Food and Drug Administration Amendments Act of 2007

BIOXCEL THERAPEUTICS, INC. (NASDAQ: BTAI) SHAREHOLDER ALERT: Bernstein Liebhard LLP Reminds Investors of the Deadline to File a Lead Plaintiff Motion in a Securities Class Action Lawsuit Against BioXcel Therapeutics, Inc.

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Tuesday, July 25, 2023
LLP, Institutional review board, Record, Food and Drug Administration Amendments Act of 2007, Dementia, District court, Patient, Advertising, Complaint, Defendant, Court, Action Replay, FDA, Therapy, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry, Security (finance)

If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc.

Key Points: 
  • If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc.
  • A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.
  • If you purchased or acquired BioXcel securities, and/or would like to discuss your legal rights and options please visit BioXcel Therapeutics, Inc.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

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Friday, July 21, 2023
Curium, CONDOR, 18F, Prostate cancer, PSMA, Molecular imaging, European Directive on Traditional Herbal Medicinal Products, Cancer, PET, PYTHON, Google Images, Committee, Manuscript, Food and Drug Administration Amendments Act of 2007, MD, Patient, Master of Science, Chief Medical Officer (Ireland), PET/CT, European Medicines Agency, Phase, FDA, Recurrence, MD–PhD, European Journal, Food, European Journal of Nuclear Medicine and Molecular Imaging, Medical imaging, Nuclear medicine

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.

Key Points: 
  • PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.
  • The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.
  • The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety profiles of [18F]DCFPyL and [18F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent.
  • This study successfully met the primary endpoint.

Berkshire Sterile Enhances Data Integrity with New Data Management System

Retrieved on: 
Wednesday, July 19, 2023
GMP, Data management, Database, Manufacturing operations, BSM, Associate, LabX Media Group, Food and Drug Administration Amendments Act of 2007, Mettler Toledo, Title 21 CFR Part 11, FDA, Food, Software, Medical device

BSM will implement a state-of-the-art Mettler Data Management System, LabX, to improve data integrity for GMP activities.

Key Points: 
  • BSM will implement a state-of-the-art Mettler Data Management System, LabX, to improve data integrity for GMP activities.
  • The new Mettler Data Management System seamlessly networks Mettler Toledo scales and other instruments, including Karl Fishers to transfer generated data onto a single platform.
  • The new system eliminates the need for printouts and weight slips, streamlining operations and improving data integrity and permanence.
  • "We are pleased to introduce the Mettler Data Management System to our operations," said Steven Kinney, Associate Director of Manufacturing Operations.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against BioXcel Therapeutics, Inc. (BTAI)

Retrieved on: 
Wednesday, July 19, 2023
Institutional review board, Record, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, Investment, Patient, Court, Defendant, FDA, Therapy, GPM, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • Glancy Prongay & Murray LLP, Los Angeles

Artelo Biosciences to Present New Mechanism of Action Data on ART26.12 at the Gordon Research Conference on July 20, 2023

Retrieved on: 
Wednesday, July 19, 2023
Gordon Research Conferences, Diabetic neuropathy, Cancer, National Center for Advancing Translational Sciences, Doctor of Philosophy, Transcriptome, Pain, Gordon, Food and Drug Administration Amendments Act of 2007, FABP, Therapy, IND, Conference, Food, Pharmaceutical industry

https://www.grc.org/cannabinoid-function-in-the-cns-conference/2023/

Key Points: 
  • https://www.grc.org/cannabinoid-function-in-the-cns-conference/2023/
    “I am looking forward to sharing our data on the potential applications of inhibiting fatty acid binding proteins from our extensive library of compounds,” said Professor O’Sullivan.
  • “We are particularly excited to share new information on the effects of our FABP inhibitor ART26.12 on not only cannabinoid receptors, but other receptors implicated in pain signaling, as well as lipidomic and transcriptome data that help us understand how ART26.12 elicits its effects in peripheral neuropathies.”
    Professor O’Sullivan’s presentation on Thursday, July 20, 2023 includes data on ART26.12, Artelo’s lead compound targeting a variety of painful neuropathies, as well as the potential of FABP inhibitors beyond peripheral neuropathies.
  • ART26.12 was selected from Artelo’s platform of inhibitors to FABPs as its first candidate drug.
  • The Company recently announced it expects pre-IND meeting feedback on its IND planning and development strategy from the Food and Drug Administration during the third quarter of this year with the goal of initiating clinical development in early 2024.

Virios Therapeutics Announces Positive Data Demonstrating Improvement in Multiple Long-COVID Symptoms Following Treatment with a Combination of Valacyclovir and Celecoxib in an Exploratory, Open-Label, Proof of Concept Study

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Monday, July 17, 2023
PROMIS, Myalgia, NRS, Brookings Institution, Arthralgia, Headache, Female, FM, Overalls, Health status of Asian Americans, Celecoxib, BHC, COVID, Doctor of Philosophy, Fatigue, Pain, Food and Drug Administration Amendments Act of 2007, Long COVID, Medical director, COVID-19, Patient, Center of excellence, Dysautonomia, Fibromyalgia, Nausea, Conditional sentence, Diagnosis, Health, Therapy, PASC, Valaciclovir, Food, Post-exertional malaise, Pharmaceutical industry, MD

This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.

