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Approved Peptide Drugs Articles & Analysis
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Watertown, MA - June 29, 2025 - Biopharma PEG, a leading innovator in high-quality polyethylene glycol (PEG) derivatives, today announced it has successfully obtained Drug Master File (DMF) approval from the U.S. Food and Drug Administration (FDA) for its self-developed HZ-PEG-HZ (1K) product. The assigned DMF number is 041864. This significant achievement underscores Biopharma PEG's robust ...
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. The MAA is complicated by the need to consider both European economic integration and the independence of individual member states. As a specialist in regulatory matters, Proregulations has ...
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 drug development is more critical ...
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, CQ-001 (cannabidiol + proprietary API composition), to treat rare ...
Cebranopadol is the first and only dual nociceptin/orphanin FQ peptide (NOP) receptor and µ-opioid peptide (MOP) receptor agonist (dual-NMR) analgesic in clinical development for the treatment of moderate to severe pain, as well as opioid use disorder (OUD). ...
ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers. ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat. ORSERDU is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need. The Menarini Group (“Menarini”), a ...
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. VeriSIM Life has developed a whole-body ...
Follows recent financing round led by Novalis LifeSciences LLC, with investors Dr. Marijn Dekkers and Moderna’s co-founder Dr. Kenneth Chien joining the board of directors Strategic focus includes customized lipid nanoparticles (cLNPs) mRNA chemistries and process capabilities as enabling technologies driving company excellence etherna (“the Company”), a leading ...
ByeTheRNA
ATG-037 is Antengene’s oral small molecule CD73 inhibitor; KEYTRUDA® (pembrolizumab) is MSD’s anti-PD-1 therapy The clinical trial collaboration will focus on evaluating ATG-037 as a monotherapy and in combination with KEYTRUDA® for the treatment of locally advanced or metastatic solid tumors The study of ATG-037 monotherapy started enrolling patients in Q2 2022 and will ...
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 Applications ...
” Orphan Drug Designation is granted to drugs or biological products for the treatment of rare diseases or conditions that impact fewer than 200,000 people in the United States. Incentives that come with the designation include eligibility for federal grants, research and development tax credits, a waiver of prescription drug user fees, ...
Fusion proteins consist of two major roles: to improve the stability and prolong the metabolism of functional proteins in vivo, as well as to fuse one or more functional fragments to form highly effective targeted drugs. FDA-approved fusion proteins to date are used as agonists of receptor function, such as romiplostim and alefacept; as antagonists that block ...
BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop transformative medicines in neuroscience and immuno-oncology, today announced that Vimal Mehta, Ph.D., Founder and Chief Executive Officer, and Matt Wiley, Chief Commercial Officer, will participate in a virtual fireside chat at the Bank of America 2022 Biotech SMID Cap ...
SERENITY III will evaluate the efficacy and safety of BXCL501 for at-home use Top-line pivotal data expected in 1H 2023 Estimated 23 million annual agitation episodes in the home-setting would more than double current market opportunity for BXCL501 in the U.S. 1-4 BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence approaches to develop ...
Antengene is proud to announce that the oral presentation for ATG-031 (anti-CD24 monoclonal antibody) presented at the 37th Society for Immunotherapy of Cancer Annual Meeting (SITC 2022) was selected for the SITC top 100 abstracts. ATG-031 is a first-in-class, humanized anti-CD24 antibody. ATG-031 potently binds to CD24-postive tumor cells. ATG-031 blocks the interaction between CD24 and ...
In the US, there are a small number of prescription drugs approved for DED, including Restasis (Allergan), Xiidra (Novartis), Eysuvis (Kala), and Tyrvaya (Oyster Point). ...
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. ATG-037 IND in Australia has been started enrolling in that phase I study. -The STAMINA-001 study will evaluate ATG-037 as a ...
Optibrium and Lhasa Limited publish joint peer-reviewed research in the Journal of Medicinal Chemistry, expanding predictive modelling beyond human Cytochrome P450. 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 ...
Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced it has executed a Master Services Agreement (MSA) with Societal CDMO, Inc. (NASD: SCTL), a bi-coastal contract development and manufacturing ...