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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 ...
Changsha, China – 18 March 2025 – Hunan Huateng Pharmaceutical Co., Ltd., a global leader in PEG derivatives and CDMO services for APIs and intermediates, is pleased to announce its participation in CPHI Japan 2025. The company will exhibit its comprehensive product lines and cutting-edge capabilities at Booth No. 4X-06, located at Tokyo Big Sight, Tokyo, Japan, from April 9th to ...
The US-based chemical supplier Alfa Chemistry announced the launch of a new sub-website for the supply of functional polymers, including Adsorptive Polymers, Biomedical Polymers, Electrofunctional Polymers, Functional PEGs, Photoactive Polymers, Silicone Polymers and more. With unstopping efforts, the company continues to offer chemicals for specialized applications, such as catalysts, fatty ...
The Covid-19 epidemic has changed the world in many ways, and many clinical trials have been done to research more about it. According to the World Health Organization (WHO), 12,969 clinical trials were done in America in 2021. Even in pre-pandemic times, clinical trials have always been an ongoing process. Clinical trial managers work on cutting-edge studies and contribute to ...
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 devices. The blog - http://www.nasaldrugdeliveryblog.com - invites scientists, researchers ...
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 Funding Will Accelerate Development of an Intramuscular Formulation of ENA-001, a Novel Agnostic Respiratory Stimulant, for the Potential Treatment of Community Drug Overdose and as a Medical Countermeasure for Mass Casualty Events. The Funding Supports Development of an Intramuscular ENA-001 From Pre-Clinical Toxicology Through Filing for Approval in the United States Enalare Therapeutics ...
Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR), the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Company has submitted for approval to commence a real-time iCMR-guided ventricular tachycardia (VT) ablation clinical trial. The name of the study is “Vision-MR Ablation of VT” or VISABL-VT. VISABL-VT is a prospective, ...
ByImricor
The National Institutes of Health (NIH) has awarded Berkshire Biomedical Awarded $266,000 to support continued development of an automated, at-home methadone administration system. 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). The system delivers the liquid ...
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 ...
Modular Medical, Inc. (the "Company" or "Modular Medical")(NASDAQ:MODD) today announced that it has appointed industry veteran Kevin Schmid as its Chief Operating Officer. Mr. 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 ...
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 ...
CardioWise® and Lucem Health™ announced that CardioWise has become a founding member of the Lucem Health Innovation Collaborative, a partner program designed to help AI/ML innovation move to the forefront of healthcare. The collaborative launched by Mayo Clinic along with other investing partners will help digital health innovators create, deploy, and commercialize transformational ...
ApiJect Holdings, Inc., the parent company of ApiJect Systems, Corp., a medical technology public-benefit corporation transforming the fill and finish and delivery of injectable vaccines and medicines, announced today that it had completed a $111 million private round of investment. This investment round values ApiJect at approximately $300 million. The new round was led by Royalty Pharma and ...
BRIM Biotechnology, Inc. (“BRIM”) a clinical-stage company developing novel regenerative therapies in ophthalmology, today announces it has entered into a new strategic partnership with Ora®, Inc. (“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 ...
Cerapedics, a private ortho-biologics company, today announced that results from a clinical trial evaluating i-FACTOR Peptide Enhanced Bone Graft in non-instrumented lumbar fusion surgery has been published in the May 2020, Volume 20, Issue 5 print of The Spine Journal as the lead article. The data demonstrate that elderly patients in Denmark treated with i-FACTOR bone graft plus local bone had a ...
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 (TLIF) surgery in patients with ...
NeuroSigma, Inc., a bioelectronic medical device company, today announced FDA Breakthrough Device Designation for its Monarch eTNS System® for “adjunctive use for reducing the frequency of seizures in individuals 18 years of age or older diagnosed with epilepsy characterized by partial-onset seizures, with or without secondary generalization, that are refractory to two or more ...
HAMILTON, BERMUDA / ACCESSWIRE / February 7, 2022 / Altamira Therapeutics Ltd. (NASDAQ:CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, announced today that it has entered into an agreement for the marketing and distribution of Bentrio™ (the "Agreement"), its nasal spray for protection against airborne viruses and allergens, with Avernus ...
BioCardia®, Inc. (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 therapy to ...