Food and Drug Administration Amendments Act of 2007

CISCRP's Journey to Better Health Mobile Exhibit to Visit Philadelphia and Baltimore, September & October 2023

Retrieved on: 
Wednesday, August 9, 2023
Heart, RV, Partnership, Food and Drug Administration Amendments Act of 2007, Health equity, Journey, Research, Office of Minority Health, Information, City, FDA, Health literacy, Food, Medical device, Tourism, MD

BOSTON, Aug. 9, 2023 /PRNewswire-PRWeb/ -- The Center for Information and Study on Clinical Research Participation (CISCRP), a nonprofit organization dedicated to educating and informing the public about the clinical research process, was a recipient of an award by the Food and Drug Administration's Office of Minority Health and Health Equity (FDA OMHHE). The OMHHE innovation award will fund a grassroots pilot research project designed to offer and integrate educational programming and resources about clinical research into the heart of communities.

Key Points: 
  • The OMHHE innovation award will fund a grassroots pilot research project designed to offer and integrate educational programming and resources about clinical research into the heart of communities.
  • The research project seeks to identify practices that address some of the underlying issues of underrepresentation in clinical research through a coordinated, grassroots mobile community education and engagement campaign.
  • CISCRP – in partnership with patient communities and health literacy experts – has developed an educational exhibit within a mobile RV and will be visiting community events and festivals in the cities of Philadelphia, PA, and Baltimore, MD, this fall.
  • In September and October 2023, the Journey to Better Health mobile exhibit will be attending multiple events in both cities.

BIOXCEL THERAPEUTICS, INC. (NASDAQ: BTAI) DEADLINE 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.

Retrieved on: 
Tuesday, August 8, 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.

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

Retrieved on: 
Friday, August 4, 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

Merit Medical’s WRAPSODY™ Arteriovenous Access Efficacy (WAVE) Pivotal Study Completes Enrollment

Retrieved on: 
Thursday, August 3, 2023
Maintenance, Investigational device exemption, AVG, Bachelor of Medicine, Bachelor of Surgery, Ioctl, MMSI, AVG Technologies, Sale, Blood, Food and Drug Administration Amendments Act of 2007, FRCR, PMA, Data analysis, FSVM, WAVE, MD, Patient, Physician, Queen Elizabeth Hospital Birmingham, European, AV, United Kingdom, MRCP, Trial of the century, IDE, Occlusion, FDA, CIE, Queen Elizabeth Hospital, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, AVF, Arteriovenous fistula, Food, Safety, Pharmaceutical industry, Medical device, Merit

SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study.

Key Points: 
  • SOUTH JORDAN, Utah, Aug. 03, 2023 (GLOBE NEWSWIRE) -- Merit Medical Systems, Inc. (NASDAQ: MMSI), a leading global manufacturer and marketer of healthcare technology, today announced the completion of enrollment in its WRAPSODY Arteriovenous Access Efficacy (WAVE) pivotal study.
  • Creation and maintenance of an arteriovenous fistula or graft (AVF/AVG) to achieve long-term vascular access (access to blood vessels) is required for patients undergoing hemodialysis.
  • Merit intends to collect safety and efficacy outcomes throughout the study follow-up period.
  • Merit intends to follow patients enrolled in the WAVE study for 24 months following completion of enrollment.

Etiometry Gains FDA Clearance of AI-Based Algorithm that Alerts Risk of Hypercapnia for Neonates in Critical Care

Retrieved on: 
Tuesday, August 1, 2023
Cardiology, Data Management, Technology, FDA, Other Health, Health, Health Technology, Medical Devices, Software, Artificial Intelligence, Hospitals, Abstract, NICU, PCO2, Multimedia, Hypercapnia, Annals of Pediatric Cardiology, Congress, Food and Drug Administration Amendments Act of 2007, Patient, Risk, Picus, Digital, Nursing care plan, ICU, Intensive care unit, Environment, Food, Medical device, Nursing

View the full release here: https://www.businesswire.com/news/home/20230801099358/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230801099358/en/
    Etiometry’s IVCO2 Index™ alerts risk of hypercapnia in critical care patients.
  • This algorithm was recently FDA cleared for use on neonates.
  • Vigilant monitoring for hypercapnia is critical for maximizing neurodevelopmental outcomes and preventing complications in these fragile patients.
  • “The IVCO2 Index™ is a first-of-its-kind algorithm that increases the ability to detect hypercapnia risk without needing additional hardware attached to these fragile patients,” said Dimitar Baronov, CTO of Etiometry.