Key Points: 
  • This open-label, single-center, investigator-initiated study was conducted at the Bateman Horne Center (“BHC”) with an unrestricted investigational grant.
  • Treatment with Val/Cel was generally well tolerated, with an observed safety profile consistent with the known safety profiles of valacyclovir and celecoxib.
  • There were no serious adverse events observed in this study and only one treated patient discontinued treatment due to adverse events, possibly related to Val/Cel treatment.
  • “We look forward to engaging the Food and Drug Administration to discuss progressing this novel treatment option into active Phase 2 clinical development.”

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against BioXcel Therapeutics, Inc. (BTAI)

Retrieved on: 
Thursday, July 13, 2023
Institutional review board, Record, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, Investment, Patient, Court, Defendant, FDA, Therapy, GPM, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry

LOS ANGELES, July 13, 2023 (GLOBE NEWSWIRE) -- Glancy Prongay & Murray LLP (“GPM”) reminds investors of the upcoming September 5, 2023 deadline to file a lead plaintiff motion in the class action filed on behalf of investors who purchased or otherwise acquired BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) securities between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.
  • Glancy Prongay & Murray LLP, Los Angeles

Bernstein Litowitz Berger & Grossmann LLP Announces Pendency of Class Action and Proposed Settlement For Purchasers of BioMarin Pharmaceutical Inc. Common Stock from March 3, 2020 through August 18, 2020, Inclusive

Retrieved on: 
Wednesday, July 12, 2023
Agreement, Prejudice, Lead, Stipulation, Hearing, BioMarin Pharmaceutical, Class, Telephone, OR, The Honourable, Haemophilia, Person, Class Action, Federal Rules of Civil Procedure, Food and Drug Administration Amendments Act of 2007, District court, Settlement, Episcopal conference, Action, Motion, Leading Counsel, CLASS, Post office box, United States Senate Judiciary Subcommittee on Federal Courts, Oversight, Agency Action and Federal Rights, READ, ARE, Defendant, Phillip Burton, Summons, Claim, Counsel, III, Food, Tobacco, Insurance, Generic drug, Allocation, Notice, Court

YOU ARE ALSO NOTIFIED that Lead Plaintiff Arbejdsmarkedets Tillægspension and Defendants BioMarin, Jean-Jacques Bienaimé, and Dr. Henry Fuchs have reached a proposed settlement of the Action on behalf of the Settlement Class for $39,000,000 in cash (the "Settlement").

Key Points: 
  • YOU ARE ALSO NOTIFIED that Lead Plaintiff Arbejdsmarkedets Tillægspension and Defendants BioMarin, Jean-Jacques Bienaimé, and Dr. Henry Fuchs have reached a proposed settlement of the Action on behalf of the Settlement Class for $39,000,000 in cash (the "Settlement").
  • If approved by the Court, the Settlement will resolve all claims in the Action.
  • If you are a member of the Settlement Class, your rights will be affected by the pending Action and the Settlement, and you may be entitled to share in the Settlement proceeds.
  • All questions about this notice, the Settlement, or your eligibility to participate in the Settlement should be directed to Lead Counsel or the Claims Administrator.

Glancy Prongay & Murray LLP Reminds Investors of Looming Deadline in the Class Action Lawsuit Against BioXcel Therapeutics, Inc. (BTAI)

Retrieved on: 
Tuesday, July 11, 2023
Class Action Lawsuit, Professional Services, Legal, Institutional review board, Record, Suite, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, Investment, Patient, Court, Defendant, FDA, Therapy, GPM, News, Agitation, Food, Safety, Cryptocurrency, Pharmaceutical industry

You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.

Key Points: 
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • The Company announced that the program consisted of two randomized, double-blind, placebo-controlled studies: TRANQUILITY II and TRANQUILITY III.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
  • To be a member of the class action you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the class action.

NodThera is first to demonstrate reduction in neuroinflammation in the clinic with brain penetrant NLRP3 inflammasome inhibitor

Retrieved on: 
Tuesday, July 11, 2023
Faculty, Central nervous system, MIT Department of Brain and Cognitive Sciences, AFL, Pharmacokinetics, C-reactive protein, NLRP3, Gliosis, Inflammation, Biomarker, Cerebrospinal fluid, CNS, Food and Drug Administration Amendments Act of 2007, Fibrinogen, CRP, Blood, CSF, Chemokine, Cytokine, FDA, Imperial College London, Food, Neurofilament, Medicine, Neuroinflammation, Dietary supplement, Pharmaceutical industry, Medical imaging

Alan Watt, Chief Executive Officer of NodThera, said: “Taken together, these initial findings represent the first unambiguous demonstration of modulation of neuroinflammation in a human population with an NLRP3 inflammasome inhibitor.

Key Points: 
  • Alan Watt, Chief Executive Officer of NodThera, said: “Taken together, these initial findings represent the first unambiguous demonstration of modulation of neuroinflammation in a human population with an NLRP3 inflammasome inhibitor.
  • Subjects in the study were cannulated and CSF-sampled on Day 1 (pre-dose) and Day 7 following daily NT-0796 dosing.
  • CSF drug levels were confirmed as consistent with previous observations and a range of inflammatory CSF biomarkers demonstrated meaningful reductions.
  • NfL is now recognised by the Food and Drug Administration (FDA) as a key biomarker of neuroaxonal damage and neurodegeneration.