US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development
Drug Discov Today. 2023 May 15:103618. doi: 10.1016/j.drudis.2023.103618. Online ahead of print.ABSTRACTThe 505(b)(2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and regulatory strategies. Whether or not a drug qualifies for the 505(b)(2) pathway depends on the active ingredient, drug formulation, clinical indication and other factors. Clinical programs can be streamlined and accelerated, and confer unique marketing benefits, such as exclusivity, depending on the regulatory strategy and product. Considerations for chemistry, manu...
Source: Drug Discovery Today - May 17, 2023 Category: Drugs & Pharmacology Authors: William F Salminen Olu Aloba Angela Drew Agnieszka Marcinowicz Madelyn Huang Source Type: research
Automated radiosynthesis of 1 ‐(2‐[18F]fluoroethyl)‐L‐tryptophan ([18F]FETrp) for positron emission tomography (PET) imaging of cancer in humans
In this work, we report a fully automated radiosynthesis of [18F]FETrp on a Synthra RNPlus research module, including a one-pot two steps radiosynthesis, dual independent chiral and reverse-phase semipreparative HPLC purifications, and solid-phase extraction-assisted formulation. The presented approach has led to its Investigational New Drug application and approval that allows the testing of this tracer in humans. The radiotracer 1-(2-[18F]fluoroethyl)-L-tryptophan (L-[18F]FETrp or [18F]FETrp) is a substrate of indoleamine 2,3-dioxygenase, the initial and key enzyme of the kynurenine pathway associated with tumoral immune...
Source: Journal of Labelled Compounds and Radiopharmaceuticals - May 12, 2023 Category: Biochemistry Authors: Huailei Jiang,
Yan Guo,
Hancheng Cai,
Nerissa Viola,
Anthony Frank Shields,
Otto Muzik,
Csaba Juhasz Tags: RESEARCH ARTICLE Source Type: research
FDA Approves Brexpiprazole for Agitation Associated With Dementia Due to Alzheimer ’s Disease
The U.S. Food and Drug Administration (FDA) yesterdayapproved the expanded use of Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer ’s disease (AD).“Agitation associated with dementia due to Alzheimer’s disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alzheimer’s dementia,” wrote Otsuka Pharmaceutical Co. Ltd. and Lundbeck LLC, makers of the medication, in apress release. The symptoms cover “a large group of behaviors occurring in patients with Alzheimer’s disease, such as pacing, gesturing, profanity, shout...
Source: Psychiatr News - May 11, 2023 Category: Psychiatry Tags: agitation Alzheimer ' s disease brexpiprazole dementia FDA Food and Drug Administration major depressive disorder Rexulti schizophrenia Source Type: research
FDA Approves Rexulti for Agitation Associated With Dementia Due to Alzheimer ’s Disease
The U.S. Food and Drug Administration (FDA) yesterdayapproved the expanded use of Rexulti (brexpiprazole) for the treatment of agitation associated with dementia due to Alzheimer ’s disease (AD).“Agitation associated with dementia due to Alzheimer’s disease is a common neuropsychiatric symptom that is reported in approximately half of all patients with Alzheimer’s dementia,” wrote Otsuka Pharmaceutical Co. Ltd. and Lundbeck LLC, makers of the medication, in apress release. The symptoms cover “a large group of behaviors occurring in patients with Alzheimer’s disease, such as pacing, gesturing, profanity, shout...
