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Drug Approval Articles & Analysis: Older
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Watertown, MA — October 24, 2024 — Biopharma PEG is excited to announce its extensive offerings of polyethylene glycol (PEG) products, including monofunctional, homobifunctional, heterobifunctional, and multi-arm PEGs, tailored for PEGylation in biopharmaceutical applications. With over 40 PEGylated drugs approved globally, the role of PEGylation in ...
CanaQuest Medical Corp (“CanaQuest” or the “Company”) (OTC: CANQF), is pleased to announce strategic additions to its executive team with expertise in conducting clinical trials and US FDA drug approval success. The team plans to effectively navigate the regulatory approval process for Drug Candidate, ...
“The data shared today validate our clinical efforts to advance cebranopadol and reinforce the potential of this investigational therapy to contribute to a future where pain can be managed without further exacerbating the impact of drug addiction.” HAP studies are required prior to U.S. Food and Drug Administration (FDA) approval in ...
The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line ...
VeriSIM Life has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) grant for $255,908 to conduct research and development (R&D) work on rapid repurposing and translation of approved and investigational drugs for COVID-19 using its patented artificial intelligence (AI) driven biosimulation platform, BIOiSIM. ...
As founding Chief Scientific Officer (CSO) at Moderna Therapeutics, he pioneered modified mRNA as a new therapeutic and vaccine drug modality and the mRNA chemistry and delivery systems that form the basis of the approved COVID-19 mRNA vaccines. Prior to that, as VP of Research at Alnylam, he helped develop RNA interference (RNAi) as a new drug ...
ByeTheRNA
“Antengene believes that cancer treatments involving the rational combination of immuno-oncology drugs and targeted therapies may offer the greatest opportunity for substantial advances in treatment outcomes for patients with cancer,” said Dr. ...
Shanghai and Hong Kong, PRC, December 23, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has submitted New Drug ...
(“BRIM,” TPEx 6885) is pleased to announce that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye disease which causes very severe cornea damage and can lead to loss of sight. ...
Management will discuss the Company’s neuroscience and immuno-oncology programs as well as its artificial intelligence platform used to augment and accelerate the drug candidate discovery and development process. They will also discuss the Company’s ongoing commercial launch strategy for IGALMI™ (dexmedetomidine) sublingual film. ...
Pronalyse is a subdivision of Creative Proteomics, an integrated CRO company with rich experience in providing drug development services. Building on its years of experience, Creative Proteomics Pronalyse announces the launch of its fusion proteins characterization service to ensure the production of safe and effective therapeutic fusion proteins. ...
This strategic trial design follows a Type B meeting with the U.S. Food and Drug Administration and observed dose-dependent responses in a prior Phase 1/2b study assessing a range of doses. ...
The Company intends to file an investigational new drug (IND) for ATG-031 in H1:2023. About Antengene Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class ...
GlobalData predicts that the global dry eye drug market will reach approximately US$11 billion in 2028, with a compound annual growth rate of 10.6% from 2018 to 2028. ...
An objective response rate (ORR) of 52.4% was observed in relapsed or metastatic cervical cancer in Phase I/II TORCH-2 Study of ATG-008 (onatasertib) in combination with toripalimab, regardless of PD-L1 status Study builds on promising results of Phase II TORCH monotherapy study in HBV+ patients with unresectable hepatocellular carcinoma (HCC) which demonstrated an ORR of 16.7% in the 45 mg ...
ATG-037, an inhouse asset developed by Antengene and with global rights, has been approved to enter clinical studies in Australia and China, thus becoming the first oral small molecule CD73 inhibitor entering the clinical-stage in China and the wider Asia Pacific region. ...
Study demonstrates novel predictive models for drug metabolism to improve drug design and Optibrium and Lhasa Limited, two of the leading developers of software and artificial intelligence (AI) solutions for drug discovery and development, today announced the publication of a peer-reviewed study in the Journal of Medicinal Chemistry. ...
Shanghai and Hong Kong, PRC, October 31, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that the Investigational New Drug ...
XPOVIO® is the first and only exportin 1 (XPO1) inhibitor approved in Taiwan Antengene plans to submit for national health insurance reimbursement in Taiwan for XPOVIO® in Q4 2022 Shanghai and Hong Kong, PRC, October 21, 2022 — Antengene Corporation Limited (“Antengene” SEHK: 6996.HK), a leading innovative, commercial-stage global ...
“She has conducted more than 180 clinical studies and has worked on most of the major psychiatric drugs that have been approved over the last 30 years by various major pharmaceutical companies, and we deeply value her ...