Launches Pioneering Clinical Trial Programme in Middle East

Ellipses Pharma Limited (“Ellipses”), a global drug development company focused on accelerating the development of cancer treatments through an innovative drug development model, announced today it has inaugurated the first large-scale Phase 1/2 oncology clinical study of its kind in the United Arab Emirates, marking a significant milestone in the region’s healthcare landscape. “Our mission to find outstanding potential cancer treatments and develop them at pace has been made possible in a very large part...

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