Tagged News

PharmaTher Secures U.S. Patent for Advanced Ketamine Production Technology

3 years ago

PharmaTher Holdings received U.S. Patent No. 11,286,230 for "Ketamine Flow Synthesis," a continuous-flow process technology that improves ketamine and analog production efficiency.
The patented technology addresses traditional batch production limitations by offering better yield, reproducibility, and purity while requiring a smaller manufacturing footprint.
The company plans to leverage this technology to support upcoming pivotal clinical studies for Parkinson's disease and ALS, with an FDA filing expected in Q4-2022.
PharmaTher's expanding intellectual property portfolio includes novel ketamine applications for neurological disorders and innovative delivery systems like microneedle patches.

3 years ago

Respira Therapeutics has dosed the first patient in its Phase 2b VIPAH-PRN trial evaluating RT234, an innovative dry powder inhaled formulation of vardenafil for on-demand symptom relief in PAH patients.
RT234 represents a first-in-class approach for PAH, designed for "as needed" use to acutely improve exercise capacity and reduce breathlessness, unlike current maintenance therapies that don't address episodic symptoms.
The multicenter dose-escalation study will assess RT234's ability to provide rapid symptom relief for patients with NYHA Functional Class II-III PAH symptoms, potentially addressing a significant unmet need in disease management.

7 years ago

The FDA has approved emapalumab-lzsg (Gamifant) as the first treatment specifically indicated for primary hemophagocytic lymphohistiocytosis (HLH), an ultra-rare and life-threatening immune disorder.
In a pivotal phase 2/3 study of 27 patients with refractory disease, 63% demonstrated overall response and 70% proceeded to hematopoietic stem cell transplant.
The monoclonal antibody targets interferon gamma, representing the first significant improvement in primary HLH induction therapy in 24 years.
Primary HLH typically affects children within the first year of life and has a median survival of less than two months without treatment.

NCT01818492CompletedPhase 2

Swedish Orphan Biovitrum

Posted 7/1/2013

7 years ago

Life Molecular Imaging received FDA Fast Track Designation for [18F]florbetaben to diagnose cardiac amyloid light-chain (AL) and amyloid transthyretin-related (ATTR) amyloidosis.
The PET imaging agent is already approved as Neuraceq® for detecting brain amyloid plaques and has demonstrated capability to identify amyloid deposits in the heart.
A Phase 3 trial (NCT05184088) is currently underway to validate [18F]florbetaben's efficacy in cardiac amyloidosis diagnosis.
The designation aims to streamline the complex diagnostic process for cardiac AL amyloidosis, potentially providing earlier access to therapy and improved patient monitoring.

NCT05184088RecruitingPhase 3

Life Molecular Imaging GmbH

Posted 1/13/2023