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Drug Device 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. ...
Key Product Highlights: · PEG Derivatives o A vast inventory of over 3000 high-quality PEG derivatives. o Monodispersed PEG linkers and multi-arm PEGs. o Scalable production from R&D to GMP commercial levels. o Applications spanning ADCs, PROTACs, LNP drug delivery, medical devices, and more. · Pharmaceutical Intermediates o Comprehensive ...
Biomedical Polymers Biomedical polymers have and still continue to play an important role in how we support and treat patients with various diseases through their use in tissue and blood interacting medical devices and drug delivery systems. Electrofunctional Polymers Conducting electroactive polymers such as polypyrroles, polythiophenes and polyanilines are a ...
Clinical trial managers work on cutting-edge studies and contribute to developing drugs and devices. What can clinical trial managers do to hone their skills and be prepared for future opportunities? ...
Nasaldrugdeliveryblog.com opens lines of communication between drug delivery researchers, device manufacturers. The first blog to address issues related to nasal drug delivery formulation, research, delivery, and devices was launched by Kurve Technology, Inc., a leading developer of nasal drug delivery ...
Broomfield Colorado 6/16/2022. Aktiv Pharma Group (Aktiv) announced today the acceptance of its novel glass-free, film-based flexible primary drug container (PDC) technology for sterile injectables named ARCH, into the US Food and Drug Administration (FDA) Emerging Technology Program (ETP). The ETP is a collaborative effort which supports the FDA’s mission to facilitate modernization in ...
The award, stage-gated based on achievement of pre-determined milestones and deliverables, provides funding for Enalare to perform pre-clinical toxicology, human clinical studies, drug and device manufacturing, and regulatory file submission for a formulation of ENA-001 suitable for community use. ...
The application for approval to commence VISABL-VT was submitted to the Ethics Committee at the Leipzig Heart Centre (the lead clinical site) as well as the German Federal Institute for Drugs and Medical Devices (BfArM), the German Competent Authority. Both submissions took place on September 15th. ...
ByImricor
Called the COPA system, the proprietary, hand-held drug dispensing device is meant to provide at-home methadone administration as part of treatment for opioid use disorder (OUD). ...
CardioWise, Inc., is pleased to announce that Perry Johnson Registrars, Incorporated has audited the CardioWise Quality Management System (QMS) and determined CardioWise is in conformance with ISO 13485:2016. Perry Johnson Registrars Certificate C2022-02910 was issued July 16, 2022, and represents the first step in the process of obtaining a CE mark and Medical Device Registration for the ...
Schmid brings extensive operations and business development leadership experience in diabetes and drug delivery. As Vice President of Operations and Business Development at Insulet Corporation, he was instrumental in the development, manufacturing, and commercialization of wearable smart drug delivery pumps such as the Omnipod Diabetes Management System, the ...
DSR (Direct Sodium Removal) heart failure drug development: Completed enrollment in SAHARA I[i] with first-generation DSR product (“DSR 1.0”) – extending study with second-generation DSR product (“DSR 2.0”) to support US IND[ii] filing by year end Proof-of-concept delivered in diuretic-resistant heart failure patients with dramatic and durable improvements in ...
” SQuEEZ allows the surgeon to make a more informed decision for the patient, whether it is a drug, surgery, or medical device, and then follow the patient’s recovery and progress after the procedure, non-invasively and with extremely low exposure to radiation. ...
ApiJect is developing an innovative portfolio of drug delivery devices using high-speed BFS manufacturing, which is recognized by the FDA as an advanced aseptic process that forms, fills and seals a single unit dose in a continuous, automated manufacturing step. ...
(“ORA”) the world’s leading, ophthalmic research organization, for the late-stage clinical development of lead drug candidate, BRM421, for dry eye syndrome (DES). BRIM intends to initiate Phase 3 clinical studies with Ora’s support later this year.?? ...
“These results are especially encouraging as we continue to advance an investigational device exemption (IDE) clinical trial in the U.S. evaluating the safety and efficacy of our next-generation bone graft in transforaminal lumbar interbody fusion (TLIF) surgery.” i-FACTOR bone graft has over 10 years of clinical success in Europe and was approved in the U.S. for use ...
Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, announced today the completion of enrollment of the ASPIRE study, a pivotal U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study, to evaluate the safety and efficacy of P-15L Bone Graft for use in transforaminal lumbar interbody fusion ...
It is widely recognized that alternatives to antiepileptic drugs (AEDs) and surgery are a significant unmet medical need, especially for patients with incomplete seizure control who may not be candidates for, or wish to avoid the risks of, surgery and implantable devices. ...
"Avernus has a strong footprint and great network for the distribution of innovative medical device and drug products in the Middle East, and we very much look forward to working with their team. ...
(Nasdaq: BCDA), a developer of cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the CardiAMP® Cell Therapy System for the treatment of heart failure. It is believed to be the first cardiac cell ...