BTAI DEADLINE 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.

Retrieved on: 
Tuesday, August 1, 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)

Bernstein Liebhard LLP , a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).

Key Points: 
  • Bernstein Liebhard LLP , a nationally acclaimed investor rights law firm, reminds investors of the deadline to file a lead plaintiff motion in a securities class action lawsuit that has been filed on behalf of investors who purchased or acquired the securities of BioXcel Therapeutics, Inc. (“BioXcel” or the “Company”) (NASDAQ: BTAI) between December 15, 2021 and June 28, 2023, inclusive (the “Class Period”).
  • 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.
  • The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, (212) 779-1414.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against Seagate, Baxter, and BioXcel and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, August 1, 2023
Acceleration, P.C, Institutional review board, BIS, Shareholder, Office of Inspector General, U.S. Department of Health and Human Services, Face, Seagate Technology, Jordan Economic and Commerce Bureau, Software, Baxter International, Baxter, Policy, Record, EAR, Person, Seagate, Name, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, HDD, Patient, Nature, Defendant, United, FDA, Therapy, Entity List, News, NYSE, Agitation, Food, Safety, Commerce, U.S. Department of Commerce Office of Security, Cryptocurrency, Audit, Pharmaceutical industry, Huawei

Seagate Technology Holdings Plc (NASDAQ: STX)

Key Points: 
  • Seagate Technology Holdings Plc (NASDAQ: STX)
    Seagate is a leading global supplier of data storage products, including hard disk drives (“HDDs”).
  • Over the course of the Class Period, Baxter’s stock price declined by nearly 50%, eliminating billions of dollars in market capitalization.
  • BioXcel further disclosed that the fabricated email correspondence was provided to the FDA during an on-site inspection in December 2022.
  • For more information on the BioXcel class action go to: https://bespc.com/cases/BTAI

BIOXCEL ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against BioXcel Therapeutics, Inc. and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, July 28, 2023
Class Action Lawsuit, Professional Services, Legal, P.C, Institutional review board, Telephone, Jeanne Eagels, Record, Person, Nursing, Food and Drug Administration Amendments Act of 2007, Dementia, District court, Patient, Defendant, Court, FDA, Therapy, News, Agitation, Food, Safety, Pharmaceutical industry

Investors have until September 5, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until September 5, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On December 15, 2021, the Company announced that it had initiated a program to evaluate BXCL501 for the treatment of acute agitation associated with Alzheimer’s disease.
  • 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.

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

Retrieved on: 
Wednesday, July 26, 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

Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

Retrieved on: 
Wednesday, July 26, 2023
Infection, Tissue, Amputation, Surgeon, Vein, Life, Trauma, Leg, Artery, Cell, Trauma center, Sale, Regenerative medicine, Pain, Ischemia, Literature, Food and Drug Administration Amendments Act of 2007, Injury, Patient, Risk, HUMA, Level, Peripheral artery disease, FDA, HAV, BLA, Food, Caregiver, Pharmaceutical industry

DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase 2/3 vascular trauma trial (V005) that is expected to support a BLA filing for Humacyte’s HAV in vascular trauma repair. The HAV, an innovative regenerative medicine product candidate, is designed to provide surgeons with an off-the-shelf bioengineered human artery that has been observed to repopulate with the patient’s own cells to provide a durable, infection-resistant replacement for damaged and diseased arteries. The HAV has the potential to assist healthcare professionals in saving life and limb in some of the most difficult circumstances. The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.

Key Points: 
  • The results from the Phase 2/3 vascular trauma trial are intended to support a BLA filing with the Food and Drug Administration (FDA), planned for the fourth quarter 2023.
  • The V005 trial is a single-arm, open-label, pivotal study of patients suffering from vascular trauma injuries, conducted at Level 1 Trauma Centers in the U.S. and Israel.
  • Humacyte, the clinical trial sites, and contracted service providers are preparing for locking of the trial database in order to report the V005 results.
  • “The completion of the target enrollment in Humacyte’s Phase 2/3 vascular trauma trial is expected to enable BLA submission, and is another important landmark moment for our groundbreaking science.