Source: Psychiatr News - May 11, 2023 Category: Psychiatry Tags: agitation Alzheimer ' s disease brexpiprazole dementia FDA Food and Drug Administration major depressive disorder Rexulti schizophrenia Source Type: research
Randomized controlled trial data for successful new drug application for rare diseases in the United States
Randomized controlled trial (RCT) data have important implications in drug development. However, the feasibility and cost of conducting RCTs lower the motivation for drug development, especially for rare disea... (Source: Orphanet Journal of Rare Diseases)
Source: Orphanet Journal of Rare Diseases - April 19, 2023 Category: Internal Medicine Authors: Yosuke Kubota and Mamoru Narukawa Tags: Research Source Type: research
Anti-microbial lead compound Sulfonamide - Anthranilate derivative Methyl-Ester-Toluene-Sulfonamide and its purity by Liquid Chromatography to develop the New Drug Application
Biomed Chromatogr. 2023 Apr 17:e5646. doi: 10.1002/bmc.5646. Online ahead of print.ABSTRACTThe newly innovated and synthesized lead molecule Methyl-Ester-Toluene-Sulfonamide is the combined derivative of sulphonamide-anthranilate. The estimation was achieved by gradient elution using mobile phase 0.1% Triethylamine in water and with pH 2.0 as mobile phase A and mixture of acetonitrile and tetrahydrofuran in the ratio of (975:25) v/v as mobile phase B at 0.8 mL min-1 flow rate and 210 nm wavelength on Agilent 1260 infinity series HPLC system equipped with DAD detector. The column used was ACE 3 C18 PFP (250 mm × 4.6 mm) 3 ...
Source: Biomedical Chromatography : BMC - April 18, 2023 Category: Biomedical Science Authors: Girish K Deshpande Parameswari Akshinthala Naresh Kumar Katari Balasaheb Deshmukh Leela Prasad Kowtharapu Sreenivas Rao Battula Rambabu Gundla Source Type: research
Anti-microbial lead compound Sulfonamide - Anthranilate derivative Methyl-Ester-Toluene-Sulfonamide and its purity by Liquid Chromatography to develop the New Drug Application
Biomed Chromatogr. 2023 Apr 17:e5646. doi: 10.1002/bmc.5646. Online ahead of print.ABSTRACTThe newly innovated and synthesized lead molecule Methyl-Ester-Toluene-Sulfonamide is the combined derivative of sulphonamide-anthranilate. The estimation was achieved by gradient elution using mobile phase 0.1% Triethylamine in water and with pH 2.0 as mobile phase A and mixture of acetonitrile and tetrahydrofuran in the ratio of (975:25) v/v as mobile phase B at 0.8 mL min-1 flow rate and 210 nm wavelength on Agilent 1260 infinity series HPLC system equipped with DAD detector. The column used was ACE 3 C18 PFP (250 mm × 4.6 mm) 3 ...
Source: Biomedical Chromatography : BMC - April 18, 2023 Category: Biomedical Science Authors: Girish K Deshpande Parameswari Akshinthala Naresh Kumar Katari Balasaheb Deshmukh Leela Prasad Kowtharapu Sreenivas Rao Battula Rambabu Gundla Source Type: research
Anti-microbial lead compound Sulfonamide - Anthranilate derivative Methyl-Ester-Toluene-Sulfonamide and its purity by Liquid Chromatography to develop the New Drug Application
Biomed Chromatogr. 2023 Apr 17:e5646. doi: 10.1002/bmc.5646. Online ahead of print.ABSTRACTThe newly innovated and synthesized lead molecule Methyl-Ester-Toluene-Sulfonamide is the combined derivative of sulphonamide-anthranilate. The estimation was achieved by gradient elution using mobile phase 0.1% Triethylamine in water and with pH 2.0 as mobile phase A and mixture of acetonitrile and tetrahydrofuran in the ratio of (975:25) v/v as mobile phase B at 0.8 mL min-1 flow rate and 210 nm wavelength on Agilent 1260 infinity series HPLC system equipped with DAD detector. The column used was ACE 3 C18 PFP (250 mm × 4.6 mm) 3 ...
Source: Biomedical Chromatography : BMC - April 18, 2023 Category: Biomedical Science Authors: Girish K Deshpande Parameswari Akshinthala Naresh Kumar Katari Balasaheb Deshmukh Leela Prasad Kowtharapu Sreenivas Rao Battula Rambabu Gundla Source Type: